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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA046620 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of California, Berkeley | OTHER |
| NYU Langone Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Engaged in Implementation Activities | 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. |
Inclusion Criteria:
- Cities and towns in Rhode Island
Exclusion Criteria:
- There are no exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Brandon DL Marshall, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University School of Public Health | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34729851 | Derived | 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. |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All 39 Rhode Island municipalities were randomly assigned to the intervention (PROVIDENT) or comparator condition. No individuals were enrolled; units were municipalities. Randomization and outcome ascertainment occurred at the municipal level. A participant count is not applicable. Data on age, sex/gender, race, and other demographics were not collected at baseline in the municipalities.
Demographic data were collected from organizational staff who participated in the Implementation Substudy.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is unknown or not reported for N=6 Implementation Substudy participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All 39 Rhode Island municipalities were randomized to the intervention or comparator condition; no participants were enrolled. | Posted | Number | Overdoses per 10,000 residents | 0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 years | Rhode Island Municipalities | Rhode Island Municipalities |
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AEs were not monitored at the individual participant level. The PROVIDENT trial does not involve direct interaction with individuals receiving harm reduction services but instead changes the environment in which these services are provided. Safety monitoring focused on identifying unanticipated problems related to changes in risk associated with these environmental changes, including issues related to privacy, confidentiality, or disruption to service provision. No reportable events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brandon DL Marshall | Brown University | 401-863-6427 | brandon_marshall@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2024 | Nov 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2024 | Oct 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| D062787 | Drug Overdose |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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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.
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Modeling teams will be blinded to intervention control group assignment. All of the investigators on the modeling teams are blinded.
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| At the time of participation in implementation evaluation activities (surveys, focus groups, or interviews) |
| BG001 | 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. |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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. |
| OG001 | 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. |
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| Other Pre-specified | Number of Participants Engaged in Implementation Activities | 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. | 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). | Posted | Count of Participants | Participants | At the time of participation in implementation evaluation activities (surveys, focus groups, or interviews) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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