Supplementary Material for: Implementing low-intensity thrombolysis monitoring for patients with acute ischemic stroke in Latin America: insights from the OPTIMISTmain process evaluation

Introduction: The Optimal Post rtPA-IV Monitoring in Ischemic Stroke Trial (OPTIMISTmain) was an international, pragmatic, stepped-wedge, cluster- randomized, non-inferiority trial designed to compare a low-intensity protocol to standard high-intensity monitoring in patients with mild-to-moderate acute ischemic stroke treated with thrombolysis. The results showed safety, feasibility and non-inferiority efficacy of the low-intensity monitoring protocol supporting hospitals to consider adopting this approach in stroke care depending on local resources and circumstances. An embedded process evaluation was undertaken to explore factors influencing implementation and impact of the intervention in Latin America. Methods: A convergent mixed-methods design was used to combine quantitative data and qualitative interviews with implementers and patients (or family members) as participating hospitals in Chile and Mexico. Purposive sampling ensured that a diverse range of experiences and discourses were captured, and normalization process theory (NPT) guided the identification of factors facilitating or hindering the incorporation of low-intensity monitoring. The analysis focused on key implementation outcomes. Results: Low-intensity monitoring was widely accepted by clinicians who found it efficient, straightforward to implement, and potentially cost-saving for hospital services. Patients and families expressed acceptance, emphasizing the protocol´s potential to support continuous improvements in healthcare. Implementation challenges included staff turnover across shifts and hospital units, reliance on external contractors, and resistance to changing established care routines. Factors enabling successful implementation included strong team communication, dedicated stroke units, and ongoing feedback. Overall, the intervention demonstrated high acceptability, adoption and appropriateness, fidelity (median of 17 assessments in both countries), and sustainability. Feasibility outcomes were more variable, reflecting organizational challenges at the healthcare system level, such as for example initial resistance of nursing teams and high workloads in emergency services. Conclusions: Implementation of a novel low-intensity monitoring protocol was well accepted by healthcare staff and offers potential benefits to patients with mild-to-moderate acute ischemic stroke admitted to hospitals in Latin America. Embedding a process evaluation into the main trial provided valuable insights into the challenges of implementing a complex intervention. A comprehensive understanding of the factors influencing organization change is critical to improving health outcomes.

## 引言
缺血性卒中静脉rtPA溶栓后最优监测方案试验（OPTIMISTmain）是一项国际务实性阶梯式整群随机非劣效性试验，旨在对比接受溶栓治疗的轻中度急性缺血性卒中患者，采用低强度监测方案与标准高强度监测方案的临床效果。研究结果证实，低强度监测方案具备安全性、可行性及非劣效性，可支持医院结合当地资源与实际情况，考虑在卒中诊疗中应用该方案。本研究嵌入过程评估环节，以探究拉丁美洲地区该干预措施的实施影响因素与实施效果。

## 方法
本研究采用收敛性混合研究设计，整合定量数据与智利、墨西哥参与医院的实施者、患者（或家属）的定性访谈资料。通过目的性抽样确保采集到多样化的实践经验与话语体系，并以正常化过程理论（Normalization Process Theory, NPT）为框架，识别推动或阻碍低强度监测方案落地的相关因素。分析聚焦于关键实施结局指标。

## 结果
低强度监测方案获得了临床医护人员的广泛认可，他们认为该方案高效易行，且可为医院节省医疗服务成本。患者及家属亦表示接受该方案，并强调其有望推动医疗服务的持续优化。实施过程中面临的挑战包括跨班次与跨科室的人员流动、对外包服务的依赖，以及对既有诊疗常规变革的抵触。推动方案成功实施的有利因素包括高效的团队沟通、专属卒中单元，以及持续的反馈机制。总体而言，该干预措施展现出较高的可接受性、采用率与适配性，实施保真度（两国均为17次评估的中位数）及可持续性均表现良好。可行性结局则存在较大差异，反映出医疗系统层面的组织性挑战，例如护理团队最初的抵触情绪，以及急诊科室繁重的工作负荷。

## 结论
新型低强度监测方案的实施获得了拉美地区医院医护人员的高度认可，可为收治的轻中度急性缺血性卒中患者带来潜在获益。在主试验中嵌入过程评估环节，为理解复杂干预措施的实施挑战提供了宝贵洞见。全面掌握影响组织变革的各类因素，对于改善健康结局至关重要。