Overdose Prevention Strategies for Substance Use Disorders

(FORTRESS Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how overdose fatality review teams (OFRs) identify and manage overdose cases by implementing a new data dashboard and training in data-driven decision making (DDDM). The approach shifts from reviewing individual cases to using broader, real-time data to identify intervention points for at-risk individuals with proven treatments. The trial will compare this new method to standard OFR practices in terms of implementation and effectiveness. Local OFR team members or leaders of related organizations, such as police chiefs or health directors, may be suitable for participating in surveys or interviews. The trial seeks to reduce overdose rates by improving the quality of recommendations made by OFR teams. As an unphased trial, it offers participants the chance to contribute to innovative approaches that could significantly enhance community health outcomes.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that this overdose prevention strategy is safe?

Research has shown that using data to make decisions benefits projects addressing substance use problems. While specific safety information for humans is not yet available, similar projects, such as the HEAL Data2Action program, have been safely implemented. These programs use data to guide actions, aiming to reduce overdose rates and enhance treatment. They focus on presenting information in easy-to-understand formats to aid decision-making. This suggests the approach is safe, as it involves training and data use rather than direct medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Data-Driven Decision Making (DDDM) approach in overdose prevention because it offers a fresh perspective beyond traditional methods. Unlike typical overdose prevention strategies that often rely on static protocols, DDDM uses real-time data to tailor interventions specifically to community needs. This method empowers local teams with actionable insights, potentially leading to more responsive and effective prevention efforts. By focusing on dynamic decision-making, DDDM could significantly enhance the adaptability and success of overdose prevention programs.

What evidence suggests that this trial's intervention could be effective for overdose prevention?

This trial will compare two approaches to overdose prevention strategies for substance use disorders. One arm, labeled FORTRESS, involves participating counties receiving training in data-driven decision-making and an inventory of overdose-prevention strategies. Research has shown that data-driven decisions can help prevent overdoses. For example, the Data2Action Oregon project found that presenting data in simple formats helped predict overdose risks and improved treatment decisions. Another study in Cayuga County showed that using a data dashboard facilitated information sharing and supported effective decision-making to prevent overdoses. These findings suggest that data-guided actions can enhance strategies to reduce overdose rates and assist people with substance use disorders. ^{1 2 5 6 7}

Who Is on the Research Team?

Matthew C Aalsma, PhD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

This trial is for members of local overdose fatality review (OFR) teams or leaders in Indiana organizations involved with OFR, such as public jail administrators and health directors. It also includes residents of Indiana who have had fatal or non-fatal overdoses.

Inclusion Criteria

FORTRESS staff personnel recruited to complete surveys, focus groups and/or interviews must be:

Residents of Indiana that have experienced fatal and/or non-fatal overdose as identified by administrative data sources

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.)

Exclusion Criteria

N/A

Timeline for a Trial Participant

Design and Training

The FORTRESS team designs the 'Overdose Touchpoints Dashboard' and trains OFR team members in 'Data-Driven Decision Making' (DDDM).

14 months

Cluster-randomized Stepped-wedge Trial

Conduct a trial comparing the impact of the intervention (dashboard + DDDM training) versus standard OFR practices on implementation and effectiveness outcomes.

40 months

Follow-up

Participants are monitored for changes in attitudes toward evidence-based overdose prevention strategies and the quality of OFR recommendations.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Data-Driven Decision Making (DDDM)

Trial Overview The FORTRESS project aims to improve how OFR teams work by giving them a data dashboard and training in Data-Driven Decision Making (DDDM). The study will compare these new tools against standard practices to see if they can better prevent overdoses.

How Is the Trial Designed?

Group I: FORTRESS Experimental Treatment 2 Interventions

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

Group II: OFR Team Practice as Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In 2022, the US faced over 80,000 opioid overdose deaths, highlighting the severe impact of opioid use disorder (OUD) on public health and society.

The article emphasizes the importance of using analytics and modeling to inform policies aimed at understanding and addressing the opioid epidemic, including prevention, treatment, and potential reforms in regulation and criminal justice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responding to the US opioid crisis: leveraging analytics to support decision making. Brandeau, ML.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06852170

Data2Action Oregon Project: Supporting Data-driven ... This study aims to make data that are relevant to decision makers available to them in easy-to-use formats so that they can make timely, evidence-informed ...

2. heal.nih.gov heal.nih.gov/research/cross-cutting-research/translating-data-action-prevent-overdose

HEAL Data2Action (HD2A) The HEAL Data2Action (HD2A) program utilizes data to drive actions, aiming to reduce overdoses and enhance opioid use disorder treatment and pain ...

3. withpower.com withpower.com/trial/phase-substance-related-disorders-8-2023-fd22a

Overdose Prevention Strategies for Substance Use ... This approach has been effective in predicting overdose risk and could improve treatment decisions and outcomes for people with substance use disorders.

4. resultant.com resultant.com/insights/client-stories/applying-advanced-analytics-to-a-pervasive-and-growing-issue-the-data-driven-addiction-prevention-and-recovery-project/

Data-Driven Addiction Prevention and Recovery Through DDAPR, Indiana can live up to its commitment to using data-driven decision making to create effective policies and ensure the best possible outcomes.

5. ojphi.jmir.org ojphi.jmir.org/2025/1/e68977

Data Dashboard Acceptability, Use, and Perceived ... This study suggests that the Cayuga County Overdose Data Dashboard effectively disseminates information and enables data-driven decision-making in the region.

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/00469580241227020

Visual Analytics for Data-Driven Understanding of the ... This paper details the development of an innovative visual analytics dashboard, aimed at enhancing our understanding of the substance use ...

7. cdc.gov cdc.gov/overdose-prevention/php/od2a/prevention.html

Overdose Data to Action: Prevention Strategies OD2A prevention strategies rely on strong, multisectoral partnerships, such as those between public health, public safety, harm reduction, ...