Physician Coaching to Reduce Opioid-related Harms

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Substance Abuse
• Intervention / Treatment: Other: Physician coaching

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 53132

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinicians with prescribing authority at community-based primary care clinics

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Rate of Opioid Prescribing	The proportion of patients with a chronic pain diagnosis receiving daily opioids.	Up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA); Center for Health Enhancement System Studies
• Investigators: Principal Investigator: Andrew R Quanbeck, PhD, Center for Health Enhancement Systems Studies

Publications and helpful links

General Publications

• Quanbeck A, Brown RT, Zgierska AE, Jacobson N, Robinson JM, Johnson RA, Deyo BM, Madden L, Tuan WJ, Alagoz E. A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care. Implement Sci. 2018 Jan 25;13(1):21. doi: 10.1186/s13012-018-0713-1.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Opioid
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pain; Neurologic Manifestations; Substance-Related Disorders; Chronic Pain
• Other Study ID Numbers: 2015-0280; 1R34DA036720-01A1 (U.S. NIH Grant/Contract)