Trials. 2013 Sep 18;14:301. doi: 10.1186/1745-6215-14-301.
An ageing population increases demand on health and social care. New approaches are needed to shift care from hospital to community and general practice. A predictive risk stratification tool (Prism) has been developed for general practice that estimates risk of an emergency hospital admission in the following year. We present a protocol for the evaluation of Prism.
METHODS/DESIGN: We will undertake a mixed methods progressive cluster-randomised trial. Practices begin as controls, delivering usual care without Prism. Practices will receive Prism and training randomly, and thereafter be able to use Prism with clinical and technical support. We will compare costs, processes of care, satisfaction and patient outcomes at baseline, 6 and 18 months, using routine data and postal questionnaires. We will assess technical performance by comparing predicted against actual emergency admissions. Focus groups and interviews will be undertaken to understand how Prism is perceived and adopted by practitioners and policy makers. We will model data using generalised linear models and survival analysis techniques to determine whether any differences exist between intervention and control groups. We will take account of covariates and explanatory factors. In the economic evaluation we will carry out a cost-effectiveness analysis to examine incremental cost per emergency admission to hospital avoided and will examine costs versus changes in primary and secondary outcomes in a cost-consequence analysis. We will also examine changes in quality of life of patients across the risk spectrum. We will record and transcribe focus groups and interviews and analyse them thematically. We have received full ethical and R and D approvals for the study and Information Governance Review Panel (IGRP) permission for the use of routine data. We will comply with the CONSORT guidelines and will disseminate the findings at national and international conferences and in peer-reviewed journals.
The proposed study will provide information on costs and effects of Prism; how it is used in practice, barriers and facilitators to its implementation; and its perceived value in supporting the management of patients with and at risk of developing chronic conditions.
Controlled Clinical Trials ISRCTN no. ISRCTN55538212.
人口老龄化增加了对医疗和社会保健的需求。需要新的方法将护理从医院转移到社区和全科医生诊所。我们为全科医生开发了一种预测风险分层工具（Prism），用于估计下一年紧急住院的风险。我们提出了一个评估 Prism 的方案。
方法/设计：我们将进行一项混合方法的渐进式聚类随机试验。诊所开始作为对照，不使用 Prism 提供常规护理。诊所将随机接受 Prism 和培训，此后可以在临床和技术支持下使用 Prism。我们将使用常规数据和邮寄问卷在基线、6 个月和 18 个月时比较成本、护理过程、满意度和患者结局。我们将通过比较预测与实际急诊入院来评估技术性能。我们将通过焦点小组和访谈来了解从业者和政策制定者对 Prism 的看法和采用情况。我们将使用广义线性模型和生存分析技术来建模数据，以确定干预组和对照组之间是否存在差异。我们将考虑协变量和解释因素。在经济评估中，我们将进行成本效益分析，以确定每避免一次急诊入院的增量成本，并在成本效益分析中考察成本与主要和次要结局变化的关系。我们还将检查整个风险范围内患者的生活质量变化。我们将记录和转录焦点小组和访谈，并进行主题分析。我们已经为这项研究获得了完整的伦理和研发批准，以及信息治理审查小组（IGRP）使用常规数据的许可。我们将遵守 CONSORT 指南，并在国家和国际会议以及同行评议期刊上传播研究结果。
拟议的研究将提供有关 Prism 的成本和效果的信息；它在实践中的使用方式、实施的障碍和促进因素；以及它在支持管理患有和有发展为慢性疾病风险的患者方面的感知价值。
对照临床试验 ISRCTN 编号 ISRCTN55538212。
