Physician Coaching to Reduce Opioid-related Harms

NCT ID: NCT02433496

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53132 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-06-30

Brief 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.

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.

Conditions

Substance Abuse; Chronic Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Physician coaching

Intervention Type: OTHER

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Center for Health Enhancement System Studies

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew R Quanbeck, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Enhancement Systems Studies

Locations

University of Wisconsin - Madison

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29370813 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R34DA036720-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-0280

Identifier Type: -

Identifier Source: org_study_id