Implementing the COMFORT Guidelines for Postpartum Pain Management

Active, not recruiting

• Conditions: Opioid Stewardship; Postpartum Pain; Maternity Care; Obstetric Care
• Interventions: Behavioral: REP; Behavioral: Facillitation

• Registration Number: NCT06285123
• Lead Sponsor: University of Michigan

Brief Summary

A new national clinical practice guideline (CPG) for pain management after childbirth aims to mitigate peripartum opioid-related risks without compromising or exacerbating existing inequities in pain management in the United States. Standard dissemination approaches are often insufficient to change clinical practice-more active implementation efforts are generally required. Replicating Effective Programs (REP) is a theory-driven implementation intervention that is publicly available and highly scalable, but REP alone may be insufficient for effectively embedding the CPG across all maternity sites. For sites needing more support, REP can be augmented with facilitation (e.g., individualized consultation with site champions to overcome local barriers to CPG adoption, "Enhanced-REP" \[E-REP\]). Because E-REP is more expensive and difficult to scale than REP, it is essential to identify those settings where REP alone is effective versus those where REP may need augmentation, but this has not been evaluated in maternity contexts. Our objective is to determine the effect of a new postpartum pain management CPG, as implemented by REP and E-REP, on postpartum opioid prescribing (primary outcome: rate and amount of opioid prescribed within three days of childbirth), overall, by hospital, and among key subgroups.

This is a non-responder randomized trial within the Obstetrics Initiative (OBI), a perinatal collaborative quality initiative funded by Blue Cross Blue Shield of Michigan that includes 68 member hospitals serving more than 120,000 postpartum people over an approximately 15-month study time period. Hospitals not initially responding to REP (defined by performance below the top 15th percentile of all OBI hospitals for a) inpatient order for opioid-sparing postpartum pain management, \[e.g., scheduled acetaminophen and ibuprofen\], or b) amount of opioid prescribed at discharge, or c) provision of non-medication pain management interventions) will be allocated, via block randomization, to either continue REP vs. augment REP with facilitation (E-REP).

The primary analysis will evaluate the rate of postpartum opioid-sparing prescribing metrics at the time of discharge (primary outcome) and opioid prescription refills and high-risk prescribing (secondary outcomes) before and after CPG implementation with REP, using interrupted time series analyses. Inequities in outcomes by patient, procedure, prescriber, and hospital factors will be evaluated. Exploratory analyses will examine temporal trends in patient-reported outcomes. The effects of continued REP vs. E-REP among non-responder sites will also be examined. Finally, implementation outcomes will be characterized using clinician and patient surveys and qualitative methods.

Detailed Description

This record is for one observational study with two unique institutional identifiers (HUM00248235 and HUM00248331). Because outcome measure 6 met a different exemption criteria than the other outcome measures, the IRB issued two unique identifiers, although both identifiers are for the same study. To avoid creating duplicate records, and to accurately represent this as a single study, only one record was registered in the ClinicalTrials.gov system.

Study Timeline

• Study Start: 2024-01-26
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-02-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-07
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

-All hospitals fully participating in the Obstetrics Initiative (OBI), a Blue Cross Blue Shield of Michigan (BCBSM)-funded collaborative of Michigan hospitals dedicated to maternity care quality improvement.

Exclusion Criteria

-Hospitals partially participating or not participating in OBI.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Responders REP/Facillitation	REP	-
Responders	REP	-
Non-Responders REP/Facillitation	Facillitation	-
Non-Responders REP	REP	-

Primary Outcome Measures

Name	Time	Method
Postpartum opioid prescribing - Rate	18 months	Rate of opioid prescribing within three days of discharge from the childbirth hospitalization
Postpartum opioid prescribing - Amount	18 months	Amount of opioid prescribed (oral morphine equivalent) within three days of discharge from the childbirth hospitalization

Secondary Outcome Measures

Name	Time	Method
High-risk opioid prescribing	18 months	Prescription \>50 oral morphine equivalents, overlapping opioid/benzodiazepine prescribing, and overlapping opioid prescriptions, all in the 30 days after discharge from the childbirth hospitalization
Refill opioid prescribing	18 months	Rate of refill opioid prescriptions in the 30 days after discharge from the childbirth hospitalization

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States