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

22. april 2022 opdateret af: Dr. Jean-François Légaré, New Brunswick Heart Centre

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Participant
Patients who were sent home with the intervention post-surgery
Enhed: THE-FACS
Telehealth home-monitoring tablet and blood pressure cuff
Ingen indgriben: Historical controls

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rates of emergency room visit and readmission to hospital
Tidsramme: 30 days of discharge post-cardiac surgery
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of hospital stay (LOS, days) and discharge disposition
Tidsramme: Duration of stay at the hospital post-cardiac surgery
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
Tidsramme: 30 days of discharge post-cardiac surgery
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
Tidsramme: 30 days of discharge post-cardiac surgery
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

New Brunswick Heart Centre

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. oktober 2019

Primær færdiggørelse (Faktiske)

18. marts 2020

Studieafslutning (Faktiske)

31. december 2021

Datoer for studieregistrering

Først indsendt

6. april 2022

Først indsendt, der opfyldte QC-kriterier

22. april 2022

Først opslået (Faktiske)

27. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 100097

Plan for individuelle deltagerdata (IPD)

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Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med THE-FACS

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner