Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions

NCT ID: NCT04905160

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-18
• Study Completion Date: 2026-12-22

Brief Summary

Heart failure is a syndrome that is defined by distinctive clinical, hemodynamic, and neurohormonal findings. HF represents a final common pathway for many different cardiovascular diseases, including coronary disease, hypertension, Valvular disease, and many primary heart muscle diseases. Clinically, HF patients experience dyspnea, fatigue and diminished exercise tolerance, reflecting elevated left and/or right ventricular filling pressures and decreased cardiac output.

Detailed Description

Heart failure patients are frequently hospitalized and have a high mortality rate and accounts for over 1 million hospital admissions yearly in the U.S. It is associated with a 2-year mortality rate of up to 40% to 50. The annual mortality rate for Acute Decompensated Heart Failure (ADHF) is 21%. ADHF initial hospitalization mortality rates range from 4% to 7%, with mortality as high as 22% in high risk patients. About 30% to 60% of ADHF patients are readmitted within 3-6 months after discharge from the first hospitalization. Inpatient treatment for ADHF consists of diuretics, vasodilators and inotropes. Hospital admissions for ADHF have increased precipitously during the past few decades and are projected to continue to increase in the future. To optimize patient outcomes and reduce the costs associated with this disorder, evidenced-based device and pharmacotherapy is essential. Diuretics, Beta blockers, RAAS blockers and cardiac resynchronization therapy are all useful to some extent in improving outcomes of quality of life and survival. In spite of optimized therapy, there is still relentless progression of disease and clinical exacerbations of fluid retention that precipitates hospital admissions and readmissions increasing poor quality outcomes as well as the cost burden for individual, hospitals, ACOs, payers and society as a whole. There is an urgent need to decrease hospital readmissions in Post Myocardial Infarction patients and subjects with recurrent CHF. This project will use patient empowerment and new technologies to increase QOL of patients as well as to reduce readmissions

Conditions

Heart Failure; ADHF; Acute MI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MI

Phase 1 subjects 18 years or above hospitalized with a primary diagnosis of ADHF or acute MI. Patients will measure their vitals Weight, Sitting BP, Fluid Status, Heart Rate, Respiration Rate each morning for 30 days after discharge. The monitoring of this data of each patient daily will be done by dedicated H2O care team and hospitalist. The hospitalist will coordinate with the patient, the home health team, SNFs and the cardiologists as needed to correct/treat any major abnormalities picked up by the remote monitoring system in order to prevent readmissions. Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Group Type: EXPERIMENTAL

COMPASSION Digital Biomarker

Intervention Type: OTHER

Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Subjects Testing Positive Covid-19 Antigen Test

Phase 2 subjects 50 years or older with positive Covid-19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in this arm of the study. Subjects will be randomized within 48 hours of Covid-19 antigen positive status. Patients will measure their vitals Weight, Sitting BP, Fluid Status, Heart Rate, Respiration Rate each morning for 30 days after discharge. The monitoring of this data of each patient daily will be done by dedicated H2O care team and hospitalist. The hospitalist will coordinate with the patient, the home health team, SNFs and the cardiologists as needed to correct/treat any major abnormalities picked up by the remote monitoring system in order to prevent readmissions. Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Group Type: EXPERIMENTAL

COMPASSION Digital Biomarker

Intervention Type: OTHER

Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Interventions

COMPASSION Digital Biomarker

Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Men and women over 18 years of age are included. Eligible subjects must be hospitalized with a primary diagnosis of ADHF or acute MI. The diagnosis of HF is established by the presence of typical symptoms, signs, and objective evidence of pulmonary congestion, elevated BNP or N-terminal pro B-type natriuretic peptide (NT-pro BNP) or impaired cardiac function. Acute MI is diagnosed by presence of chest pain, arm pain, or dyspnea with elevated Troponin and/or EKG changes suggestive of Acute coronary syndrome requiring intervention or optimal medical therapy.

Exclusion Criteria

1. Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2

2. All subjects 18 years or above will be a criteria for inclusion for Phase 1

3. For Phase 2, men and women 50 years or older with positive Covid19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in the intervention arm of the study;

4. For phase 2, subjects should be able to be randomized within 48 hours of Covid19 antigen positive status

5. Patients considered unreliable by the investigator concerning the requirements for follow-up visits

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TwinEpidemic

UNKNOWN

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: collaborator

Intel Corporation

INDUSTRY

Sponsor Role: collaborator

Heart Health Organization East Valley

UNKNOWN

Sponsor Role: collaborator

Aventyn, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kris Vijay, MD

Role: STUDY_CHAIR

Abrazo Arizona Heart

Raj Bhat, MD

Role: STUDY_DIRECTOR

Pioneer Hospitalists

Zaki Lababidi, MD

Role: PRINCIPAL_INVESTIGATOR

Gilbert Cardiology

Ashok Solsi, MD

Role: PRINCIPAL_INVESTIGATOR

Premier Cardiovascular Center

Locations

Multiple Locations

Phoenix, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Navin Govind

Role: CONTACT

vitalbeat@aventyn.com

2317942328

Sharolynn Mclurg

Role: CONTACT

Facility Contacts

Puja Chandler

Role: primary

Other Identifiers

AVDH 001

Identifier Type: -

Identifier Source: org_study_id