Implementing the COMFORT Guidelines for Postpartum Pain Management

Postpartum Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06285123
• Other study ID #: HUM00248235 and HUM00248331
• Secondary ID: 1U01FD007803-01
• Status: Active, not recruiting
• Start date: January 26, 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: April 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postpartum Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Implementation outcomes - reach	Characteristics of patients receiving guideline-concordant care vs. all patients	21 months
Other	Implementation outcomes - adoption	Characteristics of responding hospitals and providers vs. all hospitals and providers	21 months
Other	Implementation outcomes - feasibility	Provider perceptions of implementation intervention feasibility, as assessed by surveys and/or qualitative methods	21 months
Other	Implementation outcomes - acceptability	Provider perceptions of implementation intervention acceptability, as assessed by surveys and/or qualitative methods	21 months
Other	Implementation outcomes - appropriateness	Provider perceptions of implementation intervention appropriateness, as assessed by surveys and/or qualitative methods	21 months
Other	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
Other	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
Other	Implementation outcomes - costs of delivering implementation	Coordinating Center costs for offering implementation support	21 months
Primary	Postpartum opioid prescribing - Rate	Rate of opioid prescribing within three days of discharge from the childbirth hospitalization	18 months
Primary	Postpartum opioid prescribing - Amount	Amount of opioid prescribed (oral morphine equivalent) within three days of discharge from the childbirth hospitalization	18 months
Secondary	Refill opioid prescribing	Rate of refill opioid prescriptions in the 30 days after discharge from the childbirth hospitalization	18 months
Secondary	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