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Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. When PPH occurs, early identification of bleeding and prompt management using evidence-based guidelines, can avert most PPH-related severe morbidities and deaths. However, adherence to the World Health Organiza...

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Autores principales: Bohren, Meghan A., Lorencatto, Fabiana, Coomarasamy, Arri, Althabe, Fernando, Devall, Adam J., Evans, Cherrie, Oladapo, Olufemi T., Lissauer, David, Akter, Shahinoor, Forbes, Gillian, Thomas, Eleanor, Galadanci, Hadiza, Qureshi, Zahida, Fawcus, Sue, Hofmeyr, G. Justus, Al-beity, Fadhlun Alwy, Kasturiratne, Anuradhani, Kumarendran, Balachandran, Mammoliti, Kristie-Marie, Vogel, Joshua P., Gallos, Ioannis, Miller, Suellen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8278177/
https://www.ncbi.nlm.nih.gov/pubmed/34261508
http://dx.doi.org/10.1186/s12978-021-01162-3
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author Bohren, Meghan A.
Lorencatto, Fabiana
Coomarasamy, Arri
Althabe, Fernando
Devall, Adam J.
Evans, Cherrie
Oladapo, Olufemi T.
Lissauer, David
Akter, Shahinoor
Forbes, Gillian
Thomas, Eleanor
Galadanci, Hadiza
Qureshi, Zahida
Fawcus, Sue
Hofmeyr, G. Justus
Al-beity, Fadhlun Alwy
Kasturiratne, Anuradhani
Kumarendran, Balachandran
Mammoliti, Kristie-Marie
Vogel, Joshua P.
Gallos, Ioannis
Miller, Suellen
author_facet Bohren, Meghan A.
Lorencatto, Fabiana
Coomarasamy, Arri
Althabe, Fernando
Devall, Adam J.
Evans, Cherrie
Oladapo, Olufemi T.
Lissauer, David
Akter, Shahinoor
Forbes, Gillian
Thomas, Eleanor
Galadanci, Hadiza
Qureshi, Zahida
Fawcus, Sue
Hofmeyr, G. Justus
Al-beity, Fadhlun Alwy
Kasturiratne, Anuradhani
Kumarendran, Balachandran
Mammoliti, Kristie-Marie
Vogel, Joshua P.
Gallos, Ioannis
Miller, Suellen
author_sort Bohren, Meghan A.
collection PubMed
description BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. When PPH occurs, early identification of bleeding and prompt management using evidence-based guidelines, can avert most PPH-related severe morbidities and deaths. However, adherence to the World Health Organization recommended practices remains a critical challenge. A potential solution to inefficient and inconsistent implementation of evidence-based practices is the application of a ‘clinical care bundle’ for PPH management. A clinical care bundle is a set of discrete, evidence-based interventions, administered concurrently, or in rapid succession, to every eligible person, along with teamwork, communication, and cooperation. Once triggered, all bundle components must be delivered. The E-MOTIVE project aims to improve the detection and first response management of PPH through the implementation of the “E-MOTIVE” bundle, which consists of (1) Early PPH detection using a calibrated drape, (2) uterine Massage, (3) Oxytocic drugs, (4) Tranexamic acid, (5) Intra Venous fluids, and (6) genital tract Examination and escalation when necessary. The objective of this paper is to describe the protocol for the formative phase of the E-MOTIVE project, which aims to design an implementation strategy to support the uptake of this bundle into practice. METHODS: We will use behavior change and implementation science frameworks [e.g. capability, opportunity, motivation and behavior (COM-B) and theoretical domains framework (TDF)] to guide data collection and analysis, in Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania. There are four methodological components: qualitative interviews; surveys; systematic reviews; and design workshops. We will triangulate findings across data sources, participant groups, and countries to explore factors influencing current PPH detection and management, and potentially influencing E-MOTIVE bundle implementation. We will use these findings to develop potential strategies to improve implementation, which will be discussed and agreed with key stakeholders from each country in intervention design workshops. DISCUSSION: This formative protocol outlines our strategy for the systematic development of the E-MOTIVE implementation strategy. This focus on implementation considers what it would take to support roll-out and implementation of the E-MOTIVE bundle. Our approach therefore aims to maximize internal validity in the trial alongside future scalability, and implementation of the E-MOTIVE bundle in routine practice, if proven to be effective. Trial registration: ClinicalTrials.gov: NCT04341662 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12978-021-01162-3.
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spelling pubmed-82781772021-07-14 Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol Bohren, Meghan A. Lorencatto, Fabiana Coomarasamy, Arri Althabe, Fernando Devall, Adam J. Evans, Cherrie Oladapo, Olufemi T. Lissauer, David Akter, Shahinoor Forbes, Gillian Thomas, Eleanor Galadanci, Hadiza Qureshi, Zahida Fawcus, Sue Hofmeyr, G. Justus Al-beity, Fadhlun Alwy Kasturiratne, Anuradhani Kumarendran, Balachandran Mammoliti, Kristie-Marie Vogel, Joshua P. Gallos, Ioannis Miller, Suellen Reprod Health Study Protocol BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. When PPH occurs, early identification of bleeding and prompt management using evidence-based guidelines, can avert most PPH-related severe morbidities and deaths. However, adherence to the World Health Organization recommended practices remains a critical challenge. A potential solution to inefficient and inconsistent implementation of evidence-based practices is the application of a ‘clinical care bundle’ for PPH management. A clinical care bundle is a set of discrete, evidence-based interventions, administered concurrently, or in rapid succession, to every eligible person, along with teamwork, communication, and cooperation. Once triggered, all bundle components must be delivered. The E-MOTIVE project aims to improve the detection and first response management of PPH through the implementation of the “E-MOTIVE” bundle, which consists of (1) Early PPH detection using a calibrated drape, (2) uterine Massage, (3) Oxytocic drugs, (4) Tranexamic acid, (5) Intra Venous fluids, and (6) genital tract Examination and escalation when necessary. The objective of this paper is to describe the protocol for the formative phase of the E-MOTIVE project, which aims to design an implementation strategy to support the uptake of this bundle into practice. METHODS: We will use behavior change and implementation science frameworks [e.g. capability, opportunity, motivation and behavior (COM-B) and theoretical domains framework (TDF)] to guide data collection and analysis, in Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania. There are four methodological components: qualitative interviews; surveys; systematic reviews; and design workshops. We will triangulate findings across data sources, participant groups, and countries to explore factors influencing current PPH detection and management, and potentially influencing E-MOTIVE bundle implementation. We will use these findings to develop potential strategies to improve implementation, which will be discussed and agreed with key stakeholders from each country in intervention design workshops. DISCUSSION: This formative protocol outlines our strategy for the systematic development of the E-MOTIVE implementation strategy. This focus on implementation considers what it would take to support roll-out and implementation of the E-MOTIVE bundle. Our approach therefore aims to maximize internal validity in the trial alongside future scalability, and implementation of the E-MOTIVE bundle in routine practice, if proven to be effective. Trial registration: ClinicalTrials.gov: NCT04341662 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12978-021-01162-3. BioMed Central 2021-07-14 /pmc/articles/PMC8278177/ /pubmed/34261508 http://dx.doi.org/10.1186/s12978-021-01162-3 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Bohren, Meghan A.
Lorencatto, Fabiana
Coomarasamy, Arri
Althabe, Fernando
Devall, Adam J.
Evans, Cherrie
Oladapo, Olufemi T.
Lissauer, David
Akter, Shahinoor
Forbes, Gillian
Thomas, Eleanor
Galadanci, Hadiza
Qureshi, Zahida
Fawcus, Sue
Hofmeyr, G. Justus
Al-beity, Fadhlun Alwy
Kasturiratne, Anuradhani
Kumarendran, Balachandran
Mammoliti, Kristie-Marie
Vogel, Joshua P.
Gallos, Ioannis
Miller, Suellen
Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol
title Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol
title_full Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol
title_fullStr Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol
title_full_unstemmed Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol
title_short Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol
title_sort formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (e-motive): study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8278177/
https://www.ncbi.nlm.nih.gov/pubmed/34261508
http://dx.doi.org/10.1186/s12978-021-01162-3
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