Opioïden- en pijnbehandeling in inheemse gemeenschappen (OPTIC)-onderzoek (OPTIC)
Opioïden- en pijnbehandeling in inheemse gemeenschappen (OPTIC) Proef: implementatie van screening en korte interventie
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Kamilla L Venner, PhD
- Telefoonnummer: 5059252300
- E-mail: kamilla@unm.edu
Studie Contact Back-up
- Naam: Angel R Vasquez, PhD
- E-mail: vasquez@unm.edu
Studie Locaties
-
-
California
-
Arcata, California, Verenigde Staten, 95521
- Werving
- Clinic Site A (blinded pending tribal approval)
-
Contact:
- Kamilla L Venner
- Telefoonnummer: 505-925-2300
- E-mail: kamilla@unm.edu
-
-
Minnesota
-
Minneapolis, Minnesota, Verenigde Staten, 55404
- Nog niet aan het werven
- Clinic Site C (blinded pending tribal approval)
-
Contact:
- Kamilla L Venner
- Telefoonnummer: 505-925-2300
- E-mail: kamilla@unm.edu
-
-
Washington
-
Toppenish, Washington, Verenigde Staten, 98948
- Nog niet aan het werven
- Clinic Site B (blinded pending tribal approval)
-
Contact:
- Kamilla L Venner
- Telefoonnummer: 505-925-2300
- E-mail: kamilla@unm.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Pre-Intervention
Baseline prior to any involvement with the project |
|
|
Geen tussenkomst: Intervention
A workgroup for each clinic meets for approximately 6 months to select the specific goals for the clinic to be targeted during the implementation phase. |
|
|
Actieve vergelijker: Implementation
Evidence-based implementation strategies are put into practice for approximately 6 months. |
Culturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients |
|
Geen tussenkomst: Sustainment
Measuring the degree to which the clinic maintains the implementation phase goals. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
Tijdsspanne: 6 months (or duration of implementation phase)
|
Derived from electronic medical records |
6 months (or duration of implementation phase)
|
|
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
Tijdsspanne: 6 months (or duration of sustainment phase)
|
Derived from electronic medical records |
6 months (or duration of sustainment phase)
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Matthew R Pearson, PhD, University of New Mexico
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2303044342
- RM1DA055301 (Subsidie/contract van de Amerikaanse NIH)
- 2206007094 (Andere identificatie: University of New Mexico)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Each Tribal partner has would need to agree to have their data shared.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .