Opioid OverdosePROVIDENTNCT05096429
Preventing Overdose Using Information and Data From the Environment
A study testing PROVIDENT in people with Opioid Overdose and Drug Overdose, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid Overdose, Drug Overdose
- What is being tested?
- PROVIDENT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cities and towns in Rhode Island
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
Official title: Reducing Drug-Related Mortality Using Predictive Analytics: A Randomized, Statewide, Community Intervention Trial
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.
Read the 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.
- Conditions
- Opioid Overdose, Drug Overdose
- Being tested
- PROVIDENT
- Keywords
- fentanyl, naloxone, harm reduction, machine learning, predictive analytics, community intervention, drug overdose, opioids
- Medical subject headings
- Opiate Overdose, Drug Overdose, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROVIDENTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start15 Nov 2021
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, Berkeley, NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Brandon DL Marshall, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096429
- Sponsor's protocol ID
- 1910002566
- Other IDs
- R01DA046620
- Acronym
- PROVIDENT
- Status last verified
- Nov 2025
- First submitted
- 15 Oct 2021
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34729851
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Drug-Related Mortality Using Predictive Analytics: A Randomized, Statewide, Community Intervention Trial
- ClinicalTrials.gov ID
- NCT05096429
- Acronym / sponsor ID
- PROVIDENT / 1910002566
- Conditions
- Opioid Overdose, Drug Overdose
- Keywords
- fentanyl, naloxone, harm reduction, machine learning, predictive analytics, community intervention, drug overdose, opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, Berkeley, NYU Langone Health
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Posted 9 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: PROVIDENTWithin 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cities and towns in Rhode Island
Key exclusion criteria (1 listed)
- There are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROVIDENTEach 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. | Behavioural | Intervention |
Primary outcome
Cumulative Incidence of Accidental Fatal and Non-Fatal Drug Overdoses
Time frame: 0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34729851Marshall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon DL Marshall, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROVIDENT in people with Opioid Overdose and Drug Overdose, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Accidental Fatal and Non-Fatal Drug Overdoses (time frame: 0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.