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: 1. Can telehealth improve quality of life prior to surgery 2. 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
318
Connected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub
Liverpool Heart and Chest Hospital
Liverpool, Mersey, United Kingdom
Change from baseline to admission in Healthcare related Quality of Life Change (EQ5D5L)
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.
Time frame: From baseline to admission for surgery (up to 52 weeks)
Healthcare resource use during waiting list (composite counts of admission to hospital, A&E attendance and primary care appointment utilisation)
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).
Time frame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Unplanned admissions pre- and post-surgery
Rates of unplanned admissions to hospital both pre- and post- surgery
Time frame: From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks)
Diabetes control
Change from baseline to admission on HbA1c
Time frame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Smoking cessation
Change from baseline to admission on HbA1c
Time frame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Post-operative Quality of Life Measures
Healthcare related Quality of Life Change (EQ5D5L change) as an indexed measure from 0 (worst health, equivalent to being dead) to 1 (best health).
Time frame: From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)
Change in post-operative complications
Rates of post-operative complications including mortality, stroke, lower respiratory tract infections, surgical site infections
Time frame: From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)
Length of hospital stay
Total in-hospital stay
Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)
Ventilator Time
Total cumulative time with invasive ventilation following index procedure
Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)
Length of intensive care stay
Total critical care stay for index admission
Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)
Weight loss
Change in body mass index on waiting list
Time frame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
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