Reducing ethnic and racial disparities by improving undertreatment, control, and engagement in blood pressure management with health information technology (REDUCE-BP) hybrid effectiveness-implementation pragmatic trial: Rationale and design.

BACKGROUND: While racial/ethnic disparities in blood pressure control are documented, few interventions have successfully reduced these gaps. Under-prescribing, lack of treatment intensification, and suboptimal follow-up care are thought to be central contributors. Electronic health record (EHR) tools may help address these barriers and may be enhanced with behavioral science techniques. OBJECTIVE: To evaluate the impact of a multicomponent behaviorally-informed EHR-based intervention on blood pressure control. TRIAL DESIGN: Reducing Ethnic and racial Disparities by improving Undertreatment, Control, and Engagement in Blood Pressure management with health information technology (REDUCE-BP) (NCT05030467) is a two-arm cluster-randomized hybrid type 1 pragmatic trial in a large multi-ethnic health care system. Twenty-four clinics (>350 primary care providers [PCPs] and >10,000 eligible patients) are assigned to either multi-component EHR-based intervention or usual care. Intervention clinic PCPs will receive several EHR tools designed to reduce disparities delivered at different points, including a: (1) dashboard of all patients visible upon logging on to the EHR displaying blood pressure control by race/ethnicity compared to their PCP peers and (2) set of tools in an individual patient's chart containing decision support to encourage treatment intensification, ordering home blood pressure measurement, interventions to address health-related social needs, default text for note documentation, and enhanced patient education materials. The primary outcome is patient-level change in systolic blood pressure over 12 months between arms; secondary outcomes include changes in disparities and other clinical outcomes. CONCLUSION: REDUCE-BP will provide important insights into whether an EHR-based intervention designed using behavioral science can improve hypertension control and reduce disparities.

Effect of a Biopsychosocial Intervention or Postural Therapy on Disability and Health Care Spending Among Patients With Acute and Subacute Spine Pain: The SPINE CARE Randomized Clinical Trial.

Importance: Low back and neck pain are often self-limited, but health care spending remains high. Objective: To evaluate the effects of 2 interventions that emphasize noninvasive care for spine pain. Design, Setting, and Participants: Pragmatic, cluster, randomized clinical trial conducted at 33 centers in the US that enrolled 2971 participants with neck or back pain of 3 months' duration or less (enrollment, June 2017 to March 2020; final follow-up, March 2021). Interventions: Participants were randomized at the clinic-level to (1) usual care (n = 992); (2) a risk-stratified, multidisciplinary intervention (the identify, coordinate, and enhance [ICE] care model that combines physical therapy, health coach counseling, and consultation from a specialist in pain medicine or rehabilitation) (n = 829); or (3) individualized postural therapy (IPT), a postural therapy approach that combines physical therapy with building self-efficacy and self-management (n = 1150). Main Outcomes and Measures: The primary outcomes were change in Oswestry Disability Index (ODI) score at 3 months (range, 0 [best] to 100 [worst]; minimal clinically important difference, 6) and spine-related health care spending at 1 year. A 2-sided significance threshold of .025 was used to define statistical significance. Results: Among 2971 participants randomized (mean age, 51.7 years; 1792 women [60.3%]), 2733 (92%) finished the trial. Between baseline and 3-month follow-up, mean ODI scores changed from 31.2 to 15.4 for ICE, from 29.3 to 15.4 for IPT, and from 28.9 to 19.5 for usual care. At 3-month follow-up, absolute differences compared with usual care were -5.8 (95% CI, -7.7 to -3.9; P < .001) for ICE and -4.3 (95% CI, -5.9 to -2.6; P < .001) for IPT. Mean 12-month spending was $1448, $2528, and $1587 in the ICE, IPT, and usual care groups, respectively. Differences in spending compared with usual care were -$139 (risk ratio, 0.93 [95% CI, 0.87 to 0.997]; P = .04) for ICE and $941 (risk ratio, 1.40 [95% CI, 1.35 to 1.45]; P < .001) for IPT. Conclusions and Relevance: Among patients with acute or subacute spine pain, a multidisciplinary biopsychosocial intervention or an individualized postural therapy intervention, each compared with usual care, resulted in small but statistically significant reductions in pain-related disability at 3 months. However, compared with usual care, the biopsychosocial intervention resulted in no significant difference in spine-related health care spending and the postural therapy intervention resulted in significantly greater spine-related health care spending at 1 year. Trial Registration: ClinicalTrials.gov Identifier: NCT03083886.

Association Between Cost-Saving Prescription Policy Changes and Adherence to Chronic Disease Medications: an Observational Study.

BACKGROUND: Pharmacy benefit design is one tool for improving access and adherence to medications for the management of chronic disease. OBJECTIVE: We assessed the effects of pharmacy benefit design programs, including a change in pharmacy benefit manager (PBM), institution of a prescription out-of-pocket maximum, and a mandated switch to 90 days' medication supply, on adherence to chronic disease medications over time. DESIGN: We used a difference-in-differences design to assess changes in adherence to chronic disease medications after the transition to new prescription policies. SUBJECTS: We utilized claims data from adults aged 18-64, on ≥ 1 medication for chronic disease, whose insurer instituted the prescription policies (intervention group) and a propensity score-matched comparison group from the same region. MAIN MEASURES: The outcome of interest was adherence to chronic disease medications measured by proportion of days covered (PDC) using pharmacy claims. KEY RESULTS: There were 13,798 individuals in each group after propensity score matching. Compared to the matched control group, adherence in the intervention group decreased in the first quarter of 2015 and then increased back to pre-intervention trends. Specifically, the change in adherence compared to the last quarter of 2014 in the intervention group versus controls was - 3.6 percentage points (pp) in 2015 Q1 (p < 0.001), 0.65 pp in Q2 (p = 0.024), 1.1 pp in Q3 (p < 0.001), and 1.4 pp in Q4 (p < 0.001). CONCLUSIONS: In this cohort of commercially insured adults on medications for chronic disease, a change in PBM accompanied by a prescription out-of-pocket maximum and change to 90 days' supply was associated with short-term disruptions in adherence followed by return to pre-intervention trends. A small improvement in adherence over the year of follow-up may not be clinically significant. These findings have important implications for employers, insurers, or health systems wishing to utilize pharmacy benefit design to improve management of chronic disease.

Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial.

BACKGROUND: Low back and neck pain (together, spine pain) are among the leading causes of medical visits, lost productivity, and disability. For most people, episodes of spine pain are self-limited; nevertheless, healthcare spending for this condition is extremely high. Focusing care on individuals at high-risk of progressing from acute to chronic pain may improve efficiency. Alternatively, postural therapies, which are frequently used by patients, may prevent the overuse of high-cost interventions while delivering equivalent outcomes. METHODS: The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure) trial is a cluster-randomized multi-center pragmatic clinical trial designed to evaluate the clinical effectiveness and healthcare utilization of two interventions for primary care patients with acute and subacute spine pain. The study was conducted at 33 primary care clinics in geographically distinct regions of the United States. Individuals ≥18 years presenting to primary care with neck and/or back pain of ≤3 months' duration were randomized at the clinic-level to 1) usual care, 2) a risk-stratified, multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care. The trial's two primary outcomes are change in function at 3 months and spine-related spending at one year. 2971 individuals were enrolled between June 2017 and March 2020. Follow-up was completed on March 31, 2021. DISCUSSION: The SPINE CARE trial will determine the impact on clinical outcomes and healthcare costs of two interventions for patients with spine pain presenting to primary care. TRIAL REGISTRATION NUMBER: NCT03083886.

Impact of a novel pharmacist-delivered behavioral intervention for patients with poorly-controlled diabetes: The ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic randomized trial.

BACKGROUND: Many factors contribute to suboptimal diabetes control including insufficiently-intensive treatment and non-adherence to medication and lifestyle. Determining which of these is most relevant for individual patients is challenging. Patient engagement techniques may help identify contributors to suboptimal adherence and address barriers (using motivational interviewing) and help facilitate choices among treatment augmentation options (using shared decision-making). These methods have not been used in combination to improve diabetes outcomes. OBJECTIVE: To evaluate the impact of a telephone-based patient-centered intervention on glycosylated hemoglobin (HbA1c) control for individuals with poorly-controlled diabetes. DESIGN: Two-arm pragmatic randomized control trial within an explanatory sequential mixed-methods design. SUBJECTS: 1,400 participants 18-64 years old with poorly-controlled type 2 diabetes. INTERVENTION: The intervention was delivered over the telephone by a clinical pharmacist and consisted of a 2-step process that integrated brief negotiated interviewing and shared decision-making to identify patient goals and options for enhancing diabetes management. MAIN MEASURES: The primary outcome was change in HbA1c. Secondary outcomes were medication adherence measures. Outcomes were evaluated using intention-to-treat principles; multiple imputation was used for missing values in the 12-month follow-up. We used information from pharmacist notes to elicit factors to potentially explain the intervention's effectiveness. KEY RESULTS: Participants had a mean age of 54.7 years (SD:8.3) and baseline HbA1c of 9.4 (SD:1.6). Change in HbA1c from baseline was -0.79 (SD:2.01) in the control arm and -0.75 (SD:1.76) in the intervention arm (difference:+0.04, 95%CI: -0.22, 0.30). There were no significant differences in adherence. In as-treated analyses, the intervention significantly improved diabetes control (-0.48, 95%CI: -0.91, -0.05). Qualitative findings provided several potential explanations for the findings, including insufficiently addressing patient barriers. CONCLUSIONS: A novel telephone-based patient-centered intervention did not improve HbA1c among individuals with poorly-controlled diabetes, though as-treated analyses suggest that the intervention was effective for those who received it. TRIAL REGISTRATION: ClinicalTrials.gov NCT02910089.

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.

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.

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.

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.

The role of behavioral economic incentive design and demographic characteristics in financial incentive-based approaches to changing health behaviors: a meta-analysis.

OBJECTIVE: To evaluate the use of behavioral economics to design financial incentives to promote health behavior change and to explore associations with demographic characteristics. DATA SOURCE: Studies performed by the Center for Health Incentives and Behavioral Economics at the University of Pennsylvania published between January 2006 and March 2014. STUDY INCLUSION AND EXCLUSION CRITERIA: Randomized, controlled trials with available participant-level data. Studies that did not use financial incentives to promote health behavior change were excluded. DATA EXTRACTION: Participant-level data from seven studies were pooled. DATA SYNTHESIS: Meta-analysis on the pooled sample using a random-effects model with interaction terms to examine treatment effects and whether they varied by incentive structure or demographic characteristics. RESULTS: The pooled study sample comprised 1403 participants, of whom 35% were female, 70% were white, 24% were black, and the mean age was 48 years (standard deviation 11.2 years). In the fully adjusted model, participants offered financial incentives had higher odds of behavior change (odds ratio [OR]: 3.96; p < .01) when compared to control. There were no significant interactions between financial incentives and gender, age, race, income, or education. When further adjusting for incentive structure, blacks had higher odds than whites of achieving behavior change (OR: 1.67; p < .05) with a conditional payment. Compared to lower-income participants, higher-income participants had lower odds of behavior change (OR: 0.46; p = .01) with a regret lottery. CONCLUSION: Financial incentives designed using concepts from behavioral economics were effective for promoting health behavior change. There were no large and consistent relationships between the effectiveness of financial incentives and observable demographic characteristics. Second-order examinations of incentive structure suggest potential relationships among the effectiveness of financial incentives, incentive structure, and the demographic characteristics of race and income.