The CASCADE HF Calibration and Testing Phase I and II
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Soft Launch 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: Calibration 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
|
Outcome Measures
Primary Outcome Measures
- Attrition rate [30 days from patient discharge date]
Drop out from study
- Enrollment rate [through study completion, an average of 1 year]
Enrollment rate for entire patient cohort
- Adherence rate [through study completion, an average of 1 year]
Patient adherence to patch, daily patient reported status updates and other study requirements
- Time from discharge to first non-adherence event [30 days from patient discharge date]
Days from discharge to first non-adherence event, such as non-compliant use of wearable device
Secondary Outcome Measures
- Documented Medication adherence counseling [30 days from patient discharge date]
Frequency of medication adherence counseling captured in a note within the electronic health record
- Documented Dietary counseling [30 days from patient discharge date]
Frequency of dietary counseling captured in a note within the electronic health record
- Earliness metric [30 days from patient discharge date]
Number of days between the date of the first MCI alert to date of readmission
- Diuretic escalation [30 days from patient discharge date]
Type and frequency of augmenting diuretic dosage
- 30-day readmission [30 days from patient discharge date]
30-day readmission
- Average number of events [30 days from patient discharge date]
Number of readmission within of 30 days
- Average time from discharge to readmission [through study completion, an average of 1 year]
Average time from discharge to readmission
- Communication with care team [30 days from patient discharge date]
Type and frequency of escalation to the care team including home health nurses, advanced practitioner providers, or cardiologist
Eligibility Criteria
Criteria
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
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Patient received at least one dose of IV diuretics at index hospitalization
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Patient is discharging with NorthShore Home Health services
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Symptoms corresponding to New York Heart Association function class II-IV
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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 (LVEFâ„50%)
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Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model
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Patient is at least 18 years of age
-
Patient is fluent in English
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NorthShore University HealthSystem Evanston Hospital | Evanston | Illinois | United States | 60201 |
Sponsors and Collaborators
- NorthShore University HealthSystem
- physIQ, Inc.
- Carnegie Mellon University
- Northwestern University
Investigators
- Principal Investigator: Nirav S Shah, MD, MPH, NorthShore University HealthSystem
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EH20-288