DepressionVBHINCT04106388
Virtual Behavioral Health Integration
A study testing Virtual Behavioral Health Integration in people with Depression and Substance Use Disorder, run by Wake Forest University Health Sciences at 20 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Substance Use Disorder, Anxiety
- What is being tested?
- Virtual Behavioral Health Integration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,777 participants
- Where
- 20 sitesUnited States
- Study dates
- 14 Aug 2019to 8 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Albermarle Medical Services
Albemarle, North Carolina, 28001
Charlotte Medical Clinic Arboretum
Charlotte, North Carolina, 28226
North Charlotte Medical Specialists Huntersville
Charlotte, North Carolina, 28262
Mecklenburg Medical Group - Steele Creek
Charlotte, North Carolina, 28278
NorthEast Internal and Integrative Medicine
Concord, North Carolina, 28035
East Lincoln Primary Care
Denver, North Carolina, 28037
Riverwood Medical Associates
Gastonia, North Carolina, 28056
Ardsley Internal Medicine - Harrisburg
Harrisburg, North Carolina, 28075
Dove Internal Medicine Union West
Indian Trail, North Carolina, 28079
Indian Trail Family Medicine
Indian Trail, North Carolina, 28079
Kannapolis Internal Medicine
Kannapolis, North Carolina, 28081
Kings Mountain Internal Medicine
Kings Mountain, North Carolina, 28086
West Lincoln Family Medicine
Lincolnton, North Carolina, 28092
Dove Internal Medicine - Monroe
Monroe, North Carolina, 28112
Union Family Practice
Monroe, North Carolina, 28112
Mooresville Internal Medicine Associates
Mooresville, North Carolina, 28117
Oakboro Medical Services
Oakboro, North Carolina, 28129
Richfield Medical Services
Richfield, North Carolina, 28137
Shelby Family Practice
Shelby, North Carolina, 28150
Union Primary Care
Wesley Chapel, North Carolina, 28104
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Substance Use Disorder, Anxiety
- Being tested
- Virtual Behavioral Health Integration
- Medical subject headings
- Depression, Substance-Related Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Behavioral Health IntegrationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of Care
Total cost of care reimbursed from Medicare and value-based contracts
Measured: 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
Does a patient have an inpatient, observation, or emergency department encounter after their primary care visit
Measured: 90 days from a patient's 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
Measured: 90 days from a patient's primary care visit
pharmacy Cost of Care
Pharmacy related cost of care reimbursed from Medicare and value-based contracts
Measured: 90 days from a patient's primary care visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start14 Aug 2019
- Primary completion8 Feb 2021
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Locations offering the program are randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Roberge, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106388
- Sponsor's protocol ID
- IRB00082499
- Other IDs
- 08-19-24E
- Acronym
- VBHI
- Status last verified
- Jun 2021
- First submitted
- 24 Sep 2019
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Virtual Behavioral Health Integration Into Primary Care
- ClinicalTrials.gov ID
- NCT04106388
- Acronym / sponsor ID
- VBHI / IRB00082499
- Conditions
- Depression, Substance Use Disorder, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,777 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Locations offering the program are randomized
| Arm | Type | Receives |
|---|---|---|
| Virtual Behavioral Health Integration | Experimental | Behavioral: Virtual Behavioral Health IntegrationAll patients who meet eligibility criteria at sites where the virtual behavioral health program is offered will be considered exposed to the intervention. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Behavioral Health IntegrationThe 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. | Behavioural | Virtual Behavioral Health Integration |
Primary outcome
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
3 secondary outcomes
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
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
pharmacy Cost of Care
Time frame: 90 days from a patient's primary care visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Roberge, PhD principal investigator
Wake Forest University Health Sciences
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Behavioral Health Integration in people with Depression and Substance Use Disorder, run by Wake Forest University Health Sciences at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of Care (time frame: 90 days from a patient's primary care visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.