Study protocol for a multisite randomized controlled trial of a peer navigator intervention for emergency department patients with nonfatal opioid overdose.

BACKGROUND: Patients presenting to emergency departments (EDs) after a nonfatal opioid-involved overdose are at high risk for future overdose and death. Responding to this risk, the New York City (NYC) Department of Health and Mental Hygiene operates the Relay initiative, which dispatches trained peer "Wellness Advocates" to meet patients in the ED after a suspected opioid-involved overdose and follow them for up to 90 days to provide support, education, referrals to treatment, and other resources using a harm reduction framework. METHODS: In this article, we describe the protocol for a multisite randomized controlled trial of Relay. Study participants are recruited from four NYC EDs and are randomized to receive the Relay intervention or site-directed care (the control arm). Outcomes are assessed through survey questionnaires conducted at 1-, 3-, and 6-months after the baseline visit, as well as through administrative health data. The primary outcome is the number of opioid-related adverse events, including any opioid-involved overdose or any other substance use-related ED visit, in the 12 months post-baseline. Secondary and exploratory outcomes will also be analyzed, as well as hypothesized mediators and moderators of Relay program effectiveness. CONCLUSION: We present the protocol for a multisite randomized controlled trial of a peer-delivered OD prevention intervention in EDs. We describe how the study was designed to minimize disruption to routine ED operations, and how the study was implemented and adapted during the COVID-19 pandemic. This trial is registered with ClinicalTrials.gov [NCT04317053].

Effectiveness of Goal-Directed and Outcome-Based Financial Incentives for Weight Loss in Primary Care Patients With Obesity Living in Socioeconomically Disadvantaged Neighborhoods: A Randomized Clinical Trial.

Importance: Financial incentives for weight management may increase use of evidence-based strategies while addressing obesity-related economic disparities in low-income populations. Objective: To examine the effects of 2 financial incentive strategies developed using behavioral economic theory when added to provision of weight management resources. Design, Setting, and Participants: Three-group, randomized clinical trial conducted from November 2017 to May 2021 at 3 hospital-based clinics in New York City, New York, and Los Angeles, California. A total of 1280 adults with obesity living in low-income neighborhoods were invited to participate, and 668 were enrolled. Interventions: Participants were randomly assigned to goal-directed incentives, outcome-based incentives, or a resources-only group. The resources-only group participants were given a 1-year commercial weight-loss program membership, self-monitoring tools (digital scale, food journal, and physical activity monitor), health education, and monthly one-on-one check-in visits. The goal-directed group included resources and linked financial incentives to evidence-based weight-loss behaviors. The outcome-based arm included resources and linked financial incentives to percentage of weight loss. Participants in the incentive groups could earn up to $750. Main Outcomes and Measures: Proportion of patients achieving 5% or greater weight loss at 6 months. Results: The mean (SD) age of the 668 participants enrolled was 47.7 (12.4) years; 541 (81.0%) were women, 485 (72.6%) were Hispanic, and 99 (14.8%) were Black. The mean (SD) weight at enrollment was 98.96 (20.54) kg, and the mean body mass index (calculated as weight in kilograms divided by height in meters squared) was 37.95 (6.55). At 6 months, the adjusted proportion of patients who lost at least 5% of baseline weight was 22.1% in the resources-only group, 39.0% in the goal-directed group, and 49.1% in the outcome-based incentive group (difference, 10.08 percentage points [95% CI, 1.31-18.85] for outcome based vs goal directed; difference, 27.03 percentage points [95% CI, 18.20-35.86] and 16.95 percentage points [95% CI, 8.18-25.72] for outcome based or goal directed vs resources only, respectively). However, mean percentage of weight loss was similar in the incentive arms. Mean earned incentives was $440.44 in the goal-directed group and $303.56 in the outcome-based group, but incentives did not improve financial well-being. Conclusions and Relevance: In this randomized clinical trial, outcome-based and goal-directed financial incentives were similarly effective, and both strategies were more effective than providing resources only for clinically significant weight loss in low-income populations with obesity. Future studies should evaluate cost-effectiveness and long-term outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03157713.