An interventional study of Behavioral Health - Virtual Patient Navigation in Depression, Anxiety and Substance Use Disorders, sponsored by Wake Forest University Health Sciences. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research
This research project is a pragmatic, randomized evaluation of a quality improvement initiative which seeks to evaluate the effects of standardizing the use of a BH-VPN program among patients with a telepsychiatric consult. The outcomes evaluation of this intervention has been designed to integrate with routine care and minimize frontline staff burden by deploying an evaluation in a real-world setting.
Hospital admissions are common amongst those with mental illness. Significant morbidity exists for patients who are being admitted to a psychiatric hospital from the Emergency Department (ED).Additionally, commitment to a hospital setting may have adverse effects on patients psychologically, degrade relationships with therapists, and disrupt continuity of care. ED providers often decide to admit to a psychiatric hospital because of limited availability of behavioral health resources. To better enhance transitions of care for those with mental illness, Atrium Health has designed a behavioral health virtual patient navigation (BH-VPN)program that helps coordinate services and follow-up care, while facilitating the safe discharge of patients. Patients presenting to an ED that have a tele psychiatric consult who are recommended for discharge are eligible for services. The Behavioral health Service line is expanding the program to additional rural emergency departments. Using an outcomes evaluation, the investigators will inform Atrium Health on the effect of the BH-VPN program to reduce hospital admissions among patients with a tele psychiatric consult in the ED. The proposed hypothesis is that by having the BH-VPN program available in an ED, more patients will be discharged from the ED than admitted.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 1,089 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Eligible patients must meet each of the following criteria:
Exclusion Criteria:• Patients currently enrolled in the BH-VPN program upon their index ED encounter
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All patients who meet eligibility criteria at sites where the virtual patient navigation behavioral health program is offered will be considered exposed to the intervention.
Behavioral: Behavioral Health - Virtual Patient Navigation
All patients who meet eligibility criteria at sites where the virtual patient navigator behavioral health program is not offered will be considered exposed to usual care.
Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention.
Assessing Hospital Admissions
Compare the effectiveness of having the Behavioral Health - Virtual Patient Navigation (BH-VPN) program available compared to usual care, on admission rates among patients in the ED with a telepsychiatric consult
Time frame: Up to 2 weeks from initial ED admission
45-day Post Discharge Utilization Rate
Comparing the 45-day utilization (ED, IP, OBS encounter) rate after the ED encounter between the 2 arms of the study
Time frame: 45 days
45-day Post Discharge Utilization Rate With a Self-harm Diagnosis
Compare the frequency of patients with any encounter with a self-harm diagnosis within 45 days of the ED visit between the 2 arms of the study
Time frame: 45 days
45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis
Compare the frequency of patients who return to the ED and have a telepsychiatric consult within 45 days of their initial ED visit between the 2 arms of the study
Time frame: 45 days
| Milestone | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health |
|---|---|---|
| Started | 534 | 555 |
| Completed | 534 | 555 |
| Not completed | 0 | 0 |
Compare the effectiveness of having the Behavioral Health - Virtual Patient Navigation (BH-VPN) program available compared to usual care, on admission rates among patients in the ED with a telepsychiatric consult
| Participants | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health |
|---|---|---|
| Assessing Hospital Admissions | 332 | 326 |
Comparing the 45-day utilization (ED, IP, OBS encounter) rate after the ED encounter between the 2 arms of the study
| participants | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health |
|---|---|---|
| 45-day Post Discharge Utilization Rate | 88 | 89 |
Compare the frequency of patients with any encounter with a self-harm diagnosis within 45 days of the ED visit between the 2 arms of the study
| Participants | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health |
|---|---|---|
| 45-day Post Discharge Utilization Rate With a Self-harm Diagnosis | 47 | 35 |
Compare the frequency of patients who return to the ED and have a telepsychiatric consult within 45 days of their initial ED visit between the 2 arms of the study
| Participants | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health |
|---|---|---|
| 45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis | 40 | 36 |
Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Health - Virtual Patient Navigation | 0/534 (0%) | 0/534 (0%) | 0/534 (0%) |
| Usual Care Behavioral Health | 0/555 (0%) | 0/555 (0%) | 0/555 (0%) |
| Age, Continuous(years) | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health | Total |
|---|---|---|---|
| Mean | 41.1 ± 16.0 | 41.6 ± 15.9 | 41.4 ± 16.0 |
| Sex: Female, Male(Participants) | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health | Total |
|---|---|---|---|
| Female | 222 | 248 | 470 |
| Male | 312 | 307 | 619 |
| Race (NIH/OMB)(Participants) | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 91 | 92 | 183 |
| White | 420 | 437 | 857 |
| More than one race | 16 | 18 | 34 |
| Unknown or Not Reