Ensayo sobre el tratamiento del dolor y opioides en comunidades indígenas (OPTIC) (OPTIC)
Ensayo sobre tratamiento del dolor y opioides en comunidades indígenas (OPTIC): implementación de detección e intervención breve
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kamilla L Venner, PhD
- Número de teléfono: 5059252300
- Correo electrónico: kamilla@unm.edu
Copia de seguridad de contactos de estudio
- Nombre: Angel R Vasquez, PhD
- Correo electrónico: vasquez@unm.edu
Ubicaciones de estudio
-
-
California
-
Arcata, California, Estados Unidos, 95521
- Reclutamiento
- Clinic Site A (blinded pending tribal approval)
-
Contacto:
- Kamilla L Venner
- Número de teléfono: 505-925-2300
- Correo electrónico: kamilla@unm.edu
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55404
- Aún no reclutando
- Clinic Site C (blinded pending tribal approval)
-
Contacto:
- Kamilla L Venner
- Número de teléfono: 505-925-2300
- Correo electrónico: kamilla@unm.edu
-
-
Washington
-
Toppenish, Washington, Estados Unidos, 98948
- Aún no reclutando
- Clinic Site B (blinded pending tribal approval)
-
Contacto:
- Kamilla L Venner
- Número de teléfono: 505-925-2300
- Correo electrónico: kamilla@unm.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Pre-Intervention
Baseline prior to any involvement with the project |
|
|
Sin intervención: 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. |
|
|
Comparador activo: 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 |
|
Sin intervención: Sustainment
Measuring the degree to which the clinic maintains the implementation phase goals. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
Periodo de tiempo: 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
Periodo de tiempo: 6 months (or duration of sustainment phase)
|
Derived from electronic medical records |
6 months (or duration of sustainment phase)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Matthew R Pearson, PhD, University of New Mexico
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2303044342
- RM1DA055301 (Subvención/contrato del NIH de EE. UU.)
- 2206007094 (Otro identificador: University of New Mexico)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Each Tribal partner has would need to agree to have their data shared.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .