Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial

Abstract

Objective To examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements. Research Design and Methods A multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8–9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs. Results Baseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group. Conclusions Diabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention. Trial Registration ClinicalTrials.gov ID NCT02132676

Effectiveness of shared medical appointments delivered in primary care for improving health outcomes in patients with long-term conditions: a systematic review of randomised controlled trials

“…Twenty-one trials (72%) were conducted in the USA,19–23 25 28–34 40 42–45 47 48 three in China27 35 37 and one each in Australia,24 Canada,26 Germany,36 Kenya41 and the UK 38. Nine trials measured the effectiveness, impact or efficacy of SMAs compared with usual care 19 21 25 27 32 34 42 47 48. Eight trials examined feasibility parameters,20 23 24 30 31 33 35 44 and three trials were non-inferiority/superiority trials 38 45 49.…”

“…In nine trials, participants were veterans or military personnel 22 25 29 39 40 42–45. Participants were from low-income communities in five trials,19 31 32 41 48 and uninsured communities in four US trials 20 21 30 33.…”

“…Sixteen trials (55%) had a majority of female participants 19–21 26–28 30–35 38 41 46 47. Twelve trials had a majority of male participants 22–25 28 29 37 39 40 42–45. One trial did not report the gender balance of participants 36…”

“…Six studies had a majority white population,22 25 34 42 44 46 six trials had a majority black population,19 20 23 43 45 51 three trials had a majority Hispanic population,31–33 three trials had a majority Asian population24 27 37 and one trial had a majority white-Latino population30 and one a majority non-white (black, Hispanic or Latina) 28. Nine studies did not report the ethnicity of participants 26 29 35 36 38–41 47…”

“…Two trials had a delayed 6-month waitlist control design 31 32. Three trials had a three-arm design: one examined the effectiveness of a cardiovascular risk reduction clinic compared with group medical visits and usual care40; and a second compared an automated telephone self-management service with SMAs and usual care30 a third compared a peer-to-peer support programme with SMAs and usual care 25. There was one 4-arm trial that compared usual clinical care, usual clinical care plus microfinance, SMAs only and SMAs integrated into microfinance group 41.…”