Flink Maria, Lindblad Marléne, Frykholm Oscar, Kneck Åsa, Nilsen Per, Årestedt Kristofer, Ekstedt Mirjam
Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet, Stockholm, Sweden.
Department of Social Work, Karolinska University Hospital, Stockholm, Sweden.
BMJ Open. 2017 Jul 10;7(7):e014178. doi: 10.1136/bmjopen-2016-014178.
Deficient hospital discharging and patients struggling to handle postdischarge self-management have been identified as potential causes of re-hospitalisation rates. Despite an increased interest in interventions aiming to reduce re-hospitalisation rates, there is yet no best evidence on how to support patients in being active participants in their self-management postdischarge. The aim of this paper is to describe the study protocol for an upcoming randomised controlled trial (RCT) of the Supporting Patient in Activation to Home (sPATH) intervention.
METHODS/ANALYSIS: The described study is a randomised, controlled, analysis-blinded, two-site trial, with primary outcome re-hospitalisation within 90 days. In total, 290 participants aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure who are admitted to hospital and who are living in an own home will be eligible for inclusion into an intervention (n=145) or control group (n=145). Patients who need an interpreter to communicate in Swedish, or who have a diagnosis of dementia or cognitive impairment, will be excluded from inclusion. The sPATH intervention, developed with a theoretical base in the self-determination theory, consists of five postdischarge motivational interviewing sessions (face to face or by phone). The intervention covers the self-management areas medication management, follow-up/care plan, symptoms/signs of worsening condition and relations/contacts with healthcare providers. This RCT will add to the literature on evidence to support patient activation in postdischarge self-management.
The study is approved by the Regional Research Ethics Committee (No. 2014/1498-31/2) in Stockholm, Sweden. The results of the study will be published in peer-reviewed journals and presented at international and national scientific conferences.
NCT02823795; Pre-results.
医院出院安排不足以及患者在出院后难以进行自我管理，已被确定为再入院率的潜在原因。尽管人们对旨在降低再入院率的干预措施越来越感兴趣，但对于如何支持患者积极参与出院后的自我管理，尚无最佳证据。本文旨在描述一项即将开展的关于“支持患者积极回归家庭”（sPATH）干预措施的随机对照试验（RCT）的研究方案。
方法/分析：所描述的研究是一项随机、对照、分析设盲的双中心试验，主要结局指标是90天内的再入院情况。共有290名年龄在18岁及以上、患有慢性阻塞性肺疾病或充血性心力衰竭、入院治疗且居住在自己家中的参与者将有资格被纳入干预组（n = 145）或对照组（n = 145）。需要翻译人员协助用瑞典语交流的患者，或被诊断患有痴呆症或认知障碍的患者，将被排除在外。基于自我决定理论开发的sPATH干预措施包括五次出院后的动机性访谈（面对面或通过电话）。该干预涵盖自我管理领域的药物管理、随访/护理计划、病情恶化的症状/体征以及与医疗服务提供者的关系/联系。这项RCT将为支持患者出院后自我管理中的积极参与的证据文献增添内容。
该研究已获得瑞典斯德哥尔摩地区研究伦理委员会（编号2014/1498 - 31/2）的批准。研究结果将发表在同行评审期刊上，并在国际和国内科学会议上展示。
NCT02823795；预结果。
