Heart FailureNCT03592355
Virtual Visits at Brigham and Women's Hospital
A study testing Virtual Visit in people with Heart Failure and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Clinicians slated for virtual visit rollout will be randomized (stratified by department) to either receive immediate virtual visit on-boarding (intervention arm) or delayed (3-months later) virtual visit on-boarding (control arm). The investigators plan to enroll no more than 200 clinicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Hypertension, Diabetes Mellitus
- What is being tested?
- Virtual Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2018to 1 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinician whose department is chosen for virtual visit rollout
Who cannot join
- Clinician who saw on average fewer than 20 patients monthly over the past 6 months
- Clinician who opts out of virtual visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Virtual Visits at Brigham and Women's Hospital: A Randomized Controlled Trial
Clinicians slated for virtual visit rollout will be randomized (stratified by department) to either receive immediate virtual visit on-boarding (intervention arm) or delayed (3-months later) virtual visit on-boarding (control arm). The investigators plan to enroll no more than 200 clinicians.
Any clinician in a department selected by the Brigham Health Virtual Care team for access to virtual visits is eligible, unless s/he saw less than 20 patients monthly over the last 6 months.
The Brigham Health Virtual Care team will onboard all clinicians and provide virtual visit support as per their usual protocol. The primary study endpoint is third-available appointment, a well-adopted measure of access. Other secondary endpoints revolve around continuity, efficiency, utilization, safety, cost, and patient experience.
Read the detailed description
If enrolled in the intervention arm, the following steps will occur:
- The clinician will receive the intervention arm follow-up email ("Follow-up Email - Intervention" in the Appendix).
- The Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process.
- The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform (attached).
If enrolled in the control arm, the following steps will occur:
- The clinician will receive the control arm follow-up email ("Follow-up Email - Control" in the Appendix).
- Three months from the time of the follow-up email, the Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process.
- The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform (attached).
The investigators plan to follow patients of both clinician cohorts for a total of 6-months. The investigators will perform retrospective review of patient electronic health records and patients will receive a redcap survey (attached), an evaluation mechanism already employed by the Virtual Care team.
Again, aside from the initial randomization and retrospective data collection and analysis, all of the above would have occurred irrespective of this research protocol.
- Conditions
- Heart Failure, Hypertension, Diabetes Mellitus, Stroke, BPH, Hyperlipidemia
- Being tested
- Virtual Visit
- Keywords
- virtual care, virtual visit, telemedicine
- Medical subject headings
- Heart Failure, Hypertension, Diabetes Mellitus, Stroke, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual VisitOther
Clinicians will have a synchronous video visit with their patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | If enrolled in the intervention arm, the following steps will occur:
* The Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process.
* The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform. Receives: Other: Virtual Visit |
| Control | No intervention | If enrolled in the control arm, the following steps will occur: * Three months from the time of the follow-up email, the Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process. * The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days until third available appointment
Number of days until the third available routine appointment, obtained at 12 o'clock each Friday (embargoed appointments not included). The mean of all of the weeks is a clinician's average number of days until the third available routine appointment.
Measured: Through study completion, an average of 6 months
Secondary outcomes (20)
Days until first available appointment
Number of days until the next available routine appointment, obtained at 12 o'clock each Friday (embargoed appointments not included). The mean of all of the weeks is a clinician's average number of days until the next available routine appointment.
Measured: Through study completion, an average of 6 months
Future capacity: percentage of open appointment slots
Percentage of appointment slots that are open and available for booking patients over the next four weeks, obtained at 12 o'clock each Friday (embargoed appointments not included). The mean of all of the weeks is a clinician's future capacity.
Measured: Through study completion, an average of 6 months
Frequency of visits with the usual provider of care
Ratio of the number of visits to the most frequently seen provider to the total number of visits to all providers obtained each month. The mean of all of the months is a clinician's ratio.
Measured: Through study completion, an average of 6 months
Continuity of care index
The number of visits to each individual physician divided by the total number of visits the patient had overall obtained each month. The mean of all of the months is the continuity of care index
Measured: Through study completion, an average of 6 months
No show rate
Ratio of the number of no-show visits to total visit slots obtained each week. The mean of all of the weeks is a clinician's no show rate.
Measured: Through study completion, an average of 6 months
Visit time
In-person: face time with patient per pertinent EHR fields, obtained each week. The mean of all of the weeks is a clinician's visit time.
Virtual: enter virtual waiting room to video stops, obtained each week. The mean of all of the weeks is a clinician's visit time.
Measured: Through study completion, an average of 6 months
Clinician volume per hour
Patients seen per hour, calculated at the end of the study.
Measured: Through study completion, an average of 6 months
Clinician volume per day
Patients seen per day, all calculated at the end of the study.
Measured: Through study completion, an average of 6 months
Clinician volume per month
Patients seen per month, all calculated at the end of the study.
Measured: Through study completion, an average of 6 months
Clinician volume per 6 months
Patients seen per 6 months, all calculated at the end of the study.
Measured: Through study completion, an average of 6 months
Slot utilization
Ratio of used slots to total slots, obtained each week. The mean of all of the weeks is a clinician's slot utilization.
Measured: Through study completion, an average of 6 months
Number of primary care visits
Number of primary care visits
Measured: Through study completion, an average of 6 months
Number of specialist visits
Number of specialist visits
Measured: Through study completion, an average of 6 months
Number of emergency department visits
Number of emergency department visits
Measured: Through study completion, an average of 6 months
Number of inpatient admissions
Number of inpatient admissions
Measured: Through study completion, an average of 6 months
Number of imaging studies
Number of imaging studies ordered
Measured: Through study completion, an average of 6 months
Number of labs ordered
Number of laboratory studies ordered
Measured: Through study completion, an average of 6 months
Number of medications prescribed
Number of medications prescribed
Measured: Through study completion, an average of 6 months
Patient Experience
Brigham Health Virtual Care team survey sent to participating patients
Measured: Sent electronically within 1 week of the in-person or virtual visit
Revenue from virtual or in-person visit
Revenue garnered by an individual clinician for her/his clinical activity, calculated per hour and per 6 months (denominator: total clinical hours worked).
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start13 Apr 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: COVID19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Brigham and Women's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinicians slated for virtual visit rollout will be randomized (stratified by department) to either receive immediate virtual visit on-boarding (intervention arm) or delayed (3-months later) virtual visit on-boarding (control arm).
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
- Investigators
- David Levine, MD, MPH, MA, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592355
- Sponsor's protocol ID
- 2018P000452
- Status last verified
- Sep 2021
- First submitted
- 14 May 2018
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wootton R. Twenty years of telemedicine in chronic disease management--an evidence synthesis. J Telemed Telecare. 2012 Jun;18(4):211-20. doi: 10.1258/jtt.2012.120219.
PubMed 22674020McLean S, Sheikh A, Cresswell K, Nurmatov U, Mukherjee M, Hemmi A, Pagliari C. The impact of telehealthcare on the quality and safety of care: a systematic overview. PLoS One. 2013 Aug 19;8(8):e71238. doi: 10.1371/journal.pone.0071238. eCollection 2013.
PubMed 23977001Dorsey ER, Topol EJ. State of Telehealth. N Engl J Med. 2016 Jul 14;375(2):154-61. doi: 10.1056/NEJMra1601705. No abstract available.
PubMed 27410924
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Visits at Brigham and Women's Hospital: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03592355
- Acronym / sponsor ID
- 2018P000452
- Conditions
- Heart Failure, Hypertension, Diabetes Mellitus, Stroke, BPH, Hyperlipidemia
- Keywords
- virtual care, virtual visit, telemedicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID19 pandemic
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 19 Jul 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.
Clinicians slated for virtual visit rollout will be randomized (stratified by department) to either receive immediate virtual visit on-boarding (intervention arm) or delayed (3-months later) virtual visit on-boarding (control arm). The investigators plan to enroll no more than 200 clinicians.
Any clinician in a department selected by the Brigham Health Virtual Care team for access to virtual visits is eligible, unless s/he saw less than 20 patients monthly over the last 6 months.
The Brigham Health Virtual Care team will onboard all clinicians and provide virtual visit support as per their usual protocol. The primary study endpoint is third-available appointment, a well-adopted measure of access. Other secondary endpoints revolve around continuity, efficiency, utilization, safety, cost, and patient experience.
Detailed description
If enrolled in the intervention arm, the following steps will occur:
- The clinician will receive the intervention arm follow-up email ("Follow-up Email - Intervention" in the Appendix).
