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Virtual Visits at Brigham and Women's Hospital

Primary Purpose

Heart Failure, Hypertension, Diabetes Mellitus

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Visit
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring virtual care, virtual visit, telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
Clinician volume per hour
Patients seen per hour, calculated at the end of the study.
Clinician volume per day
Patients seen per day, all calculated at the end of the study.
Clinician volume per month
Patients seen per month, all calculated at the end of the study.
Clinician volume per 6 months
Patients seen per 6 months, all calculated at the end of the study.
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.
Number of primary care visits
Number of primary care visits
Number of specialist visits
Number of specialist visits
Number of emergency department visits
Number of emergency department visits
Number of inpatient admissions
Number of inpatient admissions
Number of imaging studies
Number of imaging studies ordered
Number of labs ordered
Number of laboratory studies ordered
Number of medications prescribed
Number of medications prescribed
Patient Experience
Brigham Health Virtual Care team survey sent to participating patients
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).

Full Information

First Posted
May 14, 2018
Last Updated
September 15, 2021
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03592355
Brief Title
Virtual Visits at Brigham and Women's Hospital
Official Title
Virtual Visits at Brigham and Women's Hospital: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID19 pandemic
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Hypertension, Diabetes Mellitus, Stroke, BPH, Hyperlipidemia
Keywords
virtual care, virtual visit, telemedicine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Visit
Intervention Description
Clinicians will have a synchronous video visit with their patients.
Primary Outcome Measure Information:
Title
Days until third available appointment
Description
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.
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Days until first available appointment
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
Future capacity: percentage of open appointment slots
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
Frequency of visits with the usual provider of care
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
Continuity of care index
Description
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
Time Frame
Through study completion, an average of 6 months
Title
No show rate
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
Visit time
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
Clinician volume per hour
Description
Patients seen per hour, calculated at the end of the study.
Time Frame
Through study completion, an average of 6 months
Title
Clinician volume per day
Description
Patients seen per day, all calculated at the end of the study.
Time Frame
Through study completion, an average of 6 months
Title
Clinician volume per month
Description
Patients seen per month, all calculated at the end of the study.
Time Frame
Through study completion, an average of 6 months
Title
Clinician volume per 6 months
Description
Patients seen per 6 months, all calculated at the end of the study.
Time Frame
Through study completion, an average of 6 months
Title
Slot utilization
Description
Ratio of used slots to total slots, obtained each week. The mean of all of the weeks is a clinician's slot utilization.
Time Frame
Through study completion, an average of 6 months
Title
Number of primary care visits
Description
Number of primary care visits
Time Frame
Through study completion, an average of 6 months
Title
Number of specialist visits
Description
Number of specialist visits
Time Frame
Through study completion, an average of 6 months
Title
Number of emergency department visits
Description
Number of emergency department visits
Time Frame
Through study completion, an average of 6 months
Title
Number of inpatient admissions
Description
Number of inpatient admissions
Time Frame
Through study completion, an average of 6 months
Title
Number of imaging studies
Description
Number of imaging studies ordered
Time Frame
Through study completion, an average of 6 months
Title
Number of labs ordered
Description
Number of laboratory studies ordered
Time Frame
Through study completion, an average of 6 months
Title
Number of medications prescribed
Description
Number of medications prescribed
Time Frame
Through study completion, an average of 6 months
Title
Patient Experience
Description
Brigham Health Virtual Care team survey sent to participating patients
Time Frame
Sent electronically within 1 week of the in-person or virtual visit
Title
Revenue from virtual or in-person visit
Description
Revenue garnered by an individual clinician for her/his clinical activity, calculated per hour and per 6 months (denominator: total clinical hours worked).
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Levine, MD, MPH, MA
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22674020
Citation
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.
Results Reference
background
PubMed Identifier
23977001
Citation
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.
Results Reference
background
PubMed Identifier
27410924
Citation
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.
Results Reference
background

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Virtual Visits at Brigham and Women's Hospital

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