Ouyang Menglu, Anjum Anila, Mc Cawley Francisca Gonzalez, Wasay Mohammad, Ma Lu, Hu Xin, Chen Xiaoying, Malavera Alejandra, Li Xi, Venturelli Paula Muñoz, Silva H Asita de, Thang Nguyen Huy, Wahab Kolawole W, Pandian Jeyaraj D, Pontes-Neto Octavio M, Abanto Carlos, Cano-Nigenda Venessa, Arauz Antonio, You Chao, Jan Stephen, Song Lili, Anderson Craig S, Liu Hueiming
The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
The George Institute China Office, Beijing, China.
PLOS Glob Public Health. 2024 Dec 19;4(12):e0003711. doi: 10.1371/journal.pgph.0003711. eCollection 2024.
The third, stepped-wedge, cluster-randomized, Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3), has shown that a goal-directed multi-faceted Care Bundle incorporating protocols for the management of physiological variables was safe and effective for improving functional recovery in a broad range of patients with acute intracerebral hemorrhage (ICH). The INTERACT3 Care Bundle included time- and target-based protocols for the management of early intensive lowering of systolic blood pressure (SBP, target <140mmHg), glucose control (target 6.1-7.8 mmol/L in those without diabetes and 7.8-10.0 mmol/L in those with diabetes), anti-pyrexia treatment (target body temperature ≤37.5°C), and the rapid reversal of warfarin-related anticoagulation (target international normalized ratio <1.5). An embedded process evaluation was conducted to allow a better understanding of how the Care Bundle was implemented in different countries to enhance the transferability of this evidence in the international context. This study used a mixed-methods approach involving interviews, focus group discussions, and surveys to evaluate the implementation outcomes included fidelity, dose, reach, acceptability, appropriateness, adoption, and sustainability. Interviews (n = 27), focus group discussions (n = 3), and quantitative surveys (n = 48) were conducted in 7 low- and middle-income countries (LMICs) and 1 high-income country during 2019-2022. The Care Bundle was generally delivered as planned and well accepted by stakeholders, although some difficulties were reported in reaching the SBP and glycemic targets. Contextual factors including staff shortage, limited availability of antihypertensive drugs, and delayed systems of care processes, were common barriers to implementing the Care Bundle. Facilitating factors included good communication and collaboration with staff in emergency departments, the development of pathways within available resources, and regular training and monitoring. Our process evaluation provides useful insights into the contextual barriers which need to be addressed for effective scale up of the Care Bundle implementation in a global context. Trial registration: INTERACT3 is registered at Clinicaltrials.gov (NCT03209258) and the Chinese Clinical Trial Registry (ChiCTR-IOC-17011787).
第三个阶梯式楔形整群随机分组的急性脑出血强化护理包降压试验（INTERACT3）表明，一个目标导向的多方面护理包，纳入了生理变量管理方案，对于改善广泛的急性脑出血（ICH）患者的功能恢复是安全有效的。INTERACT3护理包包括基于时间和目标的方案，用于管理早期强化降低收缩压（SBP，目标<140mmHg）、血糖控制（无糖尿病者目标为6.1 - 7.8 mmol/L，糖尿病患者目标为7.8 - 10.0 mmol/L）、退热治疗（目标体温≤37.5°C）以及华法林相关抗凝的快速逆转（目标国际标准化比值<1.5）。进行了一项嵌入式过程评估，以便更好地了解护理包在不同国家是如何实施的，以增强这一证据在国际背景下的可转移性。本研究采用了混合方法，包括访谈、焦点小组讨论和调查，以评估实施结果，包括保真度、剂量、覆盖范围、可接受性、适宜性、采用情况和可持续性。在2019 - 2022年期间，在7个低收入和中等收入国家（LMICs）和1个高收入国家进行了访谈（n = 27）、焦点小组讨论（n = 3）和定量调查（n = 48）。护理包总体上按计划实施，利益相关者普遍接受，尽管在达到SBP和血糖目标方面报告了一些困难。包括人员短缺、抗高血压药物供应有限以及护理流程系统延迟等背景因素，是实施护理包的常见障碍。促进因素包括与急诊科工作人员的良好沟通与协作、在现有资源范围内制定路径以及定期培训和监测。我们的过程评估为在全球范围内有效扩大护理包实施规模所需解决的背景障碍提供了有用的见解。试验注册：INTERACT3在Clinicaltrials.gov（NCT03209258）和中国临床试验注册中心（ChiCTR - IOC - 17011787）注册。
