Clinical trial NCT03592355: 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
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Hypertension
Diabetes Mellitus
Stroke
BPH
Hyperlipidemia
Keywords: virtual care
virtual visit
telemedicine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Days until third available appointment
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Days until first available appointment
timeFrame: Through study completion, an average of 6 months
measure: Future capacity: percentage of open appointment slots
timeFrame: Through study completion, an average of 6 months
measure: Frequency of visits with the usual provider of care
timeFrame: Through study completion, an average of 6 months
measure: Continuity of care index
timeFrame: Through study completion, an average of 6 months
measure: No show rate
timeFrame: Through study completion, an average of 6 months
measure: Visit time
timeFrame: Through study completion, an average of 6 months
measure: Clinician volume per hour
timeFrame: Through study completion, an average of 6 months
measure: Clinician volume per day
timeFrame: Through study completion, an average of 6 months
measure: Clinician volume per month
timeFrame: Through study completion, an average of 6 months
measure: Clinician volume per 6 months
timeFrame: Through study completion, an average of 6 months
measure: Slot utilization
timeFrame: Through study completion, an average of 6 months
measure: Number of primary care visits
timeFrame: Through study completion, an average of 6 months
measure: Number of specialist visits
timeFrame: Through study completion, an average of 6 months
measure: Number of emergency department visits
timeFrame: Through study completion, an average of 6 months
measure: Number of inpatient admissions
timeFrame: Through study completion, an average of 6 months
measure: Number of imaging studies
timeFrame: Through study completion, an average of 6 months
measure: Number of labs ordered
timeFrame: Through study completion, an average of 6 months
measure: Number of medications prescribed
timeFrame: Through study completion, an average of 6 months
measure: Patient Experience
timeFrame: Sent electronically within 1 week of the in-person or virtual visit
measure: Revenue from virtual or in-person visit
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Principal Investigator
name: David Levine, MD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.