Development of Standard Operating Procedures and Care Plans

Date First Published: January 9, 2015
Date Last Revised: July 16, 2020

“I think one’s feelings waste themselves in words; they ought all to be distilled into actions which bring results.”—Florence Nightingale

This article hopes to clarify some of the issues regarding the development and use of standardized plans in the delivery of patient care. The subject is complex both in breadth and depth and reading it may be quite daunting. There are repettitions and for some content details are spread over a few sections. I hope you will bear with me and persevere. The outline below may help in its understanding.

Layout of Article

INTRODUCTION

Currently, the need to regulate health services, streamline health care funding and ensure uniform quality of care is increasingly being realized worldwide and has resulted in wider acceptance of the use of standardized documented plans. In many instances, the initiatives are driven by the need to be accountable. Health care funders now determine, or at least influence, what goes into the management of cases belonging to a diagnostic related group (DRG) and fund services on the basis of case mix.

When used in manufacturing industries and other services, the SOP describes the plan for manufacturing a product or providing a particular service product. The product nearly always has specific characteristics (specifications) and rather rigid methods of producing it. The services provided in healthcare can still be consigned as service products. The difference is that the product characteristics and the methods of delivery are subject to many variations requiring customization and personalization.

Adoption of Standard Operating Procedures

The time has come to relate patient care practices to that of other industries in order to take advantage of innovations in the latter. Within the healthcare community, the design of the service for a typical patient with an episode of a specific illness is often called the ‘Plan for the Management of a Patient’. For all intends and purposes it can be made to be equivalent to the ‘Standard Operating Procedure (SOP) and there is no reason not to call it such. The SOP can be taken to be a detailed plan applicable to the delivery of service to typical patients with a typical disease condition (the service product) in a particular facility or organization. Almost invariably, customization of the SOP would be necessary when the actual care of an individual patient is provided.

PLANNING AS PART OF THE CARE PROCESS

Planning is part of the series of processes in the delivery of patient care (described in another article). It is a series of thought processes that are then documented. These consist of:

  1. Identifying the Objectives of Care
  2. Deciding and choosing the approach and methods
  3. Deciding on and scheduling the sequence and layout of actions
  4. Ensuring that resources are available to carry out the plan
  5. Assigning responsibilities
  6. Documenting the plan

ADOPTING STANDARD OPERATING PROCEDURE AS PATIENT CARE PLANS

The quality of any service is a measure of its ability to satisfy customer needs. Clinical services can be designed according to the needs of patient groups defined by the identified diagnosis or health problem. As in any other service, the design and planning of clinical care involves translating the needs of clients (patients) into uniform specifications and standards of both the service delivery itself and more importantly the final outcome of the service.

SOP/Care Plan as a DISEASE SPECIFIC SERVICE DELIVERY PLAN

Planning is a thought process that is part of the series of processes in the delivery of patient care. It can be performed in an ad hoc or formalized manner.

Obviously, the delivery of patient care is better planned rather than provided in an ad hoc manner. The delivery of the entire service to a patient with a particular health problem can be considered as a service product. Therefore, generic plans can be designed in advance by experts who have thorough understanding of clinical care processes and the modalities available for investigations, treatment and monitoring. Currently, these generic plans take the form of Practice Guidelines. Based on these more precise plans for more specific disease and patient groups can be deigned as Standard Operating Procedures, Care Protocols or Care Plans. A compilation of these plans can be made available for use by all care providers by the health care facility (after consensus, verification and authorization) .

he delivery of a healthcare service products is best described in the form of a Standard Operating Procedure (SOP) or otherwise be termed as the Care Plan. Both terms refer to the predicted or planned policies and procedures in managing a clinical problem. Its structure and content is similar to  the SOP used in other industries. Although it is common to depict the Care Plan as a table or matrix, this is not the best way to explain it. Tables limits the amount of content and do not show sequence and layout clearly.

Service products can be designed to cater for patient groups defined by their needs which in turn are determined largely by the identified diagnosis or health problem. If the patient has more than one health problem, then combination of the generic plans would be required.

USE OF STANDARD OPERATING PROCEDURES IN PATIENT CARE

The use in health care of the Standard Operating Procedure (SOP) as a term and as a method of standardization of production or service delivery  is not only possible but also imperative. ‘Care Plan’ as a term can be used if it it is more acceptable but the purpose, structure and content is similar. Henceforth in this discussion, the SOP and Care Plans are deemed to be synonymous and both terms will be used together abbreviated as SOP/Care Plans. In practice either term can be used.

The design of SOP/Care Plans in patient care, requires the use of many tools. Their content and structure should have the following characteristics:

  1. Describe an accepted way of managing a case
  2. Clarify objectives of care (expected outcome, therapeutic end points)
  3. Identify variations in patient needs and provide alternatives (Care pathway, Decision making steps)
  4. Outline the layout and sequence of tasks (Work schedule, Task lists)
  5. Allocate responsibilities (organization of the care team)
  6. Define the control limits of both processes and outcome (built-in Quality control)

BENEFITS OF THE USE OF STANDARD OPERATING PROCEDURES / CARE PLANS

From an operations management perspective, a documented SOP/Care Plan is used for the following purposes:

  1. Provide information, guidance and decision support
  2. Clarify objectives and targets
  3. Facilitate conformance to prescribed approaches and methods
  4. Be the standard/specifications for quality measurement and control
  5. Act as a guide for staff orientation and training

For the care provider, formalized planning of care, guided by pre-designed plans, provides many advantages including:

  1. Facilitate a more structured plan
  2. Ensure comprehensive content
  3. Encourage proper choice of investigations and treatment  (remove redundancy / duplication and wastage)
  4. Encourage better resource utilization
  5. Provide information and decision support (prompts and reminders)
  6. Give a clear picture of future actions
  7. Communicate intentions to the care team (shared objectives and understanding)

From a service or departmental managerial perspective, the use of SOPs/Care Plans can engender the following:

  1. Promote uniformity and standardization
  2. Render a degree of predictability in the supply of various resources
  3. Facilitate conformance by setting the standard or specifications for quality measurement and control
  4. Encourage equitable care and remove bias
  5. Improve staff knowledge, skills, attitude and behaviour

From the perspective of strategic management, SOPs provide the foundation based on which changes and improvements can be made and benefits evaluated. A clear example would be the re-engineering of processes when computerized information technology is introduced. Without documented SOPs, the current and earlier practices cannot be compared and it would not be possible to distinguish any improvement.

Therefore, an SOP (case management plan) for the care of a patient with a defined disease condition or health problem (a service product) confers benefits for health care providers, patients and health services managers.

Despite these benefits, the apprehensions regarding “cook-book” medicine and  loss of clinical freedom need to be attended to. These concerns are valid and should be addressed by building in variations, exceptions, alternatives and contingency plans into the design of the delivery of patient care. Even so, the SOP in patient care is a reference document to be used as a guide. It has to be converted to actual plans before being applied to real care.

DESIGN OF THE SOP/CARE PLAN

SOPs/Care plans are basically packages of tasks bundled together, arranged and sequenced according to the clinical workflow. The overall plan provides direction to the clinician on tasks to be performed for a patient from the beginning to the end of the care episode. It is then further broken up into sections for various phases of the care episode.
In current practice and literature there are many conceptions and formats that are called ‘Care Plans’ discussed in an earlier article. There is a need to develop a more effective alternative approach as proposed here.

GUIDING PHILOSOPHIES AND STRATEGIES IN THE DESIGN OF THE SOP/CARE PLAN

Some of the philosophy, principles and strategies that can guide the development of a SOP/Care Plan for patient care include:

  1. Application of modern management concepts and techniques
  2. Ensuring that the plan is feasible (usable) and acceptable to users
  3. Based on evidence-based medicine
  4. Imbued with the Total Patient Care concept (Holistic Care)
  5. Reflect a team approach (care through interdisciplinary involvement and collaboration)
  6. Incorporation of quality standards and quality control
  7. Cater for an enlightened patient, advocate empowerment and encourage self help
  8. Harness information technology

These principles and strategies are deliberated further below.

Application of Modern Management Concepts and Techniques

STRATEGY BASED ON “QUALITY BY DESIGN” CONCEPTS

The design of patient care service delivery is similar to the design of other service delivery systems as practised in modern quality management (as advocated by Juran). These involved a systematic sequence of steps i.e.:

  1. Identification of primary needs of the client (the health problem, diagnosis)
  2. Identification of additional / special needs based on specific client characteristics
  3. Setting the expected or desired outcome
  4. Clarifying the components of the service delivery system
  5. Delineating the sequence and layout of work flow (the Care Pathway)
  6. Clarifying and detailing the processes involved (the Work Procedure)
  7. Choosing the most appropriate technology/modalities to be used
  8. Assignment of responsibilities to service providers
  9. Identifying the monitoring and control measures (Monitoring, Review and Evaluation, Quality Control)
  10. Providing the means for data documentation (Clinical Documentation, Forms , Charts)
  11. Catering for variations, contingencies and damage control

The topic of Quality by Design is discussed in a separate article.

Use of the “PDCA CYCLE” During Development

The Shewhart-Deming PDCA Cycle is the most effective method of developing a plan that is effective and can be implemented. At the start, the strategy, methods and layout of implementation of the plan are thought out and documented (the Plan stage). Simulations, trial runs or pilot projects are carried out (the Do stage). Various quality measures of input, processes and output are measured (the Check stage). These are used to determine feasibility, productivity, efficiency, costs and most importantly, conformance of the outcome to the desired standards. Where shortcomings in the design are detected, changes or fine-tuning is done (the Amend stage). The design of the service delivery may be altered to ensure that outcome meets desired specifications. However, it may be necessary to make only minor changes to the service specifications to make the service delivery feasible. The cycle is repeated for every change made until a satisfactory plan is “Adopted”.

New Picture (64)
The “PDCA” Cycle

Once developed, the plans will act as the standard to be followed by everyone who manages a patient suffering from the disease or symptom complex, in the facilities within the organization. This approach to standardization should not, in any way, discourage practitioners from altering practices in peculiar situations and demands. Allowance for variations may be written into the plans.

PRACTICE OF EVIDENCE-BASED MEDICINE

The care provider is confronted with a myriad of possibilities when choosing strategies, methods, approaches, technologies and modalities for investigation and treatment. Their effectiveness, appropriateness, efficiency, cost-effectiveness and safety are difficult to ascertain. Yet, it is essential that the SOPs/Care Plans in healthcare are based on evidence as well as consensus. How policies and procedures can be derived from evidence, by taking advantage of tried and tested practices, is outlined diagrammatically below:

Care Plan 2
Evidence-based Practice of Medicine

The development of practice guidelines is a major step in attempting to identify and promote care approaches with proven efficacy and effectiveness (evidence-based medicine). These guidelines when available, provides the ideal basis for developing a system of care.

Transformation of Guidelines into SOP/Care Plan

Guidelines need to be transformed (operationalized) into plans that take into account the resources, environment and objectives of the organizations providing the service. There is a need to show that these plans are feasible and effective before being adopted and endorsed by the people in charge (e.g. Clinical Services Committee, Medical Advisory Committee, Clinical Governance Committee). For the SOP/Care Plan to remain valid it has to be continually updated. The best way is to audit the SOP/Care Plan both in terms of the adherence to them and also their effectiveness in achieving intended objectives. Findings from the audit is then used to improve conformance as wel as to rectify the SOP/Care Plan itself.

INCORPORATION OF THE TOTAL PATIENT CARE CONCEPT

For an SOP/Care Plan to be comprehensive, cohesive and orderly, the Total Patient Care Concept, philosophy and approach to patient care should be adopted. A comprehensive patient care plan based on this philosophy of holistic care addresses all aspects of the patient’s health issues for both the short-term as well as the long-term. The design of these SOP/Care Plans would require the contribution of all relevant health care professionals involved in the care of each class of patients. This can be achieved through the formation of Interdepartmental or Cross-Functional Teams. The SOP must be based on good evidence (e.g. Clinical Practice Guidelines) supplemented by knowledge and experiences of members of the team. (For details, please refer to the article entitled “The Total Patient Care Concept”).

This concept also calls for each care provider to:

  1. be interested in the overall well-being of the patient,
  2. understand the entire care plan,
  3. be able to respond to patient’s queries regarding each aspect of care
  4. contribute to the success of the plan, wherever possible

CONSTRUCTION OF THE SOP/CARE PLAN

Each SOP/Care Plan describes the plan for providing a specific service product (service for patients with a particular disease or health problem). It has enough breadth and depth to cater for the following functions:

  1. explain the theoretical basis for content and layout of care
  2. guide various decisions
  3. provide the essential knowledge and instructions to help the care provider give safe, effective and appropriate care.

Varied Nature of Clinical Patient Care as Service Products

In other industries the product of manufacturing or service delivery are well defined and so also the input and processes used. This is not so in healthcare. While care can be made uniform based on the patient’s disease, the needs of each patient varies quite significantly depending on many factors.

At first, the approach must be to design standardized plans that are generic in nature i.e. applicable to typical patients with a typical disease condition. They are used initially as a reference and are then customized/individualized before being applied to the actual care of an individual patient. If the patient has more than one health problem, then the application of a combination/amalgamation of the generic plans into one actual plan would be necessary.

Amalgamation of Generic Plans into a Single Actual Plan for an Patient with Multiple Problems

During the course of patient care, the amount and clarity of information available to the care provider increases and the diagnosis  becomes clearer or new problems emerge. If these changes are significant, another more relevant plan is chosen. If the change is minor then the plan is revised accordingly.

Factors to be considered in developing SOP/Care Plans

The following factors need to be considered in the development SOP/Care Plans:

  1. Identification of the Needs of the Patient (Primary Diagnosis and other Health Problems)
    • Disease complexity (type, pathological grade)
    • Severity Level
    • Stage of the disease
    • Effects and complications
  2. Care Objectives
    • Curative therapy
    • Containment therapy (by 2O or 3O Prevention)
    • Palliative therapy
  3. Clinical Care Processes
    • Information gathering
    • Deriving conclusions
    • Planning
    • Execution
    • Review (of diagnosis, objectives and plan)
  4. Phases of Care
    • Changes in the certainty and comprehensiveness of the diagnosis
    • Progress of the disease along its natural history
    • Stage of the workflow
    • Other emerging issues

Consideration for these factors are elaborated below.

IDENTIFICATION OF PRIMARY NEEDS OF THE CLIENT

Patients do not usually present to care-providers with readily identifiable health problems. Therefore, before a service is provided, care providers need to gather information, analyze them and identify the patient’s problems. Proper planning of care requires an understanding of the needs of the patient (defined as a person who is sick). The primary needs is identified through an accurate and comprehensive diagnosis. Besides the main illness the patient often has secondary needs arising from preexisting illnesses, disabilities and other health problems. These should also be addressed.

In other industries the product of manufacturing or outcome of service delivery are well defined and so also are the input and processes used. This is not so in healthcare. While care can be made uniform based on the patient’s disease, the needs of patient varies quite significantly depending on many factors. It would seem that there as many service products as there are diseases. These would have to be further broken further into more specific service products.

DESIGN BASED ON DIAGNOSIS OF PRESENT ILLNESS

During the course of patient care, the amount and clarity of information available to the care provider increases and the diagnosis  becomes clearer or new problems emerge. If these changes are significant, another more relevant plan is chosen. If the change is minor then the plan is revised accordingly.

A diagnosis is as accurate as the amount and quality of data available to the clinician. At the initial phase, only a broad or general diagnosis may be made but as more investigations and monitoring data are made available a more specific diagnosis is possible. The type of care provided must reflect this degree of accuracy in diagnosis. It must also be noted that management also depends on the variant of the disease and the stage in its natural history. Hence, categorization, staging, severity grading and risk stratification are important prerequisites before objectives of care are determined and the right care path and care plan is chosen. Interpreting the nature of the health problem inappropriately and therefore choosing an inappropriate plan would lead to dire consequences. Work flows, algorithms or care pathways are tools that can assist health care providers to make the right decisions and provide guidance towards accepted processes of care.

A discussion on Diagnosis is available in another article.The care plan for symptom complexes, syndromes contains mainly diagnostic investigations, symptomatic relief and supportive therapy where applicable. Later when the diagnosis is more definite, the plan for a specific disease entity incorporating definitive treatment, monitoring and rehabilitation is used. If the effectiveness of therapy comes into question, the reliability of the diagnosis need to be reviewed.

Care must necessarily change with changes in diagnosis; the plans must follow accordingly. In general, plans for a particular patient need to altered according to the changing levels of accuracy of the diagnosis.

Taking The Patients Health Status into Consideration

If complete care is to be given, consideration should be given not only to the current illness but also health status before the illness began:

  1. The general health in terms of nutrition, physical ability, physiological functions and psycho-social state
  2. The existence of Concurrent, Preexisting and Unresolved Previous illnesses
  3. The existence of disabilities, handicaps, deformities ( congenital or acquired)

The plan must therefore incorporate considerations of the Total Patient Care Concept mentioned previously.

DESIGN BASED ON CARE OBJECTIVES AND STANDARDS

At the outset of every phase of patient management, the care objectives is determined and clearly stated. Preferably, definitive treatment is started only when an accurate diagnosis is made but much can be offered to the patient in the interim.

The objectives of the service provided (care of the patient) should be determined and clearly stated at the outset and at every phase of patient management. While definitive treatment preferably should be started only when an accurate diagnosis is made, much can be offered to the patient in the interim.

There are three main treatment goals depending on the potential for altering the progress of the disease i.e. :

  1. Cure of the disease
  2. Containment (by 2O or 3O Prevention)
  3. Palliation of symptoms and deranged function

For a given illness, not all of the above objectives can be achieved. While many diseases are eminently curable, some can only be contained or their harmful effects mitigated. Yet others are inherently incurable or are too far advanced. When there is potential for cure or complete resolution of the disease process, the plan is directed towards achieving it. However when there is no possibility for cure, the plan offers other beneficial therapeutic options aimed at restoring functions, symptom relief and providing comfort. These three goals can be achieved the strategies that may contain all or some of the following types of therapeutic (treatment) approaches or modalities i.e.:

  1. Definitive
  2. Symptomatic
  3. Supportive
  4. Preventive
  5. Rehabilitative
  6. Promotive

Depending on the potential for altering the progress of the disease, the main treatment strategies/actions to be taken will include:

  1. Remove or lessen effects of illness (relief symptoms, provide comfort)
  2. Maintain, restore, or improve health status and physiological function (provide support)
  3. Avoid or minimize complications of treatment
  4. Cure the disease (if possible)
  5. Prevent deterioration or recurrence

When there is potential for cure or complete resolution of the disease process, the plan is directed towards achieving it. However when there is no possibility for cure, the plan offers other beneficial therapeutic options aimed at restoring functions, mitigating effects, symptom relief and providing comfort.

