Smart Discharges for Mom & Baby 2.0: A cohort study to develop prognostic algorithms for post-discharge readmission and mortality among mother-infant dyads

Dataset Description: This dataset contains materials from the Smart Discharges for Mom & Baby parent study within the Smart Discharges program of research. Materials include the parent study ethics protocol and associated documents. See the Metadata section below for links to related publications and datasets. Background: In low-income country settings, the first six weeks after birth remain a critical period of vulnerability for both mother and newborn. Despite recommendations for routine post-discharge follow-up, few mothers and newborns receive guideline recommended care during this period. Prediction modelling of post-delivery outcomes has the potential to improve outcomes for both mother and newborn by identifying high-risk dyads, improving risk communication, and facilitating a patient-centered approach to postnatal care. Methods: This is a mixed-methods study to explore and map the current postnatal discharge processes in Uganda.We will conduct an observational cohort study (Phase I) to develop and internally validate our risk score and aim to recruit 7,000 mother and newborn dyads from Jinja Regional Referral Hospital and Mbarara Regional Referral Hospital. We will also engage with patients, families, and health workers through patient journey mapping and focus group discussions (Phases II-IV) to identify barriers and facilitators to inform the development of an evidence- and risk-based bundle of interventions to improve postnatal care (PNC) for dyads. The primary outcome is maternal and/or neonatal death or need for re-admission within six weeks of birth. Secondary outcomes include: 1. Post-natal care visits during the 6-week post-discharge period 2. Post-discharge health seeking practices for mothers/newborns during the 6-week post-discharge period 3. Causes of readmission/mortality among those who experience such outcomes, based on verbal autopsies and admission symptom/diagnosis questionnaires. Data Collection Methods: All data will be collected at the point of care using encrypted study tablets. These data will be uploaded to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). At admission, trained study nurses will systematically collect data on clinical, social and demographic variables. Following discharge, field officers will contact mothers at 6-weeks post-discharge, to determine vital status, post-discharge health-seeking, and readmission details. Verbal autopsies were conducted for participants who had died following discharge. Direct observation and interviews will be conducted on a sub-set of participants to collect process outcomes and barriers and facilitators to the patient's journey. FGDs will be digitally recorded, transcribed verbatim in the language spoken during the recording and analyzed for emerging themes. Ethics Declaration: Ethics approvals have been obtained from the Makerere University School of Public Health (MakSPH) Institutional Review Board (SPH-2021-177), the Uganda National Council of Science and Technology (UNCST) in Uganda (HS2174ES) and the University of British Columbia in Canada (H21-03709). This study has been registered at clinicaltrials.gov (NCT05730387). Associated datasets: Pending publication NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator on this page under \"collaborate with the pediatric sepsis colab.\"数据集说明：本数据集收录了「智能出院（Smart Discharges）」研究项目下「母婴智能出院（Smart Discharges for Mom & Baby）」主研究的相关材料，包含该主研究的伦理审查方案及关联文档。有关相关出版物与数据集的链接，请参阅下文的元数据（Metadata）部分。 背景：在低收入国家环境中，产后首六周仍是母亲与新生儿共同面临脆弱性的关键时期。尽管现有指南推荐出院后常规随访，但在此期间极少有母亲和新生儿能获得符合指南建议的照护。产后结局预测建模可通过识别高风险母婴对、优化风险沟通，以及推行以患者为中心的产后照护模式，有望改善母婴双方的结局。 研究方法：本研究为混合方法研究，旨在探究并梳理乌干达当前的产后出院流程。我们将开展观察性队列研究（第一阶段）以开发并内部验证我们的风险评分模型，计划从金贾区域转诊医院（Jinja Regional Referral Hospital）及姆巴拉拉区域转诊医院（Mbarara Regional Referral Hospital）招募7000对母婴对。同时，我们将通过患者旅程映射与焦点小组讨论（第二至第四阶段）与患者、家属及医护人员开展合作，识别阻碍与促进因素，以此为基础开发基于证据与风险的综合干预包，以改善母婴对的产后照护（Postnatal Care, PNC）。本研究的主要结局指标为产后六周内母亲和/或新生儿死亡，或需要再次入院。次要结局指标包括：1. 出院后六周内的产后照护就诊情况；2. 出院后六周内母亲/新生儿的出院后就医行为；3. 针对出现上述结局的受试者，通过口头尸检及入院症状/诊断问卷明确其再入院/死亡原因。 数据采集方法：所有数据将在照护现场通过加密研究专用平板电脑进行采集。采集到的数据将上传至位于加拿大温哥华不列颠哥伦比亚省儿童医院研究所的电子研究数据采集系统（Research Electronic Data Capture, REDCap）数据库。受试者入院时，经过培训的研究护士将系统采集其临床、社会人口学相关变量数据。受试者出院后，外勤人员将在出院六周后联系母亲，以确认其生存状态、出院后就医行为及再入院相关细节。对于出院后死亡的受试者，将开展口头尸检。我们将对部分受试者开展直接观察与访谈，以收集流程结局及患者就医旅程中的阻碍与促进因素相关数据。焦点小组讨论（Focus Group Discussions, FGDs）将进行数字化录音，以录制时使用的语言逐字转录，并对其进行主题分析以挖掘新兴主题。 伦理声明：本研究已获得马克雷雷大学公共卫生学院（MakSPH）机构审查委员会（编号SPH-2021-177）、乌干达国家科学技术委员会（UNCST，编号HS2174ES）以及加拿大不列颠哥伦比亚大学（编号H21-03709）的伦理批准。本研究已在clinicaltrials.gov网站注册（编号NCT05730387）。关联数据集：待发表。 受限文件说明：若您尚未成为协作实验室（CoLab）成员，请在2个工作日内完成成员申请调查以获取受限文件的访问权限。部分文件仅对协作实验室成员开放。文件所有者认为此类文件敏感性更高，将根据具体情况共享。请通过本页面"collaborate with the pediatric sepsis colab."板块联系协作实验室协调员。