Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial.

BACKGROUND: Physical activity is associated with a lower risk of major adverse cardiovascular events, but few individuals achieve guideline-recommended levels of physical activity. Strategies informed by behavioral economics increase physical activity, but their longer-term effectiveness is uncertain. We sought to determine the effect of behaviorally designed gamification, loss-framed financial incentives, or their combination on physical activity compared with attention control over 12-month intervention and 6-month postintervention follow-up periods. METHODS: Between May 2019 and January 2024, participants with clinical atherosclerotic cardiovascular disease or a 10-year risk of myocardial infarction, stroke, or cardiovascular death of ≥7.5% by the Pooled Cohort equation were enrolled in a pragmatic randomized clinical trial. Participants received a wearable device to track daily steps, established a baseline, selected a step goal increase, and were randomly assigned to control (n=151), behaviorally designed gamification (n=304), loss-framed financial incentives (n=302), or gamification+financial incentives (n=305). The primary outcome of the trial was the change in mean daily steps from baseline through the 12-month intervention period. RESULTS: A total of 1062 patients (mean±SD age, 67±8; 61% female; 31% non-White) were enrolled. Compared with control subjects, participants had significantly greater increases in mean daily steps from baseline during the 12-month intervention in the gamification arm (adjusted difference, 538.0 [95% CI, 186.2-889.9]; P=0.0027), financial incentives arm (adjusted difference, 491.8 [95% CI, 139.6-844.1]; P=0.0062), and gamification+financial incentives arm (adjusted difference, 868.0 [95% CI, 516.3-1219.7]; P<0.0001). During the 6-month follow-up, physical activity remained significantly greater in the gamification+financial incentives arm than in the control arm (adjusted difference, 576.2 [95% CI, 198.5-954]; P=0.0028), but it was not significantly greater in the gamification (adjusted difference, 459.8 [95% CI, 82.0-837.6]; P=0.0171) or financial incentives (adjusted difference, 327.9 [95% CI, -50.2 to 706]; P=0.09) arms after adjustment for multiple comparisons. CONCLUSIONS: Behaviorally designed gamification, loss-framed financial incentives, and the combination of both increased physical activity compared with control over a 12-month intervention period, with the largest effect in gamification+financial incentives. These interventions could be a useful component of strategies to reduce cardiovascular risk in high-risk patients. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT03911141.

A randomized controlled trial of gamification, financial incentives, or both to increase physical activity among patients with elevated risk for cardiovascular disease: rationale and design of the be active study.

BACKGROUND: Higher levels of physical activity are associated with improvements in cardiovascular health, and consensus guidelines recommend that individuals with or at risk for atherosclerotic cardiovascular disease (ASCVD) participate in regular physical activity. However, most adults do not achieve recommended levels of physical activity. Concepts from behavioral economics have been used to design scalable interventions that increase physical activity over short time periods, but the longer-term efficacy of these strategies is uncertain. STUDY DESIGN AND OBJECTIVES: BE ACTIVE (NCT03911141) is a pragmatic, virtual, randomized controlled trial designed to evaluate the effectiveness of 3 strategies informed by behavioral economic concepts to increase daily physical activity in patients with established ASCVD or 10-year ASCVD risk > 7.5% who are seen in primary care and cardiology clinics affiliated with the University of Pennsylvania Health System. Patients are contacted by email or text message, and complete enrollment and informed consent on the Penn Way to Health online platform. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 33% to 50%, and are randomized 1:2:2:2 to control, gamification, financial incentives, or both gamification and financial incentives. Interventions continue for 12 months, with follow-up for an additional 6 months to evaluate the durability of behavior change. The trial has met its enrollment goal of 1050 participants, with a primary endpoint of change from baseline in daily steps over the 12-month intervention period. Key secondary endpoints include change from baseline in daily steps over the 6-month post-intervention follow-up period and change in moderate to vigorous physical activity over the intervention and follow-up periods. If the interventions prove effective, their effects on life expectancy will be compared with their costs in cost-effectiveness analysis. CONCLUSIONS: BE ACTIVE is a virtual, pragmatic randomized clinical trial powered to demonstrate whether gamification, financial incentives, or both are superior to attention control in increasing physical activity. Its results will have important implications for strategies to promote physical activity in patients with or at risk for ASCVD, as well as for the design and implementation of pragmatic virtual clinical trials within health systems.

Blood Pressure Measurement Biases in Clinical Settings, Alabama, 2010-2011.

INTRODUCTION: Blood pressure measurement in clinical care settings seldom follows the protocol recommended by national guidelines, potentially leading to overestimates or underestimates of blood pressure control. We evaluated blood pressure measurement methods as a source of bias in determining blood pressure control among community-dwelling adults with diabetes. METHODS: In a community-based trial of patients with diabetes, we measured both "clinical blood pressure" (clinical BP) (taken by a community nurse or medical assistant instructed to "take the participant's blood pressure like you do in your own clinic") and "research blood pressure" (research BP) (research staff followed a guideline-concordant protocol). Each participant had both types of blood pressure assessment on the same day over the course of 2 hours. RESULTS: The 227 participants had a mean age of 59 years; 86% were black and 74% were women. The mean clinical BP was 5 mm Hg higher than the mean research BP for systolic blood pressure (P < .001) and 2 mm Hg higher for diastolic blood pressure (P < .001). The proportion of participants whose clinical BP was 130/80 mm Hg or higher was 8 percentage points higher than the proportion whose research BP was 130/80 mm Hg or higher (P < .001), and the proportion whose clinical BP was 140/90 mm Hg or higher was 10 percentage points higher than the proportion whose research BP was 140/90 mm Hg or higher (P < .001). Among those aged 65 years or older, the proportion whose clinical BP was 130/80 mm Hg or higher was 10 percentage points higher than proportion whose research BP was 130/80 mm Hg or higher, and the proportion whose clinical BP was 140/90 mm Hg or higher was 14 percentage points higher than the proportion whose research BP was 140/90 mm Hg or higher. Whites and smokers had the greatest risk for having a clinical BP 5 mm Hg or more higher than their research BP. CONCLUSION: Measurement biases in clinical settings may be a component of observed poor blood pressure control rates in real-world settings.

Remote Monitoring and Behavioral Economics in Managing Heart Failure in Patients Discharged From the Hospital: A Randomized Clinical Trial.

Importance: Close remote monitoring of patients following discharge for heart failure (HF) may reduce readmissions or death. Objective: To determine whether remote monitoring of diuretic adherence and weight changes with financial incentives reduces hospital readmissions or death following discharge with HF. Design, Setting, and Participants: The Electronic Monitoring of Patients Offers Ways to Enhance Recovery (EMPOWER) study, a 3-hospital pragmatic trial, randomized 552 adults recently discharged with HF to usual care (n = 280) or a compound intervention (n = 272) designed to inform clinicians of diuretic adherence and changes in patient weight. Patients were recruited from May 25, 2016, to April 8, 2019, and followed up for 12 months. Investigators were blinded to assignment but patients were not. Analysis was by intent to treat. Interventions: Participants randomized to the intervention arm received digital scales, electronic pill bottles for diuretic medication, and regret lottery incentives conditional on the previous day's adherence to both medication and weight measurement, with $1.40 expected daily value. Participants' physicians were alerted if participants' weights increased 1.4 kg in 24 hours or 2.3 kg in 72 hours or if diuretic medications were missed for 5 days. Alerts and weights were integrated into the electronic health record. Participants randomized to the control arm received usual care and no further study contact. Main Outcomes and Measures: Time to death or readmission for any cause within 12 months. Results: Of the 552 participants, 290 were men (52.5%); 291 patients (52.7%) were Black, 231 were White (41.8%), and 16 were Hispanic (2.9%); mean (SD) age was 64.5 (11.8) years. The mean (SD) ejection fraction was 43% (18.1%). Each month, approximately 75% of participants were 80% adherent to both medication and weight measurement. There were 423 readmissions and 26 deaths in the control group and 377 readmissions and 23 deaths in the intervention group. There was no significant difference between the 2 groups for the combined outcome of all-cause inpatient readmission or death (unadjusted hazard ratio, 0.91; 95% CI, 0.74-1.13; P = .40) and no significant differences in all-cause inpatient readmission or observation stay or death, all-cause cardiovascular readmission or death, time to first event, and total all-cause deaths. Participants in the intervention group were slightly more likely to spend fewer days in the hospital. Conclusions and Relevance: In this randomized clinical trial, there was no reduction in the combined outcome of readmission or mortality in a year-long intensive remote monitoring program with incentives for patients previously hospitalized for HF. Trial Registration: ClinicalTrials.gov Identifier: NCT02708654.

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.

Future Directions for Cost-effectiveness Analyses in Health and Medicine.

