Patients who enrolled in a trial to lower low-density lipoprotein cholesterol spoke positively of the multifaceted intervention: pillbox monitoring and financial incentives were socially acceptable.
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.
Patients who enrolled in a trial to lower low-density lipoprotein cholesterol (LDL-C)—one that included financial incentives to patients or to physicians or were shared between patients and physicians—spoke positively of the multifaceted intervention. One-on-one interviews revealed:
Patient nonadherence to recommended treatment is a barrier to improving outcomes, but the use of financial incentives to overcome this barrier is increasing.1,2 Eighty-five percent of large employers use financial incentives to improve health behaviors in realms ranging from smoking and other addictions to weight control and medication adherence.3-5 In a recent randomized controlled trial focused on reducing low-density lipoprotein cholesterol (LDL-C) among patients with high cardiovascular risk or established cardiovascular disease, incentives based on principles of behavioral economics were used to motivate both patients and providers.6 In the parent study, 340 primary care physicians (PCPs) from 3 health systems and about 15,030 of their patients were enrolled into a 4-arm trial to test alternative incentive strategies to lower LDL-C. PCPs were randomized to 1 of 4 arms: physician financial incentives, patient financial incentives, shared incentives between physicians and patients, and a control arm. Progress was monitored through quarterly LDL checks and medication adherence via pill bottle opening. The primary outcome was LDL reduction over 12 months. The intervention was a compound of multiple behavioral economic strategies.
The main trial showed significant benefits for those in the shared incentive arm, but the effectiveness of the intervention ranged across individuals. The purpose of this current study was to investigate patients’ perceptions of the intervention and learn from their stories of how the intervention affected their behaviors. The specific objectives were to investigate patients’ perceptions of financial incentives and of multiple components of the behavioral intervention, including overall thoughts about benefits and challenges and how being in the study affected their relationship with their physician. We were particularly interested in how perspectives differed between patients who succeeded in lowering their LDL-C and those who did not. Secondarily, we examined if narratives about incentives differed among patients randomized to different arms of the study.
Overview/Summary of the Underlying Intervention
The protocol for the main trial is summarized briefly here.6 A total of 1503 patients with high cardiovascular risk or established cardiovascular disease were enrolled; they were nested within 340 PCPs from the University of Pennsylvania (Penn), Geisinger Health System (GHS), and Harvard Vanguard Medical Associates (HVMA). The study compared 4 approaches to reduce LDL-C: physician incentives, patient incentives, shared physician—patient incentives, or control (no financial incentive or regular feedback). For the patient and physician incentive arms, the maximum expected value of the incentive was $1024 per enrolled patient who met LDL-C goals. PCPs and patients in the shared arm shared those possible financial incentives. Patients also received surveys, quarterly LDL-C checks, and wireless pill bottles (Vitality GlowCaps) which were used to store their cholesterol-lowering medication and electronically monitor bottle openings.
In this study, semi-structured telephone interviews were conducted with patients post intervention from February 2014 through July 2014. The methods and script were approved by the University of Pennsylvania Institutional Review Board.
Purposive targeted sampling was used. Within each of the 4 arms, the goal was to interview 10 high, 10 medium, and 10 low performers in LDL-C reduction, stratified across the 3 study sites. Within each of the 12 cells, 5 patients were targeted from GHS, 4 from Penn, and 1 from HVMA, proportional to the total patient sample at each site. Patients were interviewed in multiple waves, formed as groups of patients completed their 15-month visits. The final number of interviews is shown in Table 1. For each wave of completed data, usually for 60 to 80 patients, the mean change in LDL-C (baseline to 12-month) was calculated, then sorted by site within arms. Within each arm, the distribution was inspected and the 4 to 5 patients with the most improved, most worsened, and least changed LDL-C were prioritized, choosing only 1 patient per clinical site per wave. Therefore, “high” and “low” do not have a constant cut-off. However, across the selection waves, median changes in LDL-C among targeted patients were similar.
The interview script was developed by a study team of health economists, physicians, and qualitative researchers. They drew on the literature and their expertise to develop conversational questions related to the study elements and the potential impact of behavioral interventions. Initial scripts were piloted and revised as necessary prior to the study and were constant for the duration of active interviewing. Revisions were based on queries about unclear questions, and the order of the questions was changed to improve flow. Pilot interviews are not included in the analyses. Key questions targeted reasons for enrolling in the study, parts of the study that helped them reach the goal (surveys, wireless pill bottle, cholesterol check every 3 months, and incentives, for patients in arms that received them), challenges faced in reducing cholesterol, and the effect of the study on their relationship with their doctor.
Interviews and Coding
Two trained interviewers conducted the interviews. Recordings of the interviews were transcribed by an independent transcription agency. De-identified transcripts were imported into NVivo version 10 (QSR International Pty Ltd) for coding and analysis.
Four trained coders analyzed the data using elements from grounded theory. The team first identified broad themes based on the first 6 transcripts and then applied open codes to the transcripts. The initial set of codes was tested on each subsequent interview transcript to refine the codebook. Codes were revised iteratively by constant comparison between and within transcripts, and more content-driven axial codes were applied. A final coding scheme was established and applied to all transcripts. In a post hoc analysis, the comments about financial incentives were grouped by arm, blinded, and reviewed by the senior author, with a goal of understanding the main trial results. Inter-rater reliability was assessed on samples exceeding 20% of transcripts. The research team met weekly to resolve discrepancies via consensus.
In the following section, results are organized around the major research questions, examining perceived benefits and facilitators of study enrollment and components, barriers to study participation and meeting goals, and how study participation affected their relationships with their doctors. Results focus on themes mentioned by more than 20% of the sample. The median kappa was 0.92, with a range of 0.64 to 1.0.
A total of 110 of 120 planned interviews were completed (Table 1). They came from a targeted list of 163 patients, representing a minimum 67.5% response rate; 9 patients refused and the remainder were not reached prior to saturation. Patients providing interviews were demographically and clinically similar to those in the parent trial (Table 2).
Prevalent themes are presented in italics, with quotations summarized in the eAppendix (available at www.ajmc.com). There were few differences between patients whose LDL-C improved greatly and those who did not improve. Similarly, meaningful differences among study arms were not prevalent. When substantial differences were discovered, they are noted at the end of each section.
Reasons for Joining
Patients expressed a range of reasons for joining the study. First, the credibility of a doctor’s recommendation to join the study was a motivating factor for 40 (36%) patients. Second, 34 (31%) patients stated that they joined the study with the hope of finding a solution to their high cholesterol. A third reason for joining was increasing awareness and knowledge (n = 30; 27%). Other relatively common motivators were financial gains (n = 27; 25%), including free and more frequent monitoring, and the benevolence of helping with research (n = 25; 23%). The subgroup of interviewees whose LDL-C worsened gave more responses to this question, but the nature of what they said was not qualitatively different. The subgroup whose LDL-C improved often mentioned enrolling to facilitate healthy behaviors and to learn more about cholesterol issues.
Benefits and Facilitators: General
Patients offered a wide range of responses to queries about the benefits of enrolling in the study. Seventy-one (65%) patients described personal changes that affected the way they manage their health and their understanding of health-related topics. Commonly referenced topics were diet choice and exercise regimens. The study made patients think more about the foods that they were eating and the necessity of changing eating habits. These changes included reading labels before buying food, shopping for healthier food options, and portion control. The study also inspired patients to engage in more exercise. Some learned that they were able to control their cholesterol with diet and exercise and others learned the necessity of medication in controlling their cholesterol.
Just over half (n = 61; 55%) of the patients spoke of appreciating the increased awareness and information. Several patients explained that being in the study made them more aware of the severity of their health condition; 34 (31%) specifically mentioned improved health. The subgroup of interviewees whose LDL-C got better more often gave examples of how they changed a health behavior and more frequently spoke of more consistent use of medication.
Benefits and Facilitators: Intervention Components
Three-month visits. More than half (n = 69; 63%) of the patients mentioned the benefits of receiving blood test results every 3 months; they liked the awareness, and tracking enabled them to make appropriate adjustments as well as understand how medication use affected their cholesterol levels. It was also satisfying to see how diet and exercise changes affected their cholesterol. They also appreciated the increased access to services (n = 48; 44%) and did not find the visits inconvenient (n = 47; 43%)
Wireless medication adherence devices. Patients generally agreed that the wireless devices were a facilitator in lowering their cholesterol. The devices served as a reminder to take medication (n = 39; 35%). Many thought the devices were easy to use and expected to continue to use them after the conclusion of the study. They liked being monitored (n = 33; 30%)
Surveys. Patients did not say much about the surveys. The most prevalent comment was about increased awareness (n = 40; 36%). The surveys provided a friendly reminder of the appropriate steps that patients should be taking to keep their cholesterol under control.
