TelehealthNCT04236583
Improving the Hospital-to-Home Transition Through Post-Discharge Virtual Visits in Primary Care
A study testing Telehealth in people with Telehealth, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to test a new process for having a virtual visit with a primary care doctor after discharge from the hospital, instead of an in-person visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telehealth
- What is being tested?
- Telehealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical inpatients, age >=18, with an existing WCIMA attending as his or her PCP
- Patients with disposition to home
- Medically appropriate for a video visit (as determined by inpatient attending)
- Patients or caregivers must be able to enroll in MyChart before discharge, must be capable of using the Weill Cornell Connect app to do a video visit at home using broadband access or the equivalent (must own a device compatible with the app, e.g.
- smartphone or tablet)
- English speaking
- Cognitively able to participate or Caregiver must be able to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test a new process for having a virtual visit with a primary care doctor after discharge from the hospital, instead of an in-person visit.
Read the detailed description
The goal of this project is to fully develop the protocol for identifying patients who would benefit from a virtual visit and develop the protocol for implementing the virtual visit. The value of this project is that the results will provide ample preliminary data for a future randomized controlled trial to determine the effectiveness of the intervention. This project will have an intervention group only. The hypothesis is that the intervention can be implemented in a way that is feasible and acceptable to providers and patients.
- Conditions
- Telehealth
- Being tested
- Telehealth
- Keywords
- Video Visits, Virtual Visits, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthOther
Also called Video Visits
Post-discharge virtual visit
| Study group | Role | What they receive |
|---|---|---|
| Telehealth | Experimental | Eligible patients will be given the option to consent to having one virtual visit with their primary care physician within four weeks after discharge from the hospital. Usual follow-up care will occur during this visit. Receives: Other: Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients meeting inclusion criteria over the study period out of all patients being discharged over the same time period
Measured: 6 months post-intervention
Proportion of patients who consent to participate out of all those found to be eligible
Measured: 6 months post-intervention
Proportion of patients who successfully schedule video visits out of all of those who consent
Measured: 6 months post-intervention
Proportion of patients who successfully complete video visit out of all of those who scheduled
Measured: 6 months post-intervention
Secondary outcomes (3)
Patient satisfaction with the video visit
Based on a previously validated instrument (Parmanto et. al, Int J Telerehab 2016 Spring; 8(1): 3-10). Measured through 5-point likert scale,free response, multiple choice, and yes/no questions.
Measured: Within one month post-intervention
Physician satisfaction with the video visit
Measured through multiple choice, yes/no, and free-response (only asked if specific responses are received) questions.
Measured: Within one month post-intervention
Number of in-person visits instead of or in addition to video visit
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start28 Feb 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Per IRB COVID-19 guidance on conducting human subjects research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelehealthStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjai Sinha, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236583
- Sponsor's protocol ID
- 19-09020793
- Status last verified
- Apr 2020
- First submitted
- 17 Jan 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Hospital-to-Home Transition Through Post-Discharge Virtual Visits in Primary Care
- ClinicalTrials.gov ID
- NCT04236583
- Acronym / sponsor ID
- 19-09020793
- Conditions
- Telehealth
- Keywords
- Video Visits, Virtual Visits, Telehealth
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Per IRB COVID-19 guidance on conducting human subjects research
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Jan 2020 (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.
The purpose of this study is to test a new process for having a virtual visit with a primary care doctor after discharge from the hospital, instead of an in-person visit.
Detailed description
The goal of this project is to fully develop the protocol for identifying patients who would benefit from a virtual visit and develop the protocol for implementing the virtual visit. The value of this project is that the results will provide ample preliminary data for a future randomized controlled trial to determine the effectiveness of the intervention. This project will have an intervention group only. The hypothesis is that the intervention can be implemented in a way that is feasible and acceptable to providers and patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth | Experimental | Other: TelehealthEligible patients will be given the option to consent to having one virtual visit with their primary care physician within four weeks after discharge from the hospital. Usual follow-up care will occur during this visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Medical inpatients, age >=18, with an existing WCIMA attending as his or her PCP
- Patients with disposition to home
- Medically appropriate for a video visit (as determined by inpatient attending)
- Patients or caregivers must be able to enroll in MyChart before discharge, must be capable of using the Weill Cornell Connect app to do a video visit at home using broadband access or the equivalent (must own a device compatible with the app, e.g.
- smartphone or tablet)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TelehealthAlso: Video VisitsPost-discharge virtual visit | Other | Telehealth |
Primary outcome
Proportion of patients meeting inclusion criteria over the study period out of all patients being discharged over the same time period
Time frame: 6 months post-intervention
Proportion of patients who consent to participate out of all those found to be eligible
Time frame: 6 months post-intervention
Proportion of patients who successfully schedule video visits out of all of those who consent
Time frame: 6 months post-intervention
Proportion of patients who successfully complete video visit out of all of those who scheduled
Time frame: 6 months post-intervention
3 secondary outcomes
Patient satisfaction with the video visit
Time frame: Within one month post-intervention
Physician satisfaction with the video visit
Time frame: Within one month post-intervention
Number of in-person visits instead of or in addition to video visit
Time frame: 6 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- 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.
Sanjai Sinha, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth in people with Telehealth, run by Weill Medical College of Cornell University 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 7 inclusion and 0 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: paused, as of the sponsor's last update on 8 Apr 2020. 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?
Results are not available in the source record.
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 patients meeting inclusion criteria over the study period out of all patients being discharged over the same time period (time frame: 6 months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2020.