Trial Outcomes & Findings for Preventing Overdose Using Information and Data From the Environment (NCT NCT05096429)

Last Updated: 2026-04-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

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

Results posted on

2026-04-09

Participant Flow

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.

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.

Unit of analysis: Municipalities

Participant milestones

Participant milestones
Measure	Intervention Municipalities randomized to the intervention arm will receive neighborhood risk predictions from the PROVIDENT model. The state health department will work with state agencies and community-based organizations to direct resources to neighborhoods identified as high-risk within a municipality. All municipalities will continue receiving timely surveillance information and overdose prevention resources from the state health department in line with the state's strategic plan. Scope note: Results pertain to the municipality-level randomized trial only; implementation study data are not reported here.	Control Municipalities randomized to the control arm will continue to receive standard overdose interventions in accordance with the state's strategic plan, but without receiving information on the predicted probability of overdose risk for specific neighborhoods within a municipality based on the PROVIDENT model predictions. All municipalities will continue receiving timely surveillance information and overdose prevention resources from the state health department in line with the state's strategic plan. Scope note: Results pertain to the municipality-level randomized trial only; implementation study data are not reported here.	Implementation Substudy: Staff at Community-Based Organizations Staff at community-based organizations who participated in implementation activities (technical assistance surveys, focus groups, and/or key informant interviews).
Overall Study STARTED	0 20	0 19	43 0
Overall Study COMPLETED	0 20	0 19	43 0
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age is unknown or not reported for N=6 Implementation Substudy participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Municipalities randomized to the intervention arm will receive neighborhood risk predictions from the PROVIDENT model. The state health department will work with state agencies and community-based organizations to direct resources to neighborhoods identified as high risk within a municipality. All municipalities will continue receiving timely surveillance information and overdose prevention resources from the state health department in line with the state's strategic plan.	Control Municipalities randomized to the control arm will continue to receive standard overdose interventions in accordance with the state's strategic plan, but without receiving information on the predicted probability of overdose risk for specific neighborhoods within a municipality based on the PROVIDENT model predictions. All municipalities will continue receiving timely surveillance information and overdose prevention resources from the state health department in line with the state's strategic plan.	Implementation Substudy: Staff at Community-Based Organizations n=43 Participants Staff at community-based organizations who participated in implementation activities (technical assistance surveys, focus groups, and/or key informant interviews).	Total n=43 Participants Total of all reporting groups
Age, Continuous	—	—	40.9 years STANDARD_DEVIATION 11.3 • n=37 Participants • Age is unknown or not reported for N=6 Implementation Substudy participants.	40.9 years STANDARD_DEVIATION 11.3 • n=37 Participants • Age is unknown or not reported for N=6 Implementation Substudy participants.
Sex/Gender, Customized Female	—	—	29 Participants n=43 Participants	29 Participants n=43 Participants
Sex/Gender, Customized Male	—	—	9 Participants n=43 Participants	9 Participants n=43 Participants
Sex/Gender, Customized Unknown or Not Reported	—	—	5 Participants n=43 Participants	5 Participants n=43 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	—	7 Participants n=43 Participants	7 Participants n=43 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	—	34 Participants n=43 Participants	34 Participants n=43 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	—	2 Participants n=43 Participants	2 Participants n=43 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	1 Participants n=43 Participants	1 Participants n=43 Participants
Race (NIH/OMB) Asian	—	—	1 Participants n=43 Participants	1 Participants n=43 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=43 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Black or African American	—	—	7 Participants n=43 Participants	7 Participants n=43 Participants
Race (NIH/OMB) White	—	—	23 Participants n=43 Participants	23 Participants n=43 Participants
Race (NIH/OMB) More than one race	—	—	5 Participants n=43 Participants	5 Participants n=43 Participants
Race (NIH/OMB) Unknown or Not Reported	—	—	6 Participants n=43 Participants	6 Participants n=43 Participants

PRIMARY outcome

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

Population: All 39 Rhode Island municipalities were randomized to the intervention or comparator condition; no participants were enrolled.

Outcome measures

Outcome measures
Measure	Intervention n=20 Rhode Island Municipalities Municipalities randomized to the intervention arm will receive neighborhood risk predictions from the PROVIDENT model. The state health department will work with state agencies and community-based organizations to direct resources to neighborhoods identified as high risk within a municipality. All municipalities will continue receiving timely surveillance information and overdose prevention resources from the state health department in line with the state's strategic plan.	Control n=19 Rhode Island Municipalities Municipalities randomized to the control arm will continue to receive standard overdose interventions in accordance with the state's strategic plan, but without receiving information on the predicted probability of overdose risk for specific neighborhoods within a municipality based on the PROVIDENT model predictions. All municipalities will continue receiving timely surveillance information and overdose prevention resources from the state health department in line with the state's strategic plan.
Cumulative Incidence of Accidental Fatal and Non-Fatal Drug Overdoses	43.5 Overdoses per 10,000 residents	37.1 Overdoses per 10,000 residents

OTHER_PRE_SPECIFIED outcome

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

Population: Participants included staff members from community-based harm reduction organizations participating in the PROVIDENT trial who took part in at least one implementation evaluation activity (technical assistance surveys, focus groups, or key informant interviews).

Number of staff from participating community-based harm reduction organizations who engaged in implementation evaluation activities, including technical assistance surveys, focus groups, and key informant interviews conducted during the implementation substudy. This outcome reflects participation in implementation evaluation activities conducted as a substudy within the PROVIDENT trial; results are reported as aggregated counts of participants engaged in each activity. Participants may have contributed to more than one implementation activity.

Outcome measures

Outcome measures
Measure	Intervention n=43 Participants Municipalities randomized to the intervention arm will receive neighborhood risk predictions from the PROVIDENT model. The state health department will work with state agencies and community-based organizations to direct resources to neighborhoods identified as high risk within a municipality. All municipalities will continue receiving timely surveillance information and overdose prevention resources from the state health department in line with the state's strategic plan.	Control Municipalities randomized to the control arm will continue to receive standard overdose interventions in accordance with the state's strategic plan, but without receiving information on the predicted probability of overdose risk for specific neighborhoods within a municipality based on the PROVIDENT model predictions. All municipalities will continue receiving timely surveillance information and overdose prevention resources from the state health department in line with the state's strategic plan.
Number of Participants Engaged in Implementation Activities Participants completing implementation surveys	39 Participants	—
Number of Participants Engaged in Implementation Activities Participants participating in focus groups	12 Participants	—
Number of Participants Engaged in Implementation Activities Participants participating in key informant interviews	7 Participants	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brandon DL Marshall

Brown University

Phone: 401-863-6427

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place