Each mode of therapy needs to be planned so that the optimal quality features of the outcome are achieved. These features include:

  1. Effectiveness
  2. Safety (including avoidance of unwanted effects)
  3. Appropriateness
  4. Efficiency (especially timeliness)
  5. Sustainability
  6. Acceptability
  7. Cost-effectiveness

Therefore, setting objectives includes specifying standards of the final and also the intermediate outcomes of care, based on the desired quality features. By considering patients as clients, due attention is also given to the restoration or amelioration of the disrupted quality of life (ability to work, enjoy leisure, attend school and perform daily life activities) as the objectives of care.

Different treatment modalities pose different requisites. Plans need to take into consideration:

  1. the conditions required to ensure its success
  2. the prevention of adverse effects
  3. the steps to be taken when complications occur

DESIGN BASED ON CLINICAL WORK PROCESSES

The SOP/Care Plans must be fashioned according to sequence and content of clinical work processes

Hence the development of effective management plans requires a thorough understanding of clinical work processes. This generic set of tasks, their layout and direction is used by all clinical care providers including doctors, nurses, and allied health personnel.

Care Plan 9
Procedure and Processes

A comprehensive outline of clinical care processes applicable to all cases is shown below as a workflow chart:

The Generic Clinical Process Algorithm

Clinical care Algorithm

The priority and sequence of treatment (the workflow or process layout) will depend very much on the type, severity, progress and effects of the illness.

CHANGE IN PLAN WITH THE PHASE OF CARE

Plans are revised frequently based on the ever-changing changing needs (daily or more frequently in the case of acute illness and at almost every visit in chronic illness).

After selecting a plan based on the initial diagnosis, the care provider may alter or revise the plan based on:

  1. Changes in the understanding of the illness affecting the patient (the certainty and comprehensiveness of the diagnosis )
  2. Evolution of the disease along its natural history
  3. Advancement of the clinical process workflow
  4. Other emerging issues

Variation of the Plan Based on Changes in the Characteristics and Behaviour of the Illness

The characteristics and behaviour of a disease varies with each occurrence. Its progress may be typical or atypical. It may become better or worse. The care provider changes the plan to cope with these variations. Usually, the work flow advances as and when all tasks are completed. Although the process of care is continuous, it is convenient to divide the care into periods or phases. The phases of care of both acute and also chronic diseases are categorized into:

  1. Phase of diagnosis, stabilization and immediate care
  2. Phase of initiation and optimization of therapy
  3. Phase of maintenance of therapy, re-evaluation and modification
  4. Phase discontinuation of therapy following resolution of illness

The phases and the processes that make up the content of each phase is as shown below:

Change in the Flow of the Clinical Process

There are instances when the workflow cannot progress according to the initial plan due to various impediments or circumstances. At times the process e.g. information gathering, investigations or procures have to be repeated or abandoned. In those cases or if the prescribed treatment plan is ineffective, unacceptable or unsafe for the patient, an alternative approach or modality is used. Non-compliance by care providers or patients is also a factor that affects the progress of the workflow as well as the success in achieving the desired outcome.

The decision-making process that guides the necessity to change the Care Plan is depicted below:

Decision Making Steps in Altering the care Plan

Plans are also modified or revised if various other emerging needs appear. If pre-designed plans are not available then the care provider needs to devise the various plans him/herself. Hence, it is necessary to design and put together a comprehensive library of Care Plans to cater for certain periods/phases or scenarios in the care of a patient for each illness or health problem.

A care episode is defined as the period within which the entire care of the particular disease or health problem, affecting a patient, takes place i.e. beginning with the time of first contact with a health care practitioner to resolution of the illness/problem or death of the patient. In that episode, the patient may make several visits and during each visit. He/she may have encounters with many health care providers and may be subjected to many care events and experience various incidents.

Change of Plan with Advancing Phases of Care

ALTERNATIVES, VARIATIONS, OPTIONS AND CONTINGENCIES

CARE PLAN FOR AN ENTIRE EPISODE

The Need to Revise Plans with Changing Diagnosis  and Phases during a Care Episode

When the diagnosis is uncertain the plan for the whole care episode cannot be very definite.  The care provider can put up a plan only for the initial stage. When the diagnosis is clearer, the broad overall plan of care can be determined. Even then, because the workflow may take variable paths, only an outline of the latter stages can be stated. Once a definitive diagnosis is made and the appropriate treatment regimen is known, then the care for the rest of episode may be planned.

All in all, the plan for the entire care episode is described in the Standard Operating Procedure which should be referred to but in the medical record, a brief statement will suffice, e.g. “to treat patient as case of Acute Coronary Syndrome

MATCHING PLANS WITH VISITS AND SERVICE DELIVERY SETTINGS

The health care provider delivers care at encounters with the patient, usually during a visit i.e. when the patient comes to the health care facility (or are visited by health care provider). The type of visit and the service setting deemed suitable depends on the nature of the illness. For example a patient on an outpatient follow-up may have to be admitted for in-patient care if certain complications occur. For practical reasons and convenience, service managers schedule visits to coincide with the anticipated change-over from one phase to the next. As such, tasks to be performed and other events that the patient will experience or likely to happen is known to the care providers looking after the patient and the patient alike. The arrival for a visit may trigger a plan. However, the decision to execute the plan is made only if the patient’s status allows for or warrants the change-over. 

The care plans for the First visit is quite different from that for the Follow-up visit because at the very first visit the diagnosis is usually uncertain, while at subsequent visits, the diagnosis is more definite. Also, at later visits some part of the care process has been completed; plans need to be made only for the remainder.

Service delivery may be provided in various settings including:

  1. Outpatient visit
  2. Emergency visit
  3. Inpatient visit
  4. Day Care visit
  5. Home Care visit
  6. Teleconsultation visit
  7. Self-care

The most appropriate setting for a particular phase of care can can also be decided in advance. Decisions to start, continue or abandon plans are dependent on the data available. In inpatient care, the data available are results of clinical reassessment,  monitoring data and routine investigations. For outpatient care, these data can be made available by asking patients to come for a preliminary visit when investigations and other assessment are performed. As part of sel-care, patients may also submit records of symptom characteristics and measurements they make themselves (B.P., Temperature, Blood sugar level etc.).

However, there are situations where the transition in the plan is predictable such that a change-over of the plan can be initiated as and when the visit takes place. A good example is the care plan for the care of a patient with normal pregnancy  or a patient  undergoing Knee Replacement surgery.

The difference in settings do not significantly change the clinical content of the Care Plans but impinges mainly on administrative processes, workflow and use of resources.

PLANNING THE FREQUENCY AND DURATION OF VISITS

The extent of each phase, is a variable period. It can span a duration of mere minutes or can stretch across encounters and visits. Case managers or the primary provider set the frequency of encounters and visits based on the patient’s expected response. The number of visits per episode is by nature variable but may be intentionally fixed in a service package. A visit requires one or more identified physical resources such as room/bed within a clinic complex or ward. During the visit, the patient may have one or more encounters with different care providers using the same or different resource. The duration of each encounter is defined as time slots. All these need to be planned. In a computerized HIS, this planning is done using the scheduling and resource allocation application.

Example: Care Plan for Patient with Severe Osteoarthritis Admitted for Unilateral Knee Replacement

Task Lists

Care providers may then create their own task lists based on their role. In a computerized environment, these task lists are automatically generated but can still be amended to vary the urgency,  frequency, duration, location and assignment. The next step is to perform the tasks hence executing the plan.

CONSTRUCTING THE SOP/CARE PLAN

Operating procedures are tasks to be performed to produce a product or to offer a service (a service product). For them to be standardized, they need to be documented in a structured way. There should be an SOP for a service product. However, alternatives due to variations in the disease or the patient profile can be written in within the same SOP.

Plans must take into consideration the resources, environment and goals of the organization providing the service. There is a need to demonstrate that these plans are feasible and effective  through trial or pilot studies. Before being adopted it should be verified by the persons/committee responsible for Clinical Governance and formally endorsed by the executive body of the organization.

DIFFERENCES BETWEEN IMPLEMENTING SOP IN CLINICAL CARE AS COMPARED TO OTHER SERVICES

In manufacturing businesses, SOPs are developed for the production of a product with strict specifications. In service delivery, the service product has uniform general specifications but its delivery must be customized based on special needs of the recipient. Some of these customization can be anticipated and variations an be written for this particular group as part of the SOP.

In clinical patient care, besides the above approach, this customization must take into account the peculiar needs of a particular person. This personalisation must be done not only at the beginning of the service but also also throughout the service delivery period because the needs usually varies as the care and the disease progresses.

When using a standardized care plan as a guide, the planning process is done in two major steps i.e.:

  1. Choosing the appropriate the  Reference  (Model) Plan from the library of pre-prepared care plans
  2. Converting the chosen plan into an Actual (Operations) Plan by customizing it to cater for the special needs of the patient

Concept of Reference vs Actual SOP/Care Plan

Plans are also modified or revised if various other emerging needs appear. If pre-designed plans are not available then the care provider needs to devise the various plans him/herself. Hence, it is necessary to design and put together a comprehensive library of Care Plans to cater for certain periods/phases or scenarios in the care of a patient for each illness or health problem.

The Reference Plan is selected from a comprehensive library of documented plans provided (by whatever means). The Actual Plan is derived from the Reference Plan. When documented, it will becomes part of the Medical Record.

Reference Care Plan

Care Plans are designed mainly on the basis of diagnosis. The diagnosis is broad or general at the initial phase o care. At subsequent phases as more investigations and monitoring data are available, a more specific diagnosis is possible. Care plans must also change to reflect the type of care required for this improved degree of accuracy in diagnosis. Hence, appropriate care plans based on the variant of the disease, the stage of its natural history, categorization, staging, severity grading and risk stratification must be developed and made available. Standardized plans are generic in nature i.e. applicable to patients with a typical disease condition. They are used as a reference and are customized  before being applied to the actual care of an individual patient. If the patient has more than one health problem, then combination of the generic plans would be necessary.

The primary provider chooses a care plan that matches the diagnosis made from a library of Care Plans made available to him/her. 

Choosing a Model Plan from a Library of Reference Care Plans

Actual Care Plan

Standard plans cannot satisfy a patient’s needs fully. Besides the  attention to the illness and its effects, care plans also need to consider the general needs of the patient (i.e. a sick person). This is often unique. The care provider uses his/her own special knowledge, skills and discretion to modify the chosen plan that matches the needs of the individual patient.Patient care plans need to be individualized and customized by the care provider by synthesizing all available information, choosing the most relevant plans, combining them and adding or omitting certain options. The resultant plan is then the Actual care Plan to be implemented. 

The care provider uses his/her own special knowledge, skills and discretion to choose and modify the plan that matches the needs of the individual patient. He/she then ensures that the plan is carried out. The desired outcomes are monitored and if necessary the plan is rectified based on the response and outcome achieved.

He/she then ensures that the plan is carried out. The desired outcomes are monitored and if necessary the plan is rectified based on the response and outcome achieved.

This plan is then  communicated to other care providers by documenting it in the medical record or the Clinical Information System. Since the care of a patient is a multidisciplinary effort, each care provider has the opportunity to put into effect (operationalise) the part of the plan in their area of expertise during their encounter with the patient. They may modify their portion of the plans when needs arise. Yet, there should be consultation with other members of the care team. The patient also needs to be aware of the plan, be allowed to make queries and be involved in it.

CHOOSING THE APPROPRIATE REFERENCE PLAN

At the initial phase, only a broad or general diagnosis is made but as more investigations and monitoring data are available, a more specific diagnosis is possible. The type of care provided reflects this degree of accuracy in diagnosis, the variant of the disease and the stage of its natural history. Through categorization, staging, severity grading and risk stratification, the more appropriate care path and care plan is chosen.

Different Types of Plans

COMPONENTS OF STANDARD OPERATING PROCEDURE/CARE PLAN

SOPs/Care Plans are compiled, indexed and kept as a set of reference documents (referred to as the Work Procedure Manual) and made accessible to care providers. The documents consist of various components that address various aspects of care. The components mirror those in Standard Operating Procedures already in use in other industries and are outlined below:

Care Plan 4
Content of SOP

With training, the nomenclature and conventions used in operations management in other industries can be understood and adopted for use, just as effectively, by clinicians. This would allow people in other fields such as information technology, accounting and management to understand clinical care processes. The documents making up the SOP for a specific disease are discussed immediately below. A more detailed discussion of some of them is given later.

STRUCTURE AND CONTENT OF THE SOP

Standard Operating Procedures are descriptions of how work is to be carried out. Each comprises many specific components. Care Pathways and Care Plans can be fashioned to be Standard Operating Procedure. The SOP should contain:The components include:

  1. A title defining the service product that the plan is designed for.
  2. Description of the Service product.
  3. Care objectives including the quality features of the service and outcome standards (equivalent to quality objectives in ISO quality management system)
  4. Description of the Clinical Work Processes involved
    • Textual (narrative) description of the various work processes detailing layout, the input, technology to be used, assignment of responsibility  and expected intermediate outcome.
    • Operational policies defining constraints within which procedures are to be carried out
    • Work Flow Charts or Care Pathways (the ‘flow’ of the procedure depicted graphically)
  5. Specific Work Instructions or Protocols
  6. The Work schedule and Task lists
  7. Guide to use of charts or forms to be used as part of the work process
  8. Reference tables or lists (normal values, regimens, drug dosages etc)
  9. Quality Control Methods (Standards, Check-lists etc. i.e. equivalent to quality procedures in quality a management system)

TITLE: THE SERVICE PRODUCT

To clinicians, the ‘care’ or ‘the management of a patient’ is the provision of the entire service or care for a certain patient group according to their needs which are determined largely on the identified diagnosis or health problem. The title of the SOP/Care Plan should show that it is designed for the ‘care’ of this specific disease or health problem. As such, the Service product consists of a well-defined set of services to be provided for a typical patient (case) who has an episode of a specific illness. Yet it is, to a certain extent, still generic and would need customization, by additions or omissions, when it is used in the actual care of an individual patient.

Description of the Service Product

Following the title, what the service is for and what is contains is described briefly.

The examples below, illustrates two main service products Care of a Patient with Bronchial Asthma and Care of a Patient with Intertrochanteric Fracture of the Femur. How the service is further refined is as shown below:

Types of Service Products

In the case of Bronchial Asthma, the service can be differentiated into more refined products based on acuity of onset/urgency and then further into types based on severity levels. The care for Acute vs Chronic Asthma follow quite different approaches. Some of drugs are used for all types but a few will be used only in certain types.
In the case of Intertrochanteric Fracture of the Femur, variations the service products being offered will have different characteristics to suit the different requirements necessitated by degree of fragmentation and displacement. While the main service will contain the service elements of managing a fracture the main difference for the various types will be in the surgical treatment.

OBJECTIVES OF CARE

A statement defining the objectives of care is essential for every SOP. These may include:

  1. expected outcome,
  2. treatment end points
  3. the intended degree of restoration or amelioration of the disrupted quality of life (ability to: work, enjoy leisure, attend school and do daily life activities)
  4. avoidance of side effects or complications of treatment

It should declare the quality policy about the service being offered i.e. a statement of targets, limits and standards with regard to quality.

DESCRIPTION OF CLINICAL WORK PROCESSES

In an SOP, the Clinical Work Processes are presented in two forms i.e.

  1. A textual description (narrative)
  2. A work-flow chart

WORK FLOW/CLINICAL CARE PATHWAY

Clinical pathway is another term for work flow and algorithms when it is used in patient-care activities. They can be used interchangeably. They are the predicted or planned series of sequential work processes in managing a clinical problem. They provide the mechanism to incorporate alternatives and variations. A ‘critical’ pathway contains only the critical (important, required) steps or processes with the obvious (mundane) steps left out in the documentation (but not in practice). The term pathway has been incorrectly used to describe care plans. If the term care pathway is to be used at all it should be synonymous with Work Flow. The care pathway acts as the foundation upon which care plans are developed ultimately. It is an essential component of a documented SOP.

The path/flow of how the service is given is described textually and depicted graphically as a chart using the generic clinical work flow, described earlier, as the basis. An example is shown below:

Clinical Care Pathway for Care of a Polytraumatized Patient

The care pathway (work flow)  illustrates:

  1. the sequence of the processes
  2. the process layout (simultaneous, contingent on completion of the previous step or iterative)
  3. the decision-making steps that lead to alternative paths or variations

It is good to draw an outline of the procedures (the critical pathway) to show the entire scope of the service. It is not necessary to depict the entire pathway completely on one page as it maybe quite long. Instead, deviations and variations can be written separately and links/references made to the main document.

DETAILED TEXTUAL DESCRIPTION OF THE WORK PROCESSES

The whole work procedure needs to be described in text format. In general, the description takes the form of a sequential list of instructions on how to perform processes. At the same time the direction, input, technology to be used, persons assigned to perform the task and the expected intermediate outcome are specified. The operational policies that guide and constraint these processes, such as indications and contra-indications, alternatives, allowable variations and contingency plans, rules and criteria, are also embedded.

The sequence, direction and layout of processes or tasks that makes up a procedure must be described clearly and in detail. It is best written before or at the same time as the chart is being drawn. In a general sense, the textual description explains each workflow symbol (boxes, arrows etc.) but more importantly, it states the specifications and standards of the care process as well as the operational policies that govern them. Therefore, it is the principal component of the SOP/Care Plan.

The main tasks listed below need to be elaborated.

  1. Acquisition and documentation of clinical data (Initial Assessment, Progress Notes)
  2. Acquisition and documentation of data obtained from various investigations
  3. Analysis and interpretation of available clinical data
  4. Deriving conclusions regarding the patient’s health problems (the diagnosis) and documenting it (including severity grading, staging)
  5. Monitoring and charting of clinical parameters (Observations, serial measurements )
  6. Planning management and documenting it (with decision support)
  7. Implementation of plans: Placing orders and carrying out tasks (Performing Investigations, treatment, administering drugs)
  8. Documentation of results, procedures performed, findings, and outcome
    • Results review and interpretation
    • Quality Control Procedures (e.g. check lists)
    • Progress review, assessment of outcomes
    • Communications (Referral Notes, Replies), requests and orders
    • Summaries

OPERATIONAL POLICIES

At the operations level (i.e. when work is performed), the general policies of the institution or service unit are translated into operational policies which define goals or objectives as well as the limits within which tasks or processes are performed. These limits (rules, regulations, targets and standards) may relate to efficiency, quality, costs, responsibilities, preferences and exceptions. Operational policies are embedded within the work procedure (see above).

Example of Textual Description of the Work Processes and Operational Policies

Management of Case of Bronchial Asthma at First Follow-up Visit
01. Take history of frequency of exacerbation, limitation of activity & night-time symptoms
02. Examine patient
03. Perform PEFR
04. Assess response according to these criteria:

  1. frequency of exacerbation,
  2. limitation of activity,
  3. night-time symptoms and
  4. PEFR

05. If response is not satisfactory; review patient’s compliance to medication & advice. If the poor response is due to poor compliance then, continue the previous treatment and more effort is made to educate patient on the disease, treatment methods and need for compliance.
06. If compliance is not deemed as a problem then, consider the possibility of the need to re-assign patient to a higher severity class. The medication need to be stepped up accordingly (refer treatment chart).
07. Give explanation regarding the new added medication and further education on use of bronchodilator, use of PEFR meter and self-monitoring chart
08. End the visit and give the patient an appointment date for a follow-up visit in 1 month.

THE WORK SCHEDULE

The activities (processes, tasks) within the SOP is broken down into sets relevant for particular scheduled periods or phases of care. This is the schedule of implementation of the SOP/Care Plan and it contains:

  1. a title indicating the purpose for which it is used i.e. the health problem, the phase of care and any other indication
  2. objectives and expected outcome
  3. a list of all tasks grouped according to the method or technique or the professional competency

Care plans/SOP remains as a reference document until it is converted into an actual plan by customizing it for the individual patient.

It is helpful to present the overall schedule of the plan for the care episode as an outline in the form of a table.  Details are not presented in this overall plan but  would be written in the discrete plans for different phases or context of care.

Care Schedule or Care Matrix for the Whole Care Episode

Relationship between Diagnosis, Phases of Care and Care Plans

Criteria for Dividing the Care Episode into Different Phases of Care

Care Episode fora Specific Health Problem

Example of Series of Care Plans for Different Phases of Care (Plan for Acute Myocardial Infarct)

Modules by Phases
Plans at Different Levels of Diagnostic Certainty

The development and design of  Care Plans are described in detail below.

Multi Patient Task List View

The care set for a particular patient will consist of all or some of patient care processes. It may also include clinical administration tasks. For inpatients, these can be admission, referrals, transfer and discharge. For outpatients, these can be visit registration, follow up appointment, referral and discontinuation of visits.

ORDER SETS (CARE PACKAGE, CARE-SET, CARE-BUNDLE)

WORK INSTRUCTIONS OR PROTOCOLS

Work Instructions or Protocols provide further details on how certain processes are to be carried out. They are predetermined didactic reusable instructions for performing a certain specific task or process as prescribed or endorsed by the organization. They are usually instructions describing how to:

  1. perform of-repeated routine tasks (insert a CV line, catheterize a patient, take a blood specimen, take consent etc.)
  2. document (use of standard forms or charts, ),
  3. operate machines (user manual),
  4. use instruments,
  5. use chemicals (safely and effectively),
  6. order items (food, drugs, blood etc.)
  7. serve or administer drugs,
  8. transfuse blood or other infusions
  9. other specific tasks

Reference tables or lists may become part of this work instruction.
Since a work instructions would be performed in a similar manner at any time, location or for any indication, they may be compiled separately as an addendum to the SOP or kept in separate manuals/folders and only referred to if required. In a computerized system they can be reached through hyperlinks.

QUALITY PROCEDURE

This section addresses quality control and quality improvement activities. The quality procedure describes the steps to be taken to evaluate conformance to process specifications and outcome standards. Major parts of it are:

  1. measurement of a quality characteristic
  2. comparing with a set standard
  3. determining conformance
  4. improvement methods

It may be incorporated in the work procedure or written as a separate document (as per ISO 9002:2000 QMS standards).

GUIDE ON DOCUMENTATION (USE OF FORMS OR CHARTS)

 Relationship between Plan, Performance and Documentation

Pertinent data that is generated as results of tasks or processes must be recorded in standardized forms. In the SOP, guides are given on the use of various data documentation forms or charts used by the organization. Documentation forms should anticipate the data generated by the tasks within the SOP/Care Plan. In addition, the forms/charts also provide prompts/reminders for the care provider to perform certain tasks to obtain the data. Thus, the form itself acts as a decision support instrument

PROVISION OF CLINICAL DECISION SUPPORT

Clinical care is a knowledge driven and information dependent activity. Modern clinical practice must be re-engineered to take advantage of the advancement in knowledge and practice of clinical sciences, management science, and information and communications technology. Clinical Decision Support is the provision of guidance and knowledge at the point of care. It is an integral part of the SOP/Care Plan.

Clinical decision support is envisaged not as something separate but as built-in functions within the whole patient care. It is applied through several mechanisms:

  1. Guide to the data that must be gathered and captured
  2. Guide to making a diagnosis (diagnostic criteria)
  3. Provision and matching of care plans for various categories of patients
  4. Manual / Computerized analysis and interpretation of results (normal, abnormal, scoring, stratification, grading, staging, comparison with standards for quality control)
  5. Provision of guides, instructions, alerts, prompts, reminders and suggestions,
    • before or during the performance of certain procedures
    • In response to certain situations, occurrences, incidents, non-conformance and abnormalities
    • indications and contraindications in use of a modality

SUPPORTIVE REFERENCE DOCUMENTS

The SOP should contain reference documents that care providers can refer to when performing their tasks. The information provided should be endorsed officially by the organization . Examples of these include

  1. table of normal values,
  2. percentile charts,
  3. dosage regimens, food menu,
  4. expected / control limits, standards, specifications,
  5. regimens, recommended drug dosages and charges.
  6. lists of drugs (official drug formulary)
  7. glossary of terms ,
  8. diagnoses terminology,
  9. charge codes.
Care Plan 7
Care Process with Decision Support through Reference Documents

INDICATIONS AND CONTRAINDICATIONS FOR USE OF A MODALITY

DIAGNOSTIC CRITERIA

A diagnosis is made by interpreting certain variables including signs, symptoms, the results of clinical tests, investigation findings (laboratory, imaging, and endoscopy), monitoring parameters, clinical progress and response to treatment. Through research and experience, the medical profession has identified sets of variables that predict a diagnosis i.e. the ‘diagnostic criteria’. This knowledge can be presented (as decision support) to care providers to aid them in making a diagnosis. In certain instances, especially when a scoring system is used, these predictions have a high level of accuracy. However, a rough guide can be also of use to the clinician.

RISK STRATIFICATION / SEVERITY GRADING / STAGING

Having made the diagnosis the clinician needs to clarify further:

  1. which variant of the illness is affecting the patient
  2. which stage of the natural history of the illness has been reached
  3. what complications has accompanied the disease
  4. how the patient has responded to the disease

The clinician categorizes his/her patient according to possible risks, severity of illness, stage of development and therefore prognosis. Categorization in turn allows the clinician to choose the right pathway and start an appropriate care plan. As such, grading and scoring systems for various diseases should be adopted for each disease and the care plan should have variations for different severity levels, stages and grades.

INDICATIONS AND CONTRAINDICATIONS FOR USE OF A MODALITY

Investigation and treatment modalities, however efficacious, have limitations such as unwanted side effects and interactions. They may not be effective in certain situations or when prerequisites are not met. Care providers need to be reminded of these indications and contraindications as part of the decision-making process.

ALTERNATIVES, VARIATIONS, OPTIONS AND CONTINGENCIES

SOPs are often criticized for being rigid and didactic. In fact, by offering different directions and paths, the SOP/Care Plans offer alternatives in managing a patient based on various valid criteria. SOPs /Care plans are designed to suit different anticipated scenarios (see below). Where there is a choice of methods or material without major difference in effectiveness or safety, the care provider is given an option to choose one based on being the best suited or available. Indeed, the care provider may choose to modify  procedures and plans as long as these do not deviate from core policies and  the variance (intentional or otherwise) should be noted.

DETAILED DESCRIPTION OF THE CARE PLAN

Based on the lessons learned from the Care Plans in use up to now, it can be deduced that there are two different functions of the Care Plan, facilitated by two different entities i.e.:

  • Reference Care Plan ( a document which acts as a guide)
  • Actual Care Plan (steps to be taken to care for the particular patient)

USE OF THE REFERENCE PLAN

The Reference Care Plan is a guide that contains the following :

  1. A title defining the service to be given
  2. The intended objective and expected outcome
  3. Lists of tasks to be performed arranged in segments, grouped according to the purpose of the clinical care processes to be performed.

The Title

The title is a very concise statement indicating the patient type, the diagnosis or indication and the context such as the phase of care, the service delivery setting where the service is to be given (inpatient, outpatient and day care) and the type visit or encounter.

The title of the Care Plan indicates that it is designed for the specific disease or health problem and for a particular phase.  The model plan is generic in application. Conversion of such plans is done when the actual care of an individual patient is provided.

The Objectives and Expected Outcome

The intended objective and expected outcome is precisely indicated. These may be the expected outcome, treatment end points, the degree of restoration or amelioration of the disrupted quality of life (ability to work, enjoy leisure, attend school and perform daily life activities) and avoidance of side effects. Details such as targets, limits and standards are understood by reference to the SOP.

Lists of Tasks

The list of tasks are grouped into functional categories i.e.:

  1. Administrative tasks (Admission, Referrals, Transfer and Discharge, visit registration, follow up appointment, referral and discontinuation of visits.)
  2. Clinical Data Gathering Tasks  (Clerking or Assessment, Progress reviews)
  3. Investigations
  4. Monitoring tasks
  5. Treatment divided further based on modalities such as therapeutic procedures, medication to be supplied or administered, blood product supply and transfusion

USE OF THE REFERENCE PLAN

The Reference Care Plan is a guide that contains the following :

  1. A title defining the service to be given
  2. The intended objective and expected outcome
  3. Lists of tasks to be performed arranged in segments, grouped according to the purpose of the clinical care processes to be performed. The segments or groups include:

The title is a very concise statement indicating the patient type, the diagnosis or indication and the the context such as the phase of care, the service delivery setting where the service is to be given (inpatient, outpatient and day care) and the type visit or encounter.

The first entity is a generic plan provided as a guide to care providers to develop the second entity. If the guide is on paper (e.g. a booklet), the provider may transcribe parts of it on the case notes (paper record). If it is made available on a personal computer, then the guide can be copy-pasted and modified before being printed. The printed copy is then incorporated as part of the medical record. This reduces the extra work.The Actual Care Plan is a statement of intent delineating the objectives (outcome) and the intended sets of tasks to be performed. The record of events, tasks performed and outcome reached should not be recorded together with the plan. Instead the results obtained are documented as progress review notes, monitoring charts, procedure records, findings, outcome etc. In a completely computerized system, the issue of the need to replicate data entry does not arise because the reference plan can be accessed from a central repository as and when need. Computer software can be used to convert prescribed plans into actual plans and then into tasks to be executed. Data regarding compliance and outcome can be entered and stored in a database it can be retrieved and displayed as a report.
In this proposal, the details in the conventional Care Plan is made available in the SOP. The Care Plan itself takes on the characteristics and functions of a Work Schedule or Action Plan.

SOPtoPlan
From SOP to Care Plan

Relationship Between SOP, Reference Care Plan and Actual Care Plan

 Changes in Service Characteristics with the Context of Care

The other issue, brought into focus by Example C, is the fact that in practice the operational plan is ever-changing, evolving with changes in the patient’s condition and the work process.

Each plan needs to be fashioned according to the pertinent context in response to :

  1. the evolving diagnosis: from when the diagnosis is uncertain or provisional (symptom complex, syndrome, disease group) to when the diagnosis is certain definite (specific illness and specific procedure).
  2. phase of the workflow
  3. other changes e.g.  response to treatment, occurrence of certain complications or events, chosen treatment modality etc.

Catering for the Evolving Diagnosis

The principal criteria defining the need to vary care plans is the evolving nature of diagnosis. It is clear that  separate Care Plans need to be developed for at least two levels based on the clarity of the diagnosis:

  1. The Provisional Diagnosis:
  2. The Definitive Diagnosis:

Symptom complexes & clinical syndromes

incorporating efforts at:

  1. Clarification of diagnosis,
  2. Resuscitation, stabilization
  3. Immediate nursing care

Specific disease entity which give rise to further stages or phases

  1. Phase of initiation and optimization of therapy
  2. Phase of maintenance of therapy, monitoring and re-assessment
  3. Phase of resolution of illness and discontinuation of therapy
PlanPhaseDiagnosis
Plan According to Diagnosis and Phases of Care

Two Main Phases of the Care Episode Based on Clarity of Diagnosis

Even when the definitive diagnosis is known and a specific care plan is applied, modifications need to be made constantly based on variables such as:

  1. changes in the patient’s condition in accordance with the stages of the disease process
  2. the workflow or the treatment regimen
  3. demands arising from the patient’s response and other effects of therapy

Catering for the Advancing Workflow

Even though the content of care vary continuously with the changes in needs, for practical purposes it is convenient to design Reference Care Plans according to defined periods or phases. The care episode may be divided into phases as illustrated below:

Phase of Care
Phase of Care

Outline of the Care Episode

A care episode is defined as the period within which the management of one particular disease or health problem affecting a patient takes place i.e. beginning with the time of first contact with a health care practitioner to resolution of the illness / problem or death of the patient. In that episode, the patient may make several visits and during each visit, he or she may experience encounters with many health care providers and may experience or be subjected to many care events. Conceptually, patient care is provided in phases corresponding to the sequence of processes (workflow) described in the article on clinical work processes.

Discrete Care Plans for Different Phases

Care plans can be designed for each phase of care. During each phase, the patient makes a certain number visits to the health care facility. The number and type of visit depends on the nature of the illness. Also depending on the patient’s response, the care provider may add or reduce the number of visits. The phases of care of both acute and also chronic diseases can be categorized into:

  1. Phase of diagnosis, stabilization and immediate care
  2. Phase of initiation and optimization of therapy
  3. Phase of maintenance of therapy, monitoring and re-assessment
  4. Phase of resolution of illness and discontinuation of therapy

Catering for the other Changes

Care plans also need to vary with other changes including:

  1. response to treatment,
  2. occurrence of certain complications or events
  3. chosen treatment modality etc.

The choice of alternative plans or modifications of existing  plans is at the discretion of care providers

For patient’s receiving acute care (usually in the inpatient setting), the actual plan need to reviewed almost daily or more frequently depending on the nature of the illness and the treatment modality. In the management of chronic illness the changeover of plans depends on whether desired objectives are met.  Plans for patients on outpatient care are usually modified during a visit except in situations where patients or their carers are empowered to make their own decisions. Plans for various phases are elaborated further below.

STRUCTURE OF THE REFERENCE CARE PLAN

The SOP describes the theoretical basis for the selection of approaches, paths and methods besides providing the essential knowledge and instructions to provide care. This degree of detail means that it has be to studied conscientiously to be understood. It is therefore good for staff orientation and training or as a reference source when in doubt. As discussed earlier, the Care Plan is an integral part of the SOP. When using a Care Plan it is assumed that the care provider is conversant with the considerations already detailed out in the SOP. The theoretical rationale and detailed objectives and methods need not be repeated in detail but summarized in the Care Plan. However at the point of care, a more practical guide that is concise and precise  is required. This is provided by Reference Care Plans.

The Reference Care Plan is in three parts:

  1. the title
  2. list of tasks
  3. expected outcome

The title is a concise statement that indicates the scope, purpose and context of the use of the plan. The rest of the plan consists mainly of list of all tasks to be carried out in the care the patient.

 Example: Reference Care Plan for Initial Phase of Acute Coronary Syndrome

Care Plan Table
Reference Care Plan Table

CONVERSION OF REFERENCE PLANS TO ACTUAL PLANS

Once a model care plan is chosen for reference, the next step is to modify, customize and convert it into the Actual care Plan for use.  This plan is then  communicated to other care providers by documenting it in the medical record or the Clinical Information System. Since the care of a patient is a multidisciplinary effort, each care provider has the opportunity to put into effect (operationalise) the part of the plan in their area of expertise during their encounter with the patient. They may modify their portion of the plans when needs arise. Yet, there should be consultation with other members of the care team. The patient also needs to be aware of the plan, be allowed to make queries and be involved in it.

STRUCTURE AND CONTENT OF THE ACTUAL CARE PLAN

Care plans derived from the SOP remains as a reference document until it is converted into an actual plan by customizing it for the individual patient. The actual care plan is a specific integrated plan that will cater the needs of an individual patient. Customization is required because due consideration need to be given to two main factors:

  1. the variant of the  disease affecting the patient
  2. the patient’s response to the disease, illness or health problem

To a large extent the differences due to the latter, is contributed by his/her pre-morbid health status, physiological condition and psychological make up. Furthermore, each patient may have different concurrent or pre-existing problems including chronic illness.
Besides the  attention to the illness and its effects, care plans also need to consider the general needs of the patient (i.e. a sick person).

MODIFICATION OF PLANS

Standard plans cannot satisfy a patient’s needs fully. Patient care plans need to be individualized and customized by the care provider by synthesizing all available information, choosing the most relevant plans, combining them and adding or omitting certain options.

Customization of Case Management Plan for an Individual Patient with Multiple Needs

The Actual Care Plan is basically a work schedule made up of tasks grouped according to functions. In a paper-based information system, the care provider  responsible for a particular function may write their own schedule with their own notes in the medical record. For example doctors may write their planned tasks in the medical notes. Nurses my write the Nursing Care Plan together with other entries in the Nursing Notes part while rehabilitation therapists, optometrists and audiologists and other allied health professionals may write their own plan in their respective sections in the medical record. Whatever is recorded  is the actual plan and becomes part of the medical record.

ALTERNATIVES, VARIATIONS, OPTIONS AND CONTINGENCIES

Care Plans are often criticized for being rigid and didactic. In fact, by offering different directions and paths, care pathways provide alternatives in managing a patient based on various valid criteria. In the same way, care plans are different for different anticipated scenarios. Where there is a choice of methods or material without major difference in effectiveness or safety, the care provider is given an option to choose the one best suited or available. In instances where there is a deviation from policies and procedures (intentional or otherwise), the care provider need to indicate this variance and the reasons for it.

Executing Plans via Orders

In a fully computerized Hospital Information System, a plan can be chosen by the doctor in charge (or any other health professional assigned as the primary provider). It will then trigger Care Sets (Order sets, care bundle) for various other the designated care providers of the functional group who will then modify these sets of planned tasks (orders). These allow the care provider categories freedom to customize their own respective plans. Once confirmed these planned tasks would be recorded as the actual task list. Later when the tasks are performed this fact together with the results emanating from it would be recorded as part of the Medical Record.

Plans are realized by executing orders (planned tasks). While in the Reference plan, tasks are grouped according to purpose or function, for purposes of execution they are assigned to identified members of the care team. For example rehabilitation tasks are allocated to the Physiotherapist or Occupational therapist. The dietitian takes on the provision of appropriate diet. The social worker will address the social support issues. These care providers will have to be alerted regarding their involvement in the care of the patient through e-mail (in-box), by phone or other methods of referral.

Actual Care Plan for Acute Coronary Syndrome

Order Set for “Acute Coronary Syndrome”

Care Set for Management of Acute Myocardial Infarct

The use of the Care Plan in a computerized Hospital Information System is discussed in the article on Clinical Information System.

 The Relationship Between Stages in the Work Flow and Content of Care Plans

Relationship between Care Process, Documentation and Reference Information

The use of Care Plans in a fully integrated Hospital Information System is discussed in another article.

ORDER SETS (Care Package, Care-Set, Care-Bundle)

The tasks that addresses all aspects of the patient’s health problems for the short term, make up the content of the Actual Plan. It is often called the Care Set, Order Set or Care Bundle.

Each Care Plan is executed using pre-constituted but modifiable order sets. In a system based on paper the orders are transcribed (copied) manually from a printed copy of the Reference Plan or from a stand-alone computer. In a computerized Clinical Information System, the care provider may use the order set suggested by the system or choose one from a given list. Depending on the context or scenario, order sets can be didactic or flexible in content. In any case, the set can then be modified by exclusion or inclusion of orders.  The tasks are then assigned to the relevant provider group as a task list. Tasks are performed according to the orders.

The care provider retains control of decisions and choices. The plan is a recommendation. Quality control mechanisms such as detection of deviations or variance from the plan, unexpected results and tasks not completed via check lists are put in place.

TASKS: THE MAIN CONTENT OF CARE PLAN

The essential content of Care Plans are tasks for all or some of the patient care processes that addresses all aspects of the patient’s health problems for both the short-term as well as the long-term. These  pre-determined tasks take the form of  sets of orders often called Order sets otherwise also called Care package, Care-set and Care-bundle. Although care is necessarily continuous and often simultaneous, the content is different for different periods or phases. These periods may or may not coincide with definite moments in time such as a certain day (e.g. day of admission, the morning before surgery, first day post-surgery or day of discharge.  The care provider should be given the choice of modifying the care set by activating or inactivating the orders that it contains.

An order-set is made up of a combination and permutation of orders predetermined for each category of illness. Tasks are performed according to the orders. The care sets will consist of all patient care processes necessary for a defined period. It may also include clinical administration tasks.

The type of orders within an order set would include any or all that is necessary to carry out the patient care processes including:

  1. Administrative tasks (Admission, Referrals, Transfer and Discharge, visit registration, follow up appointment, referral and discontinuation of visits.)
  2. Generation, gathering and collection of data about the patient’s illness and the effect on his/her health.
    • Data collection tasks e.g. Clerking or Assessment using a specific clerking form and Progress reviews guided by various note types.
    • investigations by various techniques,
  3. Analysis and interpretation of data to determine the diagnosis and needs of patients
  4. Planning the case management
  5. Preventive actions,
  6. Treatment using various modalities including therapeutic procedures, medication to be supplied or administered, blood product supply and transfusion
  7. Monitoring and Review of progress of disease status of the patient’s health, effects of treatment
  8. Evaluation of outcome)
  9.  Review of diagnosis and management
  10. Rehabilitation
  11. Patient education
  12. Provision of or advise on nutrition
  13. provider-patient communications (briefing, advice)
  14. Any other therapeutic tasks
  15. Continuation of care or Final disposal of the case

For inpatients, these can be admission, referrals, transfer and discharge. For outpatients, these can be visit registration, follow up appointment, referral and discontinuation of visits.

PROCESSES AND TASKS 

Traditionally, the plan for the overall care of a patient is done by the doctor in charge (or any primary care provider). By choosing a Care Plan he/she communicates the to members of the care team on what needs to be done for the patient.

  1. Administrative tasks (Admission, Referrals, Transfer and Discharge, visit registration, follow up appointment, referral and discontinuation of visits.)
  2. Generation, gathering and collection of data about the patient’s illness and the effect on his/her health. Data collection tasks e.g. Clerking or Assessment using a specific clerking form and Progress reviews guided by various note types.
  3. Analysis and interpretation of data to determine the diagnosis and needs of patients
  4. Investigation tasks, Diagnostic tests
  5. Planning the case management
  6. Treatment using various modalities including therapeutic procedures, medication to be supplied or administered, blood product supply and transfusion
  7. Review of progress of disease (including assessment of outcome)
  8. Monitoring of the progress of the illness, status of the patient’s health, effects of treatment
  9. Review of diagnosis and management
  10. Rehabilitation
  11. Patient education
  12. Nutrition provision
  13. Any other therapeutic tasks
  14. Continuation of care or Final disposal of the case

Multi Patient Task List View

In a computerized Clinical Information System, planned tasks take the form sets of orders. The computerized provider Order Entry application (CPOE) is used to create task lists for various functions. The type of tasks within a care-set would include any or all that is necessary to carry out the patient care processes i.e.:

DECOMPOSITION OF ORDER SETS INTO TASK LISTS

Traditionally, the plan for the overall care of a patient is done by the doctor in charge (or any other primary care provider). In a computerized environment, the care plan is predetermined by consensus and executed through Order/Care Sets and can be manually or automatically triggered. From this overall plan, the care providers responsible for each aspect of care may select and activate care plans applicable for the patient. The care provider should be given the choice of modifying the care set by deselecting some of the orders or placing additional orders. All or some of the items listed in a plan/order set can be made mandatory or pre-selected while others can be actively selected or deselected by users.

EXAMPLE Order Set for “Acute Coronary Syndrome”

The care provider retains control of decisions and choices. The plan is a recommendation. Quality control mechanisms such as detection of deviations or variance from the plan, unexpected results and tasks not completed via check lists should be put in place and documented.

Chest trauma

 Division of Duration of Care into Periods

For a particular health problem, the care delivery may be divided into:

  1. Episode
  2. Phases
  3. Visits
  4. Encounters
  5. Tasks or Events
    1. Entire Care Episode
    2. A particular Phase
    3. A particular service

A care episode refers to the whole duration of service provided from beginning to end. It contains the sum of all visits.The division into Phases is conceptual rather than real. The differentiating factor is whether the illness is acute, sub-acute or chronic.Visits are instances when the patient comes to the health care facility. They can be categorized further according to service delivery systems i.e.

  1. Outpatient visit
  2. Emergency visit
  3. Inpatient visit
  4. Day Care visit
  5. Home Care visit
  6. Teleconsultation visit

Visits can also be categorized according to sequence

  1. First
  2. Follow up (FU 1, FU 2, FU 3 etc.)
  3. Final

The number of visits per episode is by nature variable but may be intentionally fixed in a service package. A visit requires one or more identified physical resources such as room/bed within a clinic complex or ward. During the visit, the patient may have one or more encounters with different care providers at the same or different resource. The duration of each encounter is defined as time slots.

Tier 2: Visits and Encounters for each Phase

The progression from one phase to the next need to be decided by the care provider based on the amount and quality of data available, the certainty of diagnosis, the appropriateness of a chosen care plan and the response to therapy. Since the Case Management Plan is an interdisciplinary effort, each care provider has the opportunity to operationalise the part of the plan in their area of expertise. Yet, there should be consultation with other members of the care team. The patient also needs to be aware of the plan, be allowed to make queries and be involved in it.

Care Schedule 2
Division of a Care Episode into Phases

Phase of Diagnosis, Stabilization and Immediate Care

This is the phase of initial contact with a health care provider. The disease process itself may be at an early or later stage of the natural history of the disease, depending on whether the patient seeks treatment early or late.In this phase, the main objective is to determine the diagnosis as accurately and comprehensively as possible. The main tasks are clinical data gathering and diagnostic investigations. At the beginning of this phase, the data available may allow the clinician to determine the diagnosis in terms of symptom complexes or syndromes. Therapy would then be directed towards symptomatic relief, resuscitation if necessary, stabilization and support (physiological, psychological, social and spiritual). Besides the diagnostic investigations, data accumulated through observing and monitoring the patient will help in arriving at a definitive diagnosis. The diagnosis need to be further refined to clarify the variant of disease, severity grade, stage of illness, risk stratification and prognosis.

