Promoting Clinical Guidelines for Opioid Prescribing

September 27, 2023 updated by: University of Wisconsin, Madison

Promoting the Implementation of Clinical Guidelines for Opioid Prescribing in Primary Care Using Systems Consultation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study evaluates a sequence and combination of implementation strategies that is tailored to the needs of stakeholders at different levels (health system, clinic, and prescriber). We will deliver an adaptive version of systems consultation that progressively and adaptively drills down to offer more and more personalized levels of implementation support. The intervention starts with academic detailing, a systems-level strategy consisting of an expert-led training session plus distance-based follow up support. This strategy continues for the 18-month intervention for all clinics, but at 3 months, half of the clinics will be randomized to receive practice facilitation. Practice facilitation is a clinic-level strategy in which a highly-skilled external change agent helps clinics improve processes related to opioid prescribing. At 6 months, half of prescribers will be randomized to receive physician peer coaching. Physician peer coaching is a clinic-level strategy in which a physician expert gives one-on-one support to prescribers in managing their patients on long-term opioid therapy. These 3 discrete strategies will be delivered in a sequential, multiple-assignment randomized trial to 38 clinics from 2 Wisconsin health systems. The study has 3 specific aims:

  1. Compare the effect over 18 months of (1). An adaptive systems consultation implementation strategy (intervention group) vs. (2). Academic detailing alone (control group) on average morphine milligram equivalent dose (the primary outcome).
  2. Develop an assessment of contextual factors that influence the effectiveness of different implementation strategies. This aim will test 4 moderators and assess other factors that affect implementation. The goal is to develop a tool that decision-makers can use to predict which implementation strategies will be most effective in different settings.
  3. Estimate the costs of delivering 4 different sequences and combinations of strategies, including the incremental cost effectiveness of adding facilitation and physician peer coaching. Results will help decision-makers weigh the costs and effects of using different implementation strategies.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Green Bay, Wisconsin, United States, 54305
        • Bellin Health Systems
      • Madison, Wisconsin, United States, 53792
        • UW Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Academic detailing only
Clinicians will attend an educational meeting and receive audit and feedback reports for 18 months.

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 18 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 travel to each clinics. 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.

Experimental: Academic detailing+practice facilitation

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 4-6, then quarterly for months 7-18.

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 18 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 travel to each clinics. 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.

Experimental: Academic detailing+practice facilitation+physician peer consul
Clinicians will receive academic detailing at month 0 and practice facilitation at month 3. At month 6, 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.

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 18 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 travel to each clinics. 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.

Experimental: Academic detailing+physician peer consulting

Clinicians of this group will attend an educational meeting and will receive a monthly audit and feedback report for 18 months.

At month 6, clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant.

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 18 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 travel to each clinics. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average morphine milligram equivalent (MME) of chronic opioid prescriptions of clinics
Time Frame: up to 30 months

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
Time Frame: up to 30 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients in a clinic who have chronic opioid prescriptions
Time Frame: up to 30 months
The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months. The number will be reported at the clinic level.
up to 30 months
Number of patients of a prescriber who have chronic opioid prescriptions
Time Frame: up to 30 months
The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months. The number will be reported at the prescriber level.
up to 30 months
Number of patients completing urine drug screens in the past 12 months
Time Frame: up to 30 months
Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have had a urine drug screen documented within the past 12 months.
up to 30 months
Number of patients completing screening for mental health and substance abuse within the past 12 months
Time Frame: up to 30 months

Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have a Patient Health Questionnaire (PHQ-9) documented within the past 12 months. The study team is not administering the screening tool, data will be provided by Wisconsin Collaborative for Healthcare Quality (WCHQ).

The PHQ-9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. It is the 9-question depression scale from the Patient Health Questionnaire. Total score can range from 1-27. Interpretation of total scores is as follows:

1-4=Minimal depression, 5-9=Mild depression, 10-14= Moderate depression, 15-19=Moderately severe depression, 20-27= Severe depression.

up to 30 months
Number of patients who are co-prescribed opioids and benzodiazepines
Time Frame: up to 30 months
Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who also have a concurrent benzodiazepine prescription.
up to 30 months
Average morphine milligram equivalent of patients who are co-prescribed opioids and benzodiazepines
Time Frame: up to 30 months
The average morphine milligram equivalent of patients who are prescribed at least 3 opioid orders in 3 consecutive months at the clinic level.
up to 30 months
Number of patients with treatment agreements within the past 12 months
Time Frame: up to 30 months
The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have documented treatment agreements within the past 12 months.
up to 30 months
Number of patients with a daily morphine milligram equivalent above 90 milligrams
Time Frame: up to 30 months
The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months and have a daily morphine milligram equivalent over 90 milligrams.
up to 30 months
Number of emergency room visits and hospitalizations per patient
Time Frame: up to 30 months
The number of hospital or emergency room visits per patient among patients who are prescribed at least 3 opioid orders in 3 consecutive months.
up to 30 months
Number of patients who attend their scheduled clinic visits
Time Frame: up to 30 months
The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who attend their scheduled clinic visits.
up to 30 months
Number of eligible clinics that participated
Time Frame: up to 30 months
The number of eligible clinics that participated in the study.
up to 30 months
Number of clinicians who participated in the study
Time Frame: up to 30 months
The number of eligible clinicians who participated in the study
up to 30 months
Number of clinicians who attended the intervention meetings
Time Frame: up to 30 months
The number of clinicians who attended the meeting for practice facilitation, physician peer consulting, and follow-up meetings.
up to 30 months
Average hours of intervention received per clinic
Time Frame: up to 30 months
The average time (in hours) of intervention that clinics received.
up to 30 months
Average hours of intervention received per prescriber
Time Frame: up to 30 months
The average time (in hours) of intervention that prescribers received.
up to 30 months
Number of adaptations made to the intervention during intervention period
Time Frame: up to 30 months
A list and count of adaptations that were made to the intervention during the intervention period will be documented.
up to 30 months
Cost of each study arm in US dollars
Time Frame: up to 30 months
The cost of each implementation sequence and combination in US dollars.
up to 30 months
Components of system-level opioid prescribing policy of the health systems
Time Frame: up to 30 months
A list and count of the components of the participating health systems' opioid prescribing policy.
up to 30 months
Quality improvement experience of the clinics
Time Frame: up to 30 months
A assessment tool is under development to capture the quality improvement experience level of clinics.
up to 30 months
Number of patients at clinics
Time Frame: up to 30 months
The total number of patients seen at clinics will be used to assess clinic size.
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrew Quanbeck, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-1276
  • A532007 (Other Identifier: UW Madison)
  • SMPH/FAMILY MED/RES GRANTS (Other Identifier: UW Madison)
  • R01DA047279 (U.S. NIH Grant/Contract)
  • Protocol Version 8/31/2020 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data collected during the trial, after deidentification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.

IPD Sharing Time Frame

Beginning 9 months after publication of primary outcomes, and ending 3 years following publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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