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临床试验/NCT03053778
NCT03053778已完成不适用

Individualised Follow-up After Valve Surgery

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 1,414 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,414
试验地点
2
主要终点
Reduction of readmission

研究概览

简要总结

This study aims to investigate the effect of an intervention consisting of early, individualised outpatient follow-up after heart valve surgery on unplanned readmissions and death within 180-days after discharge.

Furthermore, Health economics and health-related quality of life will be investigated.

详细描述

The incidence of valvular heart disease is estimated to exceed 42 million people worldwide. In Denmark 1700 patients undergo heart valve surgery every year and the number is increasing due to an ageing population. The most common heart valve diseases is aortic stenosis, followed by mitral regurgitation and aortic regurgitation, whereas only few patients are treated in Denmark for mitral stenosis and primary tricuspid valve and pulmonic valve diseases.

Heart valve surgery can be a lifesaving procedure for patients with severe symptomatic heart valve disease, but complications after heart valve surgery are common and readmissions frequent with rates exceeding 40% in Denmark. Most frequent causes for readmission, includes new onset atrial fibrillation, pleural and pericardial effusions, infections and acute heart failure. These causes can potentially be detected by careful outpatient follow-up in order to avoid unplanned readmission, and improve mental, physical and social health outcomes. A recent Danish study demonstrated that 56% of surgical heart valve patients were readmitted within a year and readmission was associated with low psychical and mental PROs. PROs' include validated patient health status surveys that allow quantification of critical patient-centered outcomes. Further previous studies have suggested an association between PROs and prolonged hospital stay, morbidity and mortality in cardiac patients. Knowledge about PROs can potentially be used to identify patients that especially may benefit from intensified follow-up after heart valve surgery.

Existing guidelines recommend that patients following valve surgery are reviewed on a regular basis by a cardiologist with special knowledge about heart valve diseases. A recent European study demonstrate though, a gap between the existing guidelines and clinical practice. A plausible way to improving the postoperative care could be to introduce a multidisciplinary heart valve clinic (HVC), where specialized nurses educates the patients while intervening and supporting the patients after surgery in collaboration with cardiologist and surgeons. This has proven efficient in improving outcomes such as, mortality, readmission and quality of life in patients with heart failure.3 A multidisciplinary teamwork can provide a timely access to a clinical review of the patient and simultaneously look for signs and symptoms of valve dysfunction.18 Although, previous studies have described the HVCs. Although, previous studies have described the HVCs, the effect gained from HVC compared to usual care on readmission, mortality, cost-utility and patient-reported outcomes have not yet systematically been investigated.

The aim for this study is firstly to describe PROs after heart valve surgery, incorporate the knowledge into a structured intervention, and secondly to evaluate a HVC and its association to PRO's, readmission, mortality and cost-utility.

The study consist of two parts,

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient having Heart Valve Surgery at Odense University Hospital, Denmark

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Early follow-up after discharge

干预措施: Early follow-up (Other)

结局指标

主要结局

Reduction of readmission

时间窗: Up to two years

Reduction of readmission. a controlled prospective intervention trial comparing readmission rates and all-cause mortality in patients undergoing individualized follow-up with a historical control Group. A propensity matching will be performed

次要结局

  • Frailty status after Heart valve surgery(Up to two years)
  • The effect of a Heart valve Clinic on patient-reported outcomes(Up to three years)
  • Differences in costs between the two groups(Up to three years)
  • Quality of Life and associations with readmission(Up to three years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Britt Borregaard

Principal Investigator

Odense University Hospital

研究点 (2)

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