The CASCADE HF Soft Launch and Calibration Phase I and II

Phase 2

Completed

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

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Phase II: Calibration (210 days)	Non-Invasive Continuous Remote Patient Monitoring	After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Phase I: Soft Launch (120 days)	Non-Invasive Continuous Remote Patient Monitoring	The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Phase I: Soft Launch (120 days)	Affective Analysis of Participant Response to Continuous Remote Patient Monitoring	The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Phase II: Calibration (210 days)	Affective Analysis of Participant Response to Continuous Remote Patient Monitoring	After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes

Primary Outcome Measures

Name	Time	Method
Attrition Rate	30 days from patient discharge date	Drop out from study
Enrollment Rate	Through study completion, an average of 30 days for each patient	Enrollment rate for entire patient cohort

Secondary Outcome Measures

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