- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675828
Virtual Visits in Heart Failure Care Transitions (VIV-HF)
September 23, 2019 updated by: Wilson Tang, The Cleveland Clinic
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of completed post discharge visits via virtual visit or in outpatient setting
Time Frame: 12 months
|
Proportion of patients who complete 7-day post discharge appointment (virtually or in-person)
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
45-day unplanned readmission and death measures stratified by visit method (virtually or in-person)
Time Frame: 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.
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wai Hong Wilson Tang, MD, The Cleveland Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2018
Primary Completion (Actual)
August 28, 2019
Study Completion (Actual)
August 28, 2019
Study Registration Dates
First Submitted
August 27, 2018
First Submitted That Met QC Criteria
September 14, 2018
First Posted (Actual)
September 18, 2018
Study Record Updates
Last Update Posted (Actual)
September 25, 2019
Last Update Submitted That Met QC Criteria
September 23, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-651
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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