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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675828
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Wilson Tang, The Cleveland Clinic

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : August 7, 2018
Actual Primary Completion Date : August 28, 2019
Actual Study Completion Date : August 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675828


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Wai Hong Wilson Tang, MD The Cleveland Clinic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wilson Tang, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03675828    
Other Study ID Numbers: 18-651
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wilson Tang, The Cleveland Clinic:
Heart Failure
Distance Health
Virtual Health
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases