HSR&D Home » Research » SDP 12-549 – HSR&D Study
VA Diabetes Prevention: Enhanced Implementation Evaluation
Laura J. Damschroder, MPH
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, MI
Funding Period: November 2013 - October 2015
Multiple large scale randomized controlled trials have shown that in people with impaired glucose tolerance, 40-60% of Type 2 diabetes cases can be prevented with lifestyles interventions that emphasize diet, exercise and weight loss. Despite the strong evidence base supporting preventability, the incidence of diabetes continues to increase. VA MOVE! does not specifically target those with pre-diabetes. Most veterans referred to VA MOVE! who do not already have a diagnosis of diabetes do not know if they are pre-diabetic. With a few exceptions, lifestyle modification interventions that target individuals with pre-diabetes and follow the Diabetes Prevention Program (DPP) curriculum are not available to Veterans with pre-diabetes in the VA. This project builds on two concurrent projects, the VA Diabetes Prevention clinical demonstration project funded by our partners at VA National Center for Health Promotion and Disease Prevention (NCP) and the QUERI funded RRP titled: VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot.
The overarching goal of this proposal is to provide our clinical partner, NCP, with evidence to guide future implementation of diabetes prevention strategies in the VA.
The specific aims of this study are to:
1. Test an implementation strategy and identify barriers and facilitators to implementation of the VA-DPP demonstration project at three VA medical centers using a mixed methods approach that is informed by the Consolidated Framework for Implementation Research (CFIR) and Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) frameworks.
2. Test for mediation of intervention effect on weight loss by constructs that are addressed differently in VA MOVE! and VA-DPP including group cohesion, intervention intensity, outcome expectations, goal awareness and commitment, and self-regulation skills.
3. Conduct cost-effectiveness and budget impact analyses of implementing the VA-DPP broadly in the VA from the perspective of the health system.
This was a Hybrid Type 3 mixed methods implementation evaluation project. Veterans referred to the VA MOVE! program at three VA medical centers were screened for the VA-DPP clinical demonstration project between August 2012 and January 2014. Veterans who had a HbA1c of 5.7-6.4 or a fasting plasma glucose of 100-125ml, lived within 60 minutes of the VAMC, and met additional inclusion criteria were assigned to the VA-DPP or MOVE! program using a systematic sampling approach. Participants were invited to complete surveys at baseline and 12 months. Medical records data were used to evaluate participation, health outcomes and conduct a cost effectiveness analyses. Qualitative data were elicited through interviews with a subset of participants. Additionally, staff interviews pre- and post-implementation were conducted and coded using the CFIR and RE-AIM implementation framework to inform implementation and to guide development of implementation strategies for future dissemination.
A total of 1850 patients were screened and/or attended a MOVE! orientation session at one of three VAMCs and were assessed for eligibility. Among these, 387 individuals met all eligibility criteria; 273 were assigned to the VA-DPP program and 114 were assigned to MOVE! program.
Among the 273 participants assigned to VA-DPP, 36% (n=98) explicitly declined to participate. However, our weight analyses at 6 and 12 months included all VA-DPP assigned participants consistent with an intent-to-treat (ITT) analytic approach. One patient who did not have a baseline weight assessment was excluded, leaving a final analytic weight sample of 386 participants (VA-DPP n=273, MOVE! n=113). For HbA1c outcomes assessment, patients were excluded who did not have a baseline HbA1c or FPG within six months of enrollment (n=6) and participants who did not complete a follow-up HbA1c test (n=71), leaving a final analytic HgA1c sample of 310 participants (VA-DPP n=210, MOVE! n=100).
Participants were mostly middle-aged with an average HbA1c of 6.0% and co-morbid hypertension. All baseline characteristics were comparable between study arms except for race/ethnicity. MOVE! program participants had a higher percentage of Hispanics and lower proportions of African Americans and Caucasians (p = 0.04). Participants were representative of the VHA population (overweight/obese males) and also reflected the racial/ethnic diversity at the three VAMCs included in this trial.
Participation rates were higher in the VA-DPP program over the 12 months. In the first 6 months, 88.3% of VA-DPP participants and 84% of MOVE! participants completed at least one session of their respective program and 55.0% and 42.4%, respectively, completed at least 4 sessions.
Based on adjusted outcomes within groups, participants in the VA-DPP had statistically significant weight loss at 6 and 12 months but MOVE! program participants did not. There were significant differences in predicted weight change between arms at 6 months (MOVE! -1.9 kg vs. VA-DPP -4.1kg, p<0.001) but not at 12 months (MOVE! -2.0 vs. VA-DPP -3.4kg, p=0.16). After controlling for covariates, HbA1c at 12 months did not show significant changes from baseline, and no difference was found in the predicted HbA1c change at 12 months by study arm (MOVE! 0.06 vs. VA-DPP -0.02, p=0.34).
The quality of coaching, reflected by fidelity ratings for coach characteristics, was rated highly for both programs. However, VA-DPP had higher fidelity ratings for four domains of program delivery. Thus, though session leaders for both programs tended to come "prepared and organized," the programs differed in many other ways, e.g., more "positive relationships among the group members" in VA-DPP than MOVE!. Additionally, VA-DPP participants reported higher satisfaction for six of eight items related to their program. Together, these differences may partially explain weight loss differences, and perhaps more importantly the higher rates of continued engagement of VA-DPP participants. Multi-faceted strategies are needed to successfully reach targeted patients and to implement and maintain the DPP in a clinical setting.
Implementation of the VA-DPP demonstration program has the potential to significantly improve health outcomes for Veterans by delaying or preventing the onset of Type 2 diabetes. The research component of the VA-DPP contributed to our knowledge about the incidence of pre-diabetes in Veterans, their attitudes and beliefs about diet, exercise and weight loss, and understanding how different programs may impact weight loss.
Preliminary VA-DPP data provided important and relevant information to NCP who updated MOVE! group visit guidance to align more closely with the DPP's curriculum for all Veterans, not just those with pre-diabetes.
This work, along with other projects, also helped lead to our newly funded MOVE! LEAP project as part of our new PRoVE QUERI program.
External Links for this Project
NIH ReporterGrant Number: I01HX001204-01
Dimensions for VADimensions for VA is a web-based tool available to VA staff that enables detailed searches of published research and research projects.
If you have VA-Intranet access, click here for more information vaww.hsrd.research.va.gov/dimensions/
VA staff not currently on the VA network can access Dimensions by registering for an account using their VA email address. Search Dimensions for this project
DRA: Aging, Older Veterans' Health and Care, Diabetes and Other Endocrine Disorders
MeSH Terms: none