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Virtual Behavioral Health Integration (VBHI)

Primary Purpose

Depression, Substance Use Disorder, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Behavioral Health Integration
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Albermarle Medical Services
  • Charlotte Medical Clinic Arboretum
  • North Charlotte Medical Specialists Huntersville
  • Mecklenburg Medical Group - Steele Creek
  • NorthEast Internal and Integrative Medicine
  • East Lincoln Primary Care
  • Riverwood Medical Associates
  • Ardsley Internal Medicine - Harrisburg
  • Dove Internal Medicine Union West
  • Indian Trail Family Medicine
  • Kannapolis Internal Medicine
  • Kings Mountain Internal Medicine
  • West Lincoln Family Medicine
  • Dove Internal Medicine - Monroe
  • Union Family Practice
  • Mooresville Internal Medicine Associates
  • Oakboro Medical Services
  • Richfield Medical Services
  • Shelby Family Practice
  • Union Primary Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Behavioral Health Integration

Usual Care - Behavioral Health

Arm Description

All patients who meet eligibility criteria at sites where the virtual behavioral health program is offered will be considered exposed to the intervention.

All patients who meet eligibility criteria at sites where the virtual behavioral health program is not offered will be considered exposed to usual care.

Outcomes

Primary Outcome Measures

Cost of Care
Total cost of care reimbursed from Medicare and value-based contracts

Secondary Outcome Measures

Compare the 90-day acute care utilization rate after the index primary care visit
Does a patient have an inpatient, observation, or emergency department encounter after their primary care visit
Compare the 90-day primary care utilization rate after the index primary care visit
Does a patient have a primary care encounter after their primary care visit
pharmacy Cost of Care
Pharmacy related cost of care reimbursed from Medicare and value-based contracts

Full Information

First Posted
September 24, 2019
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04106388
Brief Title
Virtual Behavioral Health Integration
Acronym
VBHI
Official Title
An Evaluation of Virtual Behavioral Health Integration Into Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
May 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Substance Use Disorder, Anxiety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Locations offering the program are randomized
Masking
Participant
Allocation
Randomized
Enrollment
5777 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Behavioral Health Integration
Arm Type
Experimental
Arm Description
All patients who meet eligibility criteria at sites where the virtual behavioral health program is offered will be considered exposed to the intervention.
Arm Title
Usual Care - Behavioral Health
Arm Type
No Intervention
Arm Description
All patients who meet eligibility criteria at sites where the virtual behavioral health program is not offered will be considered exposed to usual care.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Behavioral Health Integration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cost of Care
Description
Total cost of care reimbursed from Medicare and value-based contracts
Time Frame
90 days from a patient's primary care visit
Secondary Outcome Measure Information:
Title
Compare the 90-day acute care utilization rate after the index primary care visit
Description
Does a patient have an inpatient, observation, or emergency department encounter after their primary care visit
Time Frame
90 days from a patient's primary care visit
Title
Compare the 90-day primary care utilization rate after the index primary care visit
Description
Does a patient have a primary care encounter after their primary care visit
Time Frame
90 days from a patient's primary care visit
Title
pharmacy Cost of Care
Description
Pharmacy related cost of care reimbursed from Medicare and value-based contracts
Time Frame
90 days from a patient's primary care visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Roberge, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albermarle Medical Services
City
Albemarle
State/Province
North Carolina
ZIP/Postal Code
28001
Country
United States
Facility Name
Charlotte Medical Clinic Arboretum
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Facility Name
North Charlotte Medical Specialists Huntersville
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Mecklenburg Medical Group - Steele Creek
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28278
Country
United States
Facility Name
NorthEast Internal and Integrative Medicine
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28035
Country
United States
Facility Name
East Lincoln Primary Care
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Facility Name
Riverwood Medical Associates
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28056
Country
United States
Facility Name
Ardsley Internal Medicine - Harrisburg
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Dove Internal Medicine Union West
City
Indian Trail
State/Province
North Carolina
ZIP/Postal Code
28079
Country
United States
Facility Name
Indian Trail Family Medicine
City
Indian Trail
State/Province
North Carolina
ZIP/Postal Code
28079
Country
United States
Facility Name
Kannapolis Internal Medicine
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States
Facility Name
Kings Mountain Internal Medicine
City
Kings Mountain
State/Province
North Carolina
ZIP/Postal Code
28086
Country
United States
Facility Name
West Lincoln Family Medicine
City
Lincolnton
State/Province
North Carolina
ZIP/Postal Code
28092
Country
United States
Facility Name
Dove Internal Medicine - Monroe
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Union Family Practice
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Mooresville Internal Medicine Associates
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Oakboro Medical Services
City
Oakboro
State/Province
North Carolina
ZIP/Postal Code
28129
Country
United States
Facility Name
Richfield Medical Services
City
Richfield
State/Province
North Carolina
ZIP/Postal Code
28137
Country
United States
Facility Name
Shelby Family Practice
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Union Primary Care
City
Wesley Chapel
State/Province
North Carolina
ZIP/Postal Code
28104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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