- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT06565416
Opioid- und Schmerzbehandlung in indigenen Gemeinschaften (OPTIC)-Studie (OPTIC)
Opioid- und Schmerzbehandlung in indigenen Gemeinschaften (OPTIC)-Studie: Implementierung von Screening und Kurzintervention
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Kamilla L Venner, PhD
- Telefonnummer: 5059252300
- E-Mail: kamilla@unm.edu
Studieren Sie die Kontaktsicherung
- Name: Angel R Vasquez, PhD
- E-Mail: vasquez@unm.edu
Studienorte
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California
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Arcata, California, Vereinigte Staaten, 95521
- Rekrutierung
- Clinic Site A (blinded pending tribal approval)
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Kontakt:
- Kamilla L Venner
- Telefonnummer: 505-925-2300
- E-Mail: kamilla@unm.edu
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55404
- Noch keine Rekrutierung
- Clinic Site C (blinded pending tribal approval)
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Kontakt:
- Kamilla L Venner
- Telefonnummer: 505-925-2300
- E-Mail: kamilla@unm.edu
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Washington
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Toppenish, Washington, Vereinigte Staaten, 98948
- Noch keine Rekrutierung
- Clinic Site B (blinded pending tribal approval)
-
Kontakt:
- Kamilla L Venner
- Telefonnummer: 505-925-2300
- E-Mail: kamilla@unm.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Pre-Intervention
Baseline prior to any involvement with the project |
|
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Kein Eingriff: 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. |
|
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Aktiver 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 |
|
Kein Eingriff: Sustainment
Measuring the degree to which the clinic maintains the implementation phase goals. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
Zeitfenster: 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
Zeitfenster: 6 months (or duration of sustainment phase)
|
Derived from electronic medical records |
6 months (or duration of sustainment phase)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Matthew R Pearson, PhD, University of New Mexico
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2303044342
- RM1DA055301 (US NIH Stipendium/Vertrag)
- 2206007094 (Andere Kennung: University of New Mexico)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Each Tribal partner has would need to agree to have their data shared.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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