- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03592355
Virtual Visits at Brigham and Women's Hospital
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinician whose department is chosen for virtual visit rollout
Exclusion Criteria:
- Clinician who saw on average fewer than 20 patients monthly over the past 6 months
- Clinician who opts out of virtual visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
If enrolled in the intervention arm, the following steps will occur:
|
Clinicians will have a synchronous video visit with their patients.
|
No Intervention: Control
If enrolled in the control arm, the following steps will occur:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days until first available appointment
Time Frame: Through study completion, an average of 6 months
|
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.
|
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
|
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.
|
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
|
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.
|
Through study completion, an average of 6 months
|
Continuity of care index
Time Frame: Through study completion, an average of 6 months
|
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
|
Through study completion, an average of 6 months
|
No show rate
Time Frame: Through study completion, an average of 6 months
|
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.
|
Through study completion, an average of 6 months
|
Visit time
Time Frame: Through study completion, an average of 6 months
|
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. |
Through study completion, an average of 6 months
|
Clinician volume per hour
Time Frame: Through study completion, an average of 6 months
|
Patients seen per hour, calculated at the end of the study.
|
Through study completion, an average of 6 months
|
Clinician volume per day
Time Frame: Through study completion, an average of 6 months
|
Patients seen per day, all calculated at the end of the study.
|
Through study completion, an average of 6 months
|
Clinician volume per month
Time Frame: Through study completion, an average of 6 months
|
Patients seen per month, all calculated at the end of the study.
|
Through study completion, an average of 6 months
|
Clinician volume per 6 months
Time Frame: Through study completion, an average of 6 months
|
Patients seen per 6 months, all calculated at the end of the study.
|
Through study completion, an average of 6 months
|
Slot utilization
Time Frame: Through study completion, an average of 6 months
|
Ratio of used slots to total slots, obtained each week.
The mean of all of the weeks is a clinician's slot utilization.
|
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 primary care visits
|
Through study completion, an average of 6 months
|
Number of specialist visits
Time Frame: Through study completion, an average of 6 months
|
Number of specialist visits
|
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 emergency department visits
|
Through study completion, an average of 6 months
|
Number of inpatient admissions
Time Frame: Through study completion, an average of 6 months
|
Number of inpatient admissions
|
Through study completion, an average of 6 months
|
Number of imaging studies
Time Frame: Through study completion, an average of 6 months
|
Number of imaging studies ordered
|
Through study completion, an average of 6 months
|
Number of labs ordered
Time Frame: Through study completion, an average of 6 months
|
Number of laboratory studies ordered
|
Through study completion, an average of 6 months
|
Number of medications prescribed
Time Frame: Through study completion, an average of 6 months
|
Number of medications prescribed
|
Through study completion, an average of 6 months
|
Patient Experience
Time Frame: Sent electronically within 1 week of the in-person or virtual visit
|
Brigham Health Virtual Care team survey sent to participating patients
|
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
|
Revenue garnered by an individual clinician for her/his clinical activity, calculated per hour and per 6 months (denominator: total clinical hours worked).
|
Through study completion, an average of 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Levine, MD, MPH, MA, Principal Investigator
Publications and helpful links
General 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.
- Dorsey ER, Topol EJ. State of Telehealth. N Engl J Med. 2016 Jul 14;375(2):154-61. doi: 10.1056/NEJMra1601705. No abstract available.
- McLean 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P000452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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