Fatal Overdose Review Teams - Research to Enhance Surveillance Systems
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT06084221
- Status
- Enrolling By Invitation
Conditions
- Opioid-Related Disorders
- Substance-Related Disorders
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Accepted
Interventions
- Data-Driven Decision Making (DDDM) — BEHAVIORALThe intervention consists of providing real-time data on overdose touchpoints to OFRs and training in DDDM for continuous quality improvement cycles, leading to improved OFR recommendations and implementation of overdose prevention strategies.
- Overdose-prevention strategies inventory — BEHAVIORALA list of overdose prevention and harm reduction strategies will be provided to OFRs for possible implementation, depending on local needs and final dashboard development.
Study Details
This project seeks to address the overdose epidemic by working with overdose fatality review (OFR) teams. Current OFR practices rely on a case review model where OFR teams assess one or two overdose cases to make policy and program recommendations. However, the continued rise in overdose rates and number of preventable overdose deaths suggest a need to shift OFR teams away from case review and toward using timely population-level data to better inform their recommendations and actions. The goal of this project, Fatal Overdose Review Teams - Research to Enhance Surveillance Systems (FORTRESS), is to improve standard OFR practices by equipping OFRs with a data dashboard built on near real-time aggregate data, linked across multiple sources and presented in a way that helps identify common "overdose touchpoints," or opportunities to connect individuals at risk for overdose with evidence-based treatment. During the first project phase, the FORTRESS team will design the "Overdose Touchpoints Dashboard'' (Aim 1). The FORTRESS team will also train OFR team members in "Data-Driven Decision Making" (DDDM) to effectively use the dashboard. The FORTRESS team also includes individuals involved in developing the CDC's OFR best practice guidelines and a pilot study of OFR adherence to these guidelines, which will inform the FORTRESS team's development of an "OFR Fidelity Tool'' (Aim 2). This tool will be the first of its kind. For the second project phase, the FORTRESS team will conduct a cluster-randomized stepped-wedge trial comparing the impact of the intervention (dashboard + DDDM training) versus standard OFR practices on both implementation (Aim 3) and effectiveness outcomes (Aim 4). Implementation outcomes include implementation process fidelity (Stages of Implementation Completion), staff acceptance of harm reduction philosophies (qualitative interviews), OFR fidelity to CDC best practices (FORTRESS OFR Fidelity Tool), and usability of the Overdose Touchpoint Dashboard, (Systems Usability Scale). A statewide OFR data repository serves as a rich source of data on effectiveness outcomes, including OFR team recommendation quality and local actions to implement recommended overdose prevention strategies. The FORTRESS team will also survey OFR team members to assess changes in their attitudes toward evidence-based overdose prevention strategies. In sum, the FORTRESS team is uniquely qualified to help OFRs use more comprehensive available data to inform quality, action-oriented recommendations to reduce overdose. Funding for this project comes from the HEAL Initiative (https://heal.nih.gov/).
Key Dates
- Start date
- Sep 21, 2023
- Status verified
- Feb 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- No Intervention: OFR Team Practice as UsualData are collected regarding standard OFR Team practice and outcomes before implementation of the FORTRESS Intervention
- Experimental: FORTRESSParticipating counties receive both training in data-driven decision making and inventory of overdose-prevention strategies
Primary Outcome Measure
Organizational readiness to implement change [ Time Frame: Months 18, 24, 30, 36, 42, 48, 54, & 60 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | - |
Find similar trials in Indianapolis, IN
Related Studies
- Alliances to Disseminate Addiction Prevention and Treatment (ADAPT)Enrolling By Invitation · Indiana University · Indianapolis, Indiana
- Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use DisorderEnrolling By Invitation · Indiana University · Indianapolis, Indiana
- Outcome Inference in the Sensory Preconditioning Task in Opioid-Use DisorderRecruiting · National Institute on Drug Abuse (NIDA) · Baltimore, Maryland
- CRP and S&A for Inpatient VeteransRecruiting · VA Office of Research and Development · Charleston, South Carolina