Qualitative Exploration of Barriers to Statin Adherence and Lipid Control: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Financial incentives may improve health by rewarding patients for focusing on present actions-such as medication regimen adherence-that provide longer-term health benefits. Objective: To identify barriers to improving statin therapy adherence and control of cholesterol levels with financial incentives and insights for the design of future interventions. Design, Setting, and Participants: This qualitative study involved retrospective interviews with participants in a preplanned secondary analysis of a randomized clinical trial of financial incentives for statin therapy adherence. A total of 636 trial participants from several US insurer or employer populations and an academic health system were rank ordered by change in low-density lipoprotein cholesterol (LDLC) levels. Participants with the most LDLC level improvement (high-improvement group) and those with LDLC levels that did not improve (nonimprovement group) were purposively targeted, stratified across all trial groups, for semistructured telephone interviews that were performed from April 1 to June 30, 2018. Interviews were coded using a team-based, iterative approach. Data were analyzed from July 1, 2018, to October 31, 2020. Main Outcomes and Measures: The primary outcome was mean change in LDLC level from baseline to 12 months; the secondary outcome, statin therapy adherence during the first 6 months. Results: A total of 54 patients were interviewed, divided equally between high-improvement and nonimprovement groups, with a mean (SD) age of 43.5 (10.3) years; 36 (66.7%) were women, 28 (51.9%) had diabetes, and 18 (33.3%) had cardiovascular disease. Compared with the high-improvement group, the nonimprovement group had fewer interviewees with an annual income of greater than $50 000 (11 [40.7%] vs 22 [81.5%]), worse self-reported health (fair to poor, 13 [48.1%] vs 3 [11.1%]), more Black interviewees (16 [59.3%] vs 4 [14.8%]), and lower baseline LDLC levels (>160 mg/dL, 2 [7.4%] vs 25 [92.6%]). Participants in the nonimprovement group had a greater burden of chronic illness (≥2 chronic conditions, 13 [48.1%] vs 6 [22.2%]) and were less frequently employed (full-time, 6 [22.2%] vs 12 [44.4%]). In interviews, the nonimprovement group was less focused on risks of high LDLC levels, described less engagement in LDLC level management, articulated fewer specific nutritional choices for optimizing health, and recounted greater difficulty obtaining healthy food. Participants in both groups had difficulty describing the structure of the financial incentives but did recall features of the electronic pill containers used to track adherence and how those containers affected medication routines. Conclusions and Relevance: Participants in a statin adherence trial whose LDLC levels did not improve found it more difficult to create medication routines and respond to financial incentives in the context of complex living conditions and a high burden of chronic illness. These findings suggest that future studies should be more attentive to socioeconomic circumstances of trial participants. Trial Registration: ClinicalTrials.gov Identifier: NCT01798784.