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

Abstract

Background: Understanding 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.

Methods: We 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.

Results: We 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.

Conclusions: We 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 registration: ClinicalTrials.gov ID: NCT02132676 .

Keywords: Adaptation; CFIR; Diabetes; Facilitation; Formative evaluation; Implementation; Qualitative research; Shared medical appointments.

Conflict of interest statement

Author’s information

CPK was trained in epidemiology at the University of Michigan and works for the Center for Clinical Management Research (CCMR) at the Ann Arbor Veterans Affairs Healthcare System. She leads a national Implementation Research Group (IRG) of 250 members for the Center for Evaluation and Implementation Resources (CEIR) that provides continuning education, training, and sharing of best practices in implementation science. Her expertise over the last 15 years includes formative evaluation, qualitative interviewing and analysis, adaptations and fidelity, and implementation science.

MV obtained her Bachelor of Science from the University of Michigan and currently works as the research associate on the SHARES study.

MK is a physician Research Scientist at the Ann Arbor Center for Clinical Management Research (CCMR). She is also Director of the Community Engagement and Outreach Core of the Michigan Center for Diabetes Translational Research (MCDTR), one of five DTRs funded by the National Institutes of Health to provide assistance to researchers conducting novel interventions to improve diabetes care. MK has expertise in the development and evaluation of health system and behavioral interventions to improve between-clinic visit chronic disease self-management and outcomes. She has served as PI on multiple multi-site effectiveness and implementation studies evaluating different peer support models and health team outreach programs to improve glycemic, blood pressure, and other risk factor control in diabetes. She is also PI on an AHRQ grant that developed a diabetes web-based decision aid that peer mentors and other outreach workers can use with patients to improve diabetes treatment decision-making.

Ethics approval and consent to participate

The SHARES study was approved by the Veterans Affairs Central Institutional Review Board (C-IRB) (reference number 13–21). All participants consented to participate and were informed that their participation was completely voluntary. The consent process was executed as governed by the Central IRB. Staff members were provided with a Study Information Sheet at the time of recruitment and verbal consent was obtained prior to the start of the interview. Verbal consent for staff interviews was approved by the CIRB, as the study is considered minimal risk and obtaining written consent would place an additional burden on participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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