Susan Kirsh

Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

BackgroundMany interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts.MethodsWe used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts.ResultsThe CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct.ConclusionThe CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.

Shared medical appointments based on the chronic care model: a quality improvement project to address the challenges of patients with diabetes with high cardiovascular risk

Objective: The epidemic proportions and management complexity of diabetes have prompted efforts to improve clinic throughput and efficiency. One method of system redesign based on the chronic care model is the Shared Medical Appointment (SMA) in which groups of patients (8–20) are seen by a multi-disciplinary team in a 1–2 h appointment. Evaluation of the impact of SMAs on quality of care has been limited. The purpose of this quality improvement project was to improve intermediate outcome measures for diabetes (A1c, SBP, LDL-cholesterol) focusing on those patients at highest cardiovascular risk. Setting: Primary care clinic at a tertiary care academic medical center. Subjects: Patients with diabetes with one or more of the following: A1c >9%, SBP blood pressure >160 mm Hg and LDL-c >130 mg/dl were targeted for potential participation; other patients were referred by their primary care providers. Patients participated in at least one SMA from 4/05 to 9/05. Study design: Quasi-experimental with concurrent, but non-randomised controls (patients who participated in SMAs from 5/06 through 8/06; a retrospective period of observation prior to their SMA participation was used). Intervention: SMA system redesign Analytical methods: Paired and independent t tests, χ2 tests and Fisher Exact tests. Results: Each group had up to 8 patients. Patients participated in 1–7 visits. At the initial visit, 83.3% had A1c levels >9%, 30.6% had LDL-cholesterol levels >130 mg/dl, and 34.1% had SBP ⩾160 mm Hg. Levels of A1c, LDL-c and SBP all fell significantly postintervention with a mean (95% CI) decrease of A1c 1.4 (0.8, 2.1) (p<0.001), LDL-c 14.8 (2.3, 27.4) (p = 0.022) and SBP 16.0 (9.7, 22.3) (p<0.001). There were no significant differences at baseline between control and intervention groups in terms of age, baseline intermediate outcomes, or medication use. The reductions in A1c in % and SBP were greater in the intervention group relative to the control group: 1.44 vs –0.30 (p = 0.002) for A1c and 14.83 vs 2.54 mm Hg (p = 0.04) for SBP. LDL-c reduction was also greater in the intervention group, 16.0 vs 5.37 mg/dl, but the difference was not statistically significant (p = 0.29). Conclusions: We were able to initiate a programme of group visits in which participants achieved benefits in terms of cardiovascular risk reduction. Some barriers needed to be addressed, and the operations of SMAs evolved over time. Shared medical appointments for diabetes constitute a practical system redesign that may help to improve quality of care.

Nurse practitioner-led multidisciplinary teams to improve chronic illness care: the unique strengths of nurse practitioners applied to shared medical appointments/group visits.

Purpose: To describe the roles of nurse practitioners (NPs) in a novel model of healthcare delivery for patients with chronic disease: shared medical appointments (SMAs)/group visits based on the chronic care model (CCM). To map the specific skills of NPs to the six elements of the CCM: self‐management, decision support, delivery system design, clinical information systems, community resources, and organizational support. Data sources: Case studies of three disease‐specific multidisciplinary SMAs (diabetes, heart failure, and hypertension) in which NPs played a leadership role. Conclusions: NPs have multiple roles in development, implementation, and sustainability of SMAs as quality improvement interventions. Although the specific skills of NPs map out all six elements of the CCM, in our context, they had the greatest role in self‐management, decision support, and delivery system design. Implications for practice: With the increasing numbers of patients with chronic illnesses, healthcare systems are increasingly challenged to provide necessary care and empower patients to participate in that care. NPs can play a key role in helping to meet these challenges.

Tailoring an intervention to the context and system redesign related to the intervention: A case study of implementing shared medical appointments for diabetes

BackgroundIncorporating shared medical appointments (SMAs) or group visits into clinical practice to improve care and increase efficiency has become a popular intervention, but the processes to implement and sustain them have not been well described. The purpose of this study was to describe the process of implementation of SMAs in the local context of a primary care clinic over time.MethodsThe setting was a primary care clinic of an urban academic medical center of the Veterans Health Administration. We performed an in-depth case analysis utilizing both an innovations framework and a nested systems framework approach. This analysis helped organize and summarize implementation and sustainability issues, specifically: the pre-SMA local context; the processes of tailoring and implementation of the intervention; and the evolution and sustainability of the intervention and its context.ResultsBoth the improvement intervention and the local context co-adapted and evolved during implementation, ensuring sustainability. The most important promoting factors were the formation of a core team committed to quality and improvement, and the clinic leadership that was supported strongly by the team members. Tailoring had to also take into account key innovation-hindering factors, including limited resources (such as space), potential to alter longstanding patient-provider relationships, and organizational silos (disconnected groups) with core team members reporting to different supervisors.ConclusionAlthough interventions must be designed to meet the needs of the sites in which they are implemented, specific guidance tailored to the practice environment was lacking. SMAs require complex changes that impact on care routines, collaborations, and various organizational levels. Although the SMA was not envisioned originally as a form of system redesign that would alter the context in which it was implemented, it became clear that tailoring the intervention alone would not ensure sustainability, and therefore adjustments to the system were required. The innovation necessitated reconfiguring some aspects of the primary care clinic itself and other services from which the patients and the team were derived. In addition, the relationships among different parts of the system were altered.

High‐frequency binge eating predicts weight gain among veterans receiving behavioral weight loss treatments

To assess for the frequency of binge eating behavior and its association with weight loss in an overweight/obese sample of veterans.

Small-Changes Obesity Treatment Among Veterans: 12-Month Outcomes

BACKGROUND Weight-loss trials tend to recruit highly selective, non-representative samples. Effective weight-loss approaches are needed for real-world challenging populations. PURPOSE To test whether a small-changes intervention, delivered in groups or via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010-2012 and analyzed in 2013. DESIGN A three-arm, 12-month randomized pragmatic effectiveness trial. SETTING/PARTICIPANTS Four-hundred eighty-one overweight/obese participants from two Midwestern Veterans Affairs (VA) Medical Centers were randomly assigned to one of three programs: the 12-month Aspiring to Lifelong Health (ASPIRE) weight-loss program delivered (1) individually over the phone (ASPIRE-Phone) or (2) in-person group sessions (ASPIRE-Group); compared to (3) VAs standard weight-loss program (MOVE!). INTERVENTION Twenty-eight sessions with a non-clinician coach via telephone or in-person groups using a small-changes obesity treatment approach compared to a 15-30-session standard VA program. MAIN OUTCOME MEASURES Twelve-month change in weight (kilograms). RESULTS Participants in all three arms lost significant (p<0.01) weight at 12 months. Participants in the ASPIRE-Group arm lost significantly more weight at 12 months than those in the other two treatment arms (-2.8 kg, 95% CI=-3.8, -1.9, in ASPIRE-Group vs -1.4 kg, 95% CI=-2.4, -0.5, in ASPIRE-Phone and -1.4 kg, 95% CI=-2.3, -0.4) in MOVE!(®). ASPIRE-Group resulted in greater improvements in all other anthropometric measures compared to MOVE! at 12 months (p<0.05) and for all (p<0.05) but waist circumference (p=0.23) compared to ASPIRE-Phone. CONCLUSIONS Group-based delivery of the ASPIRE weight management program is more effective than MOVE! and the phone-based version of ASPIRE at promoting sustained weight loss in a predominantly male population with multiple comorbidities. The incremental benefits of group-based ASPIRE over the current MOVE! program could yield significant population-level benefits if implemented on a large scale.

A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial.

BACKGROUND Overweight/obesity rates among veterans are higher than the national average. While weight management treatment has been implemented in the Veterans Health Administration (VHA), program data shows low enrollment, participation, and weight loss. This paper presents the design, rationale and baseline characteristics of a multisite, multi-modality, randomized clinical trial assessing an innovative Small Changes (SC) approach on weight loss compared to the current weight management program in the VHA. METHOD Overweight/obese veterans were recruited from two VHA medical centers. Participants were randomized to either: 1) sc group, 2) SC phone, or 3) usual care. Participants in the SC arms met with health coaches weekly in months 1-3, bi-weekly in months 4-9, and monthly in months 10-12. Usual care participants met weekly for 12 weeks with limited options for follow-up care. The primary outcome is weight at 12 months. Secondary outcomes include physiological, behavioral, psychosocial outcomes along with participation and adherence. RESULTS Participants include 481 veterans who are middle-aged (M=55.45, SD=10.00), obese (BMI=36.45, SD=6.24), relatively sedentary (M=4721 steps per day; SD=3115), disabled (52%), men (85%) with a large minority of non-white race/ethnicity (43%) and high prevalence of physical co-morbidities (83%) (Charlson Co-morbidity Index M=1.27, SD=1.75) and mental health disorders (57%) at baseline. CONCLUSION The present study seeks to determine if an SC approach, delivered either via phone or in-person, will result in greater weight loss and program participation and adherence at 12 months compared to usual care.

The double edged sword of performance measurement.

A mong the high priority outcomes sought in reforming American health care are greater provider accountability, better processes of care and improved clinical outcomes, more satisfying care experiences for both patients and caregivers, and greater operational efficiency. Performance measurement is an essential tool for implementing strategies aimed at achieving these goals. In this issue of the Journal, Powell and colleagues describe a number of unintended consequences of implementing performance measurement in the Department of Veterans Affairs (VA) Health Care System, an early adopter of system-wide performance management. While there are significant limitations in generalizing the findings of this retrospective qualitative study, it is an important contribution to the growing body of evidence documenting the complexities of health care performance measurement and a poignant reminder that performance measurement is a tool that cuts both ways. Powell et al, report the findings of 59 semi-structured individual in-person interviews of primary care staff members and facility leaders at four VA facilities of varying size and levels of performance. They found local implementation of VA’s national performance measurement system led in some instances to provision of inappropriate clinical care, decreased provider attention to patient concerns and service, and compromised patient education and autonomy, as well as some adverse effects on primary care team dynamics. They additionally observed notable variation among the facilities in how performance data were shared with front line clinicians, strategies to improve performance, and application of rules. Concerns about the burden of reporting, clinical importance of some measures, inflexibility of automated clinical reminders and inequity in allocating financial rewards for improved performance were also commonly voiced in the interviews. While their study was not designed to determine the circumstances that led to the unintended consequences, they noted that in many cases the problems appeared to stem from local implementation methods rather than from the nationally determined performance measure definitions and policies. They observed both unintended positive and negative consequences, but described only negative effects in this report. Performance measurement is a tool widely used in diverse industries to monitor progress towards achieving identified goals and is increasingly being used in health care, although still limited due to health care’s poorly developed infrastructure supporting measurement processes and application of measure results, as well as the nascent state of health care performance measurement science. Current health care reform efforts portend far greater use of performance measurement. Multiple perils and pitfalls of performance measurement have been identified in recent years, especially in development and selection of measures, data collection, reporting and use of results. Similar to any generic tool, outcomes achieved with performance measurement depend in significant part on the specific ways the tool is utilized. Prominent recurring themes in the evolving literature about health care performance measurement systems are the need for clear performance measurement objectives, assiduous attention to measure specifications (including how individual patient circumstances and preferences will be addressed), and tight linkage of measures to outcomes or clinical processes known to be connected to outcomes. The critical importance of the context within which measurement results will be used has also become clear. The types of unintended consequences described by Powell et al. are not unique and emphasize the importance of local implementation in shaping how well broad performance measurement requirements inspire innovation and drive quality improvement. Measurement and public reporting of performance results were key features of the new performance management system implemented in the Veterans Health Administration (VHA) in 1995 as part of a multi-pronged change initiative. This integrated change strategy led to rapid and dramatic improvements in quality of care, service satisfaction and operational efficiency,prompting the Institute of Medicine, among others, to recommend that many VA quality management practices be broadly adopted in U.S. health care. However, the VHA’s leadership has turned over five times in the last 11 years, and the way performance measurement has been used during this time has changed. The changed context of performance measurement in the VA Published online January 21, 2012 JGIM

Shared medical appointments: a potential venue for education in interprofessional care.

Background Interprofessional practice has increasingly been recognized as important for chronic illness care. Recently, several health care professional-accrediting bodies have called for integration of interprofessional care and education. The shared medical appointment (SMA) is an interprofessional practice model that provides an educational opportunity. Objective A description of this innovative educational model, the challenges associated with the implementation, and the evaluation are presented. Method Mixed quantitative and qualitative analysis were utilized. Results Preliminary evaluation suggests that SMAs promote improved trainee/student understanding of both the complexity of diabetes care and the seriousness of the illness, along with an increased confidence in the ability to communicate with providers from other disciplines. Conclusion Further research to determine the efficacy of SMAs as an interprofessional training venue is needed that focuses on comprehensive assessment, necessary dose of exposure, and identification of barriers to overcome operational issues.

Building a Diabetes Registry from the Veterans Health Administration's Computerized Patient Record System

Background: Little information is available describing how to implement a disease registry from an electronic patient record system. The aim of this report is to describe the technology, methods, and utility of a diabetes registry populated by the Veterans Health Information Systems Architecture (VistA), which underlies the computerized patient record system of the Veterans Health Administration (VHA) in Veteran Affairs Integrated Service Network 10 (VISN 10). Methods: VISN 10 data from VistA were mapped to a relational SQL-based data system using KB_SQL software. Operational definitions for diabetes, active clinical management, and responsible providers were used to create views of patient-level data in the diabetes registry. Query Analyzer was used to access the data views directly. Semicustomizable reports were created by linking the diabetes registry to a Web page using Microsoft asp.net2. A retrospective observational study design was used to analyze trends in the process of care and outcomes. Results: Since October 2001, 81,227 patients with diabetes have enrolled in VISN 10: approximately 42,000 are currently under active management by VISN 10 providers. By tracking primary care visits, we assigned 91% to a clinic group responsible for diabetes care. In the Cleveland Veterans Affairs Medical Center (VAMC), the frequency of mean annual hemoglobin A1c levels ≥9% has declined significantly over 5 years. Almost 4000 patients have been seen in diabetes intervention programs in the Cleveland VAMC over the past 4 years. Conclusions: A diabetes registry can be populated from the database underlying the VHA electronic patient record database system and linked to Web-based and ad hoc queries useful for quality improvement.