Telehealth Interventions for Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Cardiac Valve Disease; Surgical Complication; Coronary Artery Disease
• Interventions: Procedure: Telehealth Monitoring

• Registration Number: NCT05621954
• Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-18
• Study Start: 2023-04-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

1. Adult patients over 18y referred and accepted for cardiac surgery
2. Able to consent to participate

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Exclusion Criteria

1. Urgent or emergent surgery
2. Surgery planned within 3 weeks of first cardiac surgery outpatient review

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth monitoring	Telehealth Monitoring	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

Primary Outcome Measures

Name	Time	Method
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).
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.

Secondary Outcome Measures

Name	Time	Method
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
Diabetes control	From baseline (randomisation) to admission for surgery (up to 52 weeks)	Change from baseline to admission on HbA1c
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).
Ventilator Time	From admission for surgery to discharge from hospital (up to 52 weeks)	Total cumulative time with invasive ventilation following index procedure
Weight loss	From baseline (randomisation) to admission for surgery (up to 52 weeks)	Change in body mass index on waiting list
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
Length of intensive care stay	From admission for surgery to discharge from hospital (up to 52 weeks)	Total critical care stay for index admission
Length of hospital stay	From admission for surgery to discharge from hospital (up to 52 weeks)	Total in-hospital stay

Trial Locations

Locations (1)

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, Mersey, United Kingdom