Telehealth Home-monitoring for Frailty in Cardiac Surgery (THE-FACS)

New Brunswick Heart Centre

Status: Completed

Conditions: Surgery; Frailty; Cardiac Event

Treatments: Device: THE-FACS

Study type: Interventional

Funder types: Other

Identifiers

NCT05349708

100097

Details and patient eligibility

About

Cardiac surgical interventions are increasingly offered to vulnerable patients or patients living with frailty. Unfortunately, frailty has been shown to be an independent predictor of poorer outcome and increased health care resources in terms of readmission to hospital or visit to the ER after discharge. We hypothesize that the use of a comprehensive Telehealth home-monitoring program could reduce emergency room visits and re-hospitalization after heart surgery.

Frailty in all patients will be determined using the Edmonton frailty scale (EFS) as is part of the current standard of care for all patients at the NBHC since 2018. We plan to implement the Telehealth intervention on all 120 consecutively enrolled patients identified as vulnerable and/or frail and discharged from hospital within 10 days of their surgery. The primary outcome of interest will be rates of ER visit and readmission to hospital within 30 days of discharge compared to propensity score matched historical control patients. A power calculation suggests that 120 patients per group are necessary explaining why the intervention group will be 120 patients. We chose to compare our intervention to a matched group of 240 individuals from historical data which already captures follows patients 30 days after surgery but is limited in its Telehealth intervention. Duration of the study is 12 months.

Enrollment: 64 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients, aged 55 years or older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement, mitral valve repair/replacement or combined CABG/valve procedures.
2. Patients defined as pre- vulnerable, vulnerable or frail based on the Edmonton frailty scale (> 4 considered pre- vulnerable) as defined prior to surgery

Exclusion criteria

1. Medical reasons for exclusion

   1. Patients who have unstable or recent unstable cardiac syndrome requiring urgent (within 24hr) or emergent surgery
   2. Acute endocarditis who are at higher risk for adverse events

2. Dialysis dependent who are at higher risk for adverse events

3. Patients who have cognitive deficits, visual impairments, inability to read or major difficulties with electronic devices that would preclude use of the intervention

4. Patients who do not have any support or potential caregivers to help facilitate their transition home

5. Patients undergoing minimally invasive surgery which has been shown to enhance recovery

6. Patients unable to be discharged home within 10 days of their surgery. The average length of hospitalization is 5 days with frail patients often requiring additional time but usually within 10 days unless some major barrier exists in allowing discharge home.

7. Patients who are transferred to another hospital for recovery or care.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Participant

Experimental group

Description:

Patients who were sent home with the intervention post-surgery

Treatment:

Device: THE-FACS

Historical controls

No Intervention group