Fatal Overdose Review Teams - Research to Enhance Surveillance Systems

Not Applicable

• Conditions: Opioid-Related Disorders; Substance-Related Disorders
• Interventions: Behavioral: Data-Driven Decision Making (DDDM); Behavioral: Overdose-prevention strategies inventory

• Registration Number: NCT06084221
• Lead Sponsor: Indiana University

Brief Summary

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/).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-21
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FORTRESS	Overdose-prevention strategies inventory	Participating counties receive both training in data-driven decision making and inventory of overdose-prevention strategies
FORTRESS	Data-Driven Decision Making (DDDM)	Participating counties receive both training in data-driven decision making and inventory of overdose-prevention strategies

Primary Outcome Measures

Name	Time	Method
Cultural Exchange Inventory (adapted to evaluate OFR team alliance)	Months 18, 24, 30, 36, 42, 48, 54, & 60	15-items that measure knowledge and attitudes between organizations that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.
Dashboard Aggregate Usage	Months 14-54	Web Cookies and anonymized IDs for each unique user to track dashboard usage that will be tracked on an on-going basis. Dr. Reda will review results monthly.
Organizational readiness to implement change	Months 18, 24, 30, 36, 42, 48, 54, & 60	12-items that assess perceived readiness to implement new innovations that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.
Organization's implementation climate (adapted to evaluate overdose prevention strategies)	Months 18, 24, 30, 36, 42, 48, 54, & 60	18-items that assesses the degree to which the climate is supportive of adopting new innovations that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.
Quality OFR Recommendations	Months 14-54	OFR team recommendations will be gathered monthly. We will be coding the quality of OFR team recommendations using the coding system that we developed in phase 1 of our FORTRESS project. This measure involves qualitative assessments of whether a recommendation meets certain standards of quality. The qualitative coding will be conducted by research staff in a digital spreadsheet.
Harm reduction acceptability scale	Months 18, 24, 30, 36, 42, 48, 54, & 60	25-items that measures the adoption of a harm reduction approach in responding to people who use substances that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.
Uptake of OFR Interventions	Months 14-54	OFR team recommendations will be gathered monthly. Uptake of an intervention will be defined as implementation of the recommendation. OFR team overdose prevention recommendations will be coded for uptake (whether or not they were implemented). This measure involves quantitative assessment of the incidence of uptake.
Systems Usability Scale	Months 18, 24, 30, 36, 42, 48, 54, & 60	10-items that assesses the usability of dashboard for OFRs that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.
Stages of Implementation Completion (SIC)	Baseline through study completion, an average of 5 years	The SIC is a measure of implementation process fidelity and allows for continuous measurement of implementation success. The SIC is an observation-based assessment tool that qualitatively measures intervention implementation process and fidelity. Assessment of the SIC results will be ongoing across the intervention time period and into sustainment.
OFR Fidelity Tool	Months 18-54	To be developed fidelity assessment tool that will be completed by each OFR facilitator after a monthly meeting.
Overdose	Month 35-40 (interim) and month 53-57 (final)	Mortality data is collected via death certificates that are submitted by county coroners to the IDOH Division of Vital Records, which include information on underlying cause of Death. Data will include all fatal accidental drug overdose deaths (X40-X44).

Trial Locations

Locations (1)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States