Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation study

BackgroundOur objective is to determine the effect of a new national clinical practice guideline (CPG) for pain management after childbirth, as implemented with less vs. more intensive implementation support, on postpartum opioid prescribing.MethodsA quasi-experimental analysis will measure the impa...

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Main Authors: Michelle H. Moniz, Amy M. Kilbourne, Alex F. Peahl, Jennifer F. Waljee, Shelytia Cocroft, Carey Simpson, Lisa Kane Low, Mark C. Bicket, Michael J. Englesbe, Molly J. Stout, Vidhya Gunaseelan, Althea Bourdeau, May Hu, Carrie Miller, Shawna N. Smith
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-03-01
Series:Frontiers in Global Women's Health
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Online Access:https://www.frontiersin.org/articles/10.3389/fgwh.2025.1504511/full
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author Michelle H. Moniz
Michelle H. Moniz
Michelle H. Moniz
Amy M. Kilbourne
Amy M. Kilbourne
Alex F. Peahl
Alex F. Peahl
Alex F. Peahl
Jennifer F. Waljee
Jennifer F. Waljee
Jennifer F. Waljee
Shelytia Cocroft
Carey Simpson
Carey Simpson
Lisa Kane Low
Lisa Kane Low
Lisa Kane Low
Mark C. Bicket
Mark C. Bicket
Mark C. Bicket
Michael J. Englesbe
Michael J. Englesbe
Michael J. Englesbe
Molly J. Stout
Molly J. Stout
Vidhya Gunaseelan
Vidhya Gunaseelan
Althea Bourdeau
Althea Bourdeau
May Hu
Carrie Miller
Carrie Miller
Shawna N. Smith
Shawna N. Smith
Shawna N. Smith
author_facet Michelle H. Moniz
Michelle H. Moniz
Michelle H. Moniz
Amy M. Kilbourne
Amy M. Kilbourne
Alex F. Peahl
Alex F. Peahl
Alex F. Peahl
Jennifer F. Waljee
Jennifer F. Waljee
Jennifer F. Waljee
Shelytia Cocroft
Carey Simpson
Carey Simpson
Lisa Kane Low
Lisa Kane Low
Lisa Kane Low
Mark C. Bicket
Mark C. Bicket
Mark C. Bicket
Michael J. Englesbe
Michael J. Englesbe
Michael J. Englesbe
Molly J. Stout
Molly J. Stout
Vidhya Gunaseelan
Vidhya Gunaseelan
Althea Bourdeau
Althea Bourdeau
May Hu
Carrie Miller
Carrie Miller
Shawna N. Smith
Shawna N. Smith
Shawna N. Smith
author_sort Michelle H. Moniz
collection DOAJ
description BackgroundOur objective is to determine the effect of a new national clinical practice guideline (CPG) for pain management after childbirth, as implemented with less vs. more intensive implementation support, on postpartum opioid prescribing.MethodsA quasi-experimental analysis will measure the impact of post-childbirth pain management guidelines on opioid prescribing in a statewide hospital collaborative, overall and among key patient subgroups at risk for inequitable care and outcomes. We will also use a randomized, non-responder design and mixed-methods approaches to evaluate the effects of Replicating Effective Programs (REP), a theory-driven, scalable implementation intervention, and Enhanced REP (E-REP; i.e., REP augmented with facilitation, which is individualized consultation with site champions to overcome local barriers) on the uptake of the CPG. The study will include hospitals 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 approximately 15 months. Hospitals not initially responding to REP—defined by performance <15th percentile of all OBI hospitals for (a) inpatient order for opioid-sparing postpartum pain management (e.g., scheduled acetaminophen and non-steroidal anti-inflammatory drugs when not contraindicated), or (b) amount of opioid prescribed at discharge—will be allocated via block randomization to continue REP or to E-REP. Using interrupted time series analyses, 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. We will evaluate inequities in outcomes by patient, procedure, prescriber, and hospital factors. Exploratory analyses will examine temporal trends in patient-reported outcomes and the effects of continued REP vs. E-REP among slower-responder sites. We will evaluate implementation outcomes (e.g., acceptability, feasibility, costs, needed REP and E-REP adaptations) using clinician and patient surveys and qualitative methods (ClinicalTrials.gov identifier: NCT06285123).DiscussionFindings will inform refinements to the REP and E-REP interventions and add to the literature on the effectiveness of facilitation to promote uptake of evidence-based clinical practices in maternity care.
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spelling doaj-art-53ccfc2ed9154519b67f2f7fd5130fbd2025-08-20T02:56:58ZengFrontiers Media S.A.Frontiers in Global Women's Health2673-50592025-03-01610.3389/fgwh.2025.15045111504511Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation studyMichelle H. Moniz0Michelle H. Moniz1Michelle H. Moniz2Amy M. Kilbourne3Amy M. Kilbourne4Alex F. Peahl5Alex F. Peahl6Alex F. Peahl7Jennifer F. Waljee8Jennifer F. Waljee9Jennifer F. Waljee10Shelytia Cocroft11Carey Simpson12Carey Simpson13Lisa Kane Low14Lisa Kane Low15Lisa Kane Low16Mark C. Bicket17Mark C. Bicket18Mark C. Bicket19Michael J. Englesbe20Michael J. Englesbe21Michael J. Englesbe22Molly J. Stout23Molly J. Stout24Vidhya Gunaseelan25Vidhya Gunaseelan26Althea Bourdeau27Althea Bourdeau28May Hu29Carrie Miller30Carrie Miller31Shawna N. Smith32Shawna N. Smith33Shawna N. Smith34Department of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor, MI, United StatesInstitute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, United StatesObstetrics Initiative, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United StatesOffice of Research and Development, Veterans Health Administration, U.S. Department of Veterans Affairs, Washington, DC, United StatesDepartment of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, United StatesDepartment of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor, MI, United StatesInstitute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, United StatesObstetrics Initiative, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United StatesInstitute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, United StatesDepartment of Surgery, University of Michigan Medical School, Ann Arbor, MI, United StatesOpioid Prescribing Engagement Network, Ann Arbor, MI, United StatesCenter for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United StatesObstetrics Initiative, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United StatesDepartment of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, United StatesDepartment of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor, MI, United StatesObstetrics Initiative, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United StatesSchool of Nursing, University of Michigan, Ann Arbor, MI, United StatesInstitute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, United StatesOpioid Prescribing Engagement Network, Ann Arbor, MI, United States0Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, United StatesInstitute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, United StatesDepartment of Surgery, University of Michigan Medical School, Ann Arbor, MI, United StatesCenter for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United StatesDepartment of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor, MI, United StatesObstetrics Initiative, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United StatesOpioid Prescribing Engagement Network, Ann Arbor, MI, United States0Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, United StatesDepartment of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor, MI, United StatesObstetrics Initiative, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United States1Department of Plastic Surgery, University of Michigan Medical School, Ann Arbor, MI, United StatesDepartment of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor, MI, United StatesObstetrics Initiative, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United StatesInstitute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, United States2Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States3Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI, United StatesBackgroundOur objective is to determine the effect of a new national clinical practice guideline (CPG) for pain management after childbirth, as implemented with less vs. more intensive implementation support, on postpartum opioid prescribing.MethodsA quasi-experimental analysis will measure the impact of post-childbirth pain management guidelines on opioid prescribing in a statewide hospital collaborative, overall and among key patient subgroups at risk for inequitable care and outcomes. We will also use a randomized, non-responder design and mixed-methods approaches to evaluate the effects of Replicating Effective Programs (REP), a theory-driven, scalable implementation intervention, and Enhanced REP (E-REP; i.e., REP augmented with facilitation, which is individualized consultation with site champions to overcome local barriers) on the uptake of the CPG. The study will include hospitals 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 approximately 15 months. Hospitals not initially responding to REP—defined by performance <15th percentile of all OBI hospitals for (a) inpatient order for opioid-sparing postpartum pain management (e.g., scheduled acetaminophen and non-steroidal anti-inflammatory drugs when not contraindicated), or (b) amount of opioid prescribed at discharge—will be allocated via block randomization to continue REP or to E-REP. Using interrupted time series analyses, 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. We will evaluate inequities in outcomes by patient, procedure, prescriber, and hospital factors. Exploratory analyses will examine temporal trends in patient-reported outcomes and the effects of continued REP vs. E-REP among slower-responder sites. We will evaluate implementation outcomes (e.g., acceptability, feasibility, costs, needed REP and E-REP adaptations) using clinician and patient surveys and qualitative methods (ClinicalTrials.gov identifier: NCT06285123).DiscussionFindings will inform refinements to the REP and E-REP interventions and add to the literature on the effectiveness of facilitation to promote uptake of evidence-based clinical practices in maternity care.https://www.frontiersin.org/articles/10.3389/fgwh.2025.1504511/fullacute painopioidpostpartumimplementationguideline
spellingShingle Michelle H. Moniz
Michelle H. Moniz
Michelle H. Moniz
Amy M. Kilbourne
Amy M. Kilbourne
Alex F. Peahl
Alex F. Peahl
Alex F. Peahl
Jennifer F. Waljee
Jennifer F. Waljee
Jennifer F. Waljee
Shelytia Cocroft
Carey Simpson
Carey Simpson
Lisa Kane Low
Lisa Kane Low
Lisa Kane Low
Mark C. Bicket
Mark C. Bicket
Mark C. Bicket
Michael J. Englesbe
Michael J. Englesbe
Michael J. Englesbe
Molly J. Stout
Molly J. Stout
Vidhya Gunaseelan
Vidhya Gunaseelan
Althea Bourdeau
Althea Bourdeau
May Hu
Carrie Miller
Carrie Miller
Shawna N. Smith
Shawna N. Smith
Shawna N. Smith
Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation study
Frontiers in Global Women's Health
acute pain
opioid
postpartum
implementation
guideline
title Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation study
title_full Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation study
title_fullStr Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation study
title_full_unstemmed Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation study
title_short Can theory-driven implementation interventions help clinician champions promote opioid stewardship after childbirth? Protocol for a pragmatic implementation study
title_sort can theory driven implementation interventions help clinician champions promote opioid stewardship after childbirth protocol for a pragmatic implementation study
topic acute pain
opioid
postpartum
implementation
guideline
url https://www.frontiersin.org/articles/10.3389/fgwh.2025.1504511/full
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