Clinical trial NCT06285123: Implementing the COMFORT Guidelines for Postpartum Pain Management
Official title: Implementing the COMFORT Guidelines for Postpartum Pain Management: a Statewide Quality Improvement Project in the Obstetrics Initiative
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Postpartum Pain
Opioid Stewardship
Maternity Care
Obstetric Care
Keywords: Quality Improvement
Clinical Practice Guidelines
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2024-02-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postpartum opioid prescribing - Rate
timeFrame: 18 months
measure: Postpartum opioid prescribing - Amount
timeFrame: 18 months
Secondary outcomes:
measure: Refill opioid prescribing
timeFrame: 18 months
measure: High-risk opioid prescribing
timeFrame: 18 months
Other outcomes:
measure: Patient-reported outcomes
timeFrame: 21 months
measure: Implementation outcomes - reach
timeFrame: 21 months
measure: Implementation outcomes - adoption
timeFrame: 21 months
measure: Implementation outcomes - feasibility
timeFrame: 21 months
measure: Implementation outcomes - acceptability
timeFrame: 21 months
measure: Implementation outcomes - appropriateness
timeFrame: 21 months
measure: Implementation outcomes - fidelity
timeFrame: 21 months
measure: Implementation outcomes - potential mechanisms of implementation
timeFrame: 21 months
measure: Implementation outcomes - costs of delivering implementation
timeFrame: 21 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: