Clinical trial NCT06852170: Data2Action Oregon Project: Supporting Data-driven Decision-Making for Substance Use Services, Policy, and Overdose Prevention
Official title: Supporting Data-driven Decision-Making to Support Substance Use Service Expansion Policies and to Prevent Overdoses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Abuse
Decision Making, Shared
Implementation Science
Decision Making
Organizations
Substance-related Disorders
Policy
Keywords: Health Services Research
Sequential
Stepped Wedge
Substance Abuse
Implementation Science
Decision making
Substance-related disorders
Substance abuse treatment centers
Policy
Decision Making, Shared
Organizations
Focus Groups
Harm Reduction
Policy Making
Law Enforcement
User-Centered Design
Public Health
Opioid-Related Disorders
Naloxone
Methamphetamine
Health Disparate, Minority and Vulnerable Populations
Health Policy
Stakeholder engagement
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of California, San Diego
First posted: 2025-02-28
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This project uses an adapted cluster-randomized and stepped-wedge design. Randomization will occur at two instances- one for the initial intervention assignment (Co-Design Sessions), and then another for timing of assignment to the second intervention (Data Products)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Oregon's decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use services and mitigate the growing opioid and methamphetamine epidemics in their state. Consistent with the HEAL Data2Action call for Innovation projects that drive action with data in real-world settings, this study will refine and test the impact of a novel implementation strategy to engage cross- sector decision makers and make data that they identify as relevant to their decisions available to them in easy- to-use products. The proposed study aims to not only address critical knowledge gaps regarding how and when data can inform impactful, transparent decision-making, but to provide decision makers with the data that they need to achieve community-wide substance use prevention and treatment goals, including the increased delivery of high-quality, evidence-informed, services and the prevention of overdoses.

Detailed description: PROJECT SUMMARY Cross-sector decision makers-such as community service providers, public health, justice, advocates, and payers-are calling for actionable data to be collected and shared in sustainable, useful ways. In 2022 national survey data, Oregon ranked last in the U.S. for access to substance use services and first in opioid and methamphetamine use. A recent state- wide analysis estimated that service gaps may even be larger than previously estimated. This study aims to make data that are relevant to decision makers available to them in easy-to-use formats so that they can make timely, evidence-informed decisions to reduce substance use service gaps and overdoses, and ultimately improve Oregonian's health. Major, innovative policy decisions about substance use are being in made in Oregon right now. This policy context is accounted for in study design, activities, and analyses. One is a first-of-its-kind policy in the United States-Ballot Measure 110 (M110). M110 is bringing unprecedented levels of funding to expand services aligned with the pillars of overdose prevention statewide, and it decriminalized the possession of personal amounts of substances. More recently, HB 4002 re-criminalized simple possession and set aside funding for counties to establish criminal legal system deflection programs. Both critics and advocates of M110 and HB 4002 have called for better data to provide a holistic picture of substance use service and service- recipient impacts, and to inform looming decisions such as how to allocate opioid settlement funds. To meet this need, consistent with goals of the NIH Helping to End Addiction Long-term Data2Action Program call for Innovation Projects with cross-sector partnerships, the investigators will develop, refine, and test a policy implementation strategy-Co-Design Sessions (CDS)-to engage cross-sector decision makers in conversations about what data are of priority to them and to develop feasible protocols for linking and disseminating data through products that they co-design (e.g., reports, simulations, dashboards). In the current project phase, which includes the clinical trial, counties will be cluster randomized to participate in CDS and receive fully tailored data products (N = 18) or to later receive products only (N = 18) in a stepped-wedge design. The investigators will: (Aim 1) identify whether CDS is an efficient, generalizable strategy to optimize policy implementation based on the comparative usability of CDS-generated data products between counties; (Aim 2) test the impact of CDS on substance use service gaps and service-recipient outcomes, as well as cross-sector collaboration and trust in data as potential mechanisms of CDS; and (Aim 3) examine whether CDS-generated data products are associated with concrete actions (e.g., funding) to strengthen the availability and quality of evidence-based, culturally-responsive substance use services. Based on study results and partners' input, the investigators will provide state decision makers with recommendations and protocols for supporting sustainment of study infrastructure and output, including: feasible methods for prioritized data collection and data product dissemination, and the transfer of study-generated data to state-wide data infrastructures. The study holds strong potential for immediate, real-world impact.

Eligibility criteria: Inclusion Criteria:

Sample 1: Local or Regional Decision Makers

* At least 18 years old
* Has decision-making authority within their professional role related to substance use service delivery, including leadership responsible for developing policy (e.g. executive directors) OR middle-managers (e.g., case managers, supervisor) and front-line workers responsible for service delivery decisions OR Responsible for developing local or state policy related to substance use/behavioral health and/or the criminal justice system OR Advises these decision makers (e.g., legislative staff, data analysts)

These individuals will be drawn from organizations with the following perspectives: behavioral health, public health, health payer, first responders, health advocacy.

Sample 2: State or Local Decision Makers

* At least 18 years old
* Has decision-making authority within their professional role related to substance use service delivery, including leadership responsible for developing policy (e.g. executive directors) OR middle-managers (e.g., case managers, supervisor) and front-line workers responsible for service delivery decisions OR Responsible for developing local or state policy related to substance use/behavioral health and/or the criminal justice system OR Advises these decision makers (e.g., legislative staff, data analysts)

Exclusion Criteria:

* None.

Primary outcomes:
measure: Community Engagement Survey
timeFrame: Measurement will occur at five timepoints: baseline, around 15 months post-baseline, around 18 months post-baseline, around 30 months post-baseline, around 42 months post-baseline
Secondary outcomes:
measure: Data Product Usability
timeFrame: Annually for up to two years after each round of data product release in the given county (varies by condition)
measure: Social Network of Collaboration
timeFrame: Measurement will occur at five timepoints: baseline, around 15 months post-baseline, around 18 months post-baseline, around 30 months post-baseline, around 42 months post-baseline
measure: Trust in data
timeFrame: Annually for up to two years after each round of data product release in the given county (varies by condition)
Other outcomes:
measure: Data Product: Missing Data
timeFrame: Annually for up to two years after each round of data product release in the given county (varies by condition)
measure: Focus Groups
timeFrame: Annually, post-baseline, for up to 3 years
measure: Evidence Use Behavior
timeFrame: Measurement will occur at five timepoints: baseline, around 15 months post-baseline, around 18 months post-baseline, around 30 months post-baseline, around 42 months post-baseline
Locations:
city: Eugene
country: United States
facility: Chestnut Health Systems
state: Oregon
Study officials:
References: