Clinical trial NCT06565416: Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Official title: Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial: Implementation of Screening and Brief Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Opioid Misuse
Chronic Pain
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-08-22
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A provider-level implementation intervention will be administered at each of the three participating sites. The investigators will examine implementation and effectiveness outcomes before, during, and after implementation.
Primary purpose: TREATMENT

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. The investigators 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 communities. 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, the investigators 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, the investigators 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. The investigators 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) . The investigators hypothesize that the 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. The investigators 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process

Primary outcomes:
measure: Number of clients screened for chronic pain and opioid misuse/opioid use disorder
timeFrame: 6 months (or duration of implementation phase)
measure: Number of clients screened for chronic pain and opioid misuse/opioid use disorder
timeFrame: 6 months (or duration of sustainment phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Arcata
country: United States
facility: Clinic Site A (blinded pending tribal approval)
state: California
city: Minneapolis
country: United States
facility: Clinic Site C (blinded pending tribal approval)
state: Minnesota
city: Toppenish
country: United States
facility: Clinic Site B (blinded pending tribal approval)
state: Washington
Study officials:
affiliation: University of New Mexico
name: Matthew R Pearson, PhD
role: PRINCIPAL_INVESTIGATOR
References: