Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285123
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-01
Brief Title:
Implementing the COMFORT Guidelines for Postpartum Pain Management
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Implementing the COMFORT Guidelines for Postpartum Pain Management A Statewide Quality Improvement Project in the Obstetrics Initiative
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 120000 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 eg 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
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 120000 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 eg 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 ClinicalTrialsgov system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01FD007803-01 | FDA | None | httpsreporternihgovquickSearch1U01FD007803-01 |