Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities (CTN-0096)
Primary Purpose
Opioid-use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturally Centered MOUD Implementation Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring American Indian, Alaska Native, Medications for Opioid-use Disorder, Implementation, Cultural centering
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide informed consent
- English comprehension and proficiency
- Receiving services at a participating study site
- Meet criteria for a current opioid use disorder
- Self-identify as American Indian or Alaska Native
- Willing to have program data linked to assessment data
- 18 years or older
Exclusion Criteria:
- participation in research assessments contraindicated
Sites / Locations
- Southcentral FoundationRecruiting
- Native American Community ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Culturally Centered MOUD Implementation
Arm Description
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
Outcomes
Primary Outcome Measures
# consumers with OUD initiated onto MOUD
number of consumers with OUD initiated onto MOUD in the 6 months after intervention delivery compared to pre-intervention
Secondary Outcome Measures
# consumers with OUD offered MOUD
number of consumers with OUD offered MOUD in the 6 months after intervention delivery compared to pre-intervention
# consumers screened for OUD of the overall # of new consumers
number of consumers screened for OUD of the overall number of new consumers in the 6 months after intervention delivery compared to pre-intervention
# consumers with OUD retained in care for at least three months
number of consumers with OUD retained in care for at least three months in the 6 months after intervention delivery compared to pre-intervention
Full Information
NCT ID
NCT04958798
First Posted
July 6, 2021
Last Updated
July 28, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT04958798
Brief Title
Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities
Acronym
CTN-0096
Official Title
Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
University of New Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
American Indian, Alaska Native, Medications for Opioid-use Disorder, Implementation, Cultural centering
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Culturally Centered MOUD Implementation
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Culturally Centered MOUD Implementation Intervention
Intervention Description
Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs
Primary Outcome Measure Information:
Title
# consumers with OUD initiated onto MOUD
Description
number of consumers with OUD initiated onto MOUD in the 6 months after intervention delivery compared to pre-intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
# consumers with OUD offered MOUD
Description
number of consumers with OUD offered MOUD in the 6 months after intervention delivery compared to pre-intervention
Time Frame
6 months
Title
# consumers screened for OUD of the overall # of new consumers
Description
number of consumers screened for OUD of the overall number of new consumers in the 6 months after intervention delivery compared to pre-intervention
Time Frame
6 months
Title
# consumers with OUD retained in care for at least three months
Description
number of consumers with OUD retained in care for at least three months in the 6 months after intervention delivery compared to pre-intervention
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide informed consent
English comprehension and proficiency
Receiving services at a participating study site
Meet criteria for a current opioid use disorder
Self-identify as American Indian or Alaska Native
Willing to have program data linked to assessment data
18 years or older
Exclusion Criteria:
participation in research assessments contraindicated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aimee Campbell, PhD
Phone
6467746138
Email
anc2002@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Paschen-Wolff, PhD
Email
Margaret.Paschen-Wolff@nyspi.columbia.edu
Facility Information:
Facility Name
Southcentral Foundation
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelley Jansen
Facility Name
Native American Community Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antony Stately, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data from this study is owned by participating Tribal clinical sites; any use of IPD requires Tribal (or equivalent organizational) approval.
Citations:
PubMed Identifier
35997562
Citation
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.
Results Reference
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Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities
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