VIV-HF: Virtual Visits in Heart Failure Care Transitions

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03675828

Collaborator

(none)

116

Enrollment

Location

Arms

12.7

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the use of virtual visits in the post-discharge care of patients with heart failure. Participants admitted to the hospital with a primary diagnosis of heart failure will be randomized at discharge to either a virtual visit or outpatient visit for their 7-day post discharge follow up visit.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Behavioral: Virtual Visit	N/A

Detailed Description

Published guidelines recommend that patients being discharged home after hospitalization for HF should be offered a 7-day post-discharge outpatient clinic visit as a way to increase engagement with care and reduce risk of poor outcomes. Unfortunately no-show rates for the 7-day post-discharge outpatient visit in this population are high, suggesting poor engagement. The investigators have previously observed a 76% no-show rate at the Cleveland Clinic Main Campus. This study is to evaluate whether use of 7-day post-discharge virtual visit versus in-person visit can improve adherence with post-discharge appointment.

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Virtual Visits in Heart Failure Care Transitions

Actual Study Start Date :

Aug 7, 2018

Actual Primary Completion Date :

Aug 28, 2019

Actual Study Completion Date :

Aug 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Visit In this arm, the 7-day post discharge visit will be completed by a scheduled virtual visit with a member of the study team using the Cleveland Clinic Online Express Care application on a computer or a tablet/phone.	Behavioral: Virtual Visit The Cleveland Clinic Express Care Online application will be used in this intervention. The subjects will have a virtual consult with a clinician from the study team that will mirror an experience had at an outpatient post-discharge visit, including review of systems and medications.
No Intervention: Outpatient Clinic In this arm, the 7-day post discharge visit will be completed by a standard-of-care, in-person outpatient visit with a member of the study team in the heart failure clinic.

Arm

Intervention/Treatment

Experimental: Virtual Visit

In this arm, the 7-day post discharge visit will be completed by a scheduled virtual visit with a member of the study team using the Cleveland Clinic Online Express Care application on a computer or a tablet/phone.

Behavioral: Virtual Visit

The Cleveland Clinic Express Care Online application will be used in this intervention. The subjects will have a virtual consult with a clinician from the study team that will mirror an experience had at an outpatient post-discharge visit, including review of systems and medications.

No Intervention: Outpatient Clinic

In this arm, the 7-day post discharge visit will be completed by a standard-of-care, in-person outpatient visit with a member of the study team in the heart failure clinic.

Outcome Measures

Primary Outcome Measures

Proportion of completed post discharge visits via virtual visit or in outpatient setting [12 months]
Proportion of patients who complete 7-day post discharge appointment (virtually or in-person)

Secondary Outcome Measures

45-day unplanned readmission and death measures stratified by visit method (virtually or in-person) [12 months]
Composite and individual components of unscheduled all-cause first occurrence of (a.) hospital readmission, (b.) emergency department visit, or (c.) death, in the first 45 days after hospital discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hospitalized for primary diagnosis of HF;
Anticipated to be discharged home;
Agreeable to longitudinal post-discharge care at Cleveland Clinic Main Campus in the first few weeks after hospital discharge;
Patient or an individual in their social support network has the ability (equipment and connectivity) to do a virtual visit after hospital discharge;

Exclusion Criteria:

Being transferred to another hospital, or being discharged to an inpatient facility or nursing home;
Being discharged to hospice;
Subject currently enrolled in an interventional research study that requires an in-person clinical visit within 7 days post-discharge.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Wai Hong Wilson Tang, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wilson Tang, Principal Investigator, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT03675828

Other Study ID Numbers:

18-651

First Posted:

Sep 18, 2018

Last Update Posted:

Sep 25, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wilson Tang, Principal Investigator, The Cleveland Clinic

Heart Failure

Distance Health

Virtual Health

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Sep 25, 2019