Substance AbuseD2A OregonNCT06852170
Data2Action Oregon Project: Supporting Data-driven Decision-Making for Substance Use Services, Policy, and Overdose Prevention
A study testing Co-Design Sessions (CDS) and Data products in people with Substance Abuse and Decision Making, Shared, run by Chestnut Health Systems at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Decision Making, Shared, Implementation Science
- What is being tested?
- Co-Design Sessions (CDS) and Data products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Harrison, MS contact
United States1 site, 1 recruiting
- Recruiting
Chestnut Health Systems
Eugene, Oregon, 97401
Gracelyn Cruden, PhD, MA, 8435139928, gcruden@chestnut.org
Amanda J Broughton, ajbroughton@chestnut.org
About this study
Official title: Supporting Data-driven Decision-Making to Support Substance Use Service Expansion Policies and to Prevent Overdoses
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.
Read the 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.
- Conditions
- Substance Abuse, Decision Making, Shared, Implementation Science, Decision Making, Organizations, Substance-related Disorders
- Being tested
- Co-Design Sessions (CDS), Data products
- 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
- Medical subject headings
- Substance-Related Disorders, Harm Reduction, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-Design Sessions (CDS)Other
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.
Data productsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Data products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Acceptability and Usability of the Data Products will be assessed through the System Usability Scale, a 10-item measure that will be tailored for the current study. Scoring is from 1 - 5, with 1 indicating "Strongly disagree" and 5 indicating "Strongly agree".
Measured: Annually for up to two years after each round of data product release in the given county (varies by condition)
Social Network of Collaboration
A study-specific measure will probe about connections that facilitate collaboration, defined as clinical referrals and client care coordination. Questions probe presence and strength of ties (e.g., whether referrals sent and/or received from other organizations). Open-ended questions probe timing, nature, and origin of collaborations (e.g., nodes).
Measured: 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
A measure of trust in data (Yoon \& Lee, 2019) was tailored for the current study. Tailoring including removing items and slight rewording of item stems (e.g., "data system" to "data"). The study measure includes 5 items answered on a Likert Scale ranging from 1= Strongly Disagree to 5 = Strongly Agree and including 0 = don't know.
Measured: Annually for up to two years after each round of data product release in the given county (varies by condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start6 Feb 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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
- Sequential
- 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)
- Masking
- None (open label)
- Enrolment
- 341 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, San Diego
- Responsible party
- Principal investigator, Gracelyn Cruden, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852170
- Sponsor's protocol ID
- R33DA059163
- Other IDs
- R33DA059163
- Acronym
- D2A Oregon
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Data-driven Decision-Making to Support Substance Use Service Expansion Policies and to Prevent Overdoses
- ClinicalTrials.gov ID
- NCT06852170
- Acronym / sponsor ID
- D2A Oregon / R33DA059163
- Conditions
- Substance Abuse, Decision Making, Shared, Implementation Science, Decision Making, Organizations, Substance-related Disorders
- Keywords
- Health Services Research, Sequential, Stepped Wedge, Substance Abuse, Implementation Science, Decision making, Substance-related disorders, Substance abuse treatment centers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 341 participants (estimated)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, San Diego
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| CDS | Experimental | Other: Co-Design Sessions (CDS), Other: Data productsThis 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. |
| No CDS | Experimental | Other: Data productsThis group will not participate in CDS. They will receive standardized data products at T3 or T4, depending on wedge assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Co-Design Sessions (CDS)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. | Other | CDS |
| Data productsData 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. | Other | CDS, No CDS |
Primary outcome
Community Engagement Survey
Time frame: 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
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.
3 secondary outcomes
Data Product Usability
Time frame: Annually for up to two years after each round of data product release in the given county (varies by condition)
Social Network of Collaboration
Time frame: 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
Time frame: Annually for up to two years after each round of data product release in the given county (varies by condition)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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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.
Jessica Harrison, MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-Design Sessions (CDS) and Data products in people with Substance Abuse and Decision Making, Shared, run by Chestnut Health Systems 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 7 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: looking for participants now, as of the sponsor's last update on 16 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gracelyn Cruden, PhD, MA (541-461-5272, gcruden@chestnut.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community Engagement Survey (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.