Telehealth Interventions for Cardiac Surgery

Coronary Artery Disease Clinical Trial

— TICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621954
• Other study ID #: TICS
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 448
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Valve Disease
• Coronary Artery Disease
• Heart Valve Diseases
• Surgical Complication

Intervention

Procedure:
• Telehealth Monitoring
Connected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub

Locations

Country	Name	City	State
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool	Mersey

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust	Liverpool Centre for Cardiovascular Science

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	Diabetes control	Change from baseline to admission on HbA1c	From baseline (randomisation) to admission for surgery (up to 52 weeks)
Secondary	Smoking cessation	Change from baseline to admission on HbA1c	From baseline (randomisation) to admission for surgery (up to 52 weeks)
Secondary	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)
Secondary	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)
Secondary	Length of hospital stay	Total in-hospital stay	From admission for surgery to discharge from hospital (up to 52 weeks)
Secondary	Ventilator Time	Total cumulative time with invasive ventilation following index procedure	From admission for surgery to discharge from hospital (up to 52 weeks)
Secondary	Length of intensive care stay	Total critical care stay for index admission	From admission for surgery to discharge from hospital (up to 52 weeks)
Secondary	Weight loss	Change in body mass index on waiting list	From baseline (randomisation) to admission for surgery (up to 52 weeks)