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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
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This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.
This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder (MOUD) in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities. The study design is a cluster randomized stepped wedge implementation trial with two steps, and two sites per step (N=4 sites). Study design and methods are informed by the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome of the trial is the number of consumers with OUD initiated onto MOUD (i.e., buprenorphine, extended-release naltrexone, or methadone) in the 6 months after intervention delivery (compared to the 6 months before intervention delivery) - capturing implementation intervention Reach. The primary outcome will be measured at the end of the six-month implementation stage and compared to the pre-intervention observation phase (prior to delivery of the implementation intervention). Primary data collection will use de-identified data from the electronic medical records (EMR) at each site beginning with data from the six months prior to intervention delivery for Step 1 sites and 12 months prior for Step 2 sites. For Step 1 sites, some secondary outcomes will also be assessed during the sustainment stage (the six months following implementation) but this will be exploratory. As part of the study, consumers with OUD will be asked to participate in additional assessments and provide informed consent. Enrolled consumer participants will be asked to complete four assessment visits (baseline, week 4, week 8, and week 12) to collect comprehensive information about mental health, cultural connectedness and spirituality, social functioning, and experiences with and acceptability of OUD treatment. Providers at each clinical site will also be asked to complete surveys at three time points to assess attitudes, knowledge, and readiness related to MOUD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally Centering MOUD Program Implementation Intervention | Experimental | Culturally centered program-level implementation intervention to increase the use of medications for opioid use disorder in healthcare and treatment settings serving AI/AN communities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally Centered MOUD Implementation Intervention | Behavioral | Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Consumers With OUD Initiated Onto MOUD | The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size. | Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Consumers With OUD Retained in Care | Retention is operationalized as the number of clients at each site during each period who had at least one visit for care in three or more months within that period using de-identified data from the EMR comparing pre-intervention to post-intervention time periods. | Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southcentral Foundation | Anchorage | Alaska | 99508 | United States | ||
| Native American Community Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40544955 | Background | Paschen-Wolff MM, Campbell ANC, Vasquez A, Kessler J, Jansen K, Arnatt CP, Rosa C, Hebden HM, Radin S, Stately A, Shaw J, Kennedy F, Matthews AG, Venner KL. Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations. Contemp Clin Trials. 2025 Aug;155:107992. doi: 10.1016/j.cct.2025.107992. Epub 2025 Jun 20. | |
| 35997562 |
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Data from this study is owned by participating Tribal clinical sites; any use of IPD requires Tribal (or equivalent organizational) approval.
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Staff participants (who completed anonymous cross-sectional surveys) were not enrolled into study arms.
De-identified electronic medical record (EMR) data from N=4 sites was collected. There was no direct client recruitment needed for the primary and secondary analyses.
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Sequence 1 sites (Sites 1 and 2) completed 6 months of standard care (pre-intervention) before receiving the 6-month program-level implementation intervention. |
| FG001 | Sequence 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2021 |
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All sites (N=4) started in standard/usual care and then were randomly assigned to receive the program level implementation intervention in sequence 1 (2 sites) or sequence 2 (2 sites).
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| Number of Consumers Screened for OUD | Screening was operationalized as the number of clients screened for OUD of the number of clients with documented OUD and a visit from the de-identified EMR comparing pre-intervention to post-intervention time periods. | Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2) |
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| Missouri Breaks | Eagle Butte | South Dakota | 57625 | United States |
| Background |
| Hirchak KA, Nadeau M, Vasquez A, Hernandez-Vallant A, Smith K, Pham C, Oliver KA, Baukol P, Lizzy K, Shaffer R, Herron J, Campbell ANC, Venner KL; CTN-0096 Collaborative Board. Centering culture in the treatment of opioid use disorder with American Indian and Alaska Native Communities: Contributions from a National Collaborative Board. Am J Community Psychol. 2023 Mar;71(1-2):174-183. doi: 10.1002/ajcp.12620. Epub 2022 Aug 23. |
Sequence 2 sites (Sites 3 and 4) completed 12 months of standard care before receiving the 6-month program-level implementation intervention.
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The baseline analysis includes participant data from the EMR (N=2,059 across 4 sites). Since this is an open cohort without information on when clients enter/leave the site, we are not able to break the sample into study time periods (across the stepped wedge design, i.e., pre-intervention, intervention, post-intervention).
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| ID | Title | Description |
|---|---|---|
| BG000 | Site 1 | Site 1 was included in Sequence 1. |
| BG001 | Site 2 | Site 2 was included in Sequence 1. |
| BG002 | Site 3 | Site 3 was included in Sequence 2. |
| BG003 | Site 4 | Site 4 was included in Sequence 2. |
| BG004 | Total | Total of all reporting groups |
| 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 | Mean age in years as reported in the EMR | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Participant sex as reported in the EMR | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity (Hispanic/Latine or Not Hispanic/Latine) as reported in the EMR | Count of Participants | Participants |
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| 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 | Number of Consumers With OUD Initiated Onto MOUD | The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size. | All eligible EMR records from 4 participating sites during specified time frame comprised of individuals with OUD diagnosis, aged 18 and over and that were identified as American Indian or Alaska Native. The total known analysis population is the same for each time point. | Posted | Number | participants | No | Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2) |
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| Secondary | Number of Consumers With OUD Retained in Care | Retention is operationalized as the number of clients at each site during each period who had at least one visit for care in three or more months within that period using de-identified data from the EMR comparing pre-intervention to post-intervention time periods. | All eligible EMR records from 4 participating sites during specified time frame comprised of individuals with OUD diagnosis, aged 18 and over and identified as AI/AN. The total known analysis population is the same for each time point. | Posted | Number | participants | No | Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2) |
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| Secondary | Number of Consumers Screened for OUD | Screening was operationalized as the number of clients screened for OUD of the number of clients with documented OUD and a visit from the de-identified EMR comparing pre-intervention to post-intervention time periods. | All eligible EMR records from three participating sites during the specified timeframe comprised of individuals with OUD diagnosis, aged 18 and over and identified as AI/AN Site 2 was not included in the screening outcome analysis because it was an addiction specialty practice and all clients have a documented substance use disorder (i.e., no screening available). The total known analysis population is the same for each time point. | Posted | Number | Participant | Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2) |
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This sample was comprised of de-identified electronic medical record data; adverse events were not able to be collected and reporting was not required.
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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 | Site 1 | Site 1 was included in Sequence 1 of the stepped wedge design. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Site 2 | Site 2 was included in Sequence 1 of the stepped wedge design. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Site 3 | Site 3 was included in Sequence 2 of the stepped wedge design. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Site 4 | Site 4 was included in Sequence 2 of the stepped wedge design. | 0 | 0 | 0 | 0 | 0 | 0 |
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Data for a secondary outcome described in the protocol (# of participants with OUD offered a MOUD) was unable to be collected and analyzed using the EMR data and is therefore not reported. Adverse events were not collected; analytic sample was comprised of de-identified EMR data.
Data collected from this study are owned by the local participating Tribes and Indigenous organizations. Any publication or sharing of data must be approved by Tribal or Indigenous organization partners.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kamilla Venner, PhD | Center on Alcohol, Substance use, & Addiction (CASAA), University of New Mexico (UNM) | (505) 933-9590 | kamilla@unm.edu |
| Dec 9, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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