Clinical trial NCT04044521: Promoting Clinical Guidelines for Opioid Prescribing
Official title: Promoting the Implementation of Clinical Guidelines for Opioid Prescribing in Primary Care Using Systems Consultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: implementation
primary care
organizational change
Centers for Disease Control opioid prescribing guidelines
clinical guidelines
systems consultation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-08-05
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The intervention will assess outcomes at the clinic and prescriber level. Prescribers are the population of interest.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 21-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 21 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics
timeFrame: up to 30 months
measure: Average Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers
timeFrame: up to 30 months
Secondary outcomes:
measure: Number of Eligible Clinics That Participated
timeFrame: up to 30 months
measure: Number of Clinicians Who Participated in the Study
timeFrame: up to 30 months
measure: Number of Patients at Clinics
timeFrame: up to 30 months
measure: Number of Clinicians Who Attended the Intervention Meetings
timeFrame: up to 30 months
measure: Average Hours of Intervention Received Per Clinic
timeFrame: up to 30 months
measure: Average Hours of Intervention Received Per Prescriber
timeFrame: up to 30 months
measure: Estimated Cost of Each Study Arm in US Dollars
timeFrame: up to 30 months
Other outcomes:
measure: Quality Improvement Experience of the Clinics
timeFrame: up to 30 months
measure: Components of System-level Opioid Prescribing Policy of the Health Systems
timeFrame: up to 30 months
measure: Number of Adaptations Made to the Intervention During Intervention Period
timeFrame: up to 30 months
measure: Number of Patients of a Prescriber Who Have Chronic Opioid Prescriptions
timeFrame: up to 30 months
measure: Number of Patients Completing Urine Drug Screens in the Past 12 Months
timeFrame: up to 30 months
measure: Number of Patients Completing Screening for Mental Health and Substance Abuse Within the Past 12 Months
timeFrame: up to 30 months
measure: Number of Patients With Treatment Agreements Within the Past 12 Months
timeFrame: up to 30 months
measure: Number of Patients With a Daily Morphine Milligram Equivalent Above 90 Milligrams
timeFrame: up to 30 months
measure: Number of Patients Who Are Co-prescribed Opioids and Benzodiazepines
timeFrame: up to 30 months
measure: Number of Emergency Room Visits and Hospitalizations Per Patient
timeFrame: up to 30 months
measure: Number of Patients Who Attend Their Scheduled Clinic Visits
timeFrame: up to 30 months
measure: Total Number of Patients in a Clinic Who Have Chronic Opioid Prescriptions
timeFrame: up to 30 months
measure: Average Morphine Milligram Equivalent of Patients Who Are Co-prescribed Opioids and Benzodiazepines
timeFrame: up to 30 months
Locations:
city: Green Bay
country: United States
facility: Bellin Health Systems
state: Wisconsin
city: Madison
country: United States
facility: UW Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Andrew Quanbeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.