Abstract and Introduction
Abstract
Objective This article describes the application of quality improvement methodology to implement a measurement tool for the assessment of functional status in pediatric patients with chronic pain referred for behavioral intervention.
Methods The Functional Disability Inventory (FDI), a validated instrument for assessment of pain-related disability, was chosen as the primary clinical outcome measure. Using improvement science methodology, PDSA (Plan-Do-Study-Act) cycles were run to evaluate: (a) regular FDI administration, (b) two administration methods, (c) regular patient feedback, and (d) documentation methods.
Results Within 1 month, psychologists were administering the FDI at least 80% of the time to patients. A high level of reliability using two administration methods (92.8%) was demonstrated. The FDI was feasible to integrate into clinical practice. Modifications to electronic records further enhanced clinician reliability of documentation.
Conclusions Quality improvement methods are an innovative way to make process changes in pediatric psychology settings to dependably gather and document evidence-based patient outcomes.
Inroduction
The Institute of Medicine (IOM) issued two landmark reports in 1999 and 2001, ("To Err is Human," and "Crossing the Quality Chasm"), citing the frequency of patients receiving insufficient, unsafe care and calling for a redesign of the United States healthcare system. [Institute of Medicine (U.S.). Committee on Quality of Health Care in America, 2001; Kohn, Corrigan, Donaldson, & Institute of Medicine (U.S.). Committee on Quality of Health Care in America.] Evidence-based practices typically have taken years to disseminate from "bench" (clinical trials) to "bedside" (clinical practice) (Balas & Boren, 2000) and often are delivered unreliably, with patients receiving recommended care only about 50% of the time (Mangione-Smith et al., 2007; McGlynn et al., 2003). Besides being the "right thing to do," patients deserve to receive those practices that have been proven effective and to be protected from "local habits" that are not grounded in empirical evidence (Berwick, 2002). Implementing evidence-based assessments to track clinical outcomes is one step toward accomplishing the goals of health care improvement in treating common pediatric conditions such as recurrent and chronic pain.
Despite research progress in the identification of empirically supported assessments for pediatric chronic pain, very little attention has been paid to how these might be efficiently and consistently integrated into actual practice in a way that is clinically meaningful. Clinical decision-making, such as when to end treatment or shift treatment goals, often occurs in the absence of systematic assessment of outcomes and therefore becomes a somewhat arbitrary practice that differs among clinicians. In an era where it is possible to use evidence-based assessment tools to assist in determining patient status and progress in treatment, many clinicians still rely on personal judgment or fail to reliably employ these tools throughout the course of treatment. This problem is compounded in large medical centers with heterogeneous patient populations and multiple providers, who vary in their implementation of evidence-based guidelines. One illustration in a pediatric psychology setting is that of our behavioral pain management program, which is a relatively high-volume service covered by multiple psychologists with no standardized practice of using evidence-based measures for assessing treatment outcomes in pediatric chronic pain. This situation is in fact typical of most healthcare settings and presents the ideal opportunity for implementing a quality improvement-based approach.
We chose pediatric patients with chronic pain to demonstrate the feasibility of using improvement science methodology to implement an assessment tool measuring clinical outcomes for several reasons: (a) chronic pain is common in children and adolescents (Perquin et al., 2000); and referrals for treatment of chronic headaches, back pain, abdominal pain, and diffuse musculoskeletal pain form a large proportion of referrals to our pediatric psychology service (Fig. 1); (b) there is good research evidence supporting the use of cognitive–behavioral therapy (CBT) to improve functioning and reduce disability in children and adolescents with chronic pain (Eccleston, Malleson, Clinch, Connell, & Sourbut, 2003; Kashikar-Zuck, Swain, Jones, & Graham, 2005; Robins, Smith, Glutting, & Bishop, 2005); and (c) several of our psychologists are already trained in delivering CBT for pediatric pain management.
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Figure 1.
Sixteen most common medical diagnoses of patients referred for services during fiscal year 2007 in the Division of Behavioral Medicine and Clinical Psychology.
While evidence-based assessment of clinical outcomes in pediatric chronic pain is an integral part of our research protocols, the integration of comparable measures into broader clinical practice remains a logistical challenge. Quality improvement methodology facilitates the translation of scientific, evidence-based assessment into a clinical practice setting in a unique way that considers contextual and environmental factors. Improvement science and clinical research share the common goal of improving patient outcomes. Nevertheless, these two methodologies often stand in tension with one another. For example, clinical research typically relies upon rigorous methodology, with narrow inclusion and exclusion criteria, large sample sizes, control groups, and lengthy duration (often years). However, this type of research can fail to consider the distinct nuances of systems such as the organizational structure and contextual factors (i.e., the processes of any given unit, clinic, or practice) (Berwick, 2008). Conversely, improvement methodology emphasizes small tests of change, small sample sizes, swift identification and response to problems, context considerations, and a lower threshold for instituting change. For our purposes, improvement methodology is well-suited for the implementation of a common assessment tool for measuring outcomes during behavioral pain management because such an endeavor is significantly impacted by contextual factors (i.e., psychologist "buy in," the clinical setting, highly diverse patient characteristics, therapists' treatment preferences) and requires flexible adaptation to our setting.
Unlike the lengthy assessments in clinical research, implementation of evidence-based clinical assessment within a healthcare setting requires a different approach. At the outset, it is crucial for clinicians to first come to consensus about a uniform indicator of clinical improvement that is practical to use in a busy clinic, acceptable to both patients and clinicians, and sensitive to treatment-related gains. While recent reviews highlight the necessity of assessing multiple core outcome domains for pediatric chronic pain (Cohen et al., 2008; McGrath et al., 2008), the magnitude of changing an entire program's clinical assessment strategy requires an initially narrow scope. A salient goal for pain assessment is to focus on patient functioning since (a) a rehabilitative model of behavioral pain management focuses primarily on return to usual levels of functioning (i.e., reduction of disability), while actively coping with and managing pain and (b) for some pain conditions (e.g., fibromyalgia and sickle cell disease), the nature of the illness implies that complete pain relief is highly unlikely. Since the assessment of functional limitations is such an important aspect of CBT for chronic pain, identifying an empirically supported assessment tool was indicated. Several measures of functional status have been used with a chronic pain population, including the Functional Disability Inventory (FDI) (Walker & Greene, 1991), the Child Activity Limitation Interview (CALI) (Palermo, Witherspoon, Valenzuela, & Drotar, 2004), and the Functional Status II (R) (Stein & Jessop, 1990). After reviewing the evidence for each of these measures, psychologists reached consensus and chose the FDI as a primary outcome measure. The FDI has been classified as a "well-established" measure, has good evidence of psychometric validity and reliability (Claar & Walker, 2006; Palermo et al., 2008), has been used in multiple pediatric pain populations, and has limited clinician burden in terms of length, administration, scoring, and interpretation (Palermo et al., 2008).
In this article, we describe the initial work towards applying evidence-based approaches to the assessment of pain-related disability in children and adolescents diagnosed with chronic pain. The primary objective is to illustrate the process of using improvement science methodology to put into practice an efficient, clinically useful measurement tool to evaluate patient functional status before, during, and at the conclusion of treatment among children and adolescents referred for outpatient, behavioral pain management.