OBJECTIVES: In 2016, the Second Panel on Cost-effectiveness in Health and Medicine updated the seminal work of the original panel from 2 decades earlier. The Second Panel had an opportunity to reflect on the evolution of cost-effectiveness analysis (CEA) and to provide guidance for the next generation of practitioners and consumers. In this article, we present key topics for future research and policy. METHODS: During the course of its deliberations, the Second Panel discussed numerous topics for advancing methods and for improving the use of CEA in decision making. We identify and consider 7 areas for which the panel believes that future research would be particularly fruitful. In each of these areas, we highlight outstanding research needs. The list is not intended as an exhaustive inventory but rather a set of key items that surfaced repeatedly in the panel's discussions. In the online Appendix , we also list and expound briefly on 8 other important topics. RESULTS: We highlight 7 key areas: CEA and perspectives (determining, valuing, and summarizing elements for the analysis), modeling (comparative modeling and model transparency), health outcomes (valuing temporary health and path states, as well as health effects on caregivers), costing (a cost catalogue, valuing household production, and productivity effects), evidence synthesis (developing theory on learning across studies and combining data from clinical trials and observational studies), estimating and using cost-effectiveness thresholds (empirically representing 2 broad concepts: opportunity costs and public willingness to pay), and reporting and communicating CEAs (written protocols and a quality scoring system). CONCLUSIONS: Cost-effectiveness analysis remains a flourishing and evolving field with many opportunities for research. More work is needed on many fronts to understand how best to incorporate CEA into policy and practice.

How Much Time Do Families Spend on the Health Care of Children with Diabetes?

INTRODUCTION: Family time caring for children with diabetes is an overlooked component of the overall burden of the condition. We document and analyze risk factors for time family members spend providing health care at home and arranging/coordinating health care for children with diabetes. METHODS: Data for 755 diabetic children and 16,161 non-diabetic children whose chronic conditions required only prescription (Rx) medication were from the 2009-2010 United States National Survey of Children with Special Health Care Needs (NS-CSHCN). We used generalized ordered logistic regressions to estimate adjusted odds ratios (AORs) of time burden by diabetes, insulin use, and stability of the child's health care needs, controlling for health and socioeconomic status. RESULTS: Nearly one-quarter of diabetic children had family members who spent 11+ h/week providing health care at home, and 8% spent 11+ h/week arranging/coordinating care, compared with 3.3% and 1.9%, respectively, of non-diabetic Rx-only children. Time providing care at home for insulin-using children was concentrated in the higher time categories: AORs for insulin-using diabetic compared to non-diabetic Rx-only children were 4.4 for 1+ h/week compared with <1 h/week, 9.7 for 6+ vs. <6 h, and 12.4 for 11+ vs. <11 h (all P < 0.05); the pattern was less pronounced for non-insulin-using children. AORs for arranging/coordinating care did not vary by time contrast: AOR = 4.2 for insulin-using, 3.0 for non-insulin-using children. CONCLUSION: Health care providers, school personnel, and policymakers need to work with family members to improve care coordination and identify other ways to reduce family time burdens caring for children with diabetes.

The impact of drug pricing policies on the health of the elderly.

BACKGROUND: Prices for prescription drugs vary widely in the United States, from the prices charged by retail pharmacies to 50% below average wholesale prices (AWP), depending on the purchaser's bargaining power. At higher drug prices, expenditures for essential preventive interventions, such as those aimed at hypertension and hypercholesterolemia, buy less health for the elderly. The magnitude of this effect, however, is unknown. METHODS: Cost-effectiveness analyses of drug interventions, which estimate their health effects and costs, sometimes include analyses of the impact of drug prices. We use results from studies of preventive drugs used by the elderly to calculate the life-years that could be purchased for $1 million of expenditure at the AWP, and at prices 20% and 40% below the AWP. This range reflects the range of prices in the United States today. RESULTS: Drug prices have a substantial effect on the amount of health that can be purchased for $1 million, especially among elderly people with several health conditions. For example, at 40% below the AWP, $1 million spent on statins yields 90 years of life for patients aged 75 to 84 with a history of myocardial infarction. At the AWP, the number of life-years for $1 million drops to 48--a loss of 42 life-years. CONCLUSIONS: A Medicare drug benefit program that supports prices at the high end of the current range could yield substantially less health for the elderly, and one that promotes differential pricing could promote unequal access to preventive medications--and thus to health--by Medicare beneficiaries across the country.

Preventing chronic disease: an important investment, but don't count on cost savings.

Over the four decades since cost-effectiveness analysis was first applied to health and medicine, hundreds of studies have shown that prevention usually adds to medical costs instead of reducing them. Medications for hypertension and elevated cholesterol, diet and exercise to prevent diabetes, and screening and early treatment for cancer all add more to medical costs than they save. Careful choices about frequency, groups to target, and component costs can increase the likelihood that interventions will be highly cost-effective or even cost-saving.