Chapter e0: The Patient Care Process

The patient care process is a fundamental series of actions that guide the activities of health professionals. All health professionals who provide direct patient care should use a systematically and consistently applied process of care in their practice.¹ Until recently, the language to describe the process for delivering comprehensive medication management services was ill defined. In 2014, the Joint Commission for Pharmacy Practitioners (JCPP) — representing 11 national pharmacy organizations — endorsed a framework for providing clinically oriented patient care services called the Pharmacist's Patient Care Process.² However, the framework and the language to describe the process are not unique to the profession of pharmacy. Indeed, medicine, nursing, and dentistry all follow a putatively similar process of care.³ (See Table 1.) For example, the American Nursing Association outlines the nursing process with steps that include assessment, diagnosis, outcomes/planning, implementation, and evaluation.⁴ The Academy of Nutrition and Dietetics collapses these general steps into four steps, outlining the nutrition care process to include nutrition assessment, diagnosis, intervention, and monitoring/evaluation.⁵ Although the care process is similar across disciplines, each health profession brings a unique set of knowledge, skills, attitudes, and values to the patient encounter.

Health professionals who provide direct patient care are often called practitioners. To practice is what health professionals do to bring their unique knowledge and skills to patients. A practice is not a physical location or simply a list of activities. Rather, a professional practice requires three essential elements: (1) a philosophy of practice, (2) a process of care, and (3) a practice management system.³ These three inter-related concepts make the delivery of patient-centered care possible.

Health professionals have an ethical obligation to promote the health and well-being of the patients they serve. Thus, a philosophy — the moral purpose and a commonly held set of values that guides the profession — is the critical foundation on which the practices of pharmacy, medicine, nursing, and dentistry are built.⁶ A philosophy of practice is often formally articulated in the professional code of ethics endorsed by professional organizations and an oath that is recited by members of the profession during rituals and ceremonies. In addition to a code of ethics, most professions have an informal set of beliefs and values that also inform the self-proclaimed and societal expectations. For example, the concept of pharmaceutical care is not formally included in the code of ethics for the professional of pharmacy or the oath of a pharmacist.^7,8 However, informally, pharmacists understand they have a unique responsibility for addressing the drug-related needs of patients and should be held accountable for preventing, identifying, and resolving drug therapy problems.⁹ Similarly, dentistry, nursing, and medicine have both formal and informal expectations that guide their professional practice.

A process of care that is systematically and consistently applied during each patient encounter increases the likelihood that optimal health outcomes are achieved.¹⁰ The patient care process used throughout this book includes five essential steps: (1) collecting subjective and objective information about the patient; (2) assessing the collected data to identify problems, determine the adequacy of current treatments, and set priorities; (3) creating an individualized care plan that is evidence-based and cost-effective; (4) implementing the care plan; and (5) monitoring the patient over time during follow-up encounters to evaluate the effectiveness of the plan and modify it as needed. (See Fig. 1.) In addition to the five fundamental steps, a patient-centered approach to decision-making is essential.¹¹ The process also involves frequent communication and collaboration with the patient and other health professionals.¹² Each step of the process must be documented. These steps are interdependent and completing all five steps is necessary to achieve the greatest impact. While the process of care is common to all, each profession has a unique body of knowledge and skills they bring to bear when assessing the data and formulating plans.³

A practice must also have a practice management system that supports the efficient and effective delivery of services.³ Without a well-defined practice management system, the practice would not be sustainable. This includes the infrastructure — the physical, financial, and human resources — as well as policies and procedures to carry out the patient care work. Successful practices have a clear mission statement that defines who the practice serves, the organizational values, and what they hope to accomplish. Furthermore, to achieve its mission, a practice must implement quality improvement methods that measure, evaluate, and improve the actions of practitioners (individually) and the practice (collectively).

While every practice is built on three essential elements — a philosophy of practice, a well defined patient care process, and a practice management system — the focus of this chapter is to describe the patient care process applied to drug therapy management and explore some environmental issues that are influencing the adoption and application of this process by pharmacists.

