Clinical trial NCT06084221: Fatal Overdose Review Teams - Research to Enhance Surveillance Systems
Official title: Fatal Overdose Review Teams - Research to Enhance Surveillance Systems (FORTRESS)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Substance-Related Disorders
Opioid-Related Disorders
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-10-16
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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/).


Eligibility criteria: Inclusion Criteria for FORTRESS staff personnel recruited to complete surveys, focus groups and/or interviews:

* 1) member of local overdose fatality review (OFR) team; OR 2) local county leader of organizations represented by OFR (OFR facilitator, public jail administrators, chief of police, judge, addiction treatment CEO/CFO, public health director, etc.).

Inclusion criteria for FORTRESS administrative data:

* all residents of Indiana that have experienced fatal and/or non-fatal overdose as identified by administrative data sources.

Exclusion Criteria

* N/A

Primary outcomes:
measure: Organizational readiness to implement change
timeFrame: Months 18, 24, 30, 36, 42, 48, 54, & 60
measure: Cultural Exchange Inventory (adapted to evaluate OFR team alliance)
timeFrame: Months 18, 24, 30, 36, 42, 48, 54, & 60
measure: Harm reduction acceptability scale
timeFrame: Months 18, 24, 30, 36, 42, 48, 54, & 60
measure: Systems Usability Scale
timeFrame: Months 18, 24, 30, 36, 42, 48, 54, & 60
measure: Stages of Implementation Completion (SIC)
timeFrame: Baseline through study completion, an average of 5 years
measure: OFR Fidelity Tool
timeFrame: Months 18-54
measure: Dashboard Aggregate Usage
timeFrame: Months 14-54
measure: Organization's implementation climate (adapted to evaluate overdose prevention strategies)
timeFrame: Months 18, 24, 30, 36, 42, 48, 54, & 60
measure: Quality OFR Recommendations
timeFrame: Months 14-54
measure: Uptake of OFR Interventions
timeFrame: Months 14-54
measure: Overdose
timeFrame: Month 35-40 (interim) and month 53-57 (final)
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Matthew C Aalsma, PhD
role: PRINCIPAL_INVESTIGATOR
References: