Smith Anne, Tucker Katherine L, Barnes Rebecca K, Drakesmith Cynthia Wright, Agwunobi Adaku, Bateman Paul A, Forbes Anna, de Lusignan Simon, Ford Gary A, Fujiwara Takeshi, Hobbs F D Richard, Koshiaris Constantinos, Mant Jonathan, McKinstry Brian, Pollock Stephanie, Rice Cathy, Yang Yaling, McManus Richard J
Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Radcliffe Primary Care Building, Oxford, OX2 6GG, UK.
Radcliffe Department of Medicine, Oxford University Hospitals NHS Foundation Trust, University of Oxford, Oxford, England.
BMC Cardiovasc Disord. 2024 Dec 19;24(1):707. doi: 10.1186/s12872-024-04279-y.
Hypertension is a key risk factor for death and disability, and blood pressure reduction is associated with significant reductions in cardiovascular risk. Large trials have shown that interventions including self-monitoring of blood pressure can reduce blood pressure but real-world data from wider implementation are lacking.
The self-monitoring and management service evaluation in primary care (SHIP) study will evaluate a novel digital intervention for hypertension management and medication titration platform ("Hypertension-Plus") that is currently undergoing initial implementation into primary care in several parts of the UK.
The study will use a mixed methods approach including both quantitative analysis of anonymised electronic health record data and qualitative analyses of interview and customer support log data. Pseudonymised data will be extracted from electronic health records and outcomes compared between those using the digital intervention and their own historical data, as well as to those not registered to the system. The primary outcome will be difference in systolic blood pressure in the 12 months before and after implementation. A further analysis will utilise self-monitored blood pressure data from the Hypertension-Plus system itself. Semi-structured qualitative interviews will be completed with implementation and clinical leads, staff and patients in six general practices located in two different geographical areas in England. Informed by the non-adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework, our analysis will identify the challenges to successful implementation and sustainability of the digital intervention in routine clinical practice and in patients' homes.
The analyses of pseudonymised data were assessed by the sponsor (The University of Oxford) as service evaluation not requiring individual consent and hence did not require ethical approval. Ethics approval for the qualitative analyses was provided by Wales REC 4 (21/WA/0280) and individual written informed consent will be gained for all participants. Results will be published in peer-reviewed journals, presented at national and international conferences and disseminated via patient and health service organisations.
This study will provide an in-depth analysis of the impact and acceptance of initial implementation of a novel digital intervention, enhancing our understanding and supporting more effective implementation of telemonitoring based hypertension management systems for blood pressure control in England.
高血压是导致死亡和残疾的关键风险因素，降低血压与显著降低心血管风险相关。大型试验表明，包括自我血压监测在内的干预措施可降低血压，但缺乏来自更广泛实施的真实世界数据。
基层医疗中的自我监测与管理服务评估（SHIP）研究将评估一种用于高血压管理和药物滴定平台（“Hypertension-Plus”）的新型数字干预措施，该平台目前正在英国多个地区初步引入基层医疗。
该研究将采用混合方法，包括对匿名电子健康记录数据的定量分析以及对访谈和客户支持日志数据的定性分析。将从电子健康记录中提取化名数据，并比较使用数字干预措施的患者与其自身历史数据以及未注册该系统的患者之间的结果。主要结局将是实施前后12个月收缩压的差异。进一步的分析将利用Hypertension-Plus系统本身的自我监测血压数据。将对位于英格兰两个不同地理区域的六家全科诊所的实施负责人、临床负责人、工作人员和患者进行半结构化定性访谈。依据非采用、放弃、扩大规模、传播和可持续性（NASSS）框架，我们的分析将确定在常规临床实践和患者家中成功实施和维持数字干预措施所面临的挑战。
赞助商（牛津大学）将对化名数据的分析评估为服务评估，不需要个人同意，因此不需要伦理批准。定性分析获得了威尔士伦理委员会4（21/WA/0280）的伦理批准，将为所有参与者获取个人书面知情同意书。研究结果将发表在同行评审期刊上，在国内和国际会议上展示，并通过患者和卫生服务组织进行传播。
本研究将对一种新型数字干预措施初步实施的影响和接受情况进行深入分析，增进我们的理解，并支持在英格兰更有效地实施基于远程监测的高血压管理系统以控制血压。
