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.

Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial.

BACKGROUND: Financial incentive designs to increase physical activity have not been well-examined. OBJECTIVE: To test the effectiveness of 3 methods to frame financial incentives to increase physical activity among overweight and obese adults. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov: NCT 02030119). SETTING: University of Pennsylvania. PARTICIPANTS: 281 adult employees (body mass index ≥27 kg/m2). INTERVENTION: 13-week intervention. Participants had a goal of 7000 steps per day and were randomly assigned to a control group with daily feedback or 1 of 3 financial incentive programs with daily feedback: a gain incentive ($1.40 given each day the goal was achieved), lottery incentive (daily eligibility [expected value approximately $1.40] if goal was achieved), or loss incentive ($42 allocated monthly upfront and $1.40 removed each day the goal was not achieved). Participants were followed for another 13 weeks with daily performance feedback but no incentives. MEASUREMENTS: Primary outcome was the mean proportion of participant-days that the 7000-step goal was achieved during the intervention. Secondary outcomes included the mean proportion of participant-days achieving the goal during follow-up and the mean daily steps during intervention and follow-up. RESULTS: The mean proportion of participant-days achieving the goal was 0.30 (95% CI, 0.22 to 0.37) in the control group, 0.35 (CI, 0.28 to 0.42) in the gain-incentive group, 0.36 (CI, 0.29 to 0.43) in the lottery-incentive group, and 0.45 (CI, 0.38 to 0.52) in the loss-incentive group. In adjusted analyses, only the loss-incentive group had a significantly greater mean proportion of participant-days achieving the goal than control (adjusted difference, 0.16 [CI, 0.06 to 0.26]; P = 0.001), but the adjusted difference in mean daily steps was not significant (861 [CI, 24 to 1746]; P = 0.056). During follow-up, daily steps decreased for all incentive groups and were not different from control. LIMITATION: Single employer. CONCLUSION: Financial incentives framed as a loss were most effective for achieving physical activity goals. PRIMARY FUNDING SOURCE: National Institute on Aging.

Individual Versus Team-Based Financial Incentives to Increase Physical Activity: A Randomized, Controlled Trial.

BACKGROUND: More than half of adults in the United States do not attain the minimum recommended level of physical activity to achieve health benefits. The optimal design of financial incentives to promote physical activity is unknown. OBJECTIVE: To compare the effectiveness of individual versus team-based financial incentives to increase physical activity. DESIGN: Randomized, controlled trial comparing three interventions to control. PARTICIPANTS: Three hundred and four adult employees from an organization in Philadelphia formed 76 four-member teams. INTERVENTIONS: All participants received daily feedback on performance towards achieving a daily 7000 step goal during the intervention (weeks 1- 13) and follow-up (weeks 14- 26) periods. The control arm received no other intervention. In the three financial incentive arms, drawings were held in which one team was selected as the winner every other day during the 13-week intervention. A participant on a winning team was eligible as follows: $50 if he or she met the goal (individual incentive), $50 only if all four team members met the goal (team incentive), or $20 if he or she met the goal individually and $10 more for each of three teammates that also met the goal (combined incentive). MAIN MEASURES: Mean proportion of participant-days achieving the 7000 step goal during the intervention. KEY RESULTS: Compared to the control group during the intervention period, the mean proportion achieving the 7000 step goal was significantly greater for the combined incentive (0.35 vs. 0.18, difference: 0.17, 95 % confidence interval [CI]: 0.07-0.28, p <0.001) but not for the individual incentive (0.25 vs 0.18, difference: 0.08, 95 % CI: -0.02-0.18, p = 0.13) or the team incentive (0.17 vs 0.18, difference: -0.003, 95 % CI: -0.11-0.10, p = 0.96). The combined incentive arm participants also achieved the goal at significantly greater rates than the team incentive (0.35 vs. 0.17, difference: 0.18, 95 % CI: 0.08-0.28, p < 0.001), but not the individual incentive (0.35 vs. 0.25, difference: 0.10, 95 % CI: -0.001-0.19, p = 0.05). Only the combined incentive had greater mean daily steps than control (difference: 1446, 95 % CI: 448-2444, p ≤ 0.005). There were no significant differences between arms during the follow-up period (weeks 14- 26). CONCLUSIONS: Financial incentives rewarded for a combination of individual and team performance were most effective for increasing physical activity. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02001194.

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.

Effect of Financial Incentives and Environmental Strategies on Weight Loss in the Healthy Weigh Study: A Randomized Clinical Trial.

Importance: Modest weight loss can lead to meaningful risk reduction in adults with obesity. Although both behavioral economic incentives and environmental change strategies have shown promise for initial weight loss, to date they have not been combined, or compared, in a randomized clinical trial. Objective: To test the relative effectiveness of financial incentives and environmental strategies, alone and in combination, on initial weight loss and maintenance of weight loss in adults with obesity. Design, Setting, and Participants: This randomized clinical trial was conducted from 2015 to 2019 at 3 large employers in Philadelphia, Pennsylvania. A 2-by-2 factorial design was used to compare the effects of lottery-based financial incentives, environmental strategies, and their combination vs usual care on weight loss and maintenance. Interventions were delivered via website, text messages, and social media. Participants included adult employees with a body mass index (BMI; weight in kilograms divided by height in meters squared) of 30 to 55 and at least 1 other cardiovascular risk factor. Data analysis was performed from June to July 2021. Interventions: Interventions included lottery-based financial incentives based on meeting weight loss goals, environmental change strategies tailored for individuals and delivered by text messages and social media, and combined incentives and environmental strategies. Main Outcome and Measures: The primary outcome was weight change from baseline to 18 months, measured in person. Results: A total of 344 participants were enrolled, with 86 participants each randomized to the financial incentives group, environmental strategies group, combined financial incentives and environmental strategies group, and usual care (control) group. Participants had a mean (SD) age of 45.6 (10.5) years and a mean (SD) BMI of 36.5 (7.1); 247 participants (71.8%) were women, 172 (50.0%) were Black, and 138 (40.1%) were White. At the primary end point of 18 months, participants in the incentives group lost a mean of 5.4 lb (95% CI, -11.3 to 0.5 lb [mean, 2.45 kg; 95% CI, -5.09 to 0.23 kg]), those in the environmental strategies group lost a mean of a 2.2 lb (95% CI, -7.7 to 3.3 lb [mean, 1.00 kg; 95% CI, -3.47 to 1.49 kg]), and the combination group lost a mean of 2.4 lb (95% CI, -8.2 to 3.3 lb [mean, 1.09 kg; 95% CI, -3.69 to 1.49 kg]) more than participants in the usual care group. Financial incentives, environmental change strategies, and their combination were not significantly more effective than usual care. At 24 months, after 6 months without an intervention, the difference in the change from baseline was similar to the 18-month results, with no significant differences among groups. Conclusions and Relevance: In this randomized clinical trial, across all study groups, participants lost a modest amount of weight but those who received financial incentives, environmental change, or the combined intervention did not lose significantly more weight than those in the usual care group. Employees with obesity may benefit from more intensive individualized weight loss strategies. Trial Registration: ClinicalTrials.gov Identifier: NCT02878343.

Effect of Financial Incentives for Process, Outcomes, or Both on Cholesterol Level Change: A Randomized Clinical Trial.

Importance: Financial incentives may improve health behaviors. It is unknown whether incentives are more effective if they target a key process (eg, medication adherence), an outcome (eg, low-density lipoprotein cholesterol [LDL-C] levels), or both. Objective: To determine whether financial incentives awarded daily for process (adherence to statins), awarded quarterly for outcomes (personalized LDL-C level targets), or awarded for process plus outcomes induce reductions in LDL-C levels compared with control. Design, Setting, and Participants: A randomized clinical trial was conducted from February 12, 2015, to October 3, 2018; data analysis was performed from October 4, 2018, to May 27, 2021, at the University of Pennsylvania Health System, Philadelphia. Participants included 764 adults with an active statin prescription, elevated risk of atherosclerotic cardiovascular disease, suboptimal LDL-C level, and evidence of imperfect adherence to statin medication. Interventions: Interventions lasted 12 months. All participants received a smart pill bottle to measure adherence and underwent LDL-C measurement every 3 months. In the process group, daily financial incentives were awarded for statin adherence. In the outcomes group, participants received incentives for achieving or sustaining at least a quarterly 10-mg/dL LDL-C level reduction. The process plus outcomes group participants were eligible for incentives split between statin adherence and quarterly LDL-C level targets. Main Outcomes and Measures: Change in LDL-C level from baseline to 12 months, determined using intention-to-treat analysis. Results: Of the 764 participants, 390 were women (51.2%); mean (SD) age was 62.4 (10.0) years, 310 (40.6%) had diabetes, 298 (39.0%) had hypertension, and mean (SD) baseline LDL-C level was 138.8 (37.6) mg/dL. Mean LDL-C level reductions from baseline to 12 months were -36.9 mg/dL (95% CI, -42.0 to -31.9 mg/dL) among control participants, -40.0 mg/dL (95% CI, -44.7 to -35.4 mg/dL) among process participants, -41.6 mg/dL (95% CI, -46.3 to -37.0 mg/dL) among outcomes participants, and -42.8 mg/dL (95% CI, -47.4 to -38.1 mg/dL) among process plus outcomes participants. In exploratory analysis among participants with diabetes and hypertension, no spillover effects of incentives were detected compared with the control group on hemoglobin A1c level and blood pressure over 12 months. Conclusions and Relevance: In this randomized clinical trial, process-, outcomes-, or process plus outcomes-based financial incentives did not improve LDL-C levels vs control. Trial Registration: ClinicalTrials.gov Identifier: NCT02246959.

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.

Framing Social Comparison Feedback With Financial Incentives for Physical Activity Promotion: A Randomized Trial.

BACKGROUND: Social comparison feedback is often used in physical activity interventions but the optimal design of feedback is unknown. METHODS: This 4-arm, randomized trial consisted of a 13-week intervention period and 13-week follow-up period. During the intervention, 4-person teams were entered into a weekly lottery valued at about $1.40/day and contingent on the team averaging ≥7000 steps per day. Social comparison feedback on performance was delivered weekly for 26 weeks, and varied by reference point (50th vs 75th percentile) and forgiveness in use of activity data (all 7 d or best 5 of 7 d). The primary outcome was the mean proportion of participant-days achieving the 7000-step goal. RESULTS: During the intervention period, the unadjusted mean proportion of participant-days that the goal was achieved was 0.47 (95% confidence interval [CI]: 0.38 to 0.56) in the 50th percentile arm, 0.38 (95% CI: 0.30 to 0.37) in the 75th percentile arm, 0.40 (95% CI: 0.31 to 0.49) in the 50th percentile with forgiveness arm, and 0.47 (95% CI: 0.38 to 0.55) in the 75th percentile with forgiveness arm. In adjusted models during the intervention and follow-up periods, there were no significant differences between arms. CONCLUSIONS: Changing social comparison feedback did not impact physical activity.

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.

The Healthy Weigh study of lottery-based incentives and environmental strategies for weight loss: Design and baseline characteristics.

