Heart FailureVIV-HFNCT03675828
Virtual Visits in Heart Failure Care Transitions
A study testing Virtual Visit in people with Heart Failure, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Virtual Visit
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Virtual Visit
- Keywords
- Heart Failure, Distance Health, Virtual Health
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual VisitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start7 Aug 2018
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Tang, The Cleveland Clinic
- Investigators
- Wai Hong Wilson Tang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675828
- Sponsor's protocol ID
- 18-651
- Acronym
- VIV-HF
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32762457
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Visits in Heart Failure Care Transitions
- ClinicalTrials.gov ID
- NCT03675828
- Acronym / sponsor ID
- VIV-HF / 18-651
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Distance Health, Virtual Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Visit | Experimental | Behavioral: Virtual VisitIn 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual VisitThe 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. | Behavioural | Virtual Visit |
Primary outcome
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)
1 secondary outcome
45-day unplanned readmission and death measures stratified by visit method (virtually or in-person)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 32762457Gorodeski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Hong Wilson Tang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Visit in people with Heart Failure, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of completed post discharge visits via virtual visit or in outpatient setting (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03675828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.