Postpartum PainNCT06285123
Implementing the COMFORT Guidelines for Postpartum Pain Management
An observational study of Postpartum Pain and Opioid Stewardship, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postpartum Pain, Opioid Stewardship, Maternity Care
- What is being tested?
- REP and Facilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- -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.
Who cannot join
- -Hospitals partially participating or not participating in OBI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Pain, Opioid Stewardship, Maternity Care, Obstetric Care
- Being tested
- REP, Facilitation
- Keywords
- Quality Improvement, Clinical Practice Guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REPBehavioural
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.
FacilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Responders | Not described Receives: Behavioral: REP | |
| Non-Responders REP | Not described Receives: Behavioral: REP | |
| Non-Responders REP/Facilitation | Not described Receives: Behavioral: REP; Behavioral: Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum opioid prescribing - Rate
Rate of opioid prescribing within three days of discharge from the childbirth hospitalization
Measured: 18 months
Postpartum opioid prescribing - Amount
Amount of opioid prescribed (oral morphine equivalent) within three days of discharge from the childbirth hospitalization
Measured: 18 months
Secondary outcomes (2)
Refill opioid prescribing
Rate of refill opioid prescriptions in the 30 days after discharge from the childbirth hospitalization
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start26 Jan 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Michelle H. Moniz, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285123
- Sponsor's protocol ID
- HUM00248235 and HUM00248331
- Other IDs
- 1U01FD007803-01
- Status last verified
- Oct 2025
- First submitted
- 1 Feb 2024
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40160195
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the COMFORT Guidelines for Postpartum Pain Management: A Statewide Quality Improvement Project in the Obstetrics Initiative
- ClinicalTrials.gov ID
- NCT06285123
- Acronym / sponsor ID
- HUM00248235 and HUM00248331
- Conditions
- Postpartum Pain, Opioid Stewardship, Maternity Care, Obstetric Care
- Keywords
- Quality Improvement, Clinical Practice Guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Responders | – | Behavioral: REP |
| Non-Responders REP | – | Behavioral: REP |
| Non-Responders REP/Facilitation | – | Behavioral: REP, Behavioral: Facilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (1 listed)
- -Hospitals partially participating or not participating in OBI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REPREP 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. | Behavioural | Non-Responders REP, Non-Responders REP/Facilitation, Responders |
| FacilitationFacilitation 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. | Behavioural | Non-Responders REP/Facilitation |
Primary outcome
Postpartum opioid prescribing - Rate
Time frame: 18 months
Rate of opioid prescribing within three days of discharge from the childbirth hospitalization
Postpartum opioid prescribing - Amount
Time frame: 18 months
Amount of opioid prescribed (oral morphine equivalent) within three days of discharge from the childbirth hospitalization
2 secondary outcomes
Refill opioid prescribing
Time frame: 18 months
High-risk opioid prescribing
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Derived from this study: PubMed 40160195Moniz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Pain and Opioid Stewardship, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum opioid prescribing - Rate (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06285123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.