Physician Coaching to Reduce Opioid-related Harms
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|ClinicalTrials.gov Identifier: NCT02433496|
Recruitment Status : Completed
First Posted : May 5, 2015
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment|
|Substance Abuse Chronic Pain||Other: Physician coaching|
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.
|Study Type :||Observational|
|Actual Enrollment :||53132 participants|
|Official Title:||Physician Coaching to Reduce Opioid-related Harms|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
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.
Other: Physician coaching
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.
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.
- Overall Rate of Opioid Prescribing [ Time Frame: Up to 3 years ]The proportion of patients with a chronic pain diagnosis receiving daily opioids.
- Rate of Opioid / Benzodiazepine Co-prescribing [ Time Frame: Up to 3 years ]Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
- Urine Drug Screening Rate [ Time Frame: Up to 3 years ]Proportion of opioid patients completing urine drug screens prior to and during the study intervention
- Mental Health Screening Rate [ Time Frame: Up to 3 years ]Proportion of opioid patients screened for mental health/substance use problems
- Use of Pain Management Agreements [ Time Frame: Up to 3 years ]Proportion of opioid patients signing pain management agreements
- High-dose Patients [ Time Frame: Up to 3 years ]Proportion of opioid prescriptions above 120 mg daily morphine equivalent
- Provider Drop-out Rate [ Time Frame: 3 months ]Number and percentage of providers who drop out of study at 3 months
- Participating Patient Demographics [ Time Frame: Up to 3 years ]Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
- Participating Clinic Characteristics [ Time Frame: Up to 12 months ]Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
- Participating Staff Characteristics [ Time Frame: Up to 12 months ]Characteristics of participating staff (profession)
- Intervention Fidelity [ Time Frame: Up to 12 months ]Total hours of coaching delivered/received among all clinics that received physician coaching.
- Intervention Cost [ Time Frame: Up to 12 months ]Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.
- Proportion With MEDD >120 mg [ Time Frame: Up to 12 months ]The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
- Average Morphine Equivalent Daily Dose (MEDD) [ Time Frame: Up to 12 months ]The average MEDD in milligrams for patients with consistent opioid Rx.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433496
|United States, Wisconsin|
|University of Wisconsin - Madison|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Andrew R Quanbeck, PhD||Center for Health Enhancement Systems Studies|