N/A N=268 Randomized Health Services Research

Promoting Clinical Guidelines for Opioid Prescribing

Opioid Use

Bottom Line

View on ClinicalTrials.gov: NCT04044521 ↗

Enrolled (actual)

268

Serious AEs

—

Results posted

Jun 2024

Primary outcome: Primary: Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics — 320.69; 372.33; 275.55; 455.62 average MME/day

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Systems consultation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics	320.69; 372.33; 275.55; 455.62	—
PRIMARY Average Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers	39.65; 45.00; 36.63; 48.98	—
SECONDARY Number of Eligible Clinics That Participated	8; 7; 8; 8	—
SECONDARY Number of Clinicians Who Participated in the Study	65; 60; 66; 77	—
SECONDARY Number of Patients at Clinics	2486; 2427; 2044; 2021	—
SECONDARY Number of Clinicians Who Attended the Intervention Meetings	6.118461538; 6.741935484; 6.228070175; 6.15	—
SECONDARY Average Hours of Intervention Received Per Clinic	12.5; 4.571428571; 14.875; 6.125	—
SECONDARY Average Hours of Intervention Received Per Prescriber	12.5; 4.571428571; 14.875; 6.125	—
SECONDARY Estimated Cost of Each Study Arm in US Dollars	7933.2; 2307.84; 9015; 4399.32	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04044521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.