Phase of Initiation, Re-assessment and Optimization of Therapy

In this phase, the disease entity/entities and accompanying health problems affecting the patient are already established with some certainty. An appropriate definitive management plan (curative, palliative / supportive, rehabilitative) is adopted and implemented. Depending on the disease, the objective of treatment would be to cure the illness, contain it or control it. As such, treatment end points need to be defined and measurements made to determine whether these end-points have been achieved. Optimization is considered achieved when the treatment regimen produces the best possible level of benefit. These factors would determine the choice of management plans including treatment approaches or modalities.(curative, palliative / supportive, rehabilitative) is adopted and implemented. Depending on the disease, the objective of treatment would be to cure the illness, contain it or control it. As such, treatment end points need to be defined and measurements made to determine whether these end-points have been achieved. Optimization is considered achieved when the treatment regimen produces the best possible level of benefit.

Care Schedule 3
Care Schedule

PRACTICAL CONSIDERATIONS IN EXECUTING PLANS

For a chosen plan, the transition from one phase of care to the next depends on:

  1. completion of planned tasks
  2. achievement of objectives for the phase

Failure to complete tasks can be due to non-conformance by care providers or non-compliance by patients. Failure to achieve objectives may be due to the two aforementioned issues or due to an inappropriate hence ineffective plan. The latter is likely to be due to inaccurate or wrong diagnosis, in which case further efforts need to be made to clarify the diagnosis. A change in plan may then become necessary.

PRACTICAL CONSIDERATIONS IN EXECUTING PLANS

Phases of Care
Framework for Patient Care Plan

Phases of Care in a Patient with Blunt Chest Trauma

CARE PLAN FOR ACUTE ILLNESS

Care of a patient with an acute illness is characterized by  varying levels of urgency and uncertainty. Setting priorities is of overriding importance. Most tasks need to be performed simultaneously. The Care plan is an indispensable aid in ensuring:

  1. quick action by defining the process sequence
  2. readiness of equipment,
  3. defining care-provider roles
  4. preparedness for any eventuality

Phase of Diagnosis and Immediate Care

In acute illness at the immediate phase, efforts are directed towards symptomatic relief, resuscitation, stabilization and support (physiological, psychological, social and spiritual). At the outset, observation and monitoring are initiated. Investigations is aimed at determining the patients general physiological status and  functions of various systems. The priority for Diagnostic investigations is to determine the system or site involved or the like pathology. Therapy must not wait for want of an accurate diagnosis.

Yet every effort must be made to obtain a definitive diagnosis so that the plan for specific treatment can be started as early as possible. The diagnosis need to be further refined to clarify the variant of disease,severity grade, stage of illness, risk and expected or desired outcome.

Customization of Case Management Plan for an Individual Patient with Multiple Needs

Example of Care Plan for Patient With Multiple Needs

Phase of Maintenance of Therapy, Re-evaluation and Modification

Once the patient has been stabilized, attention is paid to:

  1. relief of symptoms
  2. monitoring various parameters
  3. maintaining normal physiology,
  4. providing nutrition,
  5. giving psychological support
  6. taking preventive actions
  7. treatment of ongoing problem

The progress of the patient is reviewed regularly to detect deterioration or improvement, occurrence of complications of illness or treatment. The care provider reviews the diagnosis and the effectiveness of therapy. He/she then, may have to revise the Care plan and modify the treatment.
Depending on the illness, this phase may spread over a considerable period. The patient may be discharged from in-patient care and the care continues in the outpatient setting or at home.

Phase of Continuation/Discontinuation of Therapy

Depending on the nature of the illness and the response to therapy the care may reach a stage where it can be discontinued. This could be because the patient has fully recovered or the health problem has resolved or been cured.

If the illness appears to have resolved, discontinuation may be abrupt or phased out. The plan conveys the manner in which care is to be stopped including how medication or other treatment is to be tapered and what evaluation criteria need to be met to declare it safe for the care to be terminated.

On the other hand, the acute illness/health problem may be a manifestation of an underlying chronic disease.  The acute illness may also give rise to permanent or semi-permanent disability, deficiency or handicap. In both instances, long term care will then be planned and provided.

CARE PLAN FOR CHRONIC ILLNESS

preventive, education

INITIATION, STABILIZATION, MAINTENANCE, RESPONSE

These three broad strategies may contain all or some of the following therapeutic approaches i.e.:

  1. Definitive therapy
  2. Symptomatic
  3. Supportive
  4. Preventive
  5. Rehabilitative
  6. Promotive

Phase of Initial Consultation

The care of a patient with chronic illness begins with the initial contact with a health care provider. The disease process itself may be at an early or later stage of the natural history of the disease, depending on whether the patient seeks treatment early or late. In this phase, the main objective is to determine the diagnosis as accurately and comprehensively as possible. The main tasks are clinical data gathering and diagnostic investigations. At the beginning of this phase, the data available may allow the clinician to determine the diagnosis in terms of symptom complexes or syndromes.

Once the diagnosis is ascertained the care provider needs to clarify the objectives of care (expected outcome, therapeutic end points). A more definite Care Plan is then chosen and customized.

Phase of Initiation, Re-assessment and Optimization of Definitive Therapy

In this phase, the disease entity/entities and accompanying health problems affecting the patient are already established with some certainty. An appropriate definitive management plan (curative, palliative / supportive, rehabilitative) is adopted and implemented. Depending on the disease, the objective of treatment would be to be the combination of any of the following:

  1. cure the illness,
  2. contain it or control the progress
  3. mitigate the effects

As such, the care provider defines the treatment end points,  chooses the plan offering the most suitable treatment approaches or modalities. As such, treatment end points need to be defined and measurements made to determine whether these end-points have been achieved.

An example of the model care plan for this phase is shown below. (yet to be written)

Phase of Maintenance of Therapy, Re-evaluation and Modification

The main aim of this phase is to optimize the benefit of care given. The main tasks in this phase is monitoring, reassessment and progress review addressing both the disease and also the treatment. The results will reveal the behaviour of the illness and various developments. The progress of chronic diseases vary in many ways including:

  1. speed of deterioration
  2. active vs inactive periods
  3. emergence of complications

Another important aspect is the evaluation of response to and effects of therapy. These factors are assessed:

  1. conformance to the plan
  2. patient compliance
  3. detrimental effects of therapy

In this phase because of the above factors, modification and revision of the plan is often necessary.

Measurement of outcome and comparison with planned targets is an integral activity of care at this stage. Scoring systems and check lists can be used. Optimization is considered achieved when the treatment regimen produces the best possible level of benefit. The plan is then continued with minimal change.

Phase of Discontinuation / Continuation

Chronic illnesses are usually characterized by continuous progression or persistence. The care is therefore long term and usually extend throughout the life of the individual. Some may resolve and be dormant only to appear again later.Temporary cessation of therapy with planned follow up reviews may be necessary.
Rarely some diseases runs through its course and dissipates. The care can then be phased out.

It is essential that the care provider plans for the continuity of care well and ensure that it happens. He/she may delegate the responsibility to others for the convenience of the patient. The primary care doctor, family doctor or school/factory nurse are the most appropriate care providers to take on this responsibility. If it is a disability or handicap, depending on the type, then therapists, counselors,  optometrists, audiologists or social workers may be more appropriate. Self-care, home care and care by voluntary bodies may be adequate or may supplement those given by health care professionals.
Periodic review by the provider who initiated the plan may  be necessary

VARIATION BASED ON EMERGENCE OF SPECIAL NEEDS

In managing a patient, an integrated plan that will cater for all of his/her needs is necessary. For a particular disease, there are individual variations in how the disease or health problem affects a patient. How the patient responds to them also varies. The continuation of a care regimen to the next phase is contingent on the completion or success of the previous phase.

To some extent the difference in response is contributed by the patient’s pre-morbid health status (pre-existing problems including chronic illness), physiological condition and psychological make up.

After making a diagnosis, the clinician categorizes his/her patient according to possible risks, severity of illness, stage of development and therefore prognosis. Categorization in turn allows the clinician to choose the right pathway and initiate an appropriate care plan. It is also a determinant of applicability, availability, timeliness and cost effectiveness. Grading and scoring systems for various diseases have been developed and tested.

Cessation and Introduction of New Plans

Plans need to change with variations in progress of the disease, severity, complications, different phases of care and outcomes. Changes can be made manually or be suggested based on a trigger. Planned tasks may end or continue as the phases evolved.

Tasks can continue or retained in new plan. Tasks no longer necessary are not included in next plan any task can be cancelled from the task list at any time

Whether the changes are slight or major, in a computerized system, it is best that the old plan is terminated and replaced by a new plan. Previous orders that are to retained are cancelled and the orders  are remade. The new order set will then contain previous and new orders. Hence, the task list is also renewed. This will prevent confusion as to which order is to be retained and which to be continued.

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