Practice Facilitation to Improve Diabetes Care in Primary Care: A Report From the EPIC Randomized Clinical Trial

INTRODUCTION

To meet the challenges of a reformed health care system, primary care must adopt substantially new models such as the Patient-Centered Medical Home (PCMH) and integrate their work within accountable care organizations.^1–4 The PCMH has emerged as a cornerstone of primary care redesign with its strong appeal of uniting 4 compelling areas of health care reform: (1) the well-demonstrated value of primary care based on 4 core attributes,^5–6 (2) proactive, population-based approaches to chronic care, (3) consumerism and patient-centered care, and (4) new health information technology. Much of the redesign effort has focused on implementing the Chronic Care Model,^6,7 which has been associated with better health outcomes for patients with chronic conditions and, specifically, type 2 diabetes^8,9; however, data regarding adoption of this model’s principles into primary care practices have been disappointing.^10,11 Primary care practices have few mechanisms for incorporating new programs, which can slow adoption of innovations and cause disruptions when innovations are finally implemented.^12–16 With the central importance of primary care in health care redesign models such as the PCMH and accountable care organizations, effective strategies for enhancing primary care practice improvement and transformation are critically important.

Practice facilitation has emerged as a key method for assisting practices in implementing organizational changes.^17–21 Facilitators can assist practices in implementing evidence-based programs, tailoring programs to individual practice situations, improving incorporation into operations, and increasing sustainability. Emerging evidence indicates that practice facilitation can be successful in improving preventive care^18–20 and implementing aspects of the PCMH.^21–23

Different approaches to practice facilitation have been described, but studies to determine optimal characteristics of facilitation are lacking. A recent meta-analysis found a relationship between the intensity of facilitation and effect size, but no relationship between the duration of facilitation and effect size.²⁰ Aspects of facilitation are generally shared across approaches, including the formation of improvement teams consisting of diverse practice members who meet regularly to plan and implement changes²⁴; however, the strategies and theoretical framework of the change process have been quite different across various facilitation programs. The model used most widely has been based on continuous quality improvement (CQI), using a series of incremental plan-do-study-act cycles focused on quality measures to implement practice improvements.^25–27

Others have adopted more systemic approaches to change based on complexity science, including the reflective adaptive process (RAP).^28–30 Organizational culture has been shown to be associated with successful innovation and quality of care in medical practices.^31–33 RAP focuses on enhancing practice capacity to make change by improving a practice’s change culture, communication, problem solving, and organizational learning to lay the groundwork for an ongoing process of change and improvement.

We undertook a cluster-randomized controlled trial, Enhancing Practice, Improving Care (EPIC), to compare the effectiveness of 3 approaches for implementing and sustaining Chronic Care Model–based systems to improve diabetes care: (1) practice facilitation using a RAP approach to stimulate reflective conversations and improve the practice’s capacity to manage change, applying the change process to diabetes care; (2) practice facilitation using a CQI approach to implement quality improvement for diabetes to improve diabetes care; and (3) providing self-directed (SD) practices with information and resources about the Chronic Care Model and quality improvement to improve diabetes care, but without facilitation. Our hypotheses were that (1) the RAP approach would improve practice change culture to a greater and more sustained degree than the CQI or self-directed approaches; (2) the CQI approach would lead more quickly to improvement in diabetes performance measures than the RAP or SD approaches; and (3) the RAP approach would produce more sustained improvements in performance measures through positive impact on practice change and work cultures.

METHODS

RESULTS

The CONSORT (Consolidated Standards of Reporting Trials) diagram of practice, patient, clinician, and staff flow is shown in Figure 1. Before baseline data collection, 2 practices dropped out: 1 was disqualified for sharing personnel with another enrolled practice, and 1 was closed because of death of a physician. Between baseline and 9 months, 4 practices discontinued work with the facilitators. From practice-generated lists of patients with diabetes, we audited a random sample of 822 charts for diabetes process of care and outcomes. Clinician and staff response rates for the Practice Culture Assessment survey were 64% at baseline, 47% at 9 months, and 52% at 18 months.

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Figure 1

CONSORT diagram.

CONSORT = Consolidated Standards of Reporting Trials; CQI = continuous quality improvement; RAP = reflective adaptive process; SD = self-directed.

Notes: 2 RAP practices and 2 CQI practices had limited or no active participation after baseline. Clinicians surveyed using the Assessment of Clinician Diabetes Management included all physicians, nurse practitioners, and physician assistants. Clinicians and staff surveyed using the Practice Culture Assessment included everyone in any role in the practice.

DISCUSSION

In this comparative trial of 3 strategies for implementing the Chronic Care Model to improve diabetes care, all 3 study groups had significant improvement in diabetes process of care. CQI practices, which followed a prescribed strategy of implementing registries to have diabetes quality measures to motivate practice action, identify needed changes, and monitor progress, had significantly greater improvement in diabetes process measures than practices in the other 2 groups, but little change in practice culture. RAP practices, which followed a more practice-determined approach particularly aimed at improving practice culture, had significantly less improvement in diabetes measures than CQI or SD practices. RAP practices showed marginal improvement in Change Culture at 9 months followedby a decline at 18 months, along with a decline in Work Culture at 18 months. The slight but significant increases in practice chaos levels in the 2 facilitated study arms is interesting but expected, as implementation of such a change process tends to cause some chaos and disruptions in practice routines.

Traditional quality improvement strategies can be successful in implementing specific tools to improve quality measures in a focused, disease-specific area (such as the CQI intervention in our study), but this approach has been criticized for failing to achieve sustained improvements or highly adaptable practice cultures capable of innovating effectively. In this study, most improvements in overall diabetes process of care occurred during the initial 9-month period, and this improvement was sustained at 18 months.

The RAP model attempts to facilitate an adaptive learning organization that can generate ongoing efforts to enhance overall practice functioning, including quality measures. Similarto EPIC, the ULTRA project (Using Learning Teams for Reflective Adaptation) hypothesized that a facilitated RAP intervention would produce effective communication and change strategies that would subsequently lead to improved quality measures.³⁰ That study found that practices identified and addressed issues related to communication, access to care, and access to information, but none focused on improving adherence to chronic disease care guidelines, and patient outcomes were not affected.³⁰ Other studies have demonstrated that certain aspects of practice culture are associated with successful implementation of quality improvement interventions and improved patient process of care^31–33; thus, improvements in practice culture through facilitation may enhance the practice’s ability to successfully change. In this study, practice culture may have been adversely affected by facilitators leaving the practice before stable improvements were achieved.

Although significant improvements were made in diabetes measures in all 3 study groups, care was still suboptimal at the end of the study period. Implementation of major changes in practices to improve care is not a quick process, and a sustained effort by practices (and organizations supporting them) to achieve the long-term improvements is needed. Further testing of intervention models for achieving these long-term improvements is warranted. Incremental changes are helpful, but major, transformational changes are needed.

It is an interesting and fairly consistent finding in quality improvement projects that process of care measures are easier to improve and respond more quickly than patient outcome measures, a pattern seen again in our study. In Glasgow’s Diabetes Priority Program study, patients of physicians randomized to the intervention had greater improvement in diabetes process of care than patients of physicians in the control group.⁴⁰ These changes did not translate into statistically greater improvement in clinical outcomes, however. In a subsequent analysis of data from that study, Nutting et al⁴¹ demonstrated that greater clinician-reported use of elements of the Chronic Care Model was associated with improved patient clinical outcomes. This association certainly needs continued attention in our quality improvement and practice redesign efforts, as improvement in clinical outcomes are, in the long term, much more important than improved process measures.

Limitations of our study included differences in some baseline practice characteristics across groups, despite attempts to balance the groups by stratification. This imbalance could have resulted in greater room for improvement in some quality measures in CQI and SD practices. Also, the self-report Practice Culture Assessment data were potentially subject to bias, although such bias would likely be similar across groups.

The EPIC trial, framed in the context of related efforts, suggests several things: (1) traditional CQI interventions are effective at improving chronic disease quality metrics but may not improve practice culture; (2) motivated primary care practices can make some improvements with minimal assistance; (3) a short-term RAP-based intervention to improve practice culture may not be effective in primary care practices; (4) not all primary care practices may need the same type, intensity, or duration of assistance, and tailoring the approach to the practice is desirable; however, more information is necessary to guide the tailoring process; and (5) new models are needed to produce the long-term improvements in both quality measures and practice culture necessary for sustained enhancement of primary care practices. Additionally, heterogeneity in practices’ response to interventions suggests potential avenuesfor further exploration regarding which practices may respond best to which approaches, as well as identifying potential practice-level mediators of improvement.

The insights gained from the EPIC trial have ramifications for the further development and deployment of advanced primary care models that will be central in the redesigned health care system. Transforming the nation’s primary care practices will require a serious investment, and practice facilitation has been proposed as a foundation for change through a health extension service.⁴² Transformation to a PCMH requires more extensive change than improving diabetes care. The National Demonstration Project showed that even with 2 years of intense facilitation, implementing all PCMH components was very difficult.^21,22 Although we can learna great deal from disease-specific studies, the policy issues they inform must consider more complex, interdependent changes to achieve comprehensive primary care and health system redesign. Practice facilitators attempting to promote sustained change in practices will need a broad range of skills in assessing practice culture, managing group process over time, and providing instrumental assistance to strengthen the 4 pillars of primary care, develop proactive population-based chronic and preventive care, and enhance patient centeredness and self-management support. Those who deploy practice facilitators must be prepared to assist practices over time, as a quick-in, quick-out approach will be ineffective in producing sustained comprehensive change. Further study is needed to compare different approaches, to identify salient characteristics of successful practice facilitation models, to determine the optimum “dosing” of practice facilitation for various targeted outcomes, to determine the characteristics of practices that respond to various change strategies, and to refine current approaches to achieve the dual goals of implementing innovations and enhancing practice change culture.