Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol.
Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol.
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DOI：
10.1186/s12978-021-01162-3
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发表时间：
2021-07-14
影响因子：
3.4
通讯作者：
Miller S
中科院分区：
文献类型：
--
作者：
Bohren MA;Lorencatto F;Coomarasamy A;Althabe F;Devall AJ;Evans C;Oladapo OT;Lissauer D;Akter S;Forbes G;Thomas E;Galadanci H;Qureshi Z;Fawcus S;Hofmeyr GJ;Al-Beity FA;Kasturiratne A;Kumarendran B;Mammoliti KM;Vogel JP;Gallos I;Miller S
产后出血（PPH）是全球孕产妇死亡的主要原因。当PPH发生时，早期识别出血并使用循证指南进行及时管理，可以避免大多数PPH相关的严重发病率和死亡。然而，遵守世界卫生组织建议的做法仍然是一项重大挑战。一个潜在的解决方案，以证据为基础的做法，效率低下和不一致的实施是一个“临床护理包”的PPH管理的应用。临床护理包是一组离散的、基于证据的干预措施，通过团队合作、沟通和合作，沿着向每一个符合条件的人同时或快速连续地实施。一旦触发，必须交付所有捆绑组件。E-MOTIVE项目旨在通过实施“E-MOTIVE”捆绑包来改善PPH的检测和第一反应管理，该捆绑包包括（1）使用校准铺巾进行PPH早期检测，（2）子宫按摩，（3）催产药，（4）氨甲环酸，（5）静脉内液体，（6）生殖道检查，必要时升级。本文的目的是描述协议的形成阶段的E-MOTIVE项目，其目的是设计一个实施策略，以支持吸收这束付诸实践。我们将使用行为改变和实施科学框架[例如能力，机会，动机和行为（COM-B）和理论领域框架（TDF）]来指导肯尼亚，尼日利亚，南非，斯里兰卡和坦桑尼亚的数据收集和分析。有四个方法组成部分：定性访谈;调查;系统审查;和设计讲习班。我们将对数据来源、参与者群体和国家的调查结果进行三角分析，以探索影响当前PPH检测和管理的因素，并可能影响E-MOTIVE捆绑包的实施。我们将利用这些调查结果来制定潜在的战略，以改善实施情况，并将在干预措施设计研讨会上与各国的主要利益攸关方进行讨论和达成一致。该形成性协议概述了我们系统开发E-MOTIVE实施策略的策略。这种对实施的关注考虑了如何支持E-MOTIVE捆绑包的推出和实施。因此，我们的方法旨在最大限度地提高试验中的内部有效性，以及未来的可扩展性，并在常规实践中实施E-MOTIVE捆绑包，如果被证明是有效的。试验注册：ClinicalTrials.gov：NCT 04341662在线版本包含补充材料，可在10.1186/s12978-021-01162-3获得。产后出血过多是全球孕产妇死亡的主要原因。世界卫生组织（WHO）推荐了几种治疗产后出血的方法。然而，这些治疗并不是经常使用，也不是所有女性都能坚持使用。一个关键的根本问题是，卫生工作者很难确定妇女何时出血过多，因为很难测量失血量。产妇健康专家提出了一种新的临床“护理包”，用于照顾产后出血过多的妇女。护理包是将多个治疗（例如3-5个治疗）分组在一起的一种方式。然后，这些治疗同时给予妇女，或者一个接一个地快速连续进行，并得到改善团队合作，沟通和合作的策略的支持。这是我们研究初步阶段的研究方案（“E-MOTIVE”），这意味着它描述了我们计划做什么以及我们计划如何做。我们研究的目的是制定一项战略，通过与五个国家的助产士和医生的合作活动，测试E-MOTIVE捆绑包是否有效（肯尼亚、尼日利亚、南非、斯里兰卡和坦桑尼亚）制定一项战略，以测试E-MOTIVE捆绑包是否有效。我们计划通过与助产士和医生进行访谈和调查，并审查对PPH进行的其他研究，以了解在不同环境下的工作方式。我们将在研讨会上与研究国家的助产士和医生讨论我们的研究结果，根据他们的需求和偏好共同制定一项适合他们的战略。在线版本包含补充材料，可通过10.1186/s12978-021-01162-3获得。
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. Trial registration: ClinicalTrials.gov: NCT04341662 The online version contains supplementary material available at 10.1186/s12978-021-01162-3. 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. The online version contains supplementary material available at 10.1186/s12978-021-01162-3.
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