- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02433496
Physician Coaching to Reduce Opioid-related Harms
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Wisconsin
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Madison, Wisconsin, États-Unis, 53705
- University of Wisconsin - Madison
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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. |
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Overall Rate of Opioid Prescribing
Délai: Up to 3 years
|
The proportion of patients with a chronic pain diagnosis receiving daily opioids.
|
Up to 3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Rate of Opioid / Benzodiazepine Co-prescribing
Délai: Up to 3 years
|
Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
|
Up to 3 years
|
Urine Drug Screening Rate
Délai: Up to 3 years
|
Proportion of opioid patients completing urine drug screens prior to and during the study intervention
|
Up to 3 years
|
Mental Health Screening Rate
Délai: Up to 3 years
|
Proportion of opioid patients screened for mental health/substance use problems
|
Up to 3 years
|
Use of Pain Management Agreements
Délai: Up to 3 years
|
Proportion of opioid patients signing pain management agreements
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Up to 3 years
|
High-dose Patients
Délai: Up to 3 years
|
Proportion of opioid prescriptions above 120 mg daily morphine equivalent
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Up to 3 years
|
Provider Drop-out Rate
Délai: 3 months
|
Number and percentage of providers who drop out of study at 3 months
|
3 months
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Participating Patient Demographics
Délai: Up to 3 years
|
Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
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Up to 3 years
|
Participating Clinic Characteristics
Délai: 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)
|
Up to 12 months
|
Participating Staff Characteristics
Délai: Up to 12 months
|
Characteristics of participating staff (profession)
|
Up to 12 months
|
Intervention Fidelity
Délai: Up to 12 months
|
Total hours of coaching delivered/received among all clinics that received physician coaching.
|
Up to 12 months
|
Intervention Cost
Délai: Up to 12 months
|
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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Andrew R Quanbeck, PhD, Center for Health Enhancement Systems Studies
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2015-0280
- 1R34DA036720-01A1 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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