Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
- Conditions
- Opioid Use DisorderOpioid MisuseChronic Pain
- Interventions
- Behavioral: Implementation Strategies
- Registration Number
- NCT06565416
- Lead Sponsor
- University of New Mexico
- Brief Summary
The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse/opioid use disorder in three American Indian and Alaska Native (AI/AN) serving clinics. We also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder.
- Detailed Description
Given the health disparities in AI/AN populations and lack of access to quality care for comorbid chronic pain and opioid misuse/OUD, the proposed study seeks to build upon the strong relationships between the research team and the AI/AN populations that we serve. There is a dearth of prior research examining chronic pain, opioid misuse/OUD, and other comorbid conditions (mood disorders, anxiety disorders, other SUD) in AI/AN populations. Using CBPR methods, we will work with the OPTIC Collaborative Board to develop a culturally centered implementation intervention to improve screening and brief interventions with AI/AN clients with chronic pain and opioid misuse/OUD (Phase I, Aim 1). Specifically, in collaboration with the community partners and the OPTIC Collaborative Board, we will develop a provider training to increase provider skills and self-efficacy to focus conversations on managing chronic pain (rather than trying to eliminate it) and improving client functioning within cultural frameworks of wellbeing. The goal is to develop, implement, and evaluate culturally centered implementation strategies to increase screening and brief intervention for chronic pain, opioid misuse/OUD in clinics serving AI/AN communities. We will conduct a type III effectiveness-implementation trial over the course of 24 months at each clinical site utilizing EMR data and longitudinal staff surveys to test the implementation outcomes (Phase II, Aim 2) as well as patient surveys to test effectiveness outcomes (Phase II, Aim 3) . We hypothesize our culturally centered approach will increase rates of screening and brief intervention, and ultimately improve outcomes among AI/AN clients with chronic pain and OUD who receive treatment in primary care. We also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder for the purpose of identifying areas of treatment needs, and examining the efficacy of a provider-level implementation intervention delivered at the sites from which our participants will be sampled.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 225
- Willing and able to provide informed consent
- have English comprehension and proficiency
- receiving services at one of our participating study sites
- report current chronic pain and/or opioid misuse/opioid use disorder
- self-identify as American Indian/Alaska Native
- if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Implementation Implementation Strategies Evidence-based implementation strategies are put into practice for approximately 6 months.
- Primary Outcome Measures
Name Time Method Number of clients screened for chronic pain and opioid misuse/opioid use disorder 6 months (or duration of sustainment phase) Derived from electronic medical records
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Clinic Site A (blinded pending tribal approval)
🇺🇸Arcata, California, United States
Clinic Site B (blinded pending tribal approval)
🇺🇸Toppenish, Washington, United States
Clinic Site C (blinded pending tribal approval)
🇺🇸Minneapolis, Minnesota, United States