School of Population Medicine and Public Health, China Academy of Medical Science & Peking Union Medical College, Beijing, China.
Global Health Research Center, Duke Kunshan University, Suzhou, China.
Front Public Health. 2021 Nov 17;9:774907. doi: 10.3389/fpubh.2021.774907. eCollection 2021.
There is a lack of evidence concerning the effective implementation of strategies for stroke prevention and management, particularly in resource-limited settings. A primary-care-based integrated mobile health intervention (SINEMA intervention) has been implemented and evaluated a 1-year-long cluster-randomized controlled trial. This study reports the findings from the trial implementation and process evaluation that investigate the implementation of the intervention and inform factors that may influence the wider implementation of the intervention in the future. We developed an evaluation framework by employing both the RE-AIM framework and the MRC process evaluation framework to describe the implementation indicators, related enablers and barriers, and illustrate some potential impact pathways that may influence the effectiveness of the intervention in the trial. Quantitative data were collected from surveys and extracted from digital health monitoring systems. In addition, we conducted quarterly in-depth interviews with stakeholders in order to understand barriers and enablers of program implementation and effectiveness. Quantitative data analysis and thematic qualitative data analysis were applied, and the findings were synthesized based on the evaluation framework. The SINEMA intervention was successfully implemented in 25 rural villages, reached 637 patients with stroke in rural Northern China during the 12 months of the trial. Almost 90% of the participants received all follow-up visits per protocol, and about half of the participants received daily voice messages. The majority of the intervention components were adopted by village doctors with some adaptation made. The interaction between human-delivered and technology-enabled components reinforced the program implementation and effectiveness. However, characteristics of the participants, doctor-patient relationships, and the healthcare system context attributed to the variation of program implementation and effectiveness. A comprehensive evaluation of program implementation demonstrates that the SINEMA program was well implemented in rural China. Findings from this research provide additional information for program adaptation, which shed light on the future program scale-up. The study also demonstrates the feasibility of combining RE-AIM and MRC process evaluation frameworks in process and implementation evaluation in trials. www.ClinicalTrials.gov, identifier: NCT03185858.
关于预防和管理中风的策略的有效实施，特别是在资源有限的环境中，缺乏证据。已经实施并评估了一项基于初级保健的综合移动健康干预措施（SINEMA 干预措施），该措施是一项为期 1 年的群组随机对照试验。本研究报告了试验实施和过程评估的结果，这些结果调查了干预措施的实施情况，并提供了可能影响未来更广泛实施干预措施的因素。我们采用 RE-AIM 框架和 MRC 过程评估框架制定了评估框架，以描述实施指标、相关促成因素和障碍，并说明可能影响试验中干预措施有效性的一些潜在影响途径。从调查中收集了定量数据，并从数字健康监测系统中提取了数据。此外，我们每季度与利益攸关方进行深入访谈，以了解方案实施和效果的障碍和促成因素。应用了定量数据分析和专题定性数据分析，并根据评估框架综合了研究结果。SINEMA 干预措施在中国北方农村的 25 个村庄成功实施，在试验的 12 个月内，共为 637 名农村中风患者提供了服务。几乎 90%的参与者按照方案接受了所有的随访，大约一半的参与者每天收到语音信息。大多数干预措施都被乡村医生采用，并进行了一些调整。人工干预与技术支持干预之间的相互作用增强了方案的实施和效果。然而，参与者的特征、医患关系和医疗保健系统环境导致了方案实施和效果的变化。对方案实施的全面评估表明，SINEMA 方案在中国农村得到了很好的实施。这项研究为方案的适应性提供了额外的信息，为未来的方案推广提供了启示。该研究还展示了在试验中结合 RE-AIM 和 MRC 过程评估框架进行过程和实施评估的可行性。ClinicalTrials.gov，标识符：NCT03185858。
