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Randomized Controlled Trial
. 2016 Apr;31(4):402-10.
doi: 10.1007/s11606-015-3540-y.

Two Randomized Controlled Pilot Trials of Social Forces to Improve Statin Adherence among Patients with Diabetes

Peter P Reese  1   2   3 , Judd B Kessler  4 , Jalpa A Doshi  5   6 , Joelle Friedman  5 , Adam S Mussell  7 , Caroline Carney  5 , Jingsan Zhu  5 , Wenli Wang  5 , Andrea Troxel  8   5 , Peinie Young  9 , Victor Lawnicki  9 , Swapnil Rajpathak  10 , Kevin Volpp  5   4   11
Affiliations
Randomized Controlled Trial

Two Randomized Controlled Pilot Trials of Social Forces to Improve Statin Adherence among Patients with Diabetes

Peter P Reese et al. J Gen Intern Med. 2016 Apr.

Abstract

Background: Medication nonadherence is an important obstacle to cardiovascular disease management.

Objective: To improve adherence through real-time feedback based on theories of how social forces influence behavior.

Design: Two randomized controlled pilot trials called PROMOTE and SUPPORT. Participants stored statin medication in wireless-enabled pill bottles that transmitted adherence data to researchers.

Participants: Adults with diabetes and a history of low statin adherence based on pharmacy refills (i.e., Medication Possession Ratio [MPR] <80% in the pre-randomization screening period).

Intervention: In PROMOTE, each participant was randomized to 1) weekly messages in which that participant's statin adherence was compared to that of other participants (comparison), 2) weekly summaries of that participant's statin adherence (summary), or 3) control. In SUPPORT, each participant identified another person (the Medication Adherence Partner [MAP]) to receive reports about that participant's adherence, and was randomized to 1) daily reports to MAP, 2) weekly reports to MAP, 3) reports to MAP only if dose was missed, or 4) control.

Main outcomes measure: Adherence measured by pill bottle.

Key results: Among 45,000 health plan members contacted by mail, <1% joined the trial. Participants had low baseline MPRs (median = 60%, IQR 41-72%) but high pill-bottle adherence (90% in PROMOTE, 92% in SUPPORT) during the trial. In PROMOTE (n = 201) and SUPPORT (n = 200), no intervention demonstrated significantly better adherence vs.

Control: In a subgroup of PROMOTE participants with the lowest pre-study MPR, pill-bottle-measured adherence in the comparison arm (89%) was higher than the control (86%) and summary (76%) arms, but differences were non-significant (p = 0.10).

Conclusions: Interventions based on social forces did not improve medication adherence vs. control over a 3-month period. Given the low percentage of invited individuals who enrolled, the studies may have attracted participants who required little encouragement to improve adherence other than study participation.

Keywords: interventions; medication adherence; social force; social support; statins.

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Conflict of interest statement

Compliance with Ethical Standards Financial Support Funding for this study was provided by Merck, Sharpe, and Dohme Corp. The investigators had complete control over the recruitment procedures, data collection, data analysis, and presentation. Humana Inc. also provided support for the study by identifying potentially eligible members and mailing letters to those individuals. Conflict of Interest Kevin Volpp is a principal at the behavioral economics consulting firm VAL Health and has received consulting income and research support from CVS Health as well as research support from Humana, Weight Watchers, and the Vitality Institute (not related to Vitality, Inc., the manufacturer of the GlowCap pill bottle). Andrea Troxel has received consulting income from VAL Health and research support from the Vitality Institute and Weight Watchers. Jalpa Doshi has served as an advisory board member for Merck & Co., Inc., and has received research support from Humana, Pfizer, and Amgen. Peter Reese has received research support from CVS for studies of medication adherence. The other authors of this manuscript have no conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
Consort diagrams, by study.
Fig. 2
Fig. 2
PROMOTE overall mean weekly adherence, by Arm.
Fig. 3
Fig. 3
SUPPORT overall mean weekly adherence, by Arm.
See this image and copyright information in PMC

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