Clinical trial NCT05621954: Telehealth Interventions for Cardiac Surgery
Official title: Telehealth for Pre- and Post-Operative Monitoring of Cardiac Surgery Patients - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Valve Disease
Coronary Artery Disease
Surgical Complication
Keywords: Telehealth
Remote Monitoring
Waiting List
Quality of Life
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Liverpool Centre for Cardiovascular Science
First posted: 2022-11-18
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, single-centre, individual patient, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to admission in Healthcare related Quality of Life Change (EQ5D5L)
timeFrame: From baseline to admission for surgery (up to 52 weeks)
measure: Healthcare resource use during waiting list (composite counts of admission to hospital, A&E attendance and primary care appointment utilisation)
timeFrame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Secondary outcomes:
measure: Unplanned admissions pre- and post-surgery
timeFrame: From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks)
measure: Diabetes control
timeFrame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
measure: Smoking cessation
timeFrame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
measure: Post-operative Quality of Life Measures
timeFrame: From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)
measure: Change in post-operative complications
timeFrame: From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)
measure: Length of hospital stay
timeFrame: From admission for surgery to discharge from hospital (up to 52 weeks)
measure: Ventilator Time
timeFrame: From admission for surgery to discharge from hospital (up to 52 weeks)
measure: Length of intensive care stay
timeFrame: From admission for surgery to discharge from hospital (up to 52 weeks)
measure: Weight loss
timeFrame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
state: Mersey
Study officials:
References: