NCT03675828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

August 27, 2018

Last Update Submit

September 23, 2019

Conditions

Keywords

Heart FailureDistance HealthVirtual Health

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months

Secondary Outcomes (1)

  • 45-day unplanned readmission and death measures stratified by visit method (virtually or in-person)

    12 months

Study Arms (2)

Virtual Visit

EXPERIMENTAL

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

Outpatient Clinic

NO INTERVENTION

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.

Interventions

Virtual VisitBEHAVIORAL

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.

Virtual Visit

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Wai Hong Wilson Tang, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2018

First Posted

September 18, 2018

Study Start

August 7, 2018

Primary Completion

August 28, 2019

Study Completion

August 28, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations