Two randomized controlled trials of nudges to encourage referrals to centralized pharmacy services for evidence-based statin initiation in high-risk patients: Rationale and design of the SUPER LIPID program.

BACKGROUND: In patients with or at risk for atherosclerotic vascular disease, statins reduce the incidence of major adverse cardiovascular events, but the majority of US adults with an indication for statin therapy are not prescribed statins at guideline-recommended intensity. Clinicians' limited time to address preventative care issues is cited as one factor contributing to gaps in statin prescribing. Centralized pharmacy services can fulfill a strategic role for population health management through outreach, education, and statin prescribing for patients at elevated ASCVD risk, but best practices for optimizing referrals of appropriate patients are unknown. STUDY DESIGN AND OBJECTIVES: SUPER LIPID (NCT05537064) is a program consisting of two pragmatic clinical trials testing the effect of nudges in increasing referrals of appropriate patients to a centralized pharmacy service for lipid management, conducted within 11 primary care practices in a large community health system. In both trials, patients were eligible for inclusion if they had an assigned primary care provider (PCP) in a participating practice and were not prescribed a high- or moderate-intensity statin despite an indication, identified via an electronic health record (EHR) algorithm. Trial #1 was a stepped wedge trial, conducted at a single practice with randomization at the PCP level, of an interruptive EHR message that appeared during eligible patients' visits and facilitated referral to the pharmacy service. For the first 3 months, no PCPs received the message; for the second 3 months, half were randomly selected to receive the message; and for the last 3 months, all PCPs received the message. Trial #2 was a cluster-randomized trial conducted at 10 practices, with randomization at the practice level. Practices were randomized to usual care or to have eligible patients automatically referred to centralized pharmacy services via a referral order placed in PCPs EHR inboxes for co-signature. In both trials, when a patient was referred to centralized pharmacy services, a pharmacist reviewed the patient's chart, contacted the patient, and initiated statin therapy if the patient agreed. The primary endpoint of both trials was the proportion of patients prescribed a statin; secondary endpoints include the proportion of patients prescribed a statin at guideline-recommended intensity, the proportion of patients filling a statin prescription, and serum low-density lipoprotein level. CONCLUSIONS: SUPER LIPID is a pair of pragmatic clinical trials assessing the effectiveness of two strategies to encourage referral of appropriate patients to a centralized pharmacy service for lipid management. The trial results will develop the evidence base for simple, scalable, EHR-based strategies to integrate clinical pharmacists into population health management and increase appropriate statin prescribing. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov; NCT05537064.

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.

Holding the Hunger Games Hostage at the Gym: An Evaluation of Temptation Bundling.

We introduce and evaluate the effectiveness of temptation bundling-a method for simultaneously tackling two types of self-control problems by harnessing consumption complementarities. We describe a field experiment measuring the impact of bundling instantly gratifying but guilt-inducing "want" experiences (enjoying page-turner audiobooks) with valuable "should" behaviors providing delayed rewards (exercising). We explore whether such bundles increase should behaviors and whether people would pay to create these restrictive bundles. Participants were randomly assigned to a full treatment condition with gym-only access to tempting audio novels, an intermediate treatment involving encouragement to restrict audiobook enjoyment to the gym, or a control condition. Initially, full and intermediate treatment participants visited the gym 51% and 29% more frequently, respectively, than control participants, but treatment effects declined over time (particularly following Thanksgiving). After the study, 61% of participants opted to pay to have gym-only access to iPods containing tempting audiobooks, suggesting demand for this commitment device.

The effect of market reform on racial differences in hospital mortality.

OBJECTIVE: To determine whether racial differences in hospital mortality worsened after implementation of a New Jersey law in 1993 that reduced subsidies for uninsured hospital care and changed hospital payment from rate regulation to price competition. DATA SOURCES/STUDY SETTING: State discharge data for New Jersey and New York from 1990 to 1996. STUDY DESIGN: We used an interrupted time series design to compare risk-adjusted in-hospital mortality rates between states over time. Adjusting for patient characteristics, baseline interstate differences, and common intertemporal trends, we compared the effect sizes for whites and blacks in the following 4 groups: overall, uninsured, insured under age 65, and Medicare patients. DATA COLLECTION/EXTRACTION METHODS: The study sample included 1,357,394 patients admitted to New Jersey or New York hospitals between 1990 to 1996 with stroke, hip fracture, pneumonia, pulmonary embolism, congestive heart failure, or acute myocardial infarction (AMI). PRINCIPAL FINDINGS: The increase in mortality in New Jersey versus New York was significantly larger among blacks than among whites for AMI (2.4% points vs 0.1% points, P-value for difference .026) but not for the other 6 conditions. In groupings of conditions for which hospital admission is non-discretionary and conditions in which admission is discretionary, we found qualitatively larger increases in mortality for blacks but no statistically significant racial differences among patients overall, uninsured patients, insured patients under age 65, or Medicare patients. CONCLUSIONS: Market-based reform and reductions in subsidies for hospital care for the uninsured in New Jersey were associated with worsening racial disparities in in-hospital mortality for AMI but not for 6 other common conditions.

Comparing the standard rating scale and the magnifier scale for assessing risk perceptions.

OBJECTIVE: A new risk perception rating scale ("magnifier scale") was recently developed to reduce elevated perceptions of low-probability health events, but little is known about its performance. The authors tested whether the magnifier scale lowers risk perceptions for low-probability (in 0%-1% magnifying glass section of scale) but not high-probability (>1%) events compared to a standard rating scale (SRS). METHOD: In studies 1 (n = 463) and 2 (n = 105), undergraduates completed a survey assessing risk perceptions of high- and low-probability events in a randomized 2 x 2 design: in study 1 using the magnifier scale or SRS, numeric risk information provided or not, and in study 2 using the magnifier scale or SRS, high- or low-probability event. In study 3, hypertension patients at the Philadelphia Veterans Affairs hospital completed a similar survey (n = 222) assessing risk perceptions of 2 self-relevant high-probability events-heart attack and stroke-with the magnifier scale or the SRS. RESULTS: In study 1, when no risk information was provided, risk perceptions for both high- and low-probability events were significantly lower (P < 0.0001) when using the magnifier scale compared to the SRS, but risk perceptions were no different by scale when risk information was provided (interaction term: P = 0.003). In studies 2 and 3, risk perceptions for the high-probability events were significantly lower using the magnifier scale than the SRS (P = 0.015 and P = 0.014, respectively). CONCLUSIONS: The magnifier scale lowered risk perceptions but did so for low- and high-probability events, suggesting that the magnifier scale should not be used for assessments of risk perceptions for high-probability events.

The effects of price competition and reduced subsidies for uncompensated care on hospital mortality.

OBJECTIVE: To determine whether hospital mortality rates changed in New Jersey after implementation of a law that changed hospital payment from a regulated system based on hospital cost to price competition with reduced subsidies for uncompensated care and whether changes in mortality rates were affected by hospital market conditions. DATA SOURCES/STUDY SETTING: State discharge data for New Jersey and New York from 1990 to 1996. Study Design. We used an interrupted time series design to compare risk-adjusted in-hospital mortality rates between states over time. We compared the effect sizes in markets with different levels of health maintenance organization penetration and hospital market concentration and tested the sensitivity of our results to different approaches to defining hospital markets. DATA COLLECTION/EXTRACTION METHODS: The study sample included all patients under age 65 admitted to New Jersey or New York hospitals with stroke, hip fracture, pneumonia, pulmonary embolism, congestive heart failure, hip fracture, or acute myocardial infarction (AMI). PRINCIPAL FINDINGS: Mortality among patients in New Jersey improved less than in New York by 0.4 percentage points among the insured (p=.07) and 0.5 percentage points among the uninsured (p=.37). There was a relative increase in mortality for patients with AMI, congestive heart failure, and stroke, especially for uninsured patients with these conditions, but not for patients with the other four conditions we studied. Less competitive hospital markets were significantly associated with a relative decrease in mortality among insured patients. CONCLUSIONS: Market-based reforms may adversely affect mortality for some conditions but it appears the effects are not universal. Insured patients in less competitive markets fared better in the transition to price competition.

Volume-based referral for cardiovascular procedures in the United States: a cross-sectional regression analysis.

