Physician Coaching to Reduce Opioid-related Harms

Chronic Pain Clinical Trial

Official title:

Physician Coaching to Reduce Opioid-related Harms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433496
• Other study ID #: 2015-0280
• Secondary ID: 1R34DA036720-01A
• Status: Completed
• Start date: July 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53132
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Substance Abuse
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Center for Health Enhancement System Studies, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Rate of Opioid Prescribing	The proportion of patients with a chronic pain diagnosis receiving daily opioids.	Up to 3 years
Secondary	Rate of Opioid / Benzodiazepine Co-prescribing	Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.	Up to 3 years
Secondary	Urine Drug Screening Rate	Proportion of opioid patients completing urine drug screens prior to and during the study intervention	Up to 3 years
Secondary	Mental Health Screening Rate	Proportion of opioid patients screened for mental health/substance use problems	Up to 3 years
Secondary	Use of Pain Management Agreements	Proportion of opioid patients signing pain management agreements	Up to 3 years
Secondary	High-dose Patients	Proportion of opioid prescriptions above 120 mg daily morphine equivalent	Up to 3 years
Secondary	Provider Drop-out Rate	Number and percentage of providers who drop out of study at 3 months	3 months
Secondary	Participating Patient Demographics	Characteristics of participating patients vs. general patient population (race, gender, ethnicity)	Up to 3 years
Secondary	Participating Clinic Characteristics	Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)	Up to 12 months
Secondary	Participating Staff Characteristics	Characteristics of participating staff (profession)	Up to 12 months
Secondary	Intervention Fidelity	Total hours of coaching delivered/received among all clinics that received physician coaching.	Up to 12 months
Secondary	Intervention Cost	Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.	Up to 12 months
Secondary	Proportion With MEDD >120 mg	The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.	Up to 12 months
Secondary	Average Morphine Equivalent Daily Dose (MEDD)	The average MEDD in milligrams for patients with consistent opioid Rx.	Up to 12 months