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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5777

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • North Carolina
      • Albemarle, North Carolina, United States, 28001
        • Albermarle Medical Services
      • Charlotte, North Carolina, United States, 28226
        • Charlotte Medical Clinic Arboretum
      • Charlotte, North Carolina, United States, 28262
        • North Charlotte Medical Specialists Huntersville
      • Charlotte, North Carolina, United States, 28278
        • Mecklenburg Medical Group - Steele Creek
      • Concord, North Carolina, United States, 28035
        • NorthEast Internal and Integrative Medicine
      • 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
      • 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
      • Kings Mountain, North Carolina, United States, 28086
        • Kings Mountain Internal Medicine
      • Lincolnton, North Carolina, United States, 28092
        • West Lincoln Family Medicine
      • Monroe, North Carolina, United States, 28112
        • Dove Internal Medicine - Monroe
      • Monroe, North Carolina, United States, 28112
        • Union Family Practice
      • Mooresville, North Carolina, United States, 28117
        • Mooresville Internal Medicine Associates
      • Oakboro, North Carolina, United States, 28129
        • Oakboro Medical Services
      • Richfield, North Carolina, United States, 28137
        • Richfield Medical Services
      • Shelby, North Carolina, United States, 28150
        • Shelby Family Practice
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Virtual Behavioral Health Integration
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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