NCT04106388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,777

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2021

Completed
Last Updated

April 25, 2022

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

September 24, 2019

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cost of Care

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

    90 days from a patient's primary care visit

Secondary Outcomes (3)

  • Compare the 90-day acute care utilization rate after the index 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

    90 days from a patient's primary care visit

  • pharmacy Cost of Care

    90 days from a patient's primary care visit

Study Arms (2)

Virtual Behavioral Health Integration

EXPERIMENTAL

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

Usual Care - Behavioral Health

NO 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.

Interventions

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.

Virtual Behavioral Health Integration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Albermarle Medical Services

Albemarle, North Carolina, 28001, United States

Location

Charlotte Medical Clinic Arboretum

Charlotte, North Carolina, 28226, United States

Location

North Charlotte Medical Specialists Huntersville

Charlotte, North Carolina, 28262, United States

Location

Mecklenburg Medical Group - Steele Creek

Charlotte, North Carolina, 28278, United States

Location

NorthEast Internal and Integrative Medicine

Concord, North Carolina, 28035, United States

Location

East Lincoln Primary Care

Denver, North Carolina, 28037, United States

Location

Riverwood Medical Associates

Gastonia, North Carolina, 28056, United States

Location

Ardsley Internal Medicine - Harrisburg

Harrisburg, North Carolina, 28075, United States

Location

Dove Internal Medicine Union West

Indian Trail, North Carolina, 28079, United States

Location

Indian Trail Family Medicine

Indian Trail, North Carolina, 28079, United States

Location

Kannapolis Internal Medicine

Kannapolis, North Carolina, 28081, United States

Location

Kings Mountain Internal Medicine

Kings Mountain, North Carolina, 28086, United States

Location

West Lincoln Family Medicine

Lincolnton, North Carolina, 28092, United States

Location

Dove Internal Medicine - Monroe

Monroe, North Carolina, 28112, United States

Location

Union Family Practice

Monroe, North Carolina, 28112, United States

Location

Mooresville Internal Medicine Associates

Mooresville, North Carolina, 28117, United States

Location

Oakboro Medical Services

Oakboro, North Carolina, 28129, United States

Location

Richfield Medical Services

Richfield, North Carolina, 28137, United States

Location

Shelby Family Practice

Shelby, North Carolina, 28150, United States

Location

Union Primary Care

Wesley Chapel, North Carolina, 28104, United States

Location

MeSH Terms

Conditions

DepressionSubstance-Related DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Jason Roberge, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Locations offering the program are randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 27, 2019

Study Start

August 14, 2019

Primary Completion

February 8, 2021

Study Completion

May 8, 2021

Last Updated

April 25, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations