Implementing the COMFORT Guidelines for Postpartum Pain Management

NCT06285123 | Completed

• 2 other identifiers: HUM00248235 and HUM002483311U01FD007803-01
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Pain; Opioid Stewardship; Maternity Care; Obstetric Care

Keywords

Quality Improvement; Clinical Practice Guidelines

Outcome Measures

Primary Outcomes (2)

• Postpartum opioid prescribing - Rate

  Rate of opioid prescribing within three days of discharge from the childbirth hospitalization

  18 months

• Postpartum opioid prescribing - Amount

  Amount of opioid prescribed (oral morphine equivalent) within three days of discharge from the childbirth hospitalization

  18 months

Secondary Outcomes (2)

• Refill opioid prescribing

  18 months

• High-risk opioid prescribing

  18 months

Other Outcomes (9)

• Patient-reported outcomes

  21 months

• Implementation outcomes - reach

  21 months

• Implementation outcomes - adoption

  21 months

Study Arms (3)

Responders

Behavioral: REP

Non-Responders REP

Behavioral: REP

Non-Responders REP/Facilitation

Behavioral: REP; Behavioral: Facilitation

Interventions

REP BEHAVIORAL

REP is a bundle of strategies designed to help hospitals implement an evidence-based clinical practice. REP's core components include 1) user-friendly "packaging" of the clinical guidance, 2) structured clinician training, 3) performance feedback, and 4) brief technical assistance.

Non-Responders REP; Non-Responders REP/Facilitation; Responders

Facilitation BEHAVIORAL

Facilitation is a process of interactive problem-solving via a supportive consultation relationship. Facilitation is delivered by an expert who meets regularly with site quality improvement leaders to support interactive problem-solving to address local barriers and unanticipated implementation challenges. In contrast to the group-based, brief technical assistance in REP, facilitation is individualized consultation with the site clinical champion that generates highly customized, local solutions that can potentially be sustained by the local providers and champions.

Non-Responders REP/Facilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This quality project will occur within the Obstetrics Initiative (OBI), a Blue Cross Blue Shield of Michigan (BCBSM)-funded collaborative of 68 Michigan hospitals dedicated to maternity care quality improvement. OBI's member hospitals constitute diverse maternity practice settings, ranging from urban to rural, academic to community, and high to low volume maternity units. OBI's quality initiative, "Bringing Our Patients COMFORT," will promote adoption of the COMFORT CPG across member hospitals. To the degree that OBI clinical champions share OBI initiative QI resources on their units, maternity clinicians staffing OBI hospitals will be exposed to these activities. To the degree that OBI hospitals adopt the COMFORT CPG, birthing populations at these sites will be exposed to guideline-concordant care.

You may qualify if:

• 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.

You may not qualify if:

• Hospitals partially participating or not participating in OBI.

Sponsors & Collaborators

• University of Michigan: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Moniz MH, Kilbourne AM, Peahl AF, Waljee JF, Cocroft S, Simpson C, Kane Low L, Bicket MC, Englesbe MJ, Stout MJ, Gunaseelan V, Bourdeau A, Hu M, Miller C, Smith SN. Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation study. Front Glob Womens Health. 2025 Mar 14;6:1504511. doi: 10.3389/fgwh.2025.1504511. eCollection 2025.

  PMID: 40160195 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 29, 2024
• Study Start: January 26, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)