Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial.

Importance: Financial incentives can improve medication adherence and cardiovascular disease risk, but the optimal design to promote sustained adherence after incentives are discontinued is unknown. Objective: To determine whether 6-month interventions involving different financial incentives to encourage statin adherence reduce low-density lipoprotein cholesterol (LDL-C) levels from baseline to 12 months. Design, Setting, and Participants: This 4-group, randomized clinical trial was conducted from August 2013 to July 2018 among several large US insurer or employer populations and the University of Pennsylvania Health System. The study population included adults with elevated risk of cardiovascular disease, suboptimal LDL-C control, and evidence of imperfect adherence to statin medication. Data analysis was performed from July 2017 to June 2019. Interventions: The interventions lasted 6 months during which all participants received daily medication reminders and an electronic pill bottle. Statin adherence was measured by opening the bottle. For participants randomized to the 3 intervention groups, adherence was rewarded with financial incentives. The sweepstakes group involved incentives for daily adherence. In the deadline sweepstakes group, incentives were reduced if participants were adherent only after a reminder. The sweepstakes plus deposit contract group split incentives between daily adherence and a monthly deposit reduced for each day of nonadherence. Main Outcomes and Measures: The primary outcome was change in LDL-C level from baseline to 12 months. Results: Among 805 participants randomized (199 in the simple daily sweepstakes group, 204 in the deadline sweepstakes group, 201 in the sweepstakes plus deposit contract group, and 201 in the control group), the mean (SD) age was 58.5 (10.3) years; 519 participants (64.5%) were women, 514 (63.9%) had diabetes, and 273 (33.9%) had cardiovascular disease. The mean (SD) baseline LDL-C level was 143.2 (42.5) mg/dL. Measured adherence at 6 months (defined as the proportion of 180 days with electronic pill bottle opening) in the control group (0.69; 95% CI, 0.66-0.72) was lower than that in the simple sweepstakes group (0.84; 95% CI, 0.81-0.87), the deadline sweepstakes group (0.86; 95% CI, 0.83-0.89), and the sweepstakes plus deposit contract group (0.87; 95% CI, 0.84-0.90) (P < .001 for each incentive group vs control). LDL-C levels were measured for 636 participants at 12 months. Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/dL (95% CI, 27.3-37.6 mg/dL) in the sweepstakes group, 33.2 mg/dL (95% CI, 28.1-38.3 mg/dL) in the deadline sweepstakes group, and 36.5 mg/dL (95% CI, 31.3-41.7 mg/dL) in the sweepstakes plus deposit contract group (adjusted P > .99 for each incentive group vs control). Conclusions and Relevance: Compared with the control group, different financial incentives improved measured statin adherence but not LDL-C levels. This result points to the importance of directly measuring health outcomes, rather than simply adherence, in trials aimed at improving health behaviors. Trial Registration: ClinicalTrials.gov Identifier: NCT01798784.

Perspectives of adolescents with severe obesity on social Media in Preparation for weight-loss surgery: a qualitative study.

BACKGROUND: Currently the most effective treatment for severe obesity in adolescents is weight-loss surgery coupled with lifestyle behavior change. In preparation for weight-loss surgery, adolescents are required to make changes to eating and activity habits (lifestyle changes) to promote long term success. Social media support groups, which are popular among adolescents, have the potential to augment preoperative lifestyle changes. The purpose of this study was to qualitatively assess the perceived role of social media as a support tool for weight-loss, and to identify motivators and constraints to lifestyle changes and social media use in adolescents preparing for weight-loss surgery. METHODS: Thematic analysis of social media comments from 13 (3 male, 10 female) adolescents aged 16 ± 1.3 years with a body mass index (BMI) 45 ± 7.3 kg/m2 enrolled in a weight-management program preparing for bariatric surgery and who participated in a 12-week pilot social media intervention was performed. Participants commented on moderator posts and videos of nutrition, physical activity, and motivation that were shared three to four times per week. Social media comments were coded using NVivo 11.0 to identify recurrent themes and subthemes. RESULTS: 1) Social media provided accountability, emotional support, and shared behavioral strategies. 2) Motivators for lifestyle changes included family support, personal goals, and non-scale victories. 3) Challenges included negative peers, challenges with planning and tracking, and time constraints. CONCLUSION: Adolescents considering bariatric surgery identified social media as a tool for social support and reinforcement of strategies for successful behavior change. Important motivators and challenges to lifestyle changes were identified.

The Habit Formation trial of behavioral economic interventions to improve statin use and reduce the risk of cardiovascular disease: Rationale, design and methodologies.

BACKGROUND: Low adherence to statin (HMG-CoA reductase inhibitors) medication is common. Here, we report on the design and implementation of the Habit Formation trial. This clinical trial assessed whether the interventions, based on principles from behavioral economics, might improve statin adherence and lipid control in at-risk populations. We describe the rationale and methods for the trial, recruitment, conduct and follow-up. We also report on several barriers we encountered with recruitment and conduct of the trial, solutions we devised and efforts we will make to assess their impact on our study. METHODS: Habit Formation is a four-arm randomized controlled trial. Recruitment of 805 participants at elevated risk of atherosclerotic cardiovascular disease with evidence of sub-optimal statin adherence and low-density lipoprotein (LDL) control is complete. Initially, we recruited from large employers (Employers) and a national health insurance company (Insurers) using mailed letters; individuals with a statin Medication Possession Ratio less than 80% were invited to participate. Respondents were enrolled if a laboratory measurement of low-density lipoprotein was >130 mg/dL. Subsequently, we recruited participants from the Penn Medicine Health System; individuals with usual-care low-density lipoprotein of >100 mg/dL in the electronic medical record were recruited using phone, text, email, and regular mail. Eligible participants self-reported incomplete medication adherence. During a 6-month intervention period, all participants received a wireless-enabled pill bottle for their statins and daily reminder messages to take their medication. Principles of behavioral economics were used to design three financial incentives, specifically a Simple Daily Sweepstakes rewarding daily medication adherence, a Deadline Sweepstakes where participants received either a full or reduced incentive depending on whether they took their medication before or after a daily reminder or Sweepstakes Plus Deposit Contract with incentives divided between daily sweepstakes and a monthly deposit. Six months post-incentives, we compared the primary outcome, mean change from baseline low-density lipoprotein, across arms. RESULTS AND LESSONS LEARNED: Health system recruitment yielded substantially better enrollment and was cost-efficient. Despite unexpected systematic failure and/or poor availability of two wireless pill bottles, we achieved enrollment targets and implemented the interventions. For new trials, we will routinely monitor device function and have contingency plans in the event of systemic failure. CONCLUSION: Interventions used in the Habit Formation trial could be translated into clinical practice. Within a large health system, successful recruitment depended on identification of eligible individuals through their electronic medical record, along with flexible ways of contacting these individuals. Challenges with device failure were manageable. The study will add to our understanding of optimally structuring and implementing incentives to motivate durable behavior change.

The association of financial incentives for low density lipoprotein cholesterol reduction with patient activation and motivation.

There is growing interest in using financial incentives for patients to improve medication adherence, but few studies have evaluated whether financial incentives are associated with patients' activation and motivation. We analyzed survey data collected as part of a randomized clinical trial conducted from 2011 to 2014 of four financial incentive interventions to reduce low density lipoprotein cholesterol (LDL-C) among patients at risk for atherosclerotic cardiovascular disease. The main trial included 1503 patients aged 18-80 and recruited from primary care practices affiliated with three health systems. Participants were randomized into four groups: patient financial incentives, primary care physicians (PCPs) incentives, patients and PCPs shared incentives, or no incentives for LDL-C control. Patient Activation Measure (PAM) and Treatment Self Regulation Questionnaire (TSRQ) surveys were administered at baseline and 12 months. Clinical outcomes were change in LDL-C at 12 and 15 months and average medication adherence as measured by electronic pill bottle opening. Mean changes in PAM and TSRQ scores were compared between patients eligible and not eligible for incentives. Clinical outcomes were tested against baseline and change in psychosocial measures using bivariate and multivariate regression. Change in PAM score and TSRQ autonomous subscore did not differ significantly between patients eligible and not eligible for incentives. Lower baseline and greater increase in TSRQ autonomous subscore were predictive of greater 15-month decrease in LDL-C. A financial incentive intervention to improve LDL-C control was not associated with changes in patients' activation or autonomous motivation. Increases in patient autonomous motivation are predictive of long-term LDL-C control.

Moderating Effects of Patient Characteristics on the Impact of Financial Incentives.

While financial incentives to providers or patients are increasingly common as a quality improvement strategy, their impact on patient subgroups and health care disparities is unclear. To examine these patterns, we analyzed data from a randomized clinical trial of financial incentives to lower low-density lipoprotein (LDL) cholesterol levels in patients at risk for cardiovascular disease. Patients with higher baseline LDL experienced greater cholesterol reductions in the shared incentive arm (0.23 mg/dL per unit change in baseline LDL, 95% CI [-0.46, -0.00]) but were also less likely to have medication potency increases in the physician incentive arm ( OR = 0.98, 95% CI [0.97, 0.996]). Uninsured patients and those of race other than Black or White were less likely to have potency increases in the shared incentive arm ( OR = 0.15, 95% CI [0.03, 0.70] and OR = 0.09, 95% CI [0.01, 0.93], respectively). These findings suggest some differential response to incentives, particularly in the form of targeted medication changes.

Patients' views of a behavioral intervention including financial incentives.

OBJECTIVES: Clinical trials are increasingly testing the effectiveness of paying patients' financial incentives for achieving desired clinical outcomes. Some researchers and providers are concerned that patient financial incentives will harm the doctor-patient relationship. How patients feel about these approaches, and these trials, is largely unknown. This study examined patients' perceptions of a compound behavioral and financial incentive intervention used in a large multicenter trial to lower low-density lipoprotein cholesterol (LDL-C), including their perceptions of benefits and challenges and the study's effect on patients' relationship with their primary care physicians (PCPs). STUDY DESIGN: Semi-structured telephone interviews with patients post intervention. METHODS: PCPs from 3 primary care practices in the northeastern United States were randomized to 1 of 4 arms: physician financial incentives, patient financial incentives, shared incentives between physicians and patients, and a control arm. Within each arm, 10 high, 10 medium, and 10 low performers in LDL-C reduction were interviewed. Interviews targeted reasons for enrolling in the study, the specific intervention elements that helped them reach the goal (incentives, engagement, monitoring), challenges faced in reducing cholesterol, and the impact of study participation on their relationship with their PCP. RESULTS: Patients reported positive experiences with the study: 65% described personal changes to improve health and 61% reported increased awareness. Views about financial incentives varied: 71% clearly found them motivating and 36% claimed they made no difference. Patients noted that changing lifestyle (36%) and diet (65%) was difficult. Patients who substantially lowered their LDL-C revealed themes similar to those who did not. CONCLUSIONS: Overall, behavioral interventions with financial incentives appear to be socially acceptable to patients who participate in them. Both adherence monitoring and financial incentives were well received, with little effect on the physician-patient relationship.

Effect of Financial Incentives to Physicians, Patients, or Both on Lipid Levels: A Randomized Clinical Trial.

IMPORTANCE: Financial incentives to physicians or patients are increasingly used, but their effectiveness is not well established. OBJECTIVE: To determine whether physician financial incentives, patient incentives, or shared physician and patient incentives are more effective than control in reducing levels of low-density lipoprotein cholesterol (LDL-C) among patients with high cardiovascular risk. DESIGN, SETTING, AND PARTICIPANTS: Four-group, multicenter, cluster randomized clinical trial with a 12-month intervention conducted from 2011 to 2014 in 3 primary care practices in the northeastern United States. Three hundred forty eligible primary care physicians (PCPs) were enrolled from a pool of 421. Of 25,627 potentially eligible patients of those PCPs, 1503 enrolled. Patients aged 18 to 80 years were eligible if they had a 10-year Framingham Risk Score (FRS) of 20% or greater, had coronary artery disease equivalents with LDL-C levels of 120 mg/dL or greater, or had an FRS of 10% to 20% with LDL-C levels of 140 mg/dL or greater. Investigators were blinded to study group, but participants were not. INTERVENTIONS: Primary care physicians were randomly assigned to control, physician incentives, patient incentives, or shared physician-patient incentives. Physicians in the physician incentives group were eligible to receive up to $1024 per enrolled patient meeting LDL-C goals. Patients in the patient incentives group were eligible for the same amount, distributed through daily lotteries tied to medication adherence. Physicians and patients in the shared incentives group shared these incentives. Physicians and patients in the control group received no incentives tied to outcomes, but all patient participants received up to $355 each for trial participation. MAIN OUTCOMES AND MEASURES: Change in LDL-C level at 12 months. RESULTS: Patients in the shared physician-patient incentives group achieved a mean reduction in LDL-C of 33.6 mg/dL (95% CI, 30.1-37.1; baseline, 160.1 mg/dL; 12 months, 126.4 mg/dL); those in physician incentives achieved a mean reduction of 27.9 mg/dL (95% CI, 24.9-31.0; baseline, 159.9 mg/dL; 12 months, 132.0 mg/dL); those in patient incentives achieved a mean reduction of 25.1 mg/dL (95% CI, 21.6-28.5; baseline, 160.6 mg/dL; 12 months, 135.5 mg/dL); and those in the control group achieved a mean reduction of 25.1 mg/dL (95% CI, 21.7-28.5; baseline, 161.5 mg/dL; 12 months, 136.4 mg/dL; P < .001 for comparison of all 4 groups). Only patients in the shared physician-patient incentives group achieved reductions in LDL-C levels statistically different from those in the control group (8.5 mg/dL; 95% CI, 3.8-13.3; P = .002). CONCLUSIONS AND RELEVANCE: In primary care practices, shared financial incentives for physicians and patients, but not incentives to physicians or patients alone, resulted in a statistically significant difference in reduction of LDL-C levels at 12 months. This reduction was modest, however, and further information is needed to understand whether this approach represents good value. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01346189.