Identifying effective strategies for treating obesity is a clinical challenge and a public health priority. The present study is an innovative test of the relative effectiveness of lottery-based financial incentives and environmental strategies on weight loss and maintenance. The Healthy Weigh study is evaluating the comparative effectiveness of behavioral economic financial incentives and environmental strategies, separately and together, in achieving initial weight loss and maintenance of weight loss, in obese urban employee populations. Healthy Weigh is a multi-site, 4-arm randomized controlled trial (RCT) in which 344 employed participants were randomized to one of four arms. The study arms are: 1) standard employee wellness benefits and weigh-ins every 6 months (control arm/usual care); and the control/usual care plus either: 2) daily lottery incentives tied to achievement of weight loss goals (incentive arm); 3) individually tailored environmental strategies around food intake and physical activity (environmental arm); or 4) a combination of incentives and environmental strategies (combined arm). This trial used a web-based platform to enroll, communicate with, and track participant weight change. Wireless scales were used by participants in the three treatment group arms to digitally transmit daily/weekly weights. For females, the baseline median (interquartile range, IQR) for BMI and weight were 37.0 (33.5, 40.6) and 219.9 (198.1, 248.6), respectively; and for males, they were 36.0 (32.8, 39.8) and 247.9 (228.1, 279.5), respectively. The population was generally well-educated. This study demonstrated that multi-site employee-based recruitment for a weight-control intervention study is feasible but may need additional time for coordination between diverse environments.

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.

A Randomized, Controlled Trial of Lottery-Based Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults.

PURPOSE: To evaluate the effect of lottery-based financial incentives in increasing physical activity. DESIGN: Randomized, controlled trial. SETTING: University of Pennsylvania Employees. PARTICIPANTS: A total of 209 adults with body mass index ≥27. INTERVENTIONS: All participants used smartphones to track activity, were given a goal of 7000 steps per day, and received daily feedback on performance for 26 weeks. Participants randomly assigned to 1 of the 3 intervention arms received a financial incentive for 13 weeks and then were followed for 13 weeks without incentives. Daily lottery incentives were designed as a "higher frequency, smaller reward" (1 in 4 chance of winning $5), "jackpot" (1 in 400 chance of winning $500), or "combined lottery" (18% chance of $5 and 1% chance of $50). MEASURES: Mean proportion of participant days step goals were achieved. ANALYSIS: Multivariate regression. RESULTS: During the intervention, the unadjusted mean proportion of participant days that goal was achieved was 0.26 in the control arm, 0.32 in the higher frequency, smaller reward lottery arm, 0.29 in the jackpot arm, and 0.38 in the combined lottery arm. In adjusted models, only the combined lottery arm was significantly greater than control ( P = .01). The jackpot arm had a significant decline of 0.13 ( P < .001) compared to control. There were no significant differences during follow-up. CONCLUSIONS: Combined lottery incentives were most effective in increasing physical activity.

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.

A Randomized Trial of Social Comparison Feedback and Financial Incentives to Increase Physical Activity.

PURPOSE: To compare the effectiveness of different combinations of social comparison feedback and financial incentives to increase physical activity. DESIGN: Randomized trial (Clinicaltrials.gov number, NCT02030080). SETTING: Philadelphia, Pennsylvania. PARTICIPANTS: Two hundred eighty-six adults. INTERVENTIONS: Twenty-six weeks of weekly feedback on team performance compared to the 50th percentile (n = 100) or the 75th percentile (n = 64) and 13 weeks of weekly lottery-based financial incentive plus feedback on team performance compared to the 50th percentile (n = 80) or the 75th percentile (n = 44) followed by 13 weeks of only performance feedback. MEASURES: Mean proportion of participant-days achieving the 7000-step goal during the 13-week intervention. ANALYSIS: Generalized linear mixed models adjusting for repeated measures and clustering by team. RESULTS: Compared to the 75th percentile without incentives during the intervention period, the mean proportion achieving the 7000-step goal was significantly greater for the 50th percentile with incentives group (0.45 vs 0.27, difference: 0.18, 95% confidence interval [CI]: 0.04 to 0.32; P = .012) but not for the 75th percentile with incentives group (0.38 vs 0.27, difference: 0.11, 95% CI: -0.05 to 0.27; P = .19) or the 50th percentile without incentives group (0.30 vs 0.27, difference: 0.03, 95% CI: -0.10 to 0.16; P = .67). CONCLUSION: Social comparison to the 50th percentile with financial incentives was most effective for increasing physical activity.