Heart Failure
Conditions
Brief summary
The study 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, and heart failure specialists, and has the potential to transform heart failure management in the post-discharge period, where patients are the most vulnerable for readmission. This feasibility study will contribute to the understanding of post-discharge heart failure continuous remote patient monitoring, promote patient self-care, and has the potential of improving patient outcomes.
Detailed description
Heart failure is a leading cause of hospital readmission. It results in significant mortality, morbidity, and health care utilization. Effective continuous remote patient monitoring (CRPM) can reduce readmissions, but it has only been realized via invasive monitoring. The study will focus on non-invasive heart failure CRPM through a structured cascading and escalating alert system. In this feasibility study, the study team will use a wearable biosensor and collect ambulatory physiological data that are analyzed by machine learning algorithms, potentially identifying physiological perturbation in heart failure patients. Alerts from this algorithm may be cascaded with other patient status data to inform management by the home health team via a structured protocol. The escalation pathway will engage home health, advanced practitioner providers, and heart failure specialists. In the first aim, the study team will perform a soft launch on five patients with an extensive evaluation to assess feasibility for the pilot trial. In aim 2, the study team will implement the feasibility pilot study. In aim 2a, the study team will conduct surveys and semi-structured interviews with both providers and patients. The surveys and interviews will be applied at three time points (initiation, maintenance, and post-study) to evaluate perceptions, acceptance, and experience of this CRPM solution. In aim 2b, the investigators will leverage temporal data mining, feature extraction, and patient clustering methods to identify valid patterns associated with the pathophysiological events of interest, using continuous physiological data, patient reports, and electronic health record data. The study team will also compare outcome and process measures from our pilot study to a retrospective cohort matched for key demographics and disease severity. This feasibility study will provide key learning for a larger efficacy clinical trial to evaluate if this non-invasive telemonitoring solution tied to structured patient management via cascading and escalating alert pathways can improve outcomes and reduce heart failure readmission.
Interventions
Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and HF care team
Surveys and interviews with enrolled participants
Sponsors
Endeavor Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient is an inpatient at Evanston Hospital * Patient is followed by the heart failure service team after discharge * Patient has a history of heart failure * Patient received at least one dose of IV diuretic at index hospitalization * Symptoms corresponding to NYHA 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 investigator's opinion, limit the patient's ability to maintain patch device and phone * Patient has visual impairments * Patient has an allergy to hydrocolloid adhesives * Patient has present skin damage preventing them from wearing a study device * Patient has renal dysfunction requiring dialysis * Patient has CardioMEMS * Pregnancy * Patient receiving hospice care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | Through study completion, an average 1 year | Enrollment rate for entire patient cohort |
| Adherence Rate | Through study completion, an average of one year | Patient adherence to electronic patient reported outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day Readmission Rate | 30 days from patient discharge date | 30-day readmission rate from the day of discharge |
| Documented Diuretic Escalation | 30 days from patient discharge date | Number of patients on escalated diuretics dosage by the clinical care team during monitoring period |
Countries
United States
Participant flow
Pre-assignment details
The study approached a total of 61 potential participants that signed that consent forms. Out of which 39 completed the study, 16 were screen failed and 6 withdrew the consent. 15 providers participated in the study
Participants by arm
| Arm | Count |
|---|---|
| Pilot 39 eligible HF patients and 15 HF providers
Non-invasive continuous remote monitoring with structured escalation pathway: Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and HF care team
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Surveys and interviews with enrolled participants
Baseline characteristics were not collected for HF proivders | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Pilot |
|---|---|
| Age, Customized | 75 Years |
| Clinical Analytics Prediction Engine (CAPE) Readmission Risk Score | 18 Percentage |
| Comorbidities AFIB | 17 Participants |
| Comorbidities Anxiety | 13 Participants |
| Comorbidities Cardioversion/Cardiac Resynchronization Therapy | 4 Participants |
| Comorbidities CKD | 23 Participants |
| Comorbidities COPD | 9 Participants |
| Comorbidities Depression | 12 Participants |
| Comorbidities Diabetes Mellitus | 17 Participants |
| Comorbidities Hypertension | 29 Participants |
| Comorbidities Implantable Defibrillator | 7 Participants |
| Comorbidities Myocardial infarction | 4 Participants |
| Comorbidities Obesity (BMI) | 20 Participants |
| Discharge Medications ACE/ARB-Antihypertensive medications | 11 Participants |
| Discharge Medications Aldosterone Agonist - Spironolactone | 24 Participants |
| Discharge Medications Beta blockers | 29 Participants |
| Discharge Medications Digoxin | 6 Participants |
| Discharge Medications Loop diuretics | 36 Participants |
| Ejection Fraction | 52 Percentage |
| Ejection Fraction Type Heart failure with mid-range ejection fraction (Ejection Fraction of 41% to 49%) | 4 Participants |
| Ejection Fraction Type Heart failure with preserved ejection fraction (Ejection Fraction of greater than or equal to 50%) | 21 Participants |
| Ejection Fraction Type Heart failure with reduced ejection fraction (Ejection Fraction of less than 39%) | 14 Participants |
| Heart Failure Severity Diastolic Heart Failure | 17 Participants |
| Heart Failure Severity Heart Catherization in Index Stay | 12 Participants |
| Heart Failure Severity New York Heart Association Class II | 4 Participants |
| Heart Failure Severity New York Heart Association Class III | 30 Participants |
| Heart Failure Severity New York Heart Association Class IV | 5 Participants |
| Heart Failure Severity Systolic and Diastolic Heart Failure | 15 Participants |
| Heart Failure Severity Systolic Heart Failure | 6 Participants |
| Heart Failure Severity Unspecified Type of Heart Failure | 1 Participants |
| Insurance Type Commercial | 10 Participants |
| Insurance Type Government | 0 Participants |
| Insurance Type Medicaid | 2 Participants |
| Insurance Type Medicare | 25 Participants |
| Race/Ethnicity, Customized African American | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 24 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized Other | 6 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 23 Participants |
| Smoking Current | 2 Participants |
| Smoking Former | 19 Participants |
| Smoking Never | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Adherence Rate
Patient adherence to electronic patient reported outcomes
Time frame: Through study completion, an average of one year
Population: Number of patients completed at least 80% of the electronic patient reported outcomes survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot | Adherence Rate | 27 Participants |
Primary
Enrollment Rate
Enrollment rate for entire patient cohort
Time frame: Through study completion, an average 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot | Enrollment Rate | 39 Participants |
Secondary
30-day Readmission Rate
30-day readmission rate from the day of discharge
Time frame: 30 days from patient discharge date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot | 30-day Readmission Rate | 6 Participants |
Secondary
Documented Diuretic Escalation
Number of patients on escalated diuretics dosage by the clinical care team during monitoring period
Time frame: 30 days from patient discharge date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot | Documented Diuretic Escalation | 17 Participants |