Cardiac Valve Disease, Coronary Artery Disease, Surgical Complication
Conditions
Keywords
Telehealth, Remote Monitoring, Waiting List, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETelehealth Monitoring
Connected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub
Sponsors
Liverpool Centre for Cardiovascular Science
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No masking
Intervention model description
Pragmatic, single-centre, individual patient, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients over 18y referred and accepted for cardiac surgery 2. Able to consent to participate
Exclusion criteria
1. Urgent or emergent surgery 2. Surgery planned within 3 weeks of first cardiac surgery outpatient review
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to admission in Healthcare related Quality of Life Change (EQ5D5L) | 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. |
| Healthcare resource use during waiting list (composite counts of admission to hospital, A&E attendance and primary care appointment utilisation) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking cessation | From baseline (randomisation) to admission for surgery (up to 52 weeks) | Change from baseline to admission on HbA1c |
| Post-operative Quality of Life Measures | From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks) | Healthcare related Quality of Life Change (EQ5D5L change) as an indexed measure from 0 (worst health, equivalent to being dead) to 1 (best health). |
| Change in post-operative complications | From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks) | Rates of post-operative complications including mortality, stroke, lower respiratory tract infections, surgical site infections |
| Unplanned admissions pre- and post-surgery | From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks) | Rates of unplanned admissions to hospital both pre- and post- surgery |
| Ventilator Time | From admission for surgery to discharge from hospital (up to 52 weeks) | Total cumulative time with invasive ventilation following index procedure |
| Length of intensive care stay | From admission for surgery to discharge from hospital (up to 52 weeks) | Total critical care stay for index admission |
| Weight loss | From baseline (randomisation) to admission for surgery (up to 52 weeks) | Change in body mass index on waiting list |
| Length of hospital stay | From admission for surgery to discharge from hospital (up to 52 weeks) | Total in-hospital stay |
| Diabetes control | From baseline (randomisation) to admission for surgery (up to 52 weeks) | Change from baseline to admission on HbA1c |
Countries
United Kingdom
Outcome results
None listed