Clinical trial NCT02433496: Physician Coaching to Reduce Opioid-related Harms
Official title: Physician Coaching to Reduce Opioid-related Harms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Abuse
Chronic Pain
Keywords: Opioid
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Center for Health Enhancement System Studies
First posted: 2015-05-05
Enrollment: 53132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinicians with prescribing authority at community-based primary care clinics

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.

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.

Primary outcomes:
measure: Overall Rate of Opioid Prescribing
timeFrame: Up to 3 years
Secondary outcomes:
measure: Rate of Opioid / Benzodiazepine Co-prescribing
timeFrame: Up to 3 years
measure: Urine Drug Screening Rate
timeFrame: Up to 3 years
measure: Mental Health Screening Rate
timeFrame: Up to 3 years
measure: Use of Pain Management Agreements
timeFrame: Up to 3 years
measure: High-dose Patients
timeFrame: Up to 3 years
measure: Provider Drop-out Rate
timeFrame: 3 months
measure: Participating Patient Demographics
timeFrame: Up to 3 years
measure: Participating Clinic Characteristics
timeFrame: Up to 12 months
measure: Participating Staff Characteristics
timeFrame: Up to 12 months
measure: Intervention Fidelity
timeFrame: Up to 12 months
measure: Intervention Cost
timeFrame: Up to 12 months
measure: Proportion With MEDD >120 mg
timeFrame: Up to 12 months
measure: Average Morphine Equivalent Daily Dose (MEDD)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: Center for Health Enhancement Systems Studies
name: Andrew R Quanbeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.