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

Benefit of a Telehealth Home-monitoring Program for Vulnerable Patients and Patients Living With Frailty Undergoing Heart Surgery

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Surgery; Cardiac Event
• Intervention / Treatment: Device: THE-FACS

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L4L4
      • New Brunswick Heart Centre, Saint John Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participant; Patients who were sent home with the intervention post-surgery	Device: THE-FACS; Telehealth home-monitoring tablet and blood pressure cuff
No Intervention: Historical controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of emergency room visit and readmission to hospital	The aim was to compare the rate of emergency room visits and readmission to hospital within 30 days of discharge between two groups of patients: frail, post-surgery cardiac surgery patients who went home with the intervention for self-monitoring of health versus historical controls	30 days of discharge post-cardiac surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay (LOS, days) and discharge disposition	The post-surgery inclusion criterion was the LOS of 10 days or less and home-discharge. The investigators, therefore, assessed the LOS and discharge disposition of the frail participants who consented to participate in the study to understand the challenges in recovery and ability to participate in the study.	Duration of stay at the hospital post-cardiac surgery
Rate of readmission to hospital and/or ER visit and reasons	The aim of the telehealth home monitoring platform was to reduce hospital readmission and/ or ER visits within 30 days of discharge post-cardiac surgery. The investigators, therefore, wanted to explore the rates and causes for the above-mentioned outcomes.	30 days of discharge post-cardiac surgery
Percentage of patients who faced difficulties with the Telehealth intervention and causes of the same	Identification of the major challenges frail participants faced in using a technology-based home monitoring program to self-monitor their health and recovery post-cardiac surgery. A participation-satisfaction questionnaire was used to assess the percentage of patients who could/ count not use the intervention and the reasons for such (technological challenges, connectivity ussies, etc.).	30 days of discharge post-cardiac surgery

Collaborators and Investigators

• Sponsor: New Brunswick Heart Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: follow-up; outcomes; feasibility; technology; hospital readmission; remote care
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 100097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No