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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03675828
Other study ID # 18-651
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 7, 2018
Est. completion date August 28, 2019

Study information

Verified date September 2019
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date August 28, 2019
Est. primary completion date August 28, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 12 months
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