Virtual Visits in Heart Failure Care Transitions

Study Overview
=================
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.

Official Title
-----------------
Virtual Visits in Heart Failure Care Transitions

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Virtual Visit


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Visit<br>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<br>* 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.<br>|
| No Intervention: Outpatient Clinic<br>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 | Proportion of patients who complete 7-day post discharge appointment (virtually or in-person) | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Distance Health, Virtual Health