BACKGROUND: We sought to estimate the numbers of patients affected and deaths avoided by adopting the Leapfrog Group's recommended hospital procedure volume minimums for coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI). In addition to hospital risk-adjusted mortality standards, the Leapfrog Group recommends annual hospital procedure minimums of 450 for CABG and 400 for PCI to reduce procedure-associated mortality. METHODS: We conducted a retrospective analysis of a national hospital discharge database to evaluate in-hospital mortality among patients who underwent PCI (n = 2,500,796) or CABG (n = 1,496,937) between 1998 and 2001. We calculated the number of patients treated at low volume hospitals and simulated the number of deaths potentially averted by moving all patients to high volume hospitals under best-case conditions (i.e., assuming the full volume-associated reduction in mortality and the capacity to move all patients to high volume hospitals with no related harms). RESULTS: Multivariate adjusted odds of in-hospital mortality were higher for patients treated in low volume hospitals compared with high volume hospitals for CABG (OR 1.16, 95% CI 1.10-1.24) and PCI (OR 1.12, 95% CI 1.05-1.20). A policy of hospital volume minimums would have required moving 143,687 patients for CABG and 87,661 patients for PCI from low volume to high volume hospitals annually and prevented an estimated 619 CABG deaths and 109 PCI deaths. Thus, preventing a single death would have required moving 232 CABG patients or 805 PCI patients from low volume to high volume hospitals. CONCLUSION: Recommended hospital CABG and PCI volume minimums would prevent 728 deaths annually in the United States, fewer than previously estimated. It is unclear whether a policy requiring the movement of large numbers of patients to avoid relatively few deaths is feasible or effective.

The effect of increases in HMO penetration and changes in payer mix on in-hospital mortality and treatment patterns for acute myocardial infarction.

OBJECTIVE: To determine whether changes in health maintenance organization (HMO) penetration or payer mix affected in-hospital mortality and treatment patterns of patients with acute myocardial infarction (AMI). STUDY DESIGN: Observational study using patient-level logistic regression analysis and hospital and year fixed effects of data from the Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project Nationwide Inpatient Sample, a geographically diverse sample of 20% of the hospitalized patients in the United States. PATIENTS AND METHODS: Discharges of patients (n = 340,064) with a primary diagnosis of acute myocardial infarction who were treated in general medical or surgical hospitals that contributed at least 2 years of data to the HealthCare Cost and Utilization Project Nationwide Inpatient Sample from 1989 to 1996. In-hospital mortality and rates of cardiac catheterization, angioplasty, or coronary artery bypass grafting for Medicare patients or non-Medicare patients were the main outcome measures. RESULTS: Among Medicare patients, increases in HMO penetration were associated with reduced odds of receiving cardiac catheterization, angioplasty, or coronary artery bypass grafting of 3% to 16%, but were not associated with any change in mortality risk. Increases in the number of HMOs within a metropolitan statistical area, our measure of HMO competition, were associated with small but significant increases in the odds of cardiac catheterization and angioplasty of about 2%. There was no pattern of changes in cardiac procedure rates or in-hospital mortality among non-Medicare patients. CONCLUSION: Increases in HMO penetration reduced cardiac procedure rates by statistically significant but small amounts among Medicare patients with AMI, without affecting mortality rates.

Hospital percutaneous coronary intervention volume and patient mortality, 1998 to 2000: does the evidence support current procedure volume minimums?

OBJECTIVES: The aim of this study was to evaluate current American College of Cardiology/American Heart Association (ACC/AHA) hospital percutaneous coronary intervention (PCI) volume minimum recommendations. BACKGROUND: In order to reduce procedure-associated mortality, ACC/AHA guidelines recommend that hospitals offering PCIs perform at least 400 PCIs annually. It is unclear whether this volume standard applies to current practice. METHODS: We conducted a retrospective analysis of the Agency for Healthcare Research and Quality's Nationwide In-patient Sample hospital discharge database to evaluate in-hospital mortality among patients (n = 362748) who underwent PCI between 1998 and 2000 at low (5 to 199 cases/year), medium (200 to 399 cases/year), high (400 to 999 cases/year), and very high (1000 cases or more/year) PCI volume hospitals. RESULTS: Crude in-hospital mortality rates were 2.56% in low-volume hospitals, 1.83% in medium-volume hospitals, 1.64% in high-volume hospitals, and 1.36% in very high-volume hospitals (p < 0.001 for trend). Compared with patients treated in high-volume hospitals (odds ratio [OR] 1.00, referent), patients treated in low-volume hospitals remained at increased risk for mortality after adjustment for patient characteristics (OR 1.21, 95% confidence interval [CI] 1.06 to 1.28). However, patients treated in medium-volume hospitals (OR 1.02, 95% CI 0.92 to 1.14) and patients treated in very high-volume hospitals (OR 0.94, 95% CI 0.85 to 1.03) had a comparable risk of mortality. Findings were similar when high- and very high-volume hospitals were pooled together. CONCLUSIONS: We found no evidence of higher in-hospital mortality in patients undergoing PCI at medium-volume hospitals compared with patients treated at hospitals with annual PCI volumes of 400 cases of more, suggesting current ACC/AHA PCI hospital volume minimums may merit reevaluation.

Hospital coronary artery bypass graft surgery volume and patient mortality, 1998-2000.

OBJECTIVE: To evaluate the association between annual hospital coronary artery bypass graft (CABG) surgery volume and in-hospital mortality. SUMMARY BACKGROUND DATA: The Leapfrog Group recommends health care purchasers contract for CABG services only with hospitals that perform >or=500 CABGs annually to reduce mortality; it is unclear whether this standard applies to current practice. METHODS: We conducted a retrospective analysis of the National Inpatient Sample database for patients who underwent CABG in 1998-2000 (n = 228738) at low (12-249 cases/year), medium (250-499 cases/year), and high (>or=500 cases/year) CABG volume hospitals. Crude in-hospital mortality rates were 4.21% in low-volume hospitals, 3.74% in medium-volume hospitals, and 3.54% in high-volume hospitals (trend P < 0.001). Compared with patients at high-volume hospitals (odds ratio 1.00, referent), patients at low-volume hospitals remained at increased risk of mortality after multivariable adjustment (odds ratio 1.26, 95% confidence interval = 1.15-1.39). The mortality risk for patients at medium-volume hospitals was of borderline significance (odds ratio 1.11, 95% confidence interval = 1.01-1.21). However, 207 of 243 (85%) of low-volume and 151 of 169 (89%) of medium-volume hospital-years had risk-standardized mortality rates that were statistically lower or comparable to those expected. In contrast, only 11 of 169 (6%) of high-volume hospital-years had outcomes that were statistically better than expected. CONCLUSIONS: Patients at high-volume CABG hospitals were, on average, at a lower mortality risk than patients at lower-volume hospitals. However, the small size of the volume-associated mortality difference and the heterogeneity in outcomes within all CABG volume groups suggest individual hospital CABG volume is not a reliable marker of hospital CABG quality.

Market reform in New Jersey and the effect on mortality from acute myocardial infarction.

OBJECTIVE: To determine whether mortality rates for patients with acute myocardial infarction (AMI) changed in New Jersey after implementation of the Health Care Reform Act, which reduced subsidies for hospital care for the uninsured and changed hospital payment to price competition from a rate-setting system based on hospital cost. DATA SOURCES/STUDY SETTING: Patient discharge data from hospitals in New Jersey and New York from 1990 through 1996 and the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS). STUDY DESIGN: A comparison between states over time of unadjusted and risk-adjusted mortality and cardiac procedure rates. DATA COLLECTION: Discharge data were obtained for 286,640 patients with the primary diagnosis of AMI admitted to hospitals in New Jersey or New York from 1990 through 1996. Records of 364,273 NIS patients were used to corroborate time trends. PRINCIPAL FINDINGS: There were no significant differences in AMI mortality among insured patients in New Jersey relative to New York or the NIS. However, there was a relative increase in mortality of 41 to 57 percent among uninsured New Jersey patients post-reform, and their rates of expensive cardiac procedures decreased concomitantly. CONCLUSIONS: The introduction of hospital price competition and reductions in subsidies for hospital care of the uninsured were associated with an increased mortality rate among uninsured New Jersey AMI patients. A relative decrease in the use of cardiac procedures in New Jersey may partly explain this finding. Additional studies should be done to identify whether other market reforms have been associated with changes in the quality of care.

Market reform in New Jersey and quality of care: a cautionary tale.

As more that 40 states face present and projected deficits in their health care budgets, some legislatures are considering market-based reforms to control rising health care costs. This continues a trend begun in the 1990s that emphasized market competition over state regulation and mandates. However, little is known about the impact of many market-based reforms on quality of care. This Issue Brief evaluates the effect of one reform--the deregulation of hospital reimbursement rates in New Jersey--on one important outcome of care-mortality from acute myocardial infarction (heart attack). The findings serve as a reminder that cost-constraining reforms may reduce the quality of care, particularly for uninsured and other vulnerable populations.