Telehealth for Pre- and Post-Operative Monitoring of Cardiac Surgery Patients - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Healthcare resource use during waiting list (composite counts of admission to hospital, A&E attendance and primary care appointment utilisation)
研究概览
简要总结
The goal of this clinical trial is to compare telehealth monitoring at home against usual care in patients undergoing planned heart surgery. The main questions it aims to answer are:
- Can telehealth improve quality of life prior to surgery
- Can telehealth prevent serious deterioration requiring hospital or primary care attendance
Participants awaiting heart surgery will be randomly allocated to either telehealth remote monitoring of symptoms, blood pressure, heart rate, oxygen levels and activity levels or they will be allocated to usual care which is unmonitored on the waiting list for surgery.
Researchers will compare telehealth to usual care to see if it improves quality of life or prevents deteriorations on the waiting list.
详细描述
Patients on elective cardiac surgery waiting lists can deteriorate, presenting via acute services as urgent inpatients as a result of their decompensation and facing increased surgical risk. With increases in waiting times prevalent through the country, and healthcare resources under pressure from Covid-related backlogs, it is imperative to find ways to monitor and escalate the most vulnerable patients and to provide safe methods of providing healthcare interventions outside conventional hospital settings. Remote monitoring identifies patients at need, and allows tertiary-care led interventions to prevent deterioration in the first instance. Such facilities could also enhance recovery following treatment and reduce the risks of complications and readmissions post-operatively.
The benefits and risks of such programmes is, however, not well understood: additional monitoring may increase the burden of responsibility on patients or monitoring facilities without providing additional safeguards to the patient. The advantages of early detection may not translate into improved outcomes and the onus on the patient to report in may reduce quality of life rather than enhance it.
The researchers therefore seek to identify if telehealth monitoring can improve health related quality of life, reduce unplanned admissions and healthcare resource utilisation and enhance pre-habilitation using protocolised patient engagement facilities to reduce complications and improve risk-stratification metrics such as smoking status, diabetic control and BMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 18y referred and accepted for cardiac surgery
- •Able to consent to participate
排除标准
- •Urgent or emergent surgery
- •Surgery planned within 3 weeks of first cardiac surgery outpatient review
结局指标
主要结局
Healthcare resource use during waiting list (composite counts of admission to hospital, A&E attendance and primary care appointment utilisation)
时间窗: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Composite counts of admissions to hospital, Accident \& Emergency hospital attendance, and primary care appointments for this health condition or complications of this health condition adjudicated by the research team. The counts will be accrued from baseline (randomisation) to admission for surgery (up to 52 weeks).
Change from baseline to admission in Healthcare related Quality of Life Change (EQ5D5L)
时间窗: From baseline to admission for surgery (up to 52 weeks)
EQ5D5L will be measured by electronic questionnaire by the patient or a researcher on their behalf and indexed for representation on a scale from 0 (worst health, equivalent to being dead) - 1 (best health). The difference in measures between baseline (randomisation) and admission for surgery (up to 52 weeks) will be measured.
次要结局
- Unplanned admissions pre- and post-surgery(From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks))
- Diabetes control(From baseline (randomisation) to admission for surgery (up to 52 weeks))
- Smoking cessation(From baseline (randomisation) to admission for surgery (up to 52 weeks))
- Post-operative Quality of Life Measures(From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks))
- Ventilator Time(From admission for surgery to discharge from hospital (up to 52 weeks))
- Weight loss(From baseline (randomisation) to admission for surgery (up to 52 weeks))
- Change in post-operative complications(From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks))
- Length of intensive care stay(From admission for surgery to discharge from hospital (up to 52 weeks))
- Length of hospital stay(From admission for surgery to discharge from hospital (up to 52 weeks))