Prøve på opioid- og smertebehandling i urfolkssamfunn (OPTIC). (OPTIC)
Opioid- og smertebehandling i urfolkssamfunn (OPTIC) Trial: Implementering av screening og kort intervensjon
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Kamilla L Venner, PhD
- Telefonnummer: 5059252300
- E-post: kamilla@unm.edu
Studer Kontakt Backup
- Navn: Angel R Vasquez, PhD
- E-post: vasquez@unm.edu
Studiesteder
-
-
California
-
Arcata, California, Forente stater, 95521
- Rekruttering
- Clinic Site A (blinded pending tribal approval)
-
Ta kontakt med:
- Kamilla L Venner
- Telefonnummer: 505-925-2300
- E-post: kamilla@unm.edu
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater, 55404
- Har ikke rekruttert ennå
- Clinic Site C (blinded pending tribal approval)
-
Ta kontakt med:
- Kamilla L Venner
- Telefonnummer: 505-925-2300
- E-post: kamilla@unm.edu
-
-
Washington
-
Toppenish, Washington, Forente stater, 98948
- Har ikke rekruttert ennå
- Clinic Site B (blinded pending tribal approval)
-
Ta kontakt med:
- Kamilla L Venner
- Telefonnummer: 505-925-2300
- E-post: kamilla@unm.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Pre-Intervention
Baseline prior to any involvement with the project |
|
|
Ingen inngripen: 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. |
|
|
Aktiv komparator: 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 |
|
Ingen inngripen: Sustainment
Measuring the degree to which the clinic maintains the implementation phase goals. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
Tidsramme: 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
Tidsramme: 6 months (or duration of sustainment phase)
|
Derived from electronic medical records |
6 months (or duration of sustainment phase)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Matthew R Pearson, PhD, University of New Mexico
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2303044342
- RM1DA055301 (U.S. NIH-stipend/kontrakt)
- 2206007094 (Annen identifikator: University of New Mexico)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Each Tribal partner has would need to agree to have their data shared.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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