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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BH-VPN | Experimental | A 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BH-VPN | Behavioral | A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department to Inpatient Conversion Rate | admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality, Comfort, and Care (QCC) Defined Readmission Rate | readmission within 30 days to the same facility | 30 days |
| Patient-centric (Protocol Defined) Readmission Rate | readmission within 30 days to any facility which Carolinas Healthcare System have access to the data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne Sparks, MD | Wake Forest University Health Sciences | Principal Investigator |
| Jason Roberge, PhD | Wake Forest University Health Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center Mercy | Charlotte | North Carolina | 28207 | United States | ||
| Carolinas Healthcare System - Pineville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31995214 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BH-VPN | A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services. |
| FG001 | Usual Care | The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BH-VPN | A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Emergency Department to Inpatient Conversion Rate | admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting. | The number of patients that were admitted | Posted | Number | participants | 5 days |
|
We followed each patient for 45 days after the ED discharge and then followed the patient for an additional 60 days for utilization outcomes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BH-VPN | A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Roberge | Atrium Health | 704-355-0268 | Jason.Roberge@AtriumHealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2017 | Feb 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| 30 days |
| Utilization of Healthcare Services Post-discharge From Emergency Department | Number of Emergency Department, inpatient, observation encounters | 45 days |
| Charlotte |
| North Carolina |
| 28210 |
| United States |
| Carolinas Healthcare System University | Charlotte | North Carolina | 28262 | United States |
| Carolinas Healthcare System Steele Creek | Charlotte | North Carolina | 28278 | United States |
| Carolinas Healthcare System Huntersville | Huntersville | North Carolina | 28078 | United States |
| Carolinas Healthcare System - Union | Monroe | North Carolina | 28112 | United States |
| Usual Care |
The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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|
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| Secondary | Quality, Comfort, and Care (QCC) Defined Readmission Rate | readmission within 30 days to the same facility | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Patient-centric (Protocol Defined) Readmission Rate | readmission within 30 days to any facility which Carolinas Healthcare System have access to the data | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Utilization of Healthcare Services Post-discharge From Emergency Department | Number of Emergency Department, inpatient, observation encounters | Posted | Count of Participants | Participants | 45 days |
|
|
|
|
| 0 |
| 323 |
| 0 |
| 323 |
| 0 |
| 323 |
| EG001 | Usual Care | The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components. | 4 | 314 | 0 | 314 | 0 | 314 |
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