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Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial

Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial: Implementation of Screening and Brief Intervention

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06565416
Acronym
OPTIC
Enrollment
225
Registered
2024-08-22
Start date
2023-06-01
Completion date
2028-07-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Opioid Misuse, Opioid Use Disorder

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.

Interventions

Culturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients

Sponsors

University of New Mexico
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Given the single group design, it is not feasible to blind investigators or outcomes assessor. Given that the intervention occurs at the site level among providers, patients/clients can be considered blinded given that they are not the direct target of the intervention.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of clients screened for chronic pain and opioid misuse/opioid use disorder6 months (or duration of implementation phase)Derived from electronic medical records

Countries

United States

Contacts

CONTACTKamilla L Venner, PhD
kamilla@unm.edu5059252300
CONTACTAngel R Vasquez, PhD
vasquez@unm.edu
PRINCIPAL_INVESTIGATORMatthew R Pearson, PhD

University of New Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026