NCT02433496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53,132

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 6, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

April 20, 2015

Results QC Date

February 16, 2018

Last Update Submit

July 3, 2018

Conditions

Keywords

Opioid

Outcome Measures

Primary Outcomes (1)

  • Overall Rate of Opioid Prescribing

    The proportion of patients with a chronic pain diagnosis receiving daily opioids.

    Up to 3 years

Secondary Outcomes (13)

  • Rate of Opioid / Benzodiazepine Co-prescribing

    Up to 3 years

  • Urine Drug Screening Rate

    Up to 3 years

  • Mental Health Screening Rate

    Up to 3 years

  • Use of Pain Management Agreements

    Up to 3 years

  • High-dose Patients

    Up to 3 years

  • +8 more secondary outcomes

Study Arms (2)

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

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.

Interventions

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.

Physician coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinicians with prescribing authority at community-based primary care clinics

You may qualify if:

  • 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.

You may not qualify if:

  • Residents will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related DisordersChronic Pain

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

The UWHealth system introduced a new opioid-prescribing policy concurrent with the beginning of the study period and included a standardized treatment agreement that included elements of the checklist developed during this research.

Results Point of Contact

Title
Andrew Quanbeck
Organization
University of Wisconsin - Madison

Study Officials

  • Andrew R Quanbeck, PhD

    Center for Health Enhancement Systems Studies

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

May 5, 2015

Study Start

July 1, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

July 6, 2018

Results First Posted

July 6, 2018

Record last verified: 2018-07

Locations