The CASCADE HF Soft Launch and Calibration Phase I and II

Study Overview
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Brief Summary
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Invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring. Our proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, specialists, and surgeons, and has the potential to transform care management in the post-discharge period, where patients are the most vulnerable for readmission.

Official Title
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A Study to Determine the Efficacy of Continuous Ambulatory Wearable Technology and a Cascading Alert System in Reducing 30d Readmission in High Risk Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Non-Invasive Continuous Remote Patient Monitoring
* Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is an inpatient at NorthShore University HealthSystem Patient is on the heart failure consult list Patient has a history of heart failure Patient received at least one dose of IV diuretics at index hospitalization Patient is discharging with NorthShore Home Health services Symptoms corresponding to New York Heart Association function class II-IV Patient has heart failure with reduced left ventricular ejection fraction (LVEF)<40%, or HF with mid-ranged ejection fraction (LVEF 40-50%), or HF with preserved ejection fraction (LVEF≥50%) Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model Patient is at least 18 years of age Patient is fluent in English Patient agrees to protocol-required procedures Exclusion Criteria: Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to maintain patch, phone Patient has allergy to hydrocolloid adhesives Patient has present skin damage preventing them from wearing a study device Patient has renal dysfunction requiring dialysis Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase I: Soft Launch (120 days)<br>The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol. | Device: Non-Invasive Continuous Remote Patient Monitoring<br>* Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway<br>Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring<br>* Survey and qualitative interviewing of participants<br>|
| Experimental: Phase II: Calibration (210 days)<br>After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes | Device: Non-Invasive Continuous Remote Patient Monitoring<br>* Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway<br>Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring<br>* Survey and qualitative interviewing of participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition Rate | Drop out from study | 30 days from patient discharge date | 
| Enrollment Rate | Enrollment rate for entire patient cohort | Through study completion, an average of 30 days for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Diuretic Escalation | Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient. | 30 days from patient discharge date | 
| 30-day Readmission | 30-day readmission to hospital | 30 days from patient discharge date |