Effect of Nudges to Clinicians, Patients, or Both to Increase Statin Prescribing: A Cluster Randomized Clinical Trial.

Importance: Statins reduce the risk of major adverse cardiovascular events, but less than one-half of individuals in America who meet guideline criteria for a statin are actively prescribed this medication. Objective: To evaluate whether nudges to clinicians, patients, or both increase initiation of statin prescribing during primary care visits. Design, Setting, and Participants: This cluster randomized clinical trial evaluated statin prescribing of 158 clinicians from 28 primary care practices including 4131 patients. The design included a 12-month preintervention period and a 6-month intervention period between October 19, 2019, and April 18, 2021. Interventions: The usual care group received no interventions. The clinician nudge combined an active choice prompt in the electronic health record during the patient visit and monthly feedback on prescribing patterns compared with peers. The patient nudge was an interactive text message delivered 4 days before the visit. The combined nudge included the clinician and patient nudges. Main Outcomes and Measures: The primary outcome was initiation of a statin prescription during the visit. Results: The sample comprised 4131 patients with a mean (SD) age of 65.5 (10.5) years; 2120 (51.3%) were male; 1210 (29.3%) were Black, 106 (2.6%) were Hispanic, 2732 (66.1%) were White, and 83 (2.0%) were of other race or ethnicity, and 933 (22.6%) had atherosclerotic cardiovascular disease. In unadjusted analyses during the preintervention period, statins were prescribed to 5.6% of patients (105 of 1876) in the usual care group, 4.8% (97 of 2022) in the patient nudge group, 6.0% (104 of 1723) in the clinician nudge group, and 4.7% (82 of 1752) in the combined group. During the intervention, statins were prescribed to 7.3% of patients (75 of 1032) in the usual care group, 8.5% (100 of 1181) in the patient nudge group, 13.0% (128 of 981) in the clinician nudge arm, and 15.5% (145 of 937) in the combined group. In the main adjusted analyses relative to usual care, the clinician nudge significantly increased statin prescribing alone (5.5 percentage points; 95% CI, 3.4 to 7.8 percentage points; P = .01) and when combined with the patient nudge (7.2 percentage points; 95% CI, 5.1 to 9.1 percentage points; P = .001). The patient nudge alone did not change statin prescribing relative to usual care (0.9 percentage points; 95% CI, -0.8 to 2.5 percentage points; P = .32). Conclusions and Relevance: Nudges to clinicians with and without a patient nudge significantly increased initiation of a statin prescription during primary care visits. The patient nudge alone was not effective. Trial Registration: ClinicalTrials.gov Identifier: NCT04307472.

Effect of Goal-Setting Approaches Within a Gamification Intervention to Increase Physical Activity Among Economically Disadvantaged Adults at Elevated Risk for Major Adverse Cardiovascular Events: The ENGAGE Randomized Clinical Trial.

Importance: Health promotion efforts commonly communicate goals for healthy behavior, but the best way to design goal setting among high-risk patients has not been well examined. Objective: To test the effectiveness of different ways to set and implement goals within a behaviorally designed gamification intervention to increase physical activity. Design, Setting, and Participants: Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences was conducted from January 15, 2019, to June 1, 2020. The 24-week randomized clinical trial included a remotely monitored 8-week introductory intervention period, 8-week maintenance intervention period, and 8-week follow-up period. A total of 500 adults from lower-income neighborhoods in and around Philadelphia, Pennsylvania, who had either an atherosclerotic cardiovascular disease (ASCVD) condition or a 10-year ASCVD risk score greater than or equal to 7.5% were enrolled. Participants were paid for enrolling in and completing the trial. Interventions: All participants used a wearable device to track daily steps, established a baseline level, and were then randomly assigned to an attention control or 1 of 4 gamification interventions that varied only on how daily step goals were set (self-chosen or assigned) and implemented (immediately or gradually). Main Outcome Measures: The primary outcome was change in mean daily steps from baseline to the 8-week maintenance intervention period. Other outcomes included changes in minutes of moderate to vigorous physical activity. All randomly assigned participants were included in the intention-to-treat analysis. Results: Of the 500 participants, 331 individuals (66.2%) were Black, 114 were White (22.8%), and 348 were women (69.6%). Mean (SD) age was 58.5 (10.8) years and body mass index was 33.2 (7.8). A total of 215 participants (43.0%) had an ASCVD condition. Compared with the control arm, participants with self-chosen and immediate goals had significant increases in the number of daily steps during the maintenance intervention period (1384; 95% CI, 805-1963; P < .001) that were sustained during the 8-week follow-up (1391; 95% CI, 785-1998; P < .001). This group also had significant increases in daily minutes of moderate to vigorous physical activity during the maintenance intervention (4.1; 95% CI, 1.8-6.4; P < .001) that were sustained during follow-up (3.5; 95% CI, 1.1-5.8; P = .004). No other gamification arms had consistent increases in physical activity compared with the control arm. No major adverse events were reported. Conclusions and Relevance: In this trial among economically disadvantaged adults at elevated risk for major adverse cardiovascular events, a gamification intervention led to increases in physical activity that were sustained during 8 weeks of follow-up when goals were self-chosen and implemented immediately. Trial Registration: ClinicalTrials.gov Identifier: NCT03749473.

Effect of Gamification With and Without Financial Incentives to Increase Physical Activity Among Veterans Classified as Having Obesity or Overweight: A Randomized Clinical Trial.

