NDLI: Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design

Content Provider	Springer Nature : BioMed Central
Author	Leeman, Jennifer Rohweder, Catherine L. Lin, Feng-Chang Lightfoot, Alexandra F. Costello, Jennifer Medearis Farahi, Narges Harper, Kimberly Quist-Nelson, Johanna Teal, E. Nicole Vu, Maihan B. Wheeler, Sarahn Menard, M. Kathryn
Abstract	Background Hypertensive disorders of pregnancy are among the leading causes of maternal mortality and morbidity in the U.S., with rates highest among birthing people who are Black, rural residents, and/or have low-income. Severe hypertension, in particular, increases risk of stroke and other serious pregnancy complications. To promote early detection and treatment of severe hypertension, the Alliance for Innovation on Maternal Health developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN Bundle). Multiple studies have demonstrated the HTN Bundle’s effectiveness in the inpatient setting. With funding from the National Heart, Lung, and Blood Institute, we engaged community partners to adapt the HTN Bundle for the outpatient setting (i.e., O-HTN Bundle) and planned for its implementation. In this paper, we describe the protocol for a study evaluating O-HTN Bundle implementation in 20 outpatient clinics serving Black, rural, and/or low-income populations. Methods This study is a hybrid type 3 effectiveness-implementation trial with a multiple baseline design. We will implement the O-HTN Bundle in three successive cohorts of clinics using a multicomponent implementation strategy to engage community partners (coalition, patient workgroup) and support clinics (training, facilitation, education materials, and simulations of severe hypertension events). To test the strategy, we will compare clinic fidelity to evidence-based guidelines for (a) patient education on hypertension and (b) blood pressure measurement technique, with repeated measures occurring before and after strategy receipt. We will also observe strategy effects on community- and clinic-level intermediate outcomes (community engagement, organizational readiness), implementation outcomes (reach, adoption, fidelity, maintenance), and effectiveness outcomes (receipt of guideline concordant care). Analyses will address whether outcomes are equitable across Black, rural, and/or low-income subgroups. Guided by the Consolidated Framework for Implementation Research 2.0, we will use mixed methods to identify adaptations and other determinants of implementation success. Discussion This study integrates community engagement and implementation science to promote equitable and timely response to severe HTN in the outpatient setting during pregnancy and postpartum. This is one of the first studies to implement an outpatient HTN Bundle and to use simulation as a strategy to reinforce team-based delivery of guideline concordant care. Trial registration This study was registered with ClinicalTrials.gov as “Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle (AC3HIEVE).” Registration number NCT06002165, August 21, 2023: https://clinicaltrials.gov/study/NCT06002165 .
Related Links	https://bmchealthservres.biomedcentral.com/counter/pdf/10.1186/s12913-024-11579-8.pdf
Ending Page	13
Page Count	13
Starting Page	1
File Format	HTM / HTML
ISSN	14726963
DOI	10.1186/s12913-024-11579-8
Journal	BMC Health Services Research
Issue Number	1
Volume Number	24
Language	English
Publisher	BioMed Central
Publisher Date	2024-09-30
Access Restriction	Open
Subject Keyword	Public Health Health Administration Health Informatics Nursing Research Maternal health Maternal Mortality Maternal Morbidity Preeclampsia Pregnancy-related Hypertension Implementation Science Community Engagement Health Equity Pragmatic Clinical Trial Simulation
Content Type	Text
Resource Type	Article
Subject	Health Policy

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Understanding barriers and facilitators to implementation of a patient safety bundle for pregnancy-related severe hypertension in 3 North Carolina outpatient clinics: a qualitative study

IM4Equity: an implementation science meta-framework for community-engaged partnerships to advance health equity

Wireless versus routine physiologic monitoring after cesarean delivery to reduce maternal morbidity and mortality in a resource-limited setting: protocol of type 2 hybrid effectiveness-implementation study

Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS)

Invited commentary invited commentary: identifying women with hypertension during pregnancy—is high specificity sufficient? (2006).

A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities in 12 Michigan counties: rationale and study protocol

Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting

Hypertension in Pregnancy Still Remains a Serious Complication Causing Severe Morbidity and Mortality of Mother

Study protocol for the randomized controlled EVA (early vascular adjustments) trial: tailored treatment of mild hypertension in pregnancy to prevent severe hypertension and preeclampsia

Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design

Similar Documents

Understanding barriers and facilitators to implementation of a patient safety bundle for pregnancy-related severe hypertension in 3 North Carolina outpatient clinics: a qualitative study

IM4Equity: an implementation science meta-framework for community-engaged partnerships to advance health equity

Wireless versus routine physiologic monitoring after cesarean delivery to reduce maternal morbidity and mortality in a resource-limited setting: protocol of type 2 hybrid effectiveness-implementation study

Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS)

Invited commentary invited commentary: identifying women with hypertension during pregnancy—is high specificity sufficient? (2006).

A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities in 12 Michigan counties: rationale and study protocol

Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting

Hypertension in Pregnancy Still Remains a Serious Complication Causing Severe Morbidity and Mortality of Mother

Study protocol for the randomized controlled EVA (early vascular adjustments) trial: tailored treatment of mild hypertension in pregnancy to prevent severe hypertension and preeclampsia

Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design