NCT06852170

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Feb 2025Aug 2028

First Submitted

Initial submission to the registry

January 31, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

February 6, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

January 31, 2025

Last Update Submit

March 12, 2026

Conditions

Keywords

Health Services ResearchSequentialStepped WedgeSubstance AbuseImplementation ScienceDecision makingSubstance-related disordersSubstance abuse treatment centersPolicyDecision Making, SharedOrganizationsFocus GroupsHarm ReductionPolicy MakingLaw EnforcementUser-Centered DesignPublic HealthOpioid-Related DisordersNaloxoneMethamphetamineHealth Disparate, Minority and Vulnerable PopulationsHealth PolicyStakeholder engagement

Outcome Measures

Primary Outcomes (1)

  • Community Engagement Survey

    A measure of community engagement (Oetzel et al, 2018) which includes 2 subscales; collaboration, which includes 4 items answered on a Likert Scale ranging from Strongly Disagree to Strongly Agree, and synergy, which includes 7 items answered on a Likert Scale ranging from Not at All to To a Great Extent.

    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 (3)

  • Data Product Usability

    Annually for up to two years after each round of data product release in the given county (varies by condition)

  • Social Network of Collaboration

    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

  • Trust in data

    Annually for up to two years after each round of data product release in the given county (varies by condition)

Other Outcomes (3)

  • Data Product: Missing Data

    Annually for up to two years after each round of data product release in the given county (varies by condition)

  • Focus Groups

    Annually, post-baseline, for up to 3 years

  • Evidence Use Behavior

    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

Study Arms (2)

CDS

EXPERIMENTAL

This group will participate in 4 CDS to co-design and tailor data products with the study team. They will receive fully tailored Data Products at T3 or T4, depending on wedge assignment.

Other: Co-Design Sessions (CDS)Other: Data products

No CDS

EXPERIMENTAL

This group will not participate in CDS. They will receive standardized data products at T3 or T4, depending on wedge assignment.

Other: Data products

Interventions

CDS uses principles and activities from Liberating Structures (LS) and Group Model Building (GMB). Each method uses semi-structured processes for engaging partners to collaborate with one another and address complex problems. Example activities and discussions include: identifying a shared vision for how data can inform decisions related to substance use service delivery and overdose prevention; identifying relevant data that should be disseminated; identifying decisions to be supported with data. Methods from human-centered design - an approach for developing products that are useful and easy to use - will be used to refine data products developed by the study team so that the data products are acceptable and useful to end users. Together, these three methods (Liberating Structures, group model building, human-centered design) will be used to engage partners to iteratively co-design products for disseminating data back to partners to inform their daily substance use service delivery.

CDS

Data products disseminate localized data from local, state, or regional-level data sources to local (i.e., county) decision makers to inform their daily decision-making. Data products in counties assigned to CDS will receive fully tailored data products, while no-CDS counties will receive standardized data products. A suite of data products will be made available to inform diverse decisions by a variety of end users. Data products will be identified and prioritized during CDS, but may include reports, policy briefs, journey maps, and technical assistance for data interpretation.

CDSNo CDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chestnut Health Systems

Eugene, Oregon, 97401, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersHarm ReductionOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehaviorNarcotic-Related Disorders

Central Study Contacts

Gracelyn Cruden, PhD, MA

CONTACT

Jessica Harrison, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist II

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 28, 2025

Study Start

February 6, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

De-identified IPD collected by the study will be shared per procedures outlined in a NIH-approved Data Sharing and Management Plan as part of the NIH and NIH HEAL-initiative data sharing requirements. Some qualitative data will lose meaning if de-identified and will thus not be shared.

Locations