Importance: Gamification is increasingly being used for health promotion but has not been well tested with financial incentives or among veterans. Objective: To test the effectiveness of gamification with social support, with and without a loss-framed financial incentive, to increase physical activity among veterans classified as having overweight and obesity. Design, Setting, and Participants: This 3-group randomized clinical trial had a 12-week intervention period and an 8-week follow-up period. Participants included veterans with a body mass index greater than or equal to 25 who were receiving care from a single site in Philadelphia, Pennsylvania. Participants underwent a remotely monitored intervention from March 19, 2019, to August 9, 2020. Data analyses were conducted between October 1, 2020, and November 14, 2020. Interventions: All participants received a wearable device to track step counts and selected a step goal. The control group received feedback from their devices only. Participants in the 2 gamification groups were entered into a 12-week game with points and levels designed using behavioral economic principles and selected a support partner to receive weekly updates. Participants in the loss-framed financial incentive group had $120 allocated to a virtual account and lost $10 if weekly goals were not achieved. Main Outcomes and Measures: The primary outcome was the change in mean daily steps from baseline during the intervention. Secondary outcomes include proportion of days goals were achieved and changes during follow-up. Results: A total of 180 participants were randomized, 60 to the gamification with social support group, 60 to the gamification with social support and loss-framed financial incentives group, and 60 to the control group. The participants had a mean (SD) age of 56.5 (12.9) years and a mean (SD) body mass index of 33.0 (5.6); 71 participants (39.4%) were women, 90 (50.0%) were White, and 67 (37.2%) were Black. During the intervention period, compared with control group participants, participants in the gamification with financial incentives group had a significant increase in mean daily steps from baseline (adjusted difference, 1224 steps; 95% CI, 451 to 1996 steps; P = .005), but participants in the gamification without financial incentives group did not (adjusted difference, 433 steps; 95% CI, -337 to 1203 steps; P = .81). The increase for the gamification with financial incentives group was not sustained during the follow-up period, and the step count was not significantly different than that of the control group (adjusted difference, 564 steps; 95% CI, -261 to 1389 steps; P = .37). Compared with the control group, participants in the intervention groups had a significantly higher adjusted proportion of days meeting their step goal during the main intervention and follow-up period (gamification with social support group, adjusted difference from control, 0.21 participant-day; 95% CI, 0.18-0.24 participant-day; P < .001; gamification with social support and loss-framed financial incentive group, adjusted difference from control, 0.34 participant-day; 95% CI, 0.31-0.37 participant-day; P < .001). Conclusions and Relevance: Among veterans classified as having overweight and obesity, gamification with social support combined with loss-framed financial incentives was associated with a modest increase in physical activity during the intervention period, but the increase was not sustained during follow-up. Gamification without incentives did not significantly change physical activity. Trial Registration: ClinicalTrials.gov Identifier: NCT03563027.

Leveraging insights from behavioral economics to improve mobility for adults with stroke: Design and rationale of the BE Mobile clinical trial.

Physical inactivity post-stroke can negatively impact long-term health outcomes and contribute to cardiovascular deconditioning, muscle loss, and increased risk for recurrent stroke. The limited number of interventions designed to improve daily physical activity post-stroke have lacked precision in step goals, are resource intensive, and difficult to scale. The purpose of the Leveraging Insights from Behavioral Economics to Improve Mobility for Adults with Stroke (BE Mobile) trial is to examine the preliminary effectiveness of a novel gamification with social incentives intervention for improving physical activity post-stroke. This trial includes adults who have experienced an ischemic or hemorrhagic stroke ≥3 months prior to the time of recruitment who are randomized to a control or gamification arm. All participants receive a Fitbit Inspire 2 wearable device to quantify daily steps and complete a 2-week baseline run-in period followed by an 8-week intervention period. All participants select a daily step goal and the gamification arm is enrolled in a game with loss-framed points and levels to help participants achieve their daily step goal. Participants in the gamification arm also select a support partner who receives weekly updates on their progress in the game. The primary outcome is change in daily steps from baseline during the intervention period. The secondary outcome is difference in the proportion of days participants achieved their daily step goal. Results from this trial will inform future, larger studies that leverage insights from behavioral economics to help improve daily physical activity post-stroke. Trial registration: NCT #04607811.

Communication Practices of Mammography Facilities and Timely Follow-up of a Screening Mammogram with a BI-RADS 0 Assessment.

RATIONALE AND OBJECTIVES: The objective of this study was to evaluate the association of communication practices with timely follow-up of screening mammograms read as Breast Imaging Reporting and Data Systems (BI-RADS) 0 in the Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) consortium. MATERIALS AND METHODS: A radiology facility survey was conducted in 2015 with responses linked to screening mammograms obtained in 2011-2014. We considered timely follow-up to be within 15 days of the screening mammogram. Generalized estimating equation models were used to evaluate the association between modes of communication with patients and providers and timely follow-up, adjusting for PROSPR site, patient age, and race and ethnicity. RESULTS: The analysis included 34,680 mammography examinations with a BI-RADS 0 assessment among 28 facilities. Across facilities, 85.6% of examinations had a follow-up within 15 days. Patients in a facility where routine practice was to contact the patient by phone if follow-up imaging was recommended were more likely to have timely follow-up (odds ratio [OR] 4.63, 95% confidence interval [CI] 2.76-7.76), whereas standard use of mail was associated with reduced timely follow-up (OR 0.47, 95% CI 0.30-0.75). Facilities that had standard use of electronic medical records to report the need for follow-up imaging to a provider had less timely follow-up (OR 0.56, 95% CI 0.35-0.90). Facilities that routinely contacted patients by mail if they missed a follow-up imaging visit were more likely to have timely follow-up (OR 1.65, 95% CI 1.02-2.69). CONCLUSIONS: Our findings support the value of telephone communication to patients in relation to timely follow-up. Future research is needed to evaluate the role of communication in completing the breast cancer screening episode.