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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
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Center for Health Enhancement System Studies
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment
Substance Abuse Chronic Pain 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.

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Study Type : Observational
Actual Enrollment : 53132 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.



Primary Outcome Measures :
  1. Overall Rate of Opioid Prescribing [ Time Frame: Up to 3 years ]
    The proportion of patients with a chronic pain diagnosis receiving daily opioids.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Mental Health Screening Rate [ Time Frame: Up to 3 years ]
    Proportion of opioid patients screened for mental health/substance use problems

  4. Use of Pain Management Agreements [ Time Frame: Up to 3 years ]
    Proportion of opioid patients signing pain management agreements

  5. High-dose Patients [ Time Frame: Up to 3 years ]
    Proportion of opioid prescriptions above 120 mg daily morphine equivalent

  6. Provider Drop-out Rate [ Time Frame: 3 months ]
    Number and percentage of providers who drop out of study at 3 months

  7. Participating Patient Demographics [ Time Frame: Up to 3 years ]
    Characteristics of participating patients vs. general patient population (race, gender, ethnicity)

  8. 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)

  9. Participating Staff Characteristics [ Time Frame: Up to 12 months ]
    Characteristics of participating staff (profession)

  10. Intervention Fidelity [ Time Frame: Up to 12 months ]
    Total hours of coaching delivered/received among all clinics that received physician coaching.

  11. Intervention Cost [ Time Frame: Up to 12 months ]
    Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.

  12. 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.

  13. Average Morphine Equivalent Daily Dose (MEDD) [ Time Frame: Up to 12 months ]
    The average MEDD in milligrams for patients with consistent opioid Rx.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Clinicians with prescribing authority at community-based primary care clinics
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.

Information from the National Library of Medicine

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


Locations
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United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Center for Health Enhancement System Studies
Investigators
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Principal Investigator: Andrew R Quanbeck, PhD Center for Health Enhancement Systems Studies
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02433496    
Other Study ID Numbers: 2015-0280
1R34DA036720-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2015    Key Record Dates
Results First Posted: July 6, 2018
Last Update Posted: July 6, 2018
Last Verified: July 2018
Keywords provided by University of Wisconsin, Madison:
Opioid
Additional relevant MeSH terms:
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Chronic Pain
Substance-Related Disorders
Pain
Neurologic Manifestations
Chemically-Induced Disorders
Mental Disorders