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

Meghan A Bohren, Fabiana Lorencatto, Arri Coomarasamy, Fernando Althabe, Adam J Devall, Cherrie Evans, Olufemi T Oladapo, David Lissauer, Shahinoor Akter, Gillian Forbes, Eleanor Thomas, Hadiza Galadanci, Zahida Qureshi, Sue Fawcus, G Justus Hofmeyr, Fadhlun Alwy Al-Beity, Anuradhani Kasturiratne, Balachandran Kumarendran, Kristie-Marie Mammoliti, Joshua P Vogel, Ioannis Gallos, Suellen Miller, Meghan A Bohren, Fabiana Lorencatto, Arri Coomarasamy, Fernando Althabe, Adam J Devall, Cherrie Evans, Olufemi T Oladapo, David Lissauer, Shahinoor Akter, Gillian Forbes, Eleanor Thomas, Hadiza Galadanci, Zahida Qureshi, Sue Fawcus, G Justus Hofmeyr, Fadhlun Alwy Al-Beity, Anuradhani Kasturiratne, Balachandran Kumarendran, Kristie-Marie Mammoliti, Joshua P Vogel, Ioannis Gallos, Suellen Miller

Abstract

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.

Keywords: Behavior change; Care bundle; Formative research; Implementation; Intervention development; Maternal health; Maternal mortality; Obstetric hemorrhage; Postpartum hemorrhage.

Conflict of interest statement

Professor Suellen Miller’s University (University of California San Francisco) holds the license for the Trademark name “LifeWrap.” The LifeWrap is the name of one first-aid device used in refractory postpartum hemorrhage, the Non-pneumatic Anti-Shock Garment (NASG). The manufacturer of the LifeWrap NASG pays the University of California a royalty for the use of the name. Professor Justus Hofmeyr has conceived a re-usable device for postpartum blood loss monitoring, the ‘Safe Birth Tray’, which is under development by Equalize Health, a non-profit global health organization who hold the intellectual property. JH may in future benefit from sales of the device. The remaining authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
The E-MOTIVE care bundle
Fig. 2
Fig. 2
Overview of the E-MOTIVE research projects. The formative components of the project are outlined in this protocol. Subsequent publications will outline the adaptive cycles, parallel cluster randomized trial, process evaluation and cost-effectiveness. COM-B model of behavior change referring to capability, opportunity, and motivation; IDIs in-depth interviews, EtD evidence-to-decision frameworks, WHO World Health Organization
Fig. 3
Fig. 3
Integrated study conceptual frameworks: COM-B Model, Theoretical Domains Framework, Behavior Change Wheel [13]

References

    1. Say L, Chou D, Gemmill A, Tuncalp O, Moller A, Daniels J, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014;2(6):e323–e333. doi: 10.1016/S2214-109X(14)70227-X.
    1. Family Care International. A price too high to bear: the costs of maternal mortality to families and communities. Research findings. 2014 . Accessed 4 Dec 2020.
    1. Vogel JP, Oladapo OT, Dowswell T, Gülmezoglu AM. Updated WHO recommendation on intravenous tranexamic acid for the treatment of post-partum haemorrhage. Lancet Glob Health. 2018;6(1):e18–e19. doi: 10.1016/S2214-109X(17)30428-X.
    1. Khan K, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006;367:1066–1074. doi: 10.1016/S0140-6736(06)68397-9.
    1. World Health Organization. WHO recommendations for the prevention and treatment of postpartum haemorrhage. Geneva, Switzerland; 2012. . Accessed 4 Dec 2020.
    1. Althabe F, Therrien MNS, Pingray V, Hermida J, Gülmezoglu AM, Armbruster D, et al. Postpartum hemorrhage care bundles to improve adherence to guidelines: a WHO technical consultation. Int J Gynaecol Obstet. 2020;148(3):290–299. doi: 10.1002/ijgo.13028.
    1. Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, et al. Heat-stable carbetocin versus oxytocin to prevent hemorrhage after vaginal birth. N Engl J Med. 2018;379(8):743–752. doi: 10.1056/NEJMoa1805489.
    1. Alwy Al-beity F, Pembe A, Hirose A, Morris J, Leshabari S, Marrone G, et al. Effect of the competency-based 'Helping Mothers Survive Bleeding after Birth' (HMS BAB) training on maternal morbidity: a cluster-randomised trial in 20 districts in Tanzania. BMJ Glob Health. 2019;4(2):e001214. doi: 10.1136/bmjgh-2018-001214.
    1. Sotunsa J, Adeniyi A, Imaralu J, Fawole B, Adegbola O, Aimakhu C, et al. Maternal near-miss and death among women with postpartum haemorrhage: a secondary analysis of the Nigeria Near-miss and Maternal Death Survey. BJOG Int J Obstetr Gynaecol. 2019 doi: 10.1111/1471-0528.15624.
    1. Hancock A, Weeks AD, Lavender DT. Is accurate and reliable blood loss estimation the 'crucial step' in early detection of postpartum haemorrhage: an integrative review of the literature. BMC Pregnancy Childbirth. 2015;15(1):230. doi: 10.1186/s12884-015-0653-6.
    1. Resar R, Griffin FA, Haraden C, Nolan TW. Using care bundles to improve health care quality. Cambridge, MA: Institute for Healthcare Improvement; 2012.
    1. World Health Organization. WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhage. Geneva, Switzerland: World Health Organization; 2017. . Accessed 4 Dec 2020.
    1. Michie S, Van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6(1):42. doi: 10.1186/1748-5908-6-42.
    1. Patey AM, Hurt CS, Grimshaw JM, Francis JJ. Changing behaviour ‘more or less’—do theories of behaviour inform strategies for implementation and de-implementation? A critical interpretive synthesis. Implement Sci. 2018;13(1):134. doi: 10.1186/s13012-018-0826-6.
    1. Francis JJ, O’Connor D, Curran J. Theories of behaviour change synthesised into a set of theoretical groupings: introducing a thematic series on the theoretical domains framework. Implement Sci. 2012;7(1):35. doi: 10.1186/1748-5908-7-35.
    1. Lorencatto F, Charani E, Sevdalis N, Tarrant C, Davey P. Driving sustainable change in antimicrobial prescribing practice: how can social and behavioural sciences help? J Antimicrob Chemother. 2018;73(10):2613–2624. doi: 10.1093/jac/dky222.
    1. Lennox L, Green S, Howe C, Musgrave H, Bell D, Elkin S. Identifying the challenges and facilitators of implementing a COPD care bundle. BMJ Open Respir Res. 2014 doi: 10.1136/bmjresp-2014-000035.
    1. Green SA, Bell D, Mays N. Identification of factors that support successful implementation of care bundles in the acute medical setting: a qualitative study. BMC Health Serv Res. 2017;17(1):120. doi: 10.1186/s12913-017-2070-1.
    1. Roberts N, Hooper G, Lorencatto F, Storr W, Spivey M. Barriers and facilitators towards implementing the Sepsis Six care bundle (BLISS-1): a mixed methods investigation using the theoretical domains framework. Scand J Trauma Resusc Emerg Med. 2017;25(1):96. doi: 10.1186/s13049-017-0437-2.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 doi: 10.1136/bmj.a1655.
    1. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf. 2015;24(3):228–238. doi: 10.1136/bmjqs-2014-003627.
    1. Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012;7(1):37. doi: 10.1186/1748-5908-7-37.
    1. Gould NJ, Lorencatto F, During C, Rowley M, Glidewell L, Walwyn R, et al. How do hospitals respond to feedback about blood transfusion practice? A multiple case study investigation. PLoS ONE. 2018;13(11):e0206676. doi: 10.1371/journal.pone.0206676.
    1. Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95. doi: 10.1007/s12160-013-9486-6.
    1. Cane J, Richardson M, Johnston M, Ladha R, Michie S. From lists of behaviour change techniques (BCT s) to structured hierarchies: comparison of two methods of developing a hierarchy of BCT s. Br J Health Psychol. 2015;20(1):130–150. doi: 10.1111/bjhp.12102.
    1. Johnston M, Carey RN, Connell Bohlen LE, Johnston DW, Rothman AJ, de Bruin M, et al. Development of an online tool for linking behavior change techniques and mechanisms of action based on triangulation of findings from literature synthesis and expert consensus. Transl Behav Med. 2020 doi: 10.1093/tbm/ibaa050.
    1. Michie S, Atkins L, West R. The behaviour change wheel. A guide to designing interventions. 1. Great Britain: Silverback Publishing; 2014. pp. 1003–1010.
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:1258. doi: 10.1136/bmj.h1258.
    1. Francis JJ, Johnston M, Robertson C, Glidewell L, Entwistle V, Eccles MP, et al. What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol Health. 2010;25(10):1229–1245. doi: 10.1080/08870440903194015.
    1. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117. doi: 10.1186/1471-2288-13-117.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. doi: 10.1191/1478088706qp063oa.
    1. Huijg JM, Gebhardt WA, Crone MR, Dusseldorp E, Presseau J. Discriminant content validity of a theoretical domains framework questionnaire for use in implementation research. Implement Sci. 2014;9(1):11. doi: 10.1186/1748-5908-9-11.
    1. Lavrakas P. Content analysis. Encyclopedia of survey research methods (vol 1-0) Thousand Oaks: California Sage Publications; 2008.
    1. Akter S, Lorencatto F, Forbes G, Miller S, Althabe F, Coomarasamy A, et al. Perceptions and experiences of the prevention, identification and management of postpartum haemorrhage: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2020 doi: 10.1002/14651858.CD013795.
    1. Tonkin-Crine S, Anthierens S, Hood K, Yardley L, Cals JW, Francis NA, et al. Discrepancies between qualitative and quantitative evaluation of randomised controlled trial results: achieving clarity through mixed methods triangulation. Implement Sci. 2015;11(1):66. doi: 10.1186/s13012-016-0436-0.
    1. Hopf Y, Francis J, Helms P, Haughney J, Bond C. Core requirements for successful data linkage: an example of a triangulation method. BMJ Open. 2016;6(10):e011879. doi: 10.1136/bmjopen-2016-011879.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687.
    1. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Admin Policy Ment Health Ment Health Serv Res. 2011;38(2):65–76. doi: 10.1007/s10488-010-0319-7.
    1. Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004;23(5):443. doi: 10.1037/0278-6133.23.5.443.
    1. World Health Organization. Trends in Maternal Mortality 2000–2017: Estimates by WHO, UNICEF, UNFPA, World Bank Group and the United Nations Population Division. Geneva, Switzerland; 2019. . Accessed 4 Dec 2020.
    1. Kullima AA, Kawuwa MB, Audu BM, Geidam AD, Mairiga AG. Trends in maternal mortality in a tertiary institution in Northern Nigeria. Ann Afr Med. 2009;8(4):221. doi: 10.4103/1596-3519.59575.
    1. Bwana VM, Rumisha SF, Mremi IR, Lyimo EP, Mboera LEG. Patterns and causes of hospital maternal mortality in Tanzania: a 10-year retrospective analysis. PLoS ONE. 2019;14(4):e0214807. doi: 10.1371/journal.pone.0214807.
    1. Maro EW, Mosha NR, Mahande MJ, Obure J, Masenga G. Ten years trend in maternal mortality at Kilimanjaro Christian Medical Center Tanzania, 2003–2012: a descriptive retrospective tertiary hospital based study. Asian Pac J Reprod. 2016;5(3):214–220. doi: 10.1016/j.apjr.2016.04.012.
    1. National Committee for the Confidential Enquiries into Maternal Deaths. Saving Mothers 2014–2016: Seventh triennial report on confidential enquiries into maternal deaths in South Africa. 2017.
    1. Ministry of Health Kenya. Saving Mothers Lives 2017: First confidential report into maternal deaths in Kenya. 2017.
    1. Family Health Bureau Ministry of Health Care and Nutrition of Sri Lanka. Annual National Maternal Mortality Review 2016. 2016.
    1. Lissauer D, Cheshire J, Dunlop C, Taki F, Wilson A, Smith JM, et al. Development of the FAST-M maternal sepsis bundle for use in low-resource settings: a modified Delphi process. BJOG Int J Obstetr Gynaecol. 2020;127(3):416–423. doi: 10.1111/1471-0528.16005.
    1. Chang OH, Levy B, Lytle H, Pope R, Phiri H, Gellhaus T, et al. Implementation of the alliance for innovation on maternal health program to reduce maternal mortality in Malawi. Obstet Gynecol. 2019;133(3):507–514. doi: 10.1097/AOG.0000000000003108.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir