Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565416
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Opioid and Pain Treatment in Indigenous Communities OPTIC Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Opioid and Pain Treatment in Indigenous Communities OPTIC Trial Implementation of Screening and Brief Intervention
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIC
Brief Summary:
The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuseopioid use disorder in three American Indian and Alaska Native AIAN 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 misuseopioid use disorder
Detailed Description:
Given the health disparities in AIAN populations and lack of access to quality care for comorbid chronic pain and opioid misuseOUD the proposed study seeks to build upon the strong relationships between the research team and the AIAN communities There is a dearth of prior research examining chronic pain opioid misuseOUD and other comorbid conditions mood disorders anxiety disorders other SUD in AIAN 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 AIAN clients with chronic pain and opioid misuseOUD 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 misuseOUD in clinics serving AIAN 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 AIAN 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 misuseopioid 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None