The CASCADE HF Soft Launch and Calibration Phase I and II

NorthShore University HealthSystem

Status and phase: Completed; Phase 3; Phase 2

Conditions: Heart Failure

Treatments: Device: Non-Invasive Continuous Remote Patient Monitoring; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04738279

EH20-288 Cascade Soft Launch

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Phase I: Soft Launch (120 days)

Experimental group

Description:

The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.

Treatment:

Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Device: Non-Invasive Continuous Remote Patient Monitoring

Phase II: Calibration (210 days)

Experimental group

Description:

After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes

Treatment:

Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Device: Non-Invasive Continuous Remote Patient Monitoring