It is well understood that health care is a complex business. Since the turn of the twenty-first century much effort has focused on gaining control of a disparate, disjointed, costly health system that is not adequately producing desired patient outcomes despite the health care workforce laboring harder than ever. Spurred by the Institute of Medicine's Crossing the Quality Chasm report from 2001¹³ which set the framework for redesigning health care delivery, health care institutions and practitioners have embraced the Triple Aim¹⁴ with a focus on patient centeredness, safety, and quality improvement. (See Fig. 2.) The Triple Aim can only be achieved with significant changes in delivery of care and payment models.

To accelerate the requisite redesign of health care delivery, the Institute of Health Care Improvement has developed guiding principles or "rules" for workforces and health care communities. Among these principles is to standardize what works in order to reduce unnecessary variation. Standardization is important because health care systems are embedded in a network that reaches well beyond traditional walls.¹⁵ A lack of a standard process of care creates an environment that may result in unacceptable gaps in care. For a specific patient care service to be widely adopted and valued, it is imperative that clarity exists both in the execution of care and the terminology used to describe the care.

The stimulus for developing the patient care process for pharmacy was the wide variation observed as pharmacists provided direct patient care, often using the same terminology to describe diverse services or conversely, the same service is described using different terminology. As patient care services provided by pharmacists, physicians, and any other health care practitioner cannot operate in a silo, the services must be clearly articulated and well understood by patients, their caregivers, payers, and other members of the care team. Without a consistent patient care process, it has been challenging for the profession of pharmacy to communicate the pharmacist's role to groups external to the profession and establish the distinct value pharmacists bring to an interprofessional care team. Moreover, the patient must know and understand what is to be delivered and to determine how best to receive the care provided. Likewise, other members of the health care team must determine how best to integrate the pharmacist's work into their efforts caring for the patient.

Creating a standardized process of care is not unique to pharmacy. It is well recognized in health care that setting standards encourages providers to approach patient care in a consistent manner. Systematically implementing a framework for care that is consistently applied assures no important step is overlooked and actions that may lead to greater harm than benefit are reduced or eliminated. Defining the standards of care enables the generation of outcome data that can be compared and used to demonstrate the value of a service. In a rapidly changing environment, structure is essential to maintain consistency. In the hospital setting, care pathways and standard order sets are examples of standardized care processes that have been used for many years. Creating a standardized patient care process is not intended to re-invent "the wheel" but set a common framework.

Patient care is often extremely complex. Therefore, a process of care must be built on a set of fundamental steps that can address the wide range of complexity that exists among patients. The process needs to be adaptable to varied settings, diverse populations, and different acuity levels. The process described throughout this text provides a unifying and comprehensible approach that is universally recognized.

There are two aspects that typically differentiate a profession-specific process of care. First, the application of the care process is defined within the context of the profession's knowledge and expertise. For pharmacy, the patient care process is focused on a patient's medication-related needs and their experience with medication therapy.³ Dentists and dental hygienists employ a patient care process that is focused on a patient's oral health needs.¹⁶ The nursing care process is applied to provide a holistic approach to a patient's health needs and include physical and mental health, sociocultural issues, spirituality, as well as economic and life-style factors.⁴ The general approach to providing care to an individual patient in each of these disciplines is similar, however the focus of the process is distinct.

The second way in which each profession uniquely addresses a patient's needs is the manner in which patient-specific information is assessed. When assessing information collected from a patient (e.g., history of present illness, physical examination, laboratory data), physicians employ a clinical reasoning process called "differential diagnosis" to weigh the probability of one disease versus other diseases that possibly account for the patient's signs and symptoms. In the case of dental hygienists, the American Dental Hygienists Association notes that an assessment not only includes a health history and clinical assessment, but also a "risk assessment" that includes 11 areas of evaluation.⁵ For pharmacists providing comprehensive medication management, the assessment step involves a systematic examination of the indication, effectiveness, safety, and convenience of each of the patient's medications. This is a unique way of approaching a patient's health needs. No other discipline applies a systematic assessment process to a patient's medications and their medication experience in this manner.

Several publications and resources have outlined elements of the patient care process to deliver comprehensive medication management services.^2,6,12,17 There is relative consistency between these sources regarding the core elements. What varies is the specificity of the operational definition of each of the process components. Detailed operational definitions help to establish consistency across all practitioners applying the patient care process. It is important to note that this care process is not specific to a care setting – the process can be applied in any setting when providing comprehensive medication management. What often varies is the information collected and its source as well as the duration of time to complete the process. For example, in an ambulatory care clinic the patient is often the most important source of information but in a critical care unit of a hospital there is a greater reliance on laboratory tests and special diagnostic studies. Similarly, the process of care unfolds in hours or days in acute care settings, but may extend over weeks or months in chronic care environments.

Collect Information

When initiating the patient care cycle, a practitioner assures the collection of the necessary subjective and objective information about the patient and is responsible for analyzing the data in order to understand the relevant medical needs, medication-related problems, and clinical status of the patient. In some cases, this information will be directly collected by interviewing the patient or reviewing a medical record. In other cases, the practitioner may rely on other personnel to collect the information that will be used in the assessment. This may include a blood pressure determined by a clinical assistant or a list of active medications recorded by a nurse. However, it is ultimately the practitioner's responsibility to assure that all of the necessary information is collected and that the data is accurate, regardless of the source. This information is critical to the ability of the practitioner to complete an assessment that will appropriately address all of a patient's medication-related needs. (See Table 2.)

Assess Information and Formulate a Medication Therapy Problem List

Once all of the information deemed necessary to conduct a comprehensive assessment of the patient and their medication-related needs has been collected, the assessment is organized into a problem list consisting of the patient's active medical problems and medication therapy problems. Once identified, problems are prioritized to make decisions regarding the patient's medication therapy in order to offer the best opportunity to achieve the patient's overall health goals. In doing so, the practitioner reviews each medical condition and medication to make sure that each current medication is indicated (or necessary) for the condition for which it is being taken and that each condition that requires drug therapy is being appropriately treated. Then the practitioner determines whether each medication the patient is taking is effective, achieving the intended outcome. This includes assuring the medication is the most appropriate option for the patient and is at a dose that is expected to achieve the intended effect. Next, the practitioner considers the safety of each medication, assuring that the patient is not experiencing or being exposed to an unnecessary risk for adverse effects or an unintended interaction. Finally, the practitioner then evaluates each medication for convenience. This includes assuring the patient can take the medication as intended, considering issues such as access and affordability as well as sufficient knowledge and ability to appropriately administer the medication. Throughout the assessment process, practitioners must keep the patient's goals for therapy at the forefront of their decision-making. Table 3 outlines the forms of assessment applied when optimizing pharmacotherapy.

It is critical that the practitioner completes their assessment and defines a problem list considering indication, effectiveness, safety, and convenience in this order. This order of assessment ensures that the most relevant issue affecting the patient is identified. For example, there is a great deal of emphasis placed on improving patient adherence to medications, with non-adherence rates reported to range from 28 to 65%.^18,19 However, if a patient is prescribed a medication that is not indicated or is causing an adverse effect, focusing time and attention toward improving medication adherence is misguided and does not address the most important medication therapy problem. Similarly, a patient who is prescribed a medication which they cannot afford when there is an affordable alternative is not experiencing an adherence issue.

The output of the assessment is a medication therapy problem list, prioritized in the order of importance from both the patient's and practitioner's perspective. Typically, the problem list is framed in a categorical system of medication therapy problems. A nationally recognized system for categorizing the output of a practitioner's assessment is now recognized by the Pharmacy Quality Alliance. (See Table 4.) There are nine medication therapy problem categories and these align with the four areas of medication use assessment.²⁰

When this assessment approach is applied, a relatively consistent pattern of medication therapy problems emerges.^21–23 The categories identified with the greatest frequency are "needs additional therapy" and "dose too low" followed by "adherence." The other categories are observed less frequently. It should be noted that these reported trends all come from application of this assessment process in ambulatory care settings. It is likely that the distribution of medication therapy problems would differ in acute care settings.

Develop the Care Plan

Upon completion of the assessment and establishing a prioritized list of medication therapy problems, an individualized patient-centered care plan that is evidence-based and as affordable as possible for the patient is created. The plan should be developed in collaboration with the patient or caregiver to ensure that it meets with the patient's expectations and priorities. It also should be developed in collaboration with other health care professionals to ensure that all health care providers involved with the patient's care agree and support the plan.

The care plan will include goals of therapy and outline contingencies to adjust medications, doses, or delivery as well as monitoring parameters. It will establish time frames for follow-up and clearly state who will be responsible for each component of the care plan. The steps for developing a patient-centered care plan are outlined in Table 5.

Implement the Care Plan

Once a care plan is established, the real work begins. The practitioner works to prevent and resolve medication therapy problems. The care plan will likely include activities that the patient and other health care providers will be responsible; however, it is the duty of the practitioner to ensure that each of the elements of the plan have been implemented in a time frame that is reasonable and effective. (See Table 6.)

There are many tools and resources that may be used to support a patient and/or their caregivers to successfully implement the care plan. It is in this part of the patient care process where practitioners will employ strategies such as patient education, motivational interviewing techniques, tools that support medication adherence, and patient self-monitoring technologies. Each of these tools and resources are approaches to best meet the needs of the patient and their medication-related goals.

Follow-up with the Patient

After the initial implementation of a care plan, ongoing monitoring and follow-up to evaluate the effectiveness and safety of the plan are essential. The plan should be modified as needed in collaboration with other health care professionals and the patient or caregiver. This process of follow-up is critical and demonstrates the practitioner has assumed responsibility for the patient's medication-related needs. While a practitioner who serves as a consultant may not follow up to determine if the problem has been resolved, this is inconsistent with the expectations of a comprehensive medication management practice or the patient care process. As a health care practitioner who has assumed an important role in a patient's care, it is a responsibility of the practitioner to determine the outcome of drug therapy and take additional action if necessary. This process of follow-up can occur through a variety of mechanisms including face-to-face encounters, phone calls, electronic health record messaging, and telehealth technologies. (See Table 7.)

The frequency to which follow-up occurs varies from setting to setting. A practitioner practicing in an acute care environment will possibly transfer responsibility for follow-up to other providers, including another pharmacist, when the patient transitions to another setting. In the ambulatory care setting, a practitioner should ensure that a patient has a comprehensive evaluation of their medications and health status, at a minimum, annually. In some cases, the nature of the patient's medication therapy problems may be resolved to the degree to which the patient no longer requires ongoing monitoring. In such cases, the patient is referred back to the primary care provider for ongoing follow-up and monitoring.

The third critical element of practice is a practice management system. The specifics of any practice management system are based on fundamental business principles and the requirements of the particular type of health care setting where the practice exists.²⁴ In today's health care environment there are essential aspects of managing a practice that practitioners must consider – the metrics to ensure patient health outcomes are being achieved; efficient workflow; communication and documentation optimally using the power of information technology (IT); and data that accurately reflects the attribution and value the practitioner brings to patient care.

Quality Metrics

Dr. Avedis Donabedian, considered the father of quality improvement in health care, defined standards as the desired and achievable performance related to a given parameter — an objective, definable, and measurable characteristic of the structure, the process, or the outcome of the care.²⁵ In order to determine quality there must be a standard to measure the level of quality against. The patient care process sets a standard of achievable performance by defining the parameters of the process that can be measured. With the fast-paced movement toward outcome-based health care models and associated quality-based payments, it is critical to objectively measure the impact patient care services have on patient outcomes. This allows the linkage from the standard process, such as what health problems were identified and how they were addressed during the patient encounter, to desired outcomes. The quality of performance will determine their value and continued adoption. For the process to be measurable, each of the elements must be clearly defined and performed in a similar manner during each patient encounter. The lack of clarity and consistency has been the Achilles heel in the evidence to support the value of pharmacist patient care services.²⁶ The standard process gives pharmacists an opportunity to show value on a large scale because the services are comparable and clearly understood.

Workflow, Documentation, and Information Systems

The generation and analysis of data regarding the care provided and the resulting health outcomes are becoming increasingly important not only to organizations but to individual providers as well. Health care systems are rapidly embracing the power of technology to analyze information to gain important insights. This technology is only useful if clinical care is robustly documented, collected, and managed. Data is optimally collected as part of the workflow process using IT tools. Creating the requisite tools, however, requires a standard process to build cohesive systems with uniform data sets. This allows the reporting of comparable information to providers and others.

The uniform patient care process sets a standard for the workflow that allows IT systems to capture and extract data for analysis and sharing. Imagine a patient encounter with a practitioner in any setting. The practitioner often has some patient information available prior to encounter; however, the practitioner will most likely collect new information. This work can now be captured in the collect phase of the workflow. The practitioner will then assess the information and identify new or unresolved medication-related problems. This work can be captured in the assessment phase of the visit. The practitioner will then update or add to the team's plan of care for the patient and the information can be captured in the planning phase. During the encounter, the practitioner may be able to implement some or all of the plan, and this data will be captured from the implementation phase. Follow-up will capture the resolution of the identified problems over time and measure the results. The information collected can now be exchanged, extracted, and analyzed at the provider, population, organizational, and payer levels because it is defined and collected in a uniform manner.

The ability to capture clinical data is currently available through a number of coding systems. (See Table 8.) The Pharmacy Health Information Technology Collaborative has been at the forefront in assuring pharmacist patient care services are part of the IT systems being developed for the health care system in the United States.²⁷ The collaborative has developed several documents demonstrating how the patient care process and Systematic Nomenclature of Medicine – Clinical Terms (SNOMED - CT) codes may be used to document a patient interaction and linked to patient outcomes attributable to the pharmacist-provided care. The documents are easily accessible on the Pharmacy Health Information Technology (HIT) website (http://pharmacyhit.org/). It is not necessary for practitioners to know each of the codes, but to understand how they operate behind the scenes when performing and documenting their clinical activities. This will enable practitioners to assist information technologists to effectively design systems to accurately document the elements of the process which can produce the data on medication-related outcomes.

Documentation, Attribution, and Payment

Payment to health care providers for patient care services in the United States has traditionally been based on the documentation and reporting of standard processes of care. Rules and guidance from Medicare and the Center for Medicare and Medicaid Services (CMS) are considered the billing and payment standard for health care providers both for governmental and commercial payers. Eligible Medicare Part B providers such as physicians, nurse practitioners, and physician assistants must follow standards set forth in the CMS Documentation Guidelines for Evaluation and Management Services.²⁸ Pharmacists are familiar with these standards as they are essential following the SOAP (Subjective, Objectives, Assessment, and Plan) note format including chief complaint, history of present illness, past medical history, social history, family history, review of systems, physical examination, assessment, and plan. Built on top of the standard documentation requirement are the reporting of levels of decision-making and complexity of care. The added layer of documentation is determined by the number of required elements in each documentation domain. A billing code can then be assigned to that patient care encounter which, in turn, equates to the amount of payment commensurate with the level of care provided. While this process is the basis for the current fee-for-service payment structure, it is likely the general format that will remain in any new payment model. Similarly, other providers such as dieticians and physical therapists have standard processes, workflow, and documentation that enable the payment structures in their practice model.

Pharmacists have traditionally used the SOAP note format when documenting care for patients. This is particularly appropriate when providing services incident to an eligible Medicare Part B provider. It is the standard documentation required in that circumstance. However, some elements for the SOAP note, which are required when using certain billing codes, are not routinely performed by pharmacists (e.g., comprehensive physical examination). Thus, the pharmacist patient care process sets a standard that reflects the pharmacist's work, makes documentation more efficient, and enables appropriate billing and attribution in new models of care.

A standard process of care provides the structure that all practitioners should follow and, when implemented correctly and consistently, can improve the quality of care. It provides a common language that defines roles, responsibilities, and expectations. Comprehensive medication management involves a five-step process: collect, assess, plan, implement, and follow-up. A standard process of care informs the creation of quality metrics and is the foundation of practitioner workflow, the structure of health information systems, and billing for patient care services.