NCT04044521

Promoting Clinical Guidelines for Opioid Prescribing

Completed NA Results posted Last updated 17 June 2024

What this trial tests

NA trial testing Systems consultation in Opioid Use in 268 participants. Completed in 1 September 2022.

Timeline

31 January 2020

Primary endpoint
1 September 2022

1 September 2022

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	health services research
Enrollment	268
Start date	31 January 2020
Primary completion	1 September 2022
Estimated completion	1 September 2022
Sites	2 locations across United States

Drugs / interventions tested

• Systems consultation

Conditions studied

• Opioid Use — all drugs for Opioid Use →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics Primary · 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).

Group	Value	95% CI
Academic Detailing+Practice Facilitation	320.69	± 11.80
Academic Detailing Only	372.33	± 20.04
Academic Detailing+Practice Facilitation+Physician Peer Consul	275.55	± 16.78
Academic Detailing+Physician Peer Consulting	455.62	± 19.59

Average Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers Primary · 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.

Group	Value	95% CI
Academic Detailing+Practice Facilitation	39.65	± 17.24
Academic Detailing Only	45.00	± 22.46
Academic Detailing+Practice Facilitation+Physician Peer Consul	36.63	± 15.77
Academic Detailing+Physician Peer Consulting	48.98	± 20.15

Number of Eligible Clinics That Participated Secondary · up to 30 months

The number of eligible clinics that participated in the study.

Group	Value	95% CI
Academic Detailing+Practice Facilitation	8
Academic Detailing Only	7
Academic Detailing+Practice Facilitation+Physician Peer Consul	8
Academic Detailing+Physician Peer Consulting	8

Number of Clinicians Who Participated in the Study Secondary · up to 30 months

The number of eligible clinicians who participated in the study

Group	Value	95% CI
Academic Detailing+Practice Facilitation	65
Academic Detailing Only	60
Academic Detailing+Practice Facilitation+Physician Peer Consul	66
Academic Detailing+Physician Peer Consulting	77

Number of Patients at Clinics Secondary · up to 30 months

The total number of patients seen at clinics will be used to assess clinic size.

Group	Value	95% CI
Academic Detailing+Practice Facilitation	2486
Academic Detailing Only	2427
Academic Detailing+Practice Facilitation+Physician Peer Consul	2044
Academic Detailing+Physician Peer Consulting	2021

Number of Clinicians Who Attended the Intervention Meetings Secondary · up to 30 months

The number of clinicians who attended the meeting for practice facilitation, physician peer consulting, and follow-up meetings.

Group	Value	95% CI
Academic Detailing+Practice Facilitation	6.118461538	± 11.36059744
Academic Detailing Only	6.741935484	± 18.26451613
Academic Detailing+Practice Facilitation+Physician Peer Consul	6.228070175	± 22.34556254
Academic Detailing+Physician Peer Consulting	6.15	± 28.32195122

Average Hours of Intervention Received Per Clinic Secondary · up to 30 months

The average time (in hours) of intervention that clinics received.

Group	Value	95% CI
Academic Detailing+Practice Facilitation	12.5	± 17.5
Academic Detailing Only	4.571428571	± 1.673469388
Academic Detailing+Practice Facilitation+Physician Peer Consul	14.875	± 31.609375
Academic Detailing+Physician Peer Consulting	6.125	± 9.609375

Average Hours of Intervention Received Per Prescriber Secondary · up to 30 months

The average time (in hours) of intervention that prescribers received. The average time the prescriber received the intervention (in hours) is the same amount of time as the average intervention time that each clinic receives, because our intervention is at the clinic level.

Group	Value	95% CI
Academic Detailing+Practice Facilitation	12.5	± 17.5
Academic Detailing Only	4.571428571	± 1.673469388
Academic Detailing+Practice Facilitation+Physician Peer Consul	14.875	± 31.609375
Academic Detailing+Physician Peer Consulting	6.125	± 9.609375

Estimated Cost of Each Study Arm in US Dollars Secondary · up to 30 months

The estimated cost of each implementation sequence and combination in US dollars. The result is derived from the number of intervention hours calculated for each arm, multiplied by the average salary of the staff who gave the intervention (e.g., the facilitators, providers, and IT coordinator), referenced from publicly reported data (Medscape Family Medicine Physician Compensation Report).

Group	Value	95% CI
Academic Detailing+Practice Facilitation	7933.2
Academic Detailing Only	2307.84
Academic Detailing+Practice Facilitation+Physician Peer Consul	9015
Academic Detailing+Physician Peer Consulting	4399.32

Total Number of Patients in a Clinic Who Have Chronic Opioid Prescriptions Secondary · up to 30 months

The total number of patients who are prescribed at least 3 opioid orders in 3 consecutive months. The number will be reported at the clinic level.

Group	Value	95% CI
Academic Detailing+Practice Facilitation	985
Academic Detailing Only	1175
Academic Detailing+Practice Facilitation+Physician Peer Consul	681
Academic Detailing+Physician Peer Consulting	925

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Quanbeck A, Almirall D, Jacobson N, Brown RT, et al · · 2020 · cited 20× · PMID 32334632 · DOI 10.1186/s13012-020-00990-4
2. Strategies to Deimplement Opioid Prescribing in Primary Care: A Cluster Randomized Clinical Trial.
   Quanbeck A, Robinson J, Jacobson N, Li X, et al · · 2024 · cited 7× · PMID 39388183 · DOI 10.1001/jamanetworkopen.2024.38325
3. Budget Impact Analysis of the Balanced Opioid Initiative: A Cluster Randomized Trial Aimed at Deprescribing Opioids for Chronic Pain in Primary Care Settings.
   Quanbeck A, Li X, Cohen A, Butzine E, et al · · 2026 · PMID 41587849 · DOI 10.1370/afm.250171
4. Using the Framework for Reporting Adaptations and Modifications to Evidence-Based Implementation Strategies (FRAME-IS) to Document Modifications to a Multilevel Deimplementation Strategy Aimed at Reducing Opioid Prescribing for Chronic Pain.
   Garza RH, Jacobson N, Cohen A, Landeck J, et al · · 2026 · PMID 41509130 · DOI 10.1177/26334895251407338
5. Adoption of opioid-prescribing guidelines in primary care: a realist synthesis of contextual factors
   Jacobson N, Johnson R, Schlabach C, Incha J, et al · · 2021