Virtual Behavioral Health Integration

NCT ID: NCT04106388

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5777 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2021-05-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Substance Use Disorder Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Locations offering the program are randomized
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual Behavioral Health Integration

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Roberge, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Albermarle Medical Services

Albemarle, North Carolina, United States

Site Status

Charlotte Medical Clinic Arboretum

Charlotte, North Carolina, United States

Site Status

North Charlotte Medical Specialists Huntersville

Charlotte, North Carolina, United States

Site Status

Mecklenburg Medical Group - Steele Creek

Charlotte, North Carolina, United States

Site Status

NorthEast Internal and Integrative Medicine

Concord, North Carolina, United States

Site Status

East Lincoln Primary Care

Denver, North Carolina, United States

Site Status

Riverwood Medical Associates

Gastonia, North Carolina, United States

Site Status

Ardsley Internal Medicine - Harrisburg

Harrisburg, North Carolina, United States

Site Status

Dove Internal Medicine Union West

Indian Trail, North Carolina, United States

Site Status

Indian Trail Family Medicine

Indian Trail, North Carolina, United States

Site Status

Kannapolis Internal Medicine

Kannapolis, North Carolina, United States

Site Status

Kings Mountain Internal Medicine

Kings Mountain, North Carolina, United States

Site Status

West Lincoln Family Medicine

Lincolnton, North Carolina, United States

Site Status

Dove Internal Medicine - Monroe

Monroe, North Carolina, United States

Site Status

Union Family Practice

Monroe, North Carolina, United States

Site Status

Mooresville Internal Medicine Associates

Mooresville, North Carolina, United States

Site Status

Oakboro Medical Services

Oakboro, North Carolina, United States

Site Status

Richfield Medical Services

Richfield, North Carolina, United States

Site Status

Shelby Family Practice

Shelby, North Carolina, United States

Site Status

Union Primary Care

Wesley Chapel, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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08-19-24E

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00082499

Identifier Type: -

Identifier Source: org_study_id

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