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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04106388
Other study ID # IRB00082499
Secondary ID 08-19-24E
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2019
Est. completion date May 8, 2021

Study information

Verified date June 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5777
Est. completion date May 8, 2021
Est. primary completion date February 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


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.

Locations

Country Name City State
United States Albermarle Medical Services Albemarle North Carolina
United States Charlotte Medical Clinic Arboretum Charlotte North Carolina
United States Mecklenburg Medical Group - Steele Creek Charlotte North Carolina
United States North Charlotte Medical Specialists Huntersville Charlotte North Carolina
United States NorthEast Internal and Integrative Medicine Concord North Carolina
United States East Lincoln Primary Care Denver North Carolina
United States Riverwood Medical Associates Gastonia North Carolina
United States Ardsley Internal Medicine - Harrisburg Harrisburg North Carolina
United States Dove Internal Medicine Union West Indian Trail North Carolina
United States Indian Trail Family Medicine Indian Trail North Carolina
United States Kannapolis Internal Medicine Kannapolis North Carolina
United States Kings Mountain Internal Medicine Kings Mountain North Carolina
United States West Lincoln Family Medicine Lincolnton North Carolina
United States Dove Internal Medicine - Monroe Monroe North Carolina
United States Union Family Practice Monroe North Carolina
United States Mooresville Internal Medicine Associates Mooresville North Carolina
United States Oakboro Medical Services Oakboro North Carolina
United States Richfield Medical Services Richfield North Carolina
United States Shelby Family Practice Shelby North Carolina
United States Union Primary Care Wesley Chapel North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cost of Care Total cost of care reimbursed from Medicare and value-based contracts 90 days from a patient's primary care visit
Secondary 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 90 days from a patient's primary care visit
Secondary 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 90 days from a patient's primary care visit
Secondary pharmacy Cost of Care Pharmacy related cost of care reimbursed from Medicare and value-based contracts 90 days from a patient's primary care visit
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