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

Behavior change Care bundle Formative research Implementation Intervention development Maternal health Maternal mortality Obstetric hemorrhage Postpartum hemorrhage

Journal

Reproductive health
ISSN: 1742-4755
Titre abrégé: Reprod Health
Pays: England
ID NLM: 101224380

Informations de publication

Date de publication:
14 Jul 2021
Historique:
received: 08 04 2021
accepted: 17 05 2021
entrez: 15 7 2021
pubmed: 16 7 2021
medline: 29 7 2021
Statut: epublish

Résumé

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. 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. 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. ClinicalTrials.gov: NCT04341662. Excessive bleeding after birth is the leading cause of maternal death globally. The World Health Organization (WHO) has recommended several treatment options for bleeding after birth. However, these treatments are not used regularly, or consistently for all women. A key underlying issue is that it is challenging for health workers to identify when women are bleeding too much, because measuring the amount of blood loss is difficult.Maternal health experts have proposed a new clinical ‘care bundle’ for caring for women with excessive bleeding after birth. A care bundle is a way to group together multiple treatments (e.g. 3–5 treatments). These treatments are then given to the woman at the same time, or one after another in quick succession, and supported by strategies to improve teamwork, communication, and cooperation.This is a research protocol for the preliminary phase of our study (“E-MOTIVE”), which means that it is a description of what we plan to do and how we plan to do it. The aim of our study is to develop a strategy for how we will test whether the E-MOTIVE bundle works through collaborative activities with midwives and doctors in five countries (Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania) to develop a strategy for how we will test whether the E-MOTIVE bundle works. We plan to do this by conducting interviews and surveys with midwives and doctors, and reviewing other research conducted on PPH to understand what works in different settings. We will discuss our research findings in a workshop, with midwives and doctors in the study countries to co-create a strategy that will work for them, based on their needs and preferences.

Sections du résumé

BACKGROUND 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 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 CONCLUSIONS
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 BACKGROUND
ClinicalTrials.gov: NCT04341662.
Excessive bleeding after birth is the leading cause of maternal death globally. The World Health Organization (WHO) has recommended several treatment options for bleeding after birth. However, these treatments are not used regularly, or consistently for all women. A key underlying issue is that it is challenging for health workers to identify when women are bleeding too much, because measuring the amount of blood loss is difficult.Maternal health experts have proposed a new clinical ‘care bundle’ for caring for women with excessive bleeding after birth. A care bundle is a way to group together multiple treatments (e.g. 3–5 treatments). These treatments are then given to the woman at the same time, or one after another in quick succession, and supported by strategies to improve teamwork, communication, and cooperation.This is a research protocol for the preliminary phase of our study (“E-MOTIVE”), which means that it is a description of what we plan to do and how we plan to do it. The aim of our study is to develop a strategy for how we will test whether the E-MOTIVE bundle works through collaborative activities with midwives and doctors in five countries (Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania) to develop a strategy for how we will test whether the E-MOTIVE bundle works. We plan to do this by conducting interviews and surveys with midwives and doctors, and reviewing other research conducted on PPH to understand what works in different settings. We will discuss our research findings in a workshop, with midwives and doctors in the study countries to co-create a strategy that will work for them, based on their needs and preferences.

Autres résumés

Type: plain-language-summary (eng)
Excessive bleeding after birth is the leading cause of maternal death globally. The World Health Organization (WHO) has recommended several treatment options for bleeding after birth. However, these treatments are not used regularly, or consistently for all women. A key underlying issue is that it is challenging for health workers to identify when women are bleeding too much, because measuring the amount of blood loss is difficult.Maternal health experts have proposed a new clinical ‘care bundle’ for caring for women with excessive bleeding after birth. A care bundle is a way to group together multiple treatments (e.g. 3–5 treatments). These treatments are then given to the woman at the same time, or one after another in quick succession, and supported by strategies to improve teamwork, communication, and cooperation.This is a research protocol for the preliminary phase of our study (“E-MOTIVE”), which means that it is a description of what we plan to do and how we plan to do it. The aim of our study is to develop a strategy for how we will test whether the E-MOTIVE bundle works through collaborative activities with midwives and doctors in five countries (Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania) to develop a strategy for how we will test whether the E-MOTIVE bundle works. We plan to do this by conducting interviews and surveys with midwives and doctors, and reviewing other research conducted on PPH to understand what works in different settings. We will discuss our research findings in a workshop, with midwives and doctors in the study countries to co-create a strategy that will work for them, based on their needs and preferences.

Identifiants

pubmed: 34261508
doi: 10.1186/s12978-021-01162-3
pii: 10.1186/s12978-021-01162-3
pmc: PMC8278177
doi:

Banques de données

ClinicalTrials.gov
['NCT04341662']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

149

Subventions

Organisme : World Health Organization
ID : 001
Pays : International
Organisme : Medical Research Council
ID : MR/T038985/1
Pays : United Kingdom

Informations de copyright

© 2021. The Author(s).

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Auteurs

Meghan A Bohren (MA)

Gender and Women's Health Unit, Centre for Health Equity, University of Melbourne School of Population and Global Health, 207 Bouverie St, Carlton, VIC, 3053, Australia. meghan.bohren@unimelb.edu.au.

Fabiana Lorencatto (F)

Centre for Behaviour Change, University College London, London, UK. f.lorencatto@ucl.ac.uk.

Arri Coomarasamy (A)

Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health Research, University of Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2TG, UK.

Fernando Althabe (F)

Department of Sexual and Reproductive Health and Research, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Avenue Appia 20, Geneva, Switzerland.

Adam J Devall (AJ)

Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health Research, University of Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2TG, UK.

Cherrie Evans (C)

Maternal & Newborn Health Unit, Technical Leadership Office, Jhpiego, Johns Hopkins University, 1615 Thames Street, Baltimore, MD, 21231, USA.

Olufemi T Oladapo (OT)

Department of Sexual and Reproductive Health and Research, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Avenue Appia 20, Geneva, Switzerland.

David Lissauer (D)

Malawi-Liverpool-Wellcome Trust Research Institute, Queen Elizabeth Central Hospital, College of Medicine, Blantyre, Malawi.
Institute of Life Course and Medical Sciences, William Henry Duncan Building, University of Liverpool, Liverpool, UK.

Shahinoor Akter (S)

Gender and Women's Health Unit, Centre for Health Equity, University of Melbourne School of Population and Global Health, 207 Bouverie St, Carlton, VIC, 3053, Australia.

Gillian Forbes (G)

Centre for Behaviour Change, University College London, London, UK.

Eleanor Thomas (E)

Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health Research, University of Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2TG, UK.

Hadiza Galadanci (H)

Africa Center of Excellence for Population Health and Policy, Bayero University, Kano, Kano, Nigeria.

Zahida Qureshi (Z)

Department of Obstetrics and Gynaecology, School of Medicine, University of Nairobi, Kenyatta National Hospital Campus, Old Mbagathi Road, Nairobi, Kenya.

Sue Fawcus (S)

Department of Obstetrics and Gynaecology, Grooteschuur Hospital, University of Cape Town, Floor H Old Main Building, Anzio Road, Observatory, Cape Town, South Africa.

G Justus Hofmeyr (GJ)

Department of Obstetrics and Gynaecology, University of Botswana, Notwane Rd, Gaborone, Botswana.
University of the Witwatersrand, Amalinda Drive, East London, South Africa.
Walter Sisulu University, Amalinda Drive, East London, South Africa.

Fadhlun Alwy Al-Beity (FA)

Department of Obstetrics and Gynecology, Muhimbili University of Health and Allied Sciences, United Nation Road, Upanga, Dar es Salaam, Tanzania.

Anuradhani Kasturiratne (A)

Department of Public Health, Faculty of Medicine, University of Kelaniya, 6, Thalagolla Road, Ragama, 11010, Sri Lanka.

Balachandran Kumarendran (B)

Department of Community and Family Medicine, Faculty of Medicine, University of Jaffna, Adiyapatham Road, Kokkuvil, Sri Lanka.

Kristie-Marie Mammoliti (KM)

Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health Research, University of Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2TG, UK.

Joshua P Vogel (JP)

Maternal, Child and Adolescent Health Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia.

Ioannis Gallos (I)

Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health Research, University of Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2TG, UK.

Suellen Miller (S)

Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, Bixby Center, Safe Motherhood Program, University of California, San Francisco, 550 16th Street, San Francisco, CA, 94158, USA.

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