search
Back to results

Virtual Visits in Heart Failure Care Transitions (VIV-HF)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Visit
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Heart Failure, Distance Health, Virtual Health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Hospitalized for primary diagnosis of HF;
  2. Anticipated to be discharged home;
  3. Agreeable to longitudinal post-discharge care at Cleveland Clinic Main Campus in the first few weeks after hospital discharge;
  4. 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:

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Visit

Outpatient Clinic

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of completed post discharge visits via virtual visit or in outpatient setting
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)
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.

Full Information

First Posted
August 27, 2018
Last Updated
September 23, 2019
Sponsor
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT03675828
Brief Title
Virtual Visits in Heart Failure Care Transitions
Acronym
VIV-HF
Official Title
Virtual Visits in Heart Failure Care Transitions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Distance Health, Virtual Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Visit
Arm Type
Experimental
Arm Description
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.
Arm Title
Outpatient Clinic
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of completed post discharge visits via virtual visit or in outpatient setting
Description
Proportion of patients who complete 7-day post discharge appointment (virtually or in-person)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
45-day unplanned readmission and death measures stratified by visit method (virtually or in-person)
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Hong Wilson Tang, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32762457
Citation
Gorodeski EZ, Moennich LA, Riaz H, Jehi L, Young JB, Tang WHW. Virtual Versus In-Person Visits and Appointment No-Show Rates in Heart Failure Care Transitions. Circ Heart Fail. 2020 Aug;13(8):e007119. doi: 10.1161/CIRCHEARTFAILURE.120.007119. Epub 2020 Jul 30. No abstract available.
Results Reference
derived

Learn more about this trial

Virtual Visits in Heart Failure Care Transitions

We'll reach out to this number within 24 hrs