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临床试验/NCT05349708
NCT05349708已完成不适用

Benefit of a Telehealth Home-monitoring Program for Vulnerable Patients and Patients Living With Frailty Undergoing Heart Surgery

New Brunswick Heart Centre2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Rates of emergency room visit and readmission to hospital

研究概览

简要总结

Cardiac surgical interventions are increasingly offered to vulnerable patients or patients living with frailty. Unfortunately, frailty has been shown to be an independent predictor of poorer outcome and increased health care resources in terms of readmission to hospital or visit to the ER after discharge. We hypothesize that the use of a comprehensive Telehealth home-monitoring program could reduce emergency room visits and re-hospitalization after heart surgery.

Frailty in all patients will be determined using the Edmonton frailty scale (EFS) as is part of the current standard of care for all patients at the NBHC since 2018. We plan to implement the Telehealth intervention on all 120 consecutively enrolled patients identified as vulnerable and/or frail and discharged from hospital within 10 days of their surgery. The primary outcome of interest will be rates of ER visit and readmission to hospital within 30 days of discharge compared to propensity score matched historical control patients. A power calculation suggests that 120 patients per group are necessary explaining why the intervention group will be 120 patients. We chose to compare our intervention to a matched group of 240 individuals from historical data which already captures follows patients 30 days after surgery but is limited in its Telehealth intervention. Duration of the study is 12 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients, aged 55 years or older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement, mitral valve repair/replacement or combined CABG/valve procedures.
  • Patients defined as pre- vulnerable, vulnerable or frail based on the Edmonton frailty scale (> 4 considered pre- vulnerable) as defined prior to surgery

排除标准

  • Medical reasons for exclusion
  • Patients who have unstable or recent unstable cardiac syndrome requiring urgent (within 24hr) or emergent surgery
  • Acute endocarditis who are at higher risk for adverse events
  • Dialysis dependent who are at higher risk for adverse events
  • Patients who have cognitive deficits, visual impairments, inability to read or major difficulties with electronic devices that would preclude use of the intervention
  • Patients who do not have any support or potential caregivers to help facilitate their transition home
  • Patients undergoing minimally invasive surgery which has been shown to enhance recovery
  • Patients unable to be discharged home within 10 days of their surgery. The average length of hospitalization is 5 days with frail patients often requiring additional time but usually within 10 days unless some major barrier exists in allowing discharge home.
  • Patients who are transferred to another hospital for recovery or care.

结局指标

主要结局

Rates of emergency room visit and readmission to hospital

时间窗: 30 days of discharge post-cardiac surgery

The aim was to compare the rate of emergency room visits and readmission to hospital within 30 days of discharge between two groups of patients: frail, post-surgery cardiac surgery patients who went home with the intervention for self-monitoring of health versus historical controls

次要结局

  • Length of hospital stay (LOS, days) and discharge disposition(Duration of stay at the hospital post-cardiac surgery)
  • Rate of readmission to hospital and/or ER visit and reasons(30 days of discharge post-cardiac surgery)
  • Percentage of patients who faced difficulties with the Telehealth intervention and causes of the same(30 days of discharge post-cardiac surgery)

研究者

发起方
New Brunswick Heart Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jean-François Légaré

Clinical Head of Cardiac Surgery

New Brunswick Heart Centre

研究点 (2)

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