- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106388
Virtual Behavioral Health Integration (VBHI)
April 19, 2022 updated by: Wake Forest University Health Sciences
An Evaluation of Virtual Behavioral Health Integration Into Primary Care
The primary objective is to evaluate the effectiveness of the virtual behavioral health integration (VBHI) program compared to usual care, on reducing the total cost of care reimbursed from Medicare and value-based contracts within 90 days of a patient's primary care visit.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To enhance the care of patients seen in the primary care setting, Atrium Health has designed a virtual behavioral health integration program.
A behavioral health care team comprised of licensed clinicians (Behavioral Health Professionals), health coaches, a consulting psychiatric pharmacist and psychiatric providers follow patients for up to 3 months or more depending on patient need after their primary care office visit.
This virtual behavioral health integration (VBHI) program is currently available in 36 Atrium Health primary care practices providing support to over 200 providers and medical residents.
The Behavioral health Service line is expanding the program to additional primary care practices.
Atrium Health and the Carolinas Physician Alliance is interested in evaluating the effectiveness of the program on reducing the total cost of care.
Study Type
Interventional
Enrollment (Actual)
5777
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
North Carolina
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Albemarle, North Carolina, United States, 28001
- Albermarle Medical Services
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Charlotte, North Carolina, United States, 28226
- Charlotte Medical Clinic Arboretum
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Charlotte, North Carolina, United States, 28262
- North Charlotte Medical Specialists Huntersville
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Charlotte, North Carolina, United States, 28278
- Mecklenburg Medical Group - Steele Creek
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Concord, North Carolina, United States, 28035
- NorthEast Internal and Integrative Medicine
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Denver, North Carolina, United States, 28037
- East Lincoln Primary Care
-
Gastonia, North Carolina, United States, 28056
- Riverwood Medical Associates
-
Harrisburg, North Carolina, United States, 28075
- Ardsley Internal Medicine - Harrisburg
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Indian Trail, North Carolina, United States, 28079
- Dove Internal Medicine Union West
-
Indian Trail, North Carolina, United States, 28079
- Indian Trail Family Medicine
-
Kannapolis, North Carolina, United States, 28081
- Kannapolis Internal Medicine
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Kings Mountain, North Carolina, United States, 28086
- Kings Mountain Internal Medicine
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Lincolnton, North Carolina, United States, 28092
- West Lincoln Family Medicine
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Monroe, North Carolina, United States, 28112
- Dove Internal Medicine - Monroe
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Monroe, North Carolina, United States, 28112
- Union Family Practice
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Mooresville, North Carolina, United States, 28117
- Mooresville Internal Medicine Associates
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Oakboro, North Carolina, United States, 28129
- Oakboro Medical Services
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Richfield, North Carolina, United States, 28137
- Richfield Medical Services
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Shelby, North Carolina, United States, 28150
- Shelby Family Practice
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Wesley Chapel, North Carolina, United States, 28104
- Union Primary Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- Primary care office visit
- Have a Patient Health Questionnaire-9 (PHQ-9) and overall score >=10 or Question 9 >0
- Medicare or value-based contract associated with a patient in the past year at the time of the primary care visit.
Exclusion Criteria:
- A patient will contribute to the analysis once using their initial enrollment to either arm of the study.
- No insurance claim for the index primary care visit in the data warehouse upon evaluation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Behavioral Health Integration
All patients who meet eligibility criteria at sites where the virtual behavioral health program is offered will be considered exposed to the intervention.
|
The virtual behavioral health integration program, implemented in primary care settings, is a structured mental illness treatment program that includes both behavioral treatment and counseling components aimed at reducing cost of care, developing and sustaining adaptive coping strategies, and improving short term acute care utilization.
|
|
No Intervention: Usual Care - Behavioral Health
All patients who meet eligibility criteria at sites where the virtual behavioral health program is not offered will be considered exposed to usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost of Care
Time Frame: 90 days from a patient's primary care visit
|
Total cost of care reimbursed from Medicare and value-based contracts
|
90 days from a patient's primary care visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare the 90-day acute care utilization rate after the index primary care visit
Time Frame: 90 days from a patient's primary care visit
|
Does a patient have an inpatient, observation, or emergency department encounter after their primary care visit
|
90 days from a patient's primary care visit
|
|
Compare the 90-day primary care utilization rate after the index primary care visit
Time Frame: 90 days from a patient's primary care visit
|
Does a patient have a primary care encounter after their primary care visit
|
90 days from a patient's primary care visit
|
|
pharmacy Cost of Care
Time Frame: 90 days from a patient's primary care visit
|
Pharmacy related cost of care reimbursed from Medicare and value-based contracts
|
90 days from a patient's primary care visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2019
Primary Completion (Actual)
February 8, 2021
Study Completion (Actual)
May 8, 2021
Study Registration Dates
First Submitted
September 24, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (Actual)
September 27, 2019
Study Record Updates
Last Update Posted (Actual)
April 25, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00082499
- 08-19-24E (Other Identifier: Atrium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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