PROMOTE: A Pilot and Feasibility Study (PROMOTE)
6 de agosto de 2026 actualizado por: Paul Joudrey, University of Pittsburgh
PeRsOnalized MethOdone TrEatment (PROMOTE) by Implementing Shared Decision-making: A Pilot and Feasibility Study
To assess the feasibility and acceptability of implementing and evaluating shared decision making (SDM) within a single opioid treatment program (OTP) using Implementation Facilitation (IF), and to obtain pilot data on key implementation and effectiveness outcomes to inform a future full-scale hybrid type 3 implementation-effectiveness trial.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
A combination of cross-sectional (surveys) during the study period and retrospective (Electronic Health Record data) following the study period.
Tipo de estudio
De observación
Inscripción (Estimado)
58
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Research Program Manager
- Número de teléfono: +1-412-624-7263
- Correo electrónico: dmo36@pitt.edu
Ubicaciones de estudio
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Arizona
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Mesa, Arizona, Estados Unidos, 85213
- Community Medical Services Mesa, AZ on Main
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Contacto:
- Clinic Manager
- Número de teléfono: 480-977-1500
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Mesa on Main, a single OTP clinic in Arizona operated by Community Medical Services (CMS), will participate as the pilot study site.
The investigators will enroll clients and healthcare professionals from Mesa on Main to participate in cross-sectional surveys, qualitative interviews, and EHR data collection.
Descripción
Inclusion Criteria:
CLIENT INCLUSION CRITERIA
- Age ≥18 years old
- Receiving methadone treatment (i.e., self-report of ingestion of at least one administered or dispensed dose of methadone in past 7 days) at the pilot OTP
- Able and willing to provide informed consent
- Able to read and write in English or Spanish
HEALTHCARE PROFESSIONAL INCLUSION CRITERIA
- ≥18 years old
- Partners with clients to make methadone treatment decisions (e.g., peer navigator, physician, advanced practice provider, nurse, counselor)
- Able and willing to provide informed consent
- Able to read and write in English
CLIENT EHR INCLUSION CRITERIA
- ≥18 years old
- Documented receipt of at least one dose of methadone treatment (i.e., administrated or dispensed) from the participating OTP during a 6-month study period
SEMI-STRUCTURED INTERVIEW INCLUSION CRITERIA
- Clients and healthcare professionals eligible as described above may be included in semi-structured interviews. We will also include the OTP organizational leadership (e.g., clinic director, medical director, regional director). The investigators will purposively sample clients, healthcare professionals, and OTP leadership to contrast positional differences in experiences of SDM and its implementation. The investigators may modify this sampling approach based on preliminary results and advisory board feedback.
Exclusion Criteria:
CLIENT EXCLUSION CRITERIA
- Do not meet client inclusion criteria
- For the client survey, each client may complete the survey only once during the 6-month implementation period.
HEALTHCARE PROFESSIONAL EXCLUSION CRITERIA
- The investigators will exclude healthcare professionals who do not meet inclusion criteria
CLIENT EHR EXCLUSION CRITERIA
- The investigators will exclude clients who do not meet inclusion criteria
SEMI-STRUCTURED INTERVIEW EXCLUSION CRITERIA
- The investigators will exclude clients or healthcare professionals who do not meet inclusion criteria.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patient Implementation Intervention
Implementation Facilitation (IF) is a systematic approach to integrating implementation activities to support and enable individual and organizational adoption of innovations.
The IF-based implementation intervention for shared decision making in a single opioid treatment program will occur over a period of 6 months.
Patient cohort -all consented patient participants will be exposed to the Implementation Intervention.
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Implementation Facilitation (IF) is a systematic approach to integrating implementation activities to support and enable individual and organizational adoption of innovations.
IF will be tailored to support shared decision making in a single opioid treatment program (OTP) and will be implemented over a 6-month period to assess feasibility of this implementation intervention in an OPT setting.
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Health Care Provider Implementation Intervention
Implementation Facilitation (IF) is a systematic approach to integrating implementation activities to support and enable individual and organizational adoption of innovations.
The IF-based implementation intervention for shared decision making in a single opioid treatment program will occur over a period of 6 months.
Health care provider (HCP) cohort -all consented HCP participants will be exposed to the Implementation Intervention.
|
Implementation Facilitation (IF) is a systematic approach to integrating implementation activities to support and enable individual and organizational adoption of innovations.
IF will be tailored to support shared decision making in a single opioid treatment program (OTP) and will be implemented over a 6-month period to assess feasibility of this implementation intervention in an OPT setting.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of client survey recruitment and data collection procedures
Periodo de tiempo: 6-month implementation period
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Feasibility is defined as (a) recruiting n ≥ 50 clients who (b) complete the client survey during the pilot implementation period.
The investigators will calculate the frequency and proportion of clients (a) recruited (start the survey) and (b) who complete the survey.
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6-month implementation period
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Feasibility of observed client-healthcare professional encounter recruitment and data collection procedures
Periodo de tiempo: 6-month implementation period
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Feasibility of observed client-healthcare professional encounter recruitment is defined as obtaining n ≥ 20 eligible observed encounters during the pilot implementation period.
The investigators will calculate the frequency and proportion of clients and healthcare providers who participate in an observed encounter.
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6-month implementation period
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Feasibility of ascertainment of retention in methadone treatment during a 6-month period using site Electronic Health Record (EHR) data
Periodo de tiempo: 6-month period preceding the implementation period
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Feasibility is defined as successful estimation of retention in methadone treatment as defined as [1 - Pr(discontinuation of methadone)] during a 6-month period as measured by EHR data.
The investigators are assessing feasibility of obtaining this data and estimating retention from it and therefore the period from which data is obtained is irrelevant.
The probability of retention in treatment during the 6-month implementation period will be calculated as the complement of the probability of discontinuation [1 - Pr(discontinuation)], as measured via EHR data of dates of new episodes of methadone treatment (>7 days between doses).
Using a survival analytic approach accounting for recurrent events, the investigators will calculate the hazard rate for the pilot period and plot the hazard of discontinuation for visual assessment.
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6-month period preceding the implementation period
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Feasibility and acceptability of the IF intervention for OTPs.
Periodo de tiempo: 6-month implementation period
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Feasibility and acceptability of the IF intervention will be assessed qualitatively by recruiting 25 clients and 10 healthcare professionals for semi-structured interviews and documentation of IF activities via the IF activities log.
Qualitative and IF tracking log results will be presented to the study advisory board for final determination of feasibility and acceptability (Yes/No).
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6-month implementation period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of healthcare professional survey recruitment and data collection procedures
Periodo de tiempo: 6-month implementation period
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Feasibility is defined as (a) recruiting n ≥ 8 healthcare professionals who (b) complete the healthcare professional survey during the pilot implementation period.
The investigators will calculate the frequency and proportion of healthcare professionals (a) recruited (start the survey) and (b) who complete the survey.
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6-month implementation period
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Acceptability of the Spanish version of client survey
Periodo de tiempo: 6-month implementation period
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a) The proportion of clients who opt to take and complete the Spanish version of the survey versus the proportion of clients who opt to take and complete the English version.
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6-month implementation period
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Utilization of Spanish version of client survey
Periodo de tiempo: 6-month implementation period
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The number of completed Spanish surveys divided by the total number of client surveys completed.
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6-month implementation period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paul Joudrey, MD, MPH, University of Pittsburgh
- Investigador principal: Cristina Murray-Krezan, PhD, University of Pittsburgh
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de agosto de 2026
Publicado por primera vez (Actual)
11 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY26030108
- 1R61DA063659 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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