Implementing the COMFORT Guidelines for Postpartum Pain Management

Implementing the COMFORT Guidelines for Postpartum Pain Management: A Statewide Quality Improvement Project in the Obstetrics Initiative

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postpartum Pain; Opioid Stewardship; Maternity Care; Obstetric Care
• Intervention / Treatment: Behavioral: REP; Behavioral: Facillitation

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 Type: Observational
• Enrollment (Estimated): 68

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Responders	Behavioral: REP; 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	Behavioral: REP; 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/Facillitation	Behavioral: REP; 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.; Behavioral: Facillitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcomes	Pain intensity in the first week after childbirth, opioid consumption in the first week after discharge from the childbirth hospitalization, and satisfaction with pain management after discharge from the childbirth hospitalization	21 months
Implementation outcomes - reach	Characteristics of patients receiving guideline-concordant care vs. all patients	21 months
Implementation outcomes - adoption	Characteristics of responding hospitals and providers vs. all hospitals and providers	21 months
Implementation outcomes - feasibility	Provider perceptions of implementation intervention feasibility, as assessed by surveys and/or qualitative methods	21 months
Implementation outcomes - acceptability	Provider perceptions of implementation intervention acceptability, as assessed by surveys and/or qualitative methods	21 months
Implementation outcomes - appropriateness	Provider perceptions of implementation intervention appropriateness, as assessed by surveys and/or qualitative methods	21 months
Implementation outcomes - fidelity	Fidelity to assigned intervention, as measured via Coordinating Center administrative records (e.g., website downloads, training attendance, coaching call attendance)	21 months
Implementation outcomes - potential mechanisms of implementation	Qualitatively assessed indicators of potential mechanisms of effect, factors affecting implementation, and local adaptations to the guideline	21 months
Implementation outcomes - costs of delivering implementation	Coordinating Center costs for offering implementation support	21 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Food and Drug Administration (FDA)

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Quality Improvement; Clinical Practice Guidelines
• Other Study ID Numbers: HUM00248235 and HUM00248331; 1U01FD007803-01 (U.S. FDA Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No