- The Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process.
- The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform (attached).
If enrolled in the control arm, the following steps will occur:
- The clinician will receive the control arm follow-up email ("Follow-up Email - Control" in the Appendix).
- Three months from the time of the follow-up email, the Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process.
- The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform (attached).
The investigators plan to follow patients of both clinician cohorts for a total of 6-months. The investigators will perform retrospective review of patient electronic health records and patients will receive a redcap survey (attached), an evaluation mechanism already employed by the Virtual Care team.
Again, aside from the initial randomization and retrospective data collection and analysis, all of the above would have occurred irrespective of this research protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinicians slated for virtual visit rollout will be randomized (stratified by department) to either receive immediate virtual visit on-boarding (intervention arm) or delayed (3-months later) virtual visit on-boarding (control arm).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Virtual VisitIf enrolled in the intervention arm, the following steps will occur: * The Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process. * The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform. |
| Control | No intervention | –If enrolled in the control arm, the following steps will occur: * Three months from the time of the follow-up email, the Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process. * The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinician whose department is chosen for virtual visit rollout
Key exclusion criteria (2 listed)
- Clinician who saw on average fewer than 20 patients monthly over the past 6 months
- Clinician who opts out of virtual visits
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 VisitClinicians will have a synchronous video visit with their patients. | Other | Intervention |
Primary outcome
Days until third available appointment
Time frame: Through study completion, an average of 6 months
Number of days until the third available routine appointment, obtained at 12 o'clock each Friday (embargoed appointments not included). The mean of all of the weeks is a clinician's average number of days until the third available routine appointment.
20 secondary outcomes
Days until first available appointment
Time frame: Through study completion, an average of 6 months
Future capacity: percentage of open appointment slots
Time frame: Through study completion, an average of 6 months
Frequency of visits with the usual provider of care
Time frame: Through study completion, an average of 6 months
Continuity of care index
Time frame: Through study completion, an average of 6 months
No show rate
Time frame: Through study completion, an average of 6 months
Visit time
Time frame: Through study completion, an average of 6 months
Clinician volume per hour
Time frame: Through study completion, an average of 6 months
Clinician volume per day
Time frame: Through study completion, an average of 6 months
Clinician volume per month
Time frame: Through study completion, an average of 6 months
Clinician volume per 6 months
Time frame: Through study completion, an average of 6 months
Slot utilization
Time frame: Through study completion, an average of 6 months
Number of primary care visits
Time frame: Through study completion, an average of 6 months
Number of specialist visits
Time frame: Through study completion, an average of 6 months
Number of emergency department visits
Time frame: Through study completion, an average of 6 months
Number of inpatient admissions
Time frame: Through study completion, an average of 6 months
Number of imaging studies
Time frame: Through study completion, an average of 6 months
Number of labs ordered
Time frame: Through study completion, an average of 6 months
Number of medications prescribed
Time frame: Through study completion, an average of 6 months
Patient Experience
Time frame: Sent electronically within 1 week of the in-person or virtual visit
Revenue from virtual or in-person visit
Time frame: Through study completion, an average of 6 months
Results and safety
The study was stopped early (reason given: COVID19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Background: PubMed 22674020Wootton R. Twenty years of telemedicine in chronic disease management--an evidence synthesis. J Telemed Telecare. 2012 Jun;18(4):211-20. doi: 10.1258/jtt.2012.120219.
- Background: PubMed 23977001McLean S, Sheikh A, Cresswell K, Nurmatov U, Mukherjee M, Hemmi A, Pagliari C. The impact of telehealthcare on the quality and safety of care: a systematic overview. PLoS One. 2013 Aug 19;8(8):e71238. doi: 10.1371/journal.pone.0071238. eCollection 2013.
- Background: PubMed 27410924Dorsey ER, Topol EJ. State of Telehealth. N Engl J Med. 2016 Jul 14;375(2):154-61. doi: 10.1056/NEJMra1601705. 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.
David Levine, MD, MPH, MA principal investigator
Principal Investigator
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 and Hypertension, run by Brigham and Women's Hospital 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 22 Sep 2021. 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 was stopped early (reason given: COVID19 pandemic). 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?
Days until third available appointment (time frame: Through study completion, an average of 6 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 NCT03592355, which also lists 3 linked publications.
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 22 Sep 2021.