Telehealth Interventions for Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Telehealth for Pre- and Post-Operative Monitoring of Cardiac Surgery Patients - A Randomised Controlled Trial

Conditions
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Cardiac Valve Disease, Coronary Artery Disease, Surgical Complication

Intervention / Treatment
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* Procedure: Telehealth Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients over 18y referred and accepted for cardiac surgery Able to consent to participate Exclusion Criteria: Urgent or emergent surgery Surgery planned within 3 weeks of first cardiac surgery outpatient review

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, single-centre, individual patient, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth monitoring<br>Telehealth remote monitoring provided by a specialised service with a monitoring and patient education app featuring: Symptom, blood pressure, weight, heart rate and oxygen saturation monitoring with optional step counters Customised algorithms with patient feedback for prehabilitation (e.g. patient self-reporting of symptoms, activities and health-related activities with positive feedback loops and recommendations for self-directed management) Centralised weekly review and escalation to expedited surgery if deteriorations noted Post-operative monitoring with symptom, blood pressure, weight, heart rate, oxygen saturation and photographic wound review with optional step counters | Procedure: Telehealth Monitoring<br>* Connected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub<br>* Other names: Doc@Home;|
| No Intervention: Standard of Care<br>Standard of care will be no remote monitoring for patients whilst on the waiting list or after discharge from hospital. Access to tertiary services for advice, information or to report deteriorations will be through conventional existing modes such as printed or online literature provided at the time of outpatient review, telephone access to administrative staff allowing clinical information to be conveyed to the usual care team, and local primary care and emergency services for acute deteriorations. Existing standard of care remote services (e.g. wound monitoring by digital photograph reviews) will continue. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | From baseline (randomisation) to admission for surgery (up to 52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned admissions pre- and post-surgery | Rates of unplanned admissions to hospital both pre- and post- surgery | From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks) | 
| Diabetes control | Change from baseline to admission on HbA1c | From baseline (randomisation) to admission for surgery (up to 52 weeks) | 
| Smoking cessation | Change from baseline to admission on HbA1c | 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). | 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 | From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks) | 
| Length of hospital stay | Total in-hospital stay | From admission for surgery to discharge from hospital (up to 52 weeks) | 
| Ventilator Time | Total cumulative time with invasive ventilation following index procedure | From admission for surgery to discharge from hospital (up to 52 weeks) | 
| Length of intensive care stay | Total critical care stay for index admission | From admission for surgery to discharge from hospital (up to 52 weeks) | 
| Weight loss | Change in body mass index on waiting list | From baseline (randomisation) to admission for surgery (up to 52 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Remote Monitoring, Waiting List, Quality of Life