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Preventing Overdose Using Information and Data From the Environment

Reducing Drug-Related Mortality Using Predictive Analytics: A Randomized, Statewide, Community Intervention Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05096429
Acronym
PROVIDENT
Enrollment
39
Registered
2021-10-27
Start date
2021-11-15
Completion date
2024-08-15
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Overdose, Opioid Overdose

Keywords

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

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.

Detailed description

Overdose deaths have skyrocketed in the United States since 1999. The epidemic has prompted widespread federal and state actions, yet the number of people who die of an overdose continues to increase. In light of the accelerating and rapidly evolving overdose epidemic, new strategies are needed to identify communities most at risk, and to utilize resources more effectively to curb overdose deaths. To address these public health priorities, we will develop a forecasting tool to predict overdose deaths before they occur, and then conduct a randomized, statewide, community-level intervention to evaluate the impact of resource targeting based on these predictions. The study will take place in Rhode Island, a state with the 10th highest rate of overdose fatality in 2016. The study has two phases. First, we will develop a predictive analytics model that forecasts future overdose mortality at the neighborhood-level, using publicly available information and data from a multicomponent overdose surveillance system. This tool, called PROVIDENT (Preventing Overdose using Information and Data from the Environment) will be used to predict the likelihood of future overdose deaths in every neighborhood across Rhode Island. As all data to be analyzed as part of this study is collected through ongoing public health surveillance activities and the use of protected health information involves no more than a minimal risk to the privacy of individuals, the institutional review board (IRB) of record approved a waiver of research participants' authorization for use/disclosure of information about them for research purposes, in accordance with 45 Code of Federal Regulations (CFR) § 164.512(i)(2)(iv). Next, 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. Within these cities/towns, the health department will work with stakeholders to target overdose prevention interventions to neighborhoods with the highest predicted probability of future overdose deaths. Interventions include efforts to: (1) prevent high-risk prescribing (through academic detailing and other educational efforts); (2) expand access to opioid agonist therapy, including buprenorphine and methadone; (3) increase naloxone distribution (through community and pharmacy-based efforts); and (4) expand street-based peer recovery coaching and referrals. Control cities/towns will continue to receive these same interventions, but will not receive information about the neighborhoods at the highest predicted risk of overdose. Fatal and non-fatal opioid overdose rates in the control cities/towns will be compared to those that received the PROVIDENT model predictions. To achieve these aims, we will leverage a unique partnership between an academic institution and a state's health department, which allows for unprecedented access to and sharing of population-based overdose surveillance data. Our results will improve public health decision-making and inform resource allocation to communities that should be prioritized for evidence-based prevention, treatment, recovery, and overdose rescue services. If found to be effective, the PROVIDENT forecasting model will be disseminated to other states, which could adapt the tool to guide resource allocation and maximize public health impact. In sum, this project is highly responsive to a top research priority of the National Institute on Drug Abuse, and directly addresses one of the nation's most challenging public health crises.

Interventions

BEHAVIORALPROVIDENT

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.

Sponsors

Brown University
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of California, Berkeley
CollaboratorOTHER
NYU Langone Health
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Modeling teams will be blinded to intervention control group assignment. All of the investigators on the modeling teams are blinded.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

\- Cities and towns in Rhode Island

Exclusion criteria

\- There are no

Design outcomes

Primary

MeasureTime frameDescription
Cumulative Incidence of Accidental Fatal and Non-Fatal Drug Overdoses0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 yearsThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBrandon DL Marshall, PhD

Brown University

Participant flow

Recruitment details

This record reports the Phase 2 randomized cluster trial. The unit of allocation and analysis was the municipality. No individuals were enrolled or assigned to arms for the trial; outcome events were obtained from statewide overdose surveillance. This study included a nested implementation substudy of partnering organizational staff, in addition to municipal-level randomization.

Pre-assignment details

The Protocol Enrollment (N=\[39\]) reflects the number of municipalities randomized in the primary trial. The Results Reporting includes an additional arm for the Implementation Substudy, consisting of 43 staff at community-based organizations who participated in implementation activities, including surveys, focus groups, and key informant interviews. This accounts for the difference between the protocol enrollment and the total participants started.

Baseline characteristics

Characteristic
Age, Continuous40.9 years
STANDARD_DEVIATION 11.3
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
34 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
7 Participants
Race (NIH/OMB)
More than one race
5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
White
23 Participants
Sex/Gender, Customized
Female
29 Participants
Sex/Gender, Customized
Male
9 Participants
Sex/Gender, Customized
Unknown or Not Reported
5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026