Preventing Overdose Using Information and Data From the Environment

NCT05096429 | Completed Results DMC

• 2 other identifiers: 1910002566R01DA046620
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this project are to leverage surveillance data to predict future overdose outbreaks, and to evaluate the impact of a randomized, statewide, community-level intervention trial to target overdose prevention programs to neighborhoods at highest risk of future overdose deaths. This study develops and tests an opioid overdose forecasting tool, which will allow other states to identify and deploy interventions to communities at highest risk of opioid-related death. The findings from this study have the potential to significantly improve the allocation of resources to curb the opioid overdose epidemic in the United States.

Conditions

Opioid Overdose; Drug Overdose

Keywords

fentanyl; naloxone; harm reduction; machine learning; predictive analytics; community intervention; drug overdose; opioids

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of Accidental Fatal and Non-Fatal Drug Overdoses

  The primary outcome is the cumulative incidence of fatal and non-fatal drug overdoses per 10,000 residents. Fatal overdoses will be defined as drug-related deaths deemed accidental by a state medical examiner. Non-fatal overdoses will be defined as emergency medical services (EMS) runs for suspected non-fatal opioid overdoses identified and classified by the Rhode Island Emergency Medical Services Information System (RI-EMSIS). Since patient outcomes are recorded, patients who did not survive or who were dead upon arrival will be excluded to avoid double-counting.

  0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 years

Other Outcomes (1)

• Number of Participants Engaged in Implementation Activities

  At the time of participation in implementation evaluation activities (surveys, focus groups, or interviews)

Study Arms (2)

Intervention

EXPERIMENTAL

Within these cities/towns, the health department will work with stakeholders to prioritize overdose prevention interventions to neighborhoods with the highest probability of future overdose deaths, as predicted by the PROVIDENT model.

Behavioral: PROVIDENT

Control

NO INTERVENTION

Cities/towns assigned to the control arm will continue to work with the health department and distribute these interventions at existing resource levels, but without receiving information on predicted probability of overdose risk for specific neighborhoods.

Interventions

PROVIDENT BEHAVIORAL

Each of the state's 39 municipalities will be randomised to the intervention (PROVIDENT) or comparator condition. An interactive, web-based tool will be developed to visualize the PROVIDENT model predictions. Municipalities assigned to the treatment arm will receive neighborhood risk predictions from the PROVIDENT model, and state agencies and community-based organizations will direct resources to neighborhoods identified as high risk. Municipalities assigned to the control arm will continue to receive surveillance information and overdose prevention resources, but they will not receive neighborhood risk predictions from this study.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Cities and towns in Rhode Island

Sponsors & Collaborators

• Brown University: lead
• University of California, Berkeley: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• NYU Langone Health: collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

• Marshall BDL, Alexander-Scott N, Yedinak JL, Hallowell BD, Goedel WC, Allen B, Schell RC, Li Y, Krieger MS, Pratty C, Ahern J, Neill DB, Cerda M. Preventing Overdose Using Information and Data from the Environment (PROVIDENT): protocol for a randomized, population-based, community intervention trial. Addiction. 2022 Apr;117(4):1152-1162. doi: 10.1111/add.15731. Epub 2021 Nov 29.

  PMID: 34729851 DERIVED

MeSH Terms

Conditions

Opiate Overdose; Drug Overdose; Harm Reduction

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dr. Brandon DL Marshall
• Organization: Brown University

brandon_marshall@brown.edu

401-863-6427

Study Officials

• Brandon DL Marshall, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Modeling teams will be blinded to intervention control group assignment. All of the investigators on the modeling teams are blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a randomized policy experiment to evaluate whether targeting overdose prevention interventions to neighborhoods at highest risk reduces overdose morbidity and mortality. The state's department of health will receive PROVIDENT model predictions for half of the 39 cities/towns in Rhode Island.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: November 15, 2021
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)