The CASCADE HF Soft Launch and Calibration Phase I and II

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Non-Invasive Continuous Remote Patient Monitoring; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Nirav S Shah, MD, MPH; Phone Number: 8475704208; Email: nshah2@northshore.org

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem Evanston Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase I: Soft Launch (120 days); 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; 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; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring; Survey and qualitative interviewing of participants
Experimental: Phase II: Calibration (210 days); 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; 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; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring; Survey and qualitative interviewing of participants

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Collaborators: Northwestern University; physIQ, Inc.; Carnegie Mellon University
• Investigators: Principal Investigator: Nirav S Shah, MD, MPH, NorthShore University HealthSystem

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: EH20-288 Cascade Soft Launch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No