Mental HealthNCT03204643
Evaluation of Behavioral Health-Virtual Patient Navigation Team (BH-VPN)
A study testing BH-VPN in people with Mental Health, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial summary
Patients who present to one of the participating EDs with a telepsychiatric consult performed will be treated and followed per the behavioral health virtual patient navigation pathway (BH-VPN) or usual care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- BH-VPN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 637 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Jun 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Present at a participating ED
- Completed telepsychiatric consult as captured in the EMR
- Completed telepsychiatric consult Monday - Friday during Navigator's potential hours of operation.
Who cannot join
- None per the protocol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Carolinas Medical Center Mercy
Charlotte, North Carolina, 28207
Carolinas Healthcare System - Pineville
Charlotte, North Carolina, 28210
Carolinas Healthcare System University
Charlotte, North Carolina, 28262
Carolinas Healthcare System Steele Creek
Charlotte, North Carolina, 28278
Carolinas Healthcare System Huntersville
Huntersville, North Carolina, 28078
Carolinas Healthcare System - Union
Monroe, North Carolina, 28112
About this study
Official title: An Evaluation of ED to Admission Conversion Among Patients With a Telepsychiatric Consult Who Are Followed by a Behavioral Health - Virtual Patient Navigation Team
Patients who present to one of the participating EDs with a telepsychiatric consult performed will be treated and followed per the behavioral health virtual patient navigation pathway (BH-VPN) or usual care. The BH-VPN is inclusive of several components which will all be consistently applied to patients randomized to the intervention, as well as having access to behavioral health trained patient navigators. These key components are often deployed inconsistently as a part of usual care, but per the intervention, will be completed in totality for subjects who are assigned to and participate in the BH-VPN plan.
This study includes a qualitative sub-study to measure perceptions of the impact of the BH-VPN on readmission rates and patient outcomes, experiences with the services provided by the BH-VPN, and provider and clinician ideas for how to improve the services provided by the BH-VPN.
- Conditions
- Mental Health
- Being tested
- BH-VPN
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BH-VPNBehavioural
A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.
| Study group | Role | What they receive |
|---|---|---|
| BH-VPN | Experimental | A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. Receives: Behavioral: BH-VPN |
| Usual Care | No intervention | The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department to Inpatient Conversion Rate
admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.
Measured: 5 days
Secondary outcomes (3)
Quality, Comfort, and Care (QCC) Defined Readmission Rate
readmission within 30 days to the same facility
Measured: 30 days
Patient-centric (Protocol Defined) Readmission Rate
readmission within 30 days to any facility which Carolinas Healthcare System have access to the data
Measured: 30 days
Utilization of Healthcare Services Post-discharge From Emergency Department
Number of Emergency Department, inpatient, observation encounters
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start12 Jun 2017
- Primary completion14 Feb 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- Masking
- None (open label)
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne Sparks, MD, Principal investigator, Wake Forest University Health SciencesJason Roberge, PhD, Study director, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204643
- Sponsor's protocol ID
- 00021808
- Status last verified
- Jan 2020
- First submitted
- 28 Jun 2017
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roberge J, McWilliams A, Zhao J, Anderson WE, Hetherington T, Zazzaro C, Hardin E, Barrett A, Castro M, Balfour ME, Rachal J, Krull C, Sparks W. Effect of a Virtual Patient Navigation Program on Behavioral Health Admissions in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1919954. doi: 10.1001/jamanetworkopen.2019.19954.
PubMed 31995214
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of ED to Admission Conversion Among Patients With a Telepsychiatric Consult Who Are Followed by a Behavioral Health - Virtual Patient Navigation Team
- ClinicalTrials.gov ID
- NCT03204643
- Acronym / sponsor ID
- 00021808
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who present to one of the participating EDs with a telepsychiatric consult performed will be treated and followed per the behavioral health virtual patient navigation pathway (BH-VPN) or usual care. The BH-VPN is inclusive of several components which will all be consistently applied to patients randomized to the intervention, as well as having access to behavioral health trained patient navigators. These key components are often deployed inconsistently as a part of usual care, but per the intervention, will be completed in totality for subjects who are assigned to and participate in the BH-VPN plan.
This study includes a qualitative sub-study to measure perceptions of the impact of the BH-VPN on readmission rates and patient outcomes, experiences with the services provided by the BH-VPN, and provider and clinician ideas for how to improve the services provided by the BH-VPN.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BH-VPN | Experimental | Behavioral: BH-VPNA bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. |
| Usual Care | No intervention | –The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Present at a participating ED
- Completed telepsychiatric consult as captured in the EMR
- Completed telepsychiatric consult Monday - Friday during Navigator's potential hours of operation.
Key exclusion criteria (1 listed)
- None per the protocol
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 |
|---|---|---|
| BH-VPNA bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services. | Behavioural | BH-VPN |
Primary outcome
Emergency Department to Inpatient Conversion Rate
Time frame: 5 days
admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.
3 secondary outcomes
Quality, Comfort, and Care (QCC) Defined Readmission Rate
Time frame: 30 days
Patient-centric (Protocol Defined) Readmission Rate
Time frame: 30 days
Utilization of Healthcare Services Post-discharge From Emergency Department
Time frame: 45 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31995214Roberge J, McWilliams A, Zhao J, Anderson WE, Hetherington T, Zazzaro C, Hardin E, Barrett A, Castro M, Balfour ME, Rachal J, Krull C, Sparks W. Effect of a Virtual Patient Navigation Program on Behavioral Health Admissions in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1919954. doi: 10.1001/jamanetworkopen.2019.19954.
- Individual participant dataSharing planned: No
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Wayne Sparks, MD principal investigator
Wake Forest University Health Sciences
Jason Roberge, PhD study director
Wake Forest University Health Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BH-VPN in people with Mental Health, run by Wake Forest University Health Sciences at 6 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 3 inclusion and 1 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 21 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 6 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?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Emergency Department to Inpatient Conversion Rate (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03204643, which also lists 1 linked publication.
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 21 Apr 2022.