Clinical trial NCT05349708: Telehealth Home-monitoring for Frailty in Cardiac Surgery
Official title: Benefit of a Telehealth Home-monitoring Program for Vulnerable Patients and Patients Living With Frailty Undergoing Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Surgery
Cardiac Event
Keywords: technology
outcomes
hospital readmission
feasibility
follow-up
remote care
Lead sponsor: New Brunswick Heart Centre
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rates of emergency room visit and readmission to hospital
timeFrame: 30 days of discharge post-cardiac surgery
Secondary outcomes:
measure: Length of hospital stay (LOS, days) and discharge disposition
timeFrame: Duration of stay at the hospital post-cardiac surgery
measure: Rate of readmission to hospital and/or ER visit and reasons
timeFrame: 30 days of discharge post-cardiac surgery
measure: Percentage of patients who faced difficulties with the Telehealth intervention and causes of the same
timeFrame: 30 days of discharge post-cardiac surgery
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: New Brunswick Heart Centre, Saint John Regional Hospital
state: New Brunswick
Study officials:
affiliation: New Brunswick Heart Centre
name: Jean-François Légaré, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: