Physician Coaching to Reduce Opioid-related Harms
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.
The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
- University of Wisconsin - Madison
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.
Exclusion Criteria:
- Residents will be excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Physician coaching
This group includes 4 intervention primary care clinics that are part of the University of Wisconsin's Department of Family Medicine.
These clinics will receive an organizational coaching intervention that includes in-person site visits and phone/email communication.
Each participating clinic will designate one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit (during project month 13, July 2015), a follow-up site visit (month 15, October, 2015), and communicating with the coach throughout the 6-month follow-up period via phone and email.
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The coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing. The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice. |
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Control Group
This group includes 4 control primary care clinics that will not receive any intervention.
A de-identified dataset will be created to examine differences in outcome variables between intervention and control clinics.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Rate of Opioid Prescribing
Periodo de tiempo: Up to 3 years
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The proportion of patients with a chronic pain diagnosis receiving daily opioids.
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Up to 3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of Opioid / Benzodiazepine Co-prescribing
Periodo de tiempo: Up to 3 years
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Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
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Up to 3 years
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Urine Drug Screening Rate
Periodo de tiempo: Up to 3 years
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Proportion of opioid patients completing urine drug screens prior to and during the study intervention
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Up to 3 years
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Mental Health Screening Rate
Periodo de tiempo: Up to 3 years
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Proportion of opioid patients screened for mental health/substance use problems
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Up to 3 years
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Use of Pain Management Agreements
Periodo de tiempo: Up to 3 years
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Proportion of opioid patients signing pain management agreements
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Up to 3 years
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High-dose Patients
Periodo de tiempo: Up to 3 years
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Proportion of opioid prescriptions above 120 mg daily morphine equivalent
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Up to 3 years
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Provider Drop-out Rate
Periodo de tiempo: 3 months
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Number and percentage of providers who drop out of study at 3 months
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3 months
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Participating Patient Demographics
Periodo de tiempo: Up to 3 years
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Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
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Up to 3 years
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Participating Clinic Characteristics
Periodo de tiempo: Up to 12 months
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Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
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Up to 12 months
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Participating Staff Characteristics
Periodo de tiempo: Up to 12 months
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Characteristics of participating staff (profession)
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Up to 12 months
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Intervention Fidelity
Periodo de tiempo: Up to 12 months
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Total hours of coaching delivered/received among all clinics that received physician coaching.
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Up to 12 months
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Intervention Cost
Periodo de tiempo: Up to 12 months
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Total cost of coaching intervention among all clinics that received physician coaching.
At clinic level.
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Up to 12 months
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Proportion With MEDD >120 mg
Periodo de tiempo: Up to 12 months
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The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
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Up to 12 months
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Average Morphine Equivalent Daily Dose (MEDD)
Periodo de tiempo: Up to 12 months
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The average MEDD in milligrams for patients with consistent opioid Rx.
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Up to 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrew R Quanbeck, PhD, Center for Health Enhancement Systems Studies
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015-0280
- 1R34DA036720-01A1 (Subvención/contrato del NIH 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. .
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