Measurement of Outcomes

Medicine is currently driven by evidence that can be produced on the basis of patient assessment. Evidence based research allows for better measurement of outcomes of interventions by improved assessment of the severity of disease and disability of patients and assessing the outcomes of the application of specific protocols. Since the measurement of outcomes has become universal in the healthcare industry it is essential for healthcare professionals to understand and incorporate evidence based outcomes in their evaluation and management of the patient.

A handful of analytic frameworks for quality assessment have guided measure development initiatives in the public and private sectors. One of the most influential is the framework put forth by the Institute of Medicine (IOM), which includes the following six aims for the health care system:

1. Safe: avoiding harm to patients from the care that is intended to help them;
2. Effective: providing services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit (avoiding underuse and misuse, respectively);
3. Patient-centered: providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions;
4. Timely: reducing waits and sometimes-harmful delays for both those who receive and those who give care;
5. Efficient: avoiding waste, including waste of equipment, supplies, ideas, and energy; and,
6. Equitable: providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.^1,2

To provide quality care has been the essence of healthcare professionals for centuries, it is essential to measure the initial stage and record the improvement or deterioration over time to assess the quality. Donebedian defined quality as structure, process, and outcome.

In 1966 Avedis Donabedian described a framework for assessing the quality of care that is flexible enough to apply to many situations. First, structures of health care are defined as the physical and organizational aspects of care settings (e.g., facilities, equipment, personnel, operational and financial processes supporting medical care, etc). Second, the processes of patient care sit in the middle of the diagram because they rely on the structures to provide resources and mechanisms for participants to carry out patient care activities. In addition, processes are performed in order to improve patient health in terms of promoting recovery, functional restoration, survival and even patient satisfaction. This latter concept is well known as the outcomes of medical care. The three Donabedian concepts therefore consist of: structures of health care, processes of patient care and outcomes of medical care. Judgments are based on considerations such as the appropriateness, completeness and redundancy of information obtained through clinical history, physical examination and diagnostic tests; justification of diagnosis and therapy; technical competence in the performance of diagnostic and therapeutic procedures, including surgery; evidence of preventive management in health and illness; coordination and continuity of care; acceptability of care to the recipient. Care coordination is expected to be influenced by the setting and other structure variables and to exercise causal effects on patient outcomes. The positioning of care coordination implies that it is one of many important care processes, and therefore does not act in a vacuum even at the level of service delivery. Coordinating care better is only beneficial if other aspects of care delivery are optimized as well.

For example, in an organization, structure is board certification of physiatrists so they improve quality with better processes, like referring patients to cardiac rehabilitation program at discharge, causing better outcomes, such as decreased cardiac mortality.³ However, Donebedian’s triad does not take into account modern day health delivery systems. Health care is now delivered in the context of patient safety, care coordination, high reliability health care systems, and team management. When these variables are taken into account, measures of quality⁴ are:

• Evidence Based Medicine (Structure)
• Process Improvement & Decision Support (Process)
• Outcomes Management (Outcome)
• Access
• Patient Experience

Measurement of outcome can be either a patient reported outcome (PRO) measure or performance-based assessment (PBA). Integration of PRO measures is consistent with current national initiatives to enhance health care quality through performance metrics. Clinicians and researchers increasingly recognize the importance of the patient’s perspective, such as in the evaluations of the treatment efficacy/effectiveness. However, the rapid growth in the number and types of PRO can be confusing.   Optimal components of PRO are:

• Length and complexity
• Participant and administrator burden
• Easy to understand
• Quick administration
• Provision of reliable and valid composite information
• Sensitivity to meaningful treatment-related changes⁵

PBAs are clinician derived objective test previously standardized and are based on patient performance, e.g. 6-Minute Walk Test. Some scales still needs further analysis and standardization.

Measures can also be categorized into 3 groups based on what is being measured:

• Disease/Condition: e.g. anatomy, disease,
• Treatment/Intervention: e.g. exercise, medications,
• Health Services Administration: e.g. equipment, healthcare delivery.

Based on Donebedian’s definition, outcome measures can be classified into: 1) behavioral; 2) experiential; 3) clinical; and, 4) financial.  All factors that influence a patient’s health outcome are accounted by risk adjustment and severity indexing.  The relevant population and the timing of measurement of an outcome relative to the care received are most important to interpreting outcomes. For example, in referring to cardiac rehabilitation program, the timing and duration for patients with and without CHF, and the relation of such a program to mortality are important.

Many “outcome measures” actually use processes of care or use of services as “proxies” for patient’s health states.  Outcomes measures are useful in:

1. Quality improvement (QI) programs: to identify best practices and adverse outcomes
2. Cost and resources allocation, organizational and healthcare budgets: by identifying areas where intervention improves care
3. Meeting requirements for reimbursement incentives: such as Pay-For-Performance (P4P) programs based on quality scores
4. Meeting regulatory requirements
5. Licensing, and accreditation at provider and health plan level: such as the Consumer Assessment of Health Providers and Systems (CAHPS) by the U.S. Agency for Healthcare Research and Quality (AHRQ), and the Medicare Health Outcomes Survey (HOS) which uses patient reported outcomes (PRO) for QI, P4P etc. in Medicare Advantage contracts.
6. Registries and health information exchanges: by benchmarking
7. Innovation: such that well-designed databases with cross-connectivity collect meaningful data so performance is challenged to improve, leading to innovation
8. Value Based Purchasing (VBP): by increasing transparency and informed consumer choice by full disclosure on cost and quality through metrics
9. Consumer education, engagement and accountability: based on metrics and related incentives within plans
10. Increased accountability across individual and organizational providers: to create high reliability systems; such as QI strategies with Six Sigma through each of its phases of Define, Measure, Analyze, Improve and Control (DMAIC).

The validity of outcome measure results depends upon how the measure is built and whether it addresses its purpose. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in 1998 started measuring hospital quality and in 2005 Centers for Medicare and Medicaid (CMS) began publicly reporting data. A study in 2011 on 4000 hospitals showed that the effect of measurement was significant with JCAHO accredited hospitals outperforming others.⁶ However, the question today is whether accreditation is simply a marker of higher quality and more rapid improvement or if it helps with outcomes that increase the value of care provided. Therefore, measurement has now shifted towards accountability measures,⁷ which are required to meet:

1. Strong scientific evidence with research demonstrating that compliance with a process of care improves outcomes
2. The process being measured must be in proximity to the outcome it impacts
3. The measure accurately should assess whether the evidence-based process has been provided
4. The measure should be designed to minimize or eliminate unintended adverse effects.

Measuring outcomes in rehabilitation is done in post-acute care / rehabilitation (PAC) at the provider and organizational level. Functional assessment is a systematic attempt to measure objectively across domains in a scientifically proven, valid, reliable, and efficient manner. Most functional assessment scales measure disability and disease progression, and monitor rehabilitation progress by documenting changes in health and functioning as an initial, interim, and final status.

The International Classification of Functioning, Disability, and Health (ICF) Core Sets cover the biopsychosocial model of disablement process. The ICF has two parts:  part 1 comprises body functions and structure, activities, and participation; and, part 2 consists of contextual factors, environmental and personal. A study comparing the Functional Index Measure (FIM) and Barthel Index (BI), which are used as predictors for functional recovery and decision rules for the prospective payment system (PPS), showed that it may be necessary to add items from the ICF core sets for PAC to increase sensitivity and prognostic value.⁸

Functional assessment scales range from specific, such as the FIM, to general quality of life scales which like the ICF core sets address a wide range of concerns and capabilities (e.g., pain, emotional state) with a subjective approach through patient’s self-reports. Scales may be appropriate for a range of medical conditions, while others are disease-specific, such as for patients with stroke, traumatic brain injury etc. Pediatric scales assess development of various functions, including growth, intelligence, behavior, and language, usually for specific age groups. Research showed that functional assessment could be developed into a science to understand the “biology of disability,” which refers to patterns of response to disability that may be dominant and, therefore, expected consequences of disability to differentiate from unexpected functional limitations.

Much of the conceptual background to understand disablement is from the 1980 World Health Organization (WHO) report, which first identified the consequences of illness. First there is disease, or the pathophysiologic processes. Next is impairment, or the manifest deficit in organs and organ systems, including functional limitations, followed by disability, or the behavioral and performance deficits as in ADLs and then, handicap, or the physical and social disadvantages.^9,10,11

Outcome Linked to Provider Payment

Outcomes have helped or affected reimbursement in rehabilitation. Demonstration of improved outcomes to payers has resulted in an increase likelihood of re-imbursement. In fact payers are rewarding clinicians for participating in projects such as PQRS or PRO (Patient Reported Outcomes).

The PPS for Medicare Part A inpatient rehabilitation facilities (IRF) became tied to the patient’s functional status severity level at the time of admission, length of stay (LOS) and Case Mix Group (CMG) index for comorbidities provided other regulatory conditions are met.  The physiatrist’s responsibilities include understanding coding and providing clear documentation and medical justification for the decision to admit and provide ongoing care in the IRF setting. It is recommended that the rehabilitation Medical Director acts as a Physician Administrator and monitors outcomes weekly to look into: LOS, DC, CMG, FIM gain, FIM efficiency, and patient satisfaction, in addition to program specific outcomes including falls.

Subacute rehabilitation payment with Resource Utilization Groups (RUGs) is done through the Minimum Data Set (MDS) that uses multiple functional assessment scales including the Confusion Assessment Method (CAM) and Patient Health Questionnaire (PHQ 9).

Health care has become a complex industry, with faster growth in outpatient services generating significant profit margins compared to inpatient utilization and margins. (12) Since there are varying insurance payments across clinical settings, and an aging population with increased prevalence of chronic health conditions, a rational system for linking assessments is needed.  Medicare Part B payments are being linked to value based models such as the Physician Quality Reporting System (PQRS) with incentives and penalties for not reporting. Outcomes measures need to be developed in Physical Medicine & Rehabilitation (PM&R) so that they have applicability to other stakeholders in PAC, and should be compatible with electronic health records (EHR) and decision-support.

Crosscutting measures, databases and registries are needed in PM&R to define and present our value within the system as critical stakeholders in Affordable Care Act (ACA). Cost of care for chronic health has doubled that for acute by at least twice. Parsimony is crucial with cost and quality linked closely. Third-party payments are based on services rendered and expected outcomes, meaning that focus on quality is correct. Physiatrists must balance benefit of treatment with cost and account perceptions of value of treatment from the viewpoint of the payer, patient, family, and community aligned with NQS priorities.¹³

The intelligent application of information technology (IT) can help achieve better outcomes for patients and improve the experience of people receiving care. Well-structured IT systems that share information can reduce complexities in the system, speed up treatment processes and enable more people to receive treatment in non-hospital environments.  IT is essential in assessing quality, through measuring levels of harm, to tracking patient outcomes and thereby ascertaining whether treatments have delivered the desired outcomes and provided value for money. This should include patient input in a ‘co-productive’ approach. Skills shortage is an issue. There is a world shortage of expertise in manipulating and interrogating large and complex datasets.

Personal health technologies such as Web services, mobile applications, and personal monitoring devices designed for individuals to manage their own health and wellness, are expected to enable more cost effective health promotion and disease prevention. These technologies thereby can help cut the costs of healthcare, work-related absenteeism, and disability. Personal health technologies could be used to deliver complete health promotion interventions or to support face-to-face interventions. Despite the high expectations placed on personal health technologies to cost-effectively support or deliver health promotion interventions to a broad range of users, high attrition rates, and modest health-related outcomes related to sustained usage may limit their potential.

Health information technology has the potential to improve compliance with recommended processes of care and outcome measures. Research has shown that having an electronic health record (EHR) is not enough to increase patient’s attainment of clinical targets: it is the specific functions within it – such as patient identification and tracking systems, problem lists, and electronic visit notes – that lead to improvements.

The job of a Physiatrist is to treat any disability across a life span resulting from disease or injury. The focus is on the development of a comprehensive program for restoring a person’s life and improving function. The challenge is to incorporate several evidence based outcome measurement tools that will be flexible with changing legislation but will improve the quality and safety of individuals affected by different disabilities. Measurement of outcome needs to become a part of practice and not an additional administrative burden.