Financial incentives. Seventy-five patients provided comments about financial incentives. Many (n = 53; 71%) described the beneficial effect that the incentives had on their behavior, offering at least 4 different examples: 1) several thought it was good that the study provided them with a benefit other than good health, 2) many were happy to get a boost to their income and have some extra money to spend on other things, 3) multiple patients stated that the incentives made the other inconvenient aspects of the study more bearable, and 4) several patients felt the positive reinforcement motivated them to do the necessary things to lower their cholesterol and continue with the study. Most of the 42 (56%) who commented felt that the size of the incentives was adequate or better than they expected.
At the same time, 27 (38%) patients said that the incentives had minimal influence on their performance in the study; positive results were what motivated them to keep up their efforts. They were involved in the study to get healthier and learn about themselves. The blinded review of the comments about incentives yielded nothing to distinguish among the treatment arms with patient incentives.
Only 11 (15%) patients recalled talking about the incentives with their doctors; these conversations were brief affirmations of their participation in the program and encouragement to continue with their progress. Overall, 38 (51%) patients made some commentary about physicians and incentives. Although there was no prevalent theme, the tone was generally indifferent (eg, it would not affect the patient’s own performance) or supportive (eg, they were happy for their doctors to receive payment as part of the study). Few feared that physician incentives would affect the physician’s impartiality.
There were no differences among subgroups of patients related to discussions about the 3-month visits, wireless medication devices, or the surveys. The subgroup of interviewees whose LDL-C improved more often spoke about the benefits of financial incentives.
Challenges and Barriers
Healthy diet and active lifestyle. In contrast to the many experienced benefits, some barriers to improving cholesterol remained. The main downfall of 72 (65%) patients was their inability to stay away from food that is believed to contribute to higher LDL-C levels, and for others (n = 40; 36%), it was their inability to maintain a healthy lifestyle. A host of reasons were given, including friends and loved ones who regularly ate or prepared unhealthful meals, poor eating habits that developed over time, and their affinity for unhealthful food. Comments about inadequate activity were often mentioned in the same context as diet. Multiple reasons were provided, often related to the weather, amount of time required for work, travel, or being busy. Issues regarding the difficulties of maintaining a healthful diet and lifestyle were more prevalent among the subgroup whose LDL-C worsened over the study period.
Wireless medication devices. For more than half (n = 67; 61%) of the patients and for a number of different reasons, the wireless medication device used in this study (Vitality GlowCap) was seen as a nuisance, but usually temporarily. Patients on multiple medications did not like the necessity of having separate containers. Many had early technical issues, such as finding an appropriate outlet and connectivity difficulties; but for most, these were transitory issues amid an overall positive experience. The subgroup that did particularly well in improving its LDL-C more often noted issues with the wireless medication devices, but also that the issues were infrequent and/or solved.
Issues with medication. Numerous patients (n = 49; 45%) referenced regular medication use as a challenge. A significant part of the commentary was about adverse reactions, such as muscle weakness and pain and liver complications. Side effects, such as feelings of illness, muscle and joint pain, and “fuzzy memory,” were cited as reasons for dropping the medication altogether. Other patients forgot to take their medicine on a daily basis, and a significant number of patients stated they were not interested in taking any medication at all. The frequency and content of comments was similar between the high and low performers.
Relationship with doctor. Only 1 patient specifically noted a change in the relationship between the patient and physician. However, 29 (26%) indicated that the study led to more conversations with their doctor—typically about the results of their blood work, especially if the labs demonstrated “poor results.” Some noted that they saw their physician more often due to participating in the study.
Sixteen (15%) patients said they enrolled in the study because their doctor suggested it to them. Many of these were from the group who did well. Most of these comments noted that a brief conversation took place during the course of an office visit, in which the doctor brought up the study and recommended participation, and the patients subsequently agreed to join.
This qualitative process evaluation of a large randomized trial has 4 main findings. First, patients reported positive experiences with the study; they enrolled based on a genuine desire for a healthier life. The structure of the study was similarly favorable: blood draws every 3 months were informative, and the wireless medication devices—although they not without their glitches—provided valuable reminders to take one’s medication. Second, views about financial incentives were varied. Some clearly found them motivating, whereas others claimed they made no difference. Importantly, no patients found them negative. In general, discussion of the study with their physicians, including financial incentives, was not extensive. Third, patients noted that changing behavior and diet was difficult. Food preferences, habits, and social times interrupted plans to make positive changes. There was also ambivalence about taking medication, and for some, there was a clear desire to avoid medication. Fourth, patients who substantially lowered their LDL-C revealed themes similar to those who did not.
These findings contrast with some of the concerns the study team had when developing the study, as well as those voiced by others.7,8 In preparation for study launch, some team members and participating physicians wondered whether explicit financial incentives might adversely affect existing physician—patient relationships. Those concerns seem to have been unjustified. There was also concern that the wireless medication adherence devices would be seen as intrusive, but they were not. Most importantly, different experiences and feelings based on different intervention arms were anticipated; it seemed logical to think that whether a patient or their physician is being paid for outcomes might alter one’s sense of the process. In fact, no differences were found across arms. Nor were there systematic differences based on how well patients did in the intervention arm in terms of improving their LDL-C.
There is little previous research examining patient perceptions of financial incentives to improve their health. One other published paper found nearly equal proportions of a clinic population had favorable or unfavorable opinions of incentives, but the authors noted greater enthusiasm when incentives were framed as a reward rather than a penalty, when they were offered by health insurers as part of benefit design, and when the survey respondent personally had the condition for which the incentives were offered (in the case of smoking or obesity).9 Importantly, from a complementary perspective, this previous study was conducted among clinic patients who had not been enrolled in a trial of financial incentives.
Limitations and Strengths
Patients in the underlying study had to consent to participate; thus, by design, only the experiences of those who were willing to engage in the first place are represented in this study. High and low performers were oversampled, so it is possible that this sample was not effectively representative; however, the observation that no differences were observed between the extremes suggests that no differences would be observed among a more distributed sample. This study also has strengths: the team conducting this evaluation was different from the team that designed and implemented the trial, the sampling was systematic, and the sample included 110 patients, which is substantially larger than many process evaluations.
Behavioral interventions that include financial incentives offer promise to improve important health outcomes, but they must overcome 2 important evidentiary hurdles before widespread implementation. First, they need to demonstrate effectiveness. The results of the underlying study in this report suggest that a system of shared incentives offers significant benefit compared with a control incentive. Second, they must be socially acceptable. There are many stakeholders in such acceptance, including those who might finance these interventions, including the incentives, and the general public who might pass judgment upon them. This study's results suggest that patients are willing to engage in these programs and generally felt participating was a positive experience.
The authors would like to acknowledge the team from the Mixed Methods Research Lab at the University of Pennsylvania who participated in conducting interviews and coding transcripts: Shimrit Keddem, Trocon Davis, Ebony Easley, Samuel Katz, Jalal Osman, Breah Paciotti, Ashley Ryman, and Richard Sorelle.
Author Affiliations: Division of General Internal Medicine, Department of Medicine (JAS, KGV, DAA), Department of Medical Ethics and Health Policy (KGV, DF, DAA), Department of Biostatistics and Epidemiology (ABT), Center for Health Incentives and Behavioral Economics (KGV, KH, DAA), and Center for Health Care Innovation (KGV, DAA), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Ohio State University Medical School (AA), Columbus, OH; Corporal Michael J. Crescenz VA Medical Center (KGV, DAA), Philadelphia, PA; The Wharton School, University of Pennsylvania (KGV, DAA), Philadelphia, PA; Atrius Health (TI), Newton, MA; Harvard T.H. Chan School of Public Health (MR), Boston, MA; Partners Healthcare System (TDS), Boston, MA.
Source of Funding: National Institute on Aging (RC4 AG039114).
Author Disclosures: Dr Volpp has been a consultant or adviser for CVS and VAL Health, and has received grants from CVS, Humana, HMSA, and Vitality Dr Troxel was an employee of the University of Pennsylvania during the time of the study’s preparation and is on the advisory board of VAL Health. Dr Asch is a part owner and advisor to VAL Health and has received various grants and given various talks related to behavioral economics. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.
Authorship Information: Concept and design (JAS, KGV, TI, MR, DAA); acquisition of data (AA, DF, KH, TDS, DAA); analysis and interpretation of data (JAS, AA, KGV, ABT, DF, TI, MR, TDS); drafting of the manuscript (JAS, AA, DF, TI); critical revision of the manuscript for important intellectual content (JAS, KGV, ABT, KH, TI, MR, TDS, DAA); statistical analysis (JAS, ABT); provision of patients or study materials (AA, DF, KH); obtaining funding (KGV, DAA); administrative, technical, or logistic support (DF, KH); and supervision (JAS, AA, KH, TDS).
Address Correspondence to: Judy A. Shea, PhD, Perelman School of Medicine at the University of Pennsylvania, 1229 Blockley Hall, 423 Guardian Dr, Philadelphia, PA 19104. E-mail: email@example.com. REFERENCES
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