Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption

Christine P Kowalski,Miranda Veeser,Michele Heisler

doi:10.1186/s12875-018-0797-3

Abstract

BackgroundUnderstanding the many factors that influence implementation of new programs, in addition to their success or failure, is extraordinarily complex. This qualitative study examines the implementation and adaptation process of two linked clinical programs within Primary Care, diabetes shared medical appointments (SMAs) and a reciprocal Peer-to-Peer (P2P) support program for patients with poorly controlled diabetes, through the lens of the Consolidated Framework for Implementation Research (CFIR). We illustrate the role and importance of pre-implementation interviews for guiding ongoing adaptations to improve implementation of a clinical program, achieve optimal change, and avoid type III errors.MethodsWe conducted 28 semi-structured phone interviews between September of 2013 and May of 2016, four to seven interviewees at each site. The interviewees were physician champions, chiefs of primary care, pharmacists, dieticians, nurses, health psychologists, peer facilitators, and research coordinators. Modifiable barriers and facilitators to implementation were identified and adaptations documented. Data analysis started with immersion in the data to obtain a sense of the whole and then by cataloging principal themes per CFIR constructs. An iterative consensus-building process was used to code. CFIR constructs were then ranked and compared by the researchers.ResultsWe identified a subset of CFIR constructs that are most likely to play a role in the effectiveness of the diabetes SMAs and P2P program based on our work with the participating sites to date. Through the identification of barriers and facilitators, a subset of CFIR constructs arose, including evidence strength and quality, relative advantage, adaptability, complexity, patient needs and resources, compatibility, leadership engagement, available resources, knowledge and beliefs, and champions.ConclusionsWe described our method for identification of contextual factors that influenced implementation of complex diabetes clinical programs - SMAs and P2P. The qualitative phone interviews aided implementation through the identification of modifiable barriers or conversely, actionable findings. Implementation projects, and certainly clinical programs, do not have unlimited resources and these interviews allowed us to determine which facets to target and act on for each site. As the study progresses, these findings will be compared and correlated to outcome measures. This comprehensive adaptation data collection will also facilitate and enhance understanding of the future success or lack of success of implementation and inform potential for translation and public health impact. The approach of using the CFIR to guide us to actionable findings and help us better understand barriers and facilitators has broad applicability and can be used by other projects to guide, adapt, and improve implementation of research into practice.Trial registrationClinicalTrials.gov ID: NCT02132676.

Highlights

Understanding the many factors that influence implementation of new programs, in addition to their success or failure, is extraordinarily complex
Based on our work with the participating sites to date, we identified a subset of Consolidated Framework for Implementation Research (CFIR) constructs that are most likely to play a role in the implementation and possibly effectiveness of the diabetes Shared Medical Appointments (SMA) and the P2P program, including evidence strength and quality, relative advantage, adaptability, complexity, patient needs and resources, compatibility, leadership engagement, available resources, knowledge and beliefs, and champions (Table 4)
Data from any organizational aspect mentioned by interviewees, and all CFIR constructs, were coded, these specific constructs formed the basis of primary qualitative analyses due to the depth and frequency of the construct throughout the interviews and qualitative analysis

Summary

Introduction

Understanding the many factors that influence implementation of new programs, in addition to their success or failure, is extraordinarily complex. Summative data often leads to the term “implementation black box” [3]: there is no way to understand the specific reasons the intervention succeeded or failed, how it was implemented, and how local contextual factors affected implementation This is where formative evaluation comes in, to fill in these gaps and to systematically examine key features of the local implementation setting, detect and monitor unanticipated events and adjust if necessary in real-time, optimize implementation to improve potential for success, and avoid type III errors—the failure to detect differences between the original intervention plan and the ultimate manner of implementation that lead to failure to achieve outcomes [1, 4]. This understanding is essential for efforts to sustain, scale up, and disseminate any new program–otherwise there is potential for failure to account for specific contextual issues in program implementation

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Discussion

Conclusion