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

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 prerandomization 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 SUP-PORT) during the trial. In PROMOTE (n=201) and SUP-PORT (n=200), no intervention demonstrated significantly better adherence vs. control. In a subgroup of PRO-MOTE participants with the lowest pre-study MPR, pillbottle-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.

Recent Approaches to Improve Medication Adherence in Patients with Coronary Heart Disease: Progress Towards a Learning Healthcare System

“…Unfortunately, participants in neither arm significantly improved their adherence during the trial. This negative finding may be in part due to selection bias given the low percentage of invited individuals who actually enrolled [29••]. Future trials need to clarify our ability to “motivate” greater medication adherence.…”

Current Use of Statins for Primary Prevention of Cardiovascular Disease: Patient-Reported Outcomes and Adherence

“…impact on patient adherence [37]. One study compared a weekly email reporting system summarizing the patient's adherence to participants receiving no email alerts.…”

Partners and Alerts in Medication Adherence: A Randomized Clinical Trial

“…[16][17][18] Behavioral economics has shown that social forces can also motivate people to engage in beneficial actions like medication adherence, but these approaches are not well-studied. [19][20][21][22] In this study, we investigated the role of social support, in the form of suggesting participants enlist a medication adherence partner (MAP); the effect of alerting patients about their failure to adhere; and the combination of these two interventions.…”