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Fatal Overdose Review Teams - Research to Enhance Surveillance Systems (FORTRESS)

Primary Purpose

Substance-Related Disorders, Opioid-Related Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Data-Driven Decision Making (DDDM)
Overdose-prevention strategies inventory
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance-Related Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

OFR Team Practice as Usual

FORTRESS

Arm Description

Data are collected regarding standard OFR Team practice and outcomes before implementation of the FORTRESS Intervention

Participating counties receive both training in data-driven decision making and inventory of overdose-prevention strategies

Outcomes

Primary Outcome Measures

Organizational readiness to implement change
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.
Cultural Exchange Inventory (adapted to evaluate OFR team alliance)
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.
Harm reduction acceptability scale
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.
Systems Usability Scale
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)
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
To be developed fidelity assessment tool that will be completed by each OFR facilitator after a monthly meeting.
Dashboard Aggregate Usage
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.
Organization's implementation climate (adapted to evaluate overdose prevention strategies)
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
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.
Uptake of OFR Interventions
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.
Overdose
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).

Secondary Outcome Measures

Full Information

First Posted
September 25, 2023
Last Updated
October 10, 2023
Sponsor
Indiana University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT06084221
Brief Title
Fatal Overdose Review Teams - Research to Enhance Surveillance Systems
Acronym
FORTRESS
Official Title
Fatal Overdose Review Teams - Research to Enhance Surveillance Systems (FORTRESS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Opioid-Related Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OFR Team Practice as Usual
Arm Type
No Intervention
Arm Description
Data are collected regarding standard OFR Team practice and outcomes before implementation of the FORTRESS Intervention
Arm Title
FORTRESS
Arm Type
Experimental
Arm Description
Participating counties receive both training in data-driven decision making and inventory of overdose-prevention strategies
Intervention Type
Behavioral
Intervention Name(s)
Data-Driven Decision Making (DDDM)
Intervention Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Overdose-prevention strategies inventory
Intervention Description
A list of overdose prevention and harm reduction strategies will be provided to OFRs for possible implementation, depending on local needs and final dashboard development.
Primary Outcome Measure Information:
Title
Organizational readiness to implement change
Description
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.
Time Frame
Months 18, 24, 30, 36, 42, 48, 54, & 60
Title
Cultural Exchange Inventory (adapted to evaluate OFR team alliance)
Description
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.
Time Frame
Months 18, 24, 30, 36, 42, 48, 54, & 60
Title
Harm reduction acceptability scale
Description
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.
Time Frame
Months 18, 24, 30, 36, 42, 48, 54, & 60
Title
Systems Usability Scale
Description
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.
Time Frame
Months 18, 24, 30, 36, 42, 48, 54, & 60
Title
Stages of Implementation Completion (SIC)
Description
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.
Time Frame
Baseline through study completion, an average of 5 years
Title
OFR Fidelity Tool
Description
To be developed fidelity assessment tool that will be completed by each OFR facilitator after a monthly meeting.
Time Frame
Months 18-54
Title
Dashboard Aggregate Usage
Description
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.
Time Frame
Months 14-54
Title
Organization's implementation climate (adapted to evaluate overdose prevention strategies)
Description
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.
Time Frame
Months 18, 24, 30, 36, 42, 48, 54, & 60
Title
Quality OFR Recommendations
Description
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.
Time Frame
Months 14-54
Title
Uptake of OFR Interventions
Description
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.
Time Frame
Months 14-54
Title
Overdose
Description
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).
Time Frame
Month 35-40 (interim) and month 53-57 (final)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew C Aalsma, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Fatal Overdose Review Teams - Research to Enhance Surveillance Systems

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