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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New Brunswick
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Saint John、New Brunswick、カナダ、E2L4L4
- New Brunswick Heart Centre, Saint John Regional Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
- 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:
Medical reasons for exclusion
- Patients who have unstable or recent unstable cardiac syndrome requiring urgent (within 24hr) or emergent surgery
- Acute endocarditis who are at higher risk for adverse events
- Dialysis dependent who are at higher risk for adverse events
- Patients who have cognitive deficits, visual impairments, inability to read or major difficulties with electronic devices that would preclude use of the intervention
- Patients who do not have any support or potential caregivers to help facilitate their transition home
- Patients undergoing minimally invasive surgery which has been shown to enhance recovery
- 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.
- Patients who are transferred to another hospital for recovery or care.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Participant
Patients who were sent home with the intervention post-surgery
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Telehealth home-monitoring tablet and blood pressure cuff
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介入なし：Historical controls
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rates of emergency room visit and readmission to hospital
時間枠：30 days of discharge post-cardiac surgery
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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
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30 days of discharge post-cardiac surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Length of hospital stay (LOS, days) and discharge disposition
時間枠：Duration of stay at the hospital post-cardiac surgery
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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.
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Duration of stay at the hospital post-cardiac surgery
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Rate of readmission to hospital and/or ER visit and reasons
時間枠：30 days of discharge post-cardiac surgery
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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.
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30 days of discharge post-cardiac surgery
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Percentage of patients who faced difficulties with the Telehealth intervention and causes of the same
時間枠：30 days of discharge post-cardiac surgery
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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.).
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30 days of discharge post-cardiac surgery
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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