Promoting Clinical Guidelines for Opioid Prescribing

NCT04044521 | Completed Results

• 5 other identifiers: 2018-1276R01DA047279A532007SMPH/FAMILY MED/RES GRANTSProtocol Version 8/31/2020
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to understand the optimal sequencing and combination of implementation strategies that specific types of clinics and prescribers need to adopt clinical guidelines for opioid prescribing. The pragmatic goal is to give health systems a tool they can use to predict which clinics and prescribers will benefit most from which sequence and combination of implementation strategies.

Conditions

Opioid Use

Keywords

implementation; primary care; organizational change; Centers for Disease Control opioid prescribing guidelines; clinical guidelines; systems consultation

Outcome Measures

Primary Outcomes (2)

• Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics

  The average morphine milligram equivalent will be reported at the clinic level. Patients included in this outcome are those who are prescribed at least 3 opioid orders in the last 3 consecutive months. For a comparison of opioids doses, a conversion factors were developed to equate the many different opioids into one standard value. This standard value is based on morphine and its potency, referred to as morphine milligram equivalents (MME) or morphine equivalent doses (MED).

  up to 30 months

• Average Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers

  The average morphine milligram equivalent will be reported at the prescriber level. Patients included in this outcome are those who are prescribed at least 3 opioid orders in the last 3 consecutive months.

  up to 30 months

Secondary Outcomes (7)

• Number of Eligible Clinics That Participated

  up to 30 months

• Number of Clinicians Who Participated in the Study

  up to 30 months

• Number of Patients at Clinics

  up to 30 months

• Number of Clinicians Who Attended the Intervention Meetings

  up to 30 months

• Average Hours of Intervention Received Per Clinic

  up to 30 months

Other Outcomes (13)

• Quality Improvement Experience of the Clinics

  up to 30 months

• Components of System-level Opioid Prescribing Policy of the Health Systems

  up to 30 months

• Number of Adaptations Made to the Intervention During Intervention Period

  up to 30 months

Study Arms (4)

Academic detailing only

EXPERIMENTAL

Clinicians will attend an educational meeting and receive audit and feedback reports for 18 months.

Other: Systems consultation

Academic detailing+practice facilitation

EXPERIMENTAL

Clinicians of this group will attend an educational meeting and receive a monthly audit and feedback report for 18 months. At month 3, clinics will be randomized to receive practice facilitation. Clinics will be asked to follow-up with the facilitators via phone or video chat monthly for months 4-9, then quarterly for months 10-18.

Other: Systems consultation

Academic detailing+practice facilitation+physician peer consul

EXPERIMENTAL

Clinicians will receive academic detailing at month 0 and practice facilitation at month 3. At month 9, clinics will be randomized to receive physician peer consulting. Clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant.

Other: Systems consultation

Academic detailing+physician peer consulting

EXPERIMENTAL

Clinicians of this group will attend an educational meeting and will receive a monthly audit and feedback report for 18 months. At month 9, clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant.

Other: Systems consultation

Interventions

Systems consultation OTHER

Systems consultation consists of three implementation strategies: academic detailing (AD), practice facilitation (PF), and physician peer consulting (PPC). Clinics will receive a combination of these strategies for 21 months. AD: Clinicians will attend an educational meeting that will detail the study and Center for Disease Control guidelines for opioid prescribing in primary care. Clinicians will then will get a monthly audit \& feedback report on their prescribing. PF: clinics will be randomized to receive practice facilitation. Facilitators will meet with each clinic. Facilitators walk through the clinic, identify areas of opioid prescribing workflow improvement, conduct a nominal group technique with the change team, and set a Plan-Do-Study-Act cycle. Clinics will follow-up with the facilitators monthly. PPC: Clinicians of the clinics will meet quarterly with the physician peer consultant to discuss tough patient cases and panels regarding opioid prescribing.

Academic detailing only; Academic detailing+physician peer consulting; Academic detailing+practice facilitation; Academic detailing+practice facilitation+physician peer consul

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinics will be eligible for the study if they:
• are a primary care clinic (non-pediatric primary care, internal medicine, or family medicine);
• have not received the systems consultation intervention;
• do not explicitly prohibit initiating opioid therapy;
• do not exceed the performance on key measures of guideline concordance (fewer than 80% of long-term opioid patients have treatment agreements and a urine drug screen in the past 12 months)
• Prescribers will be eligible if they:
• are a primary care provider at the clinic;
• are not temporary providers who do not manage stable panels or patients;
• While patients are not subjects of study, de-identified prescriber panel data will be used to assess outcome measures. To be included in the de-identified prescriber panel data, patients must:
• have a primary care provider at the clinic;
• are prescribed opioid therapy for at least 3 consecutive months;
• do not have a cancer diagnosis or are receiving hospice care.

You may not qualify if:

• Clinics will be excluded if they are not a primary care clinic, have received the systems consultation intervention, prohibit initiating opioid therapy, or exceed the threshold on key measures of guideline concordance.
• Prescribers will be excluded if they don't have prescribing privileges or are temporary providers who do not manage stable panels or patients.
• De-identified prescriber panel data will be excluded from outcome measures if they do not have a primary care provider at the clinic, are not prescribed opioid therapy for at least 3 consecutive months, or have a cancer diagnosis or are receiving hospice care.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Bellin Health Systems

Green Bay, Wisconsin, 54305, United States

Location

UW Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Quanbeck A, Almirall D, Jacobson N, Brown RT, Landeck JK, Madden L, Cohen A, Deyo BMF, Robinson J, Johnson RA, Schumacher N. The Balanced Opioid Initiative: protocol for a clustered, sequential, multiple-assignment randomized trial to construct an adaptive implementation strategy to improve guideline-concordant opioid prescribing in primary care. Implement Sci. 2020 Apr 25;15(1):26. doi: 10.1186/s13012-020-00990-4.

  PMID: 32334632 BACKGROUND

• Quanbeck A, Robinson J, Jacobson N, Li X, Hennessy-Garza R, Landeck J, Cohen A, Madden L, Pulvermacher A, Brown R. Strategies to Deimplement Opioid Prescribing in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438325. doi: 10.1001/jamanetworkopen.2024.38325.

  PMID: 39388183 DERIVED

Limitations and Caveats

All eligible clinics in two health systems were invited to participate. Clinics that volunteered may have been more motivated to change. Also, the interventions began in Feb. 2020 shortly before COVID forcing the implementation interactions to be done virtually rather than in person. In addition, the 2016 CDC guidelines that formed the basis of the intervention were the subject of considerable debate in the medical community and were revised in Feb. 2022, near the end of the intervention period.

Results Point of Contact

• Title: Dr. Andrew Quanbeck
• Organization: University of Wisconsin-Madison

andrew.quanbeck@fammed.wisc.edu

608-609-7308

Study Officials

• Andrew Quanbeck, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention will assess outcomes at the clinic and prescriber level. Prescribers are the population of interest.

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: January 31, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 17, 2024
• Results First Posted: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 9 months after publication of primary outcomes, and ending 3 years following publication.
• Access Criteria: Proposals should be directed to PI Andrew Quanbeck at arquanbe@wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.

Locations

US (2)