Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05096429 |
| Other study ID # |
1910002566 |
| Secondary ID |
R01DA046620 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2021 |
| Est. completion date |
August 15, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Brown University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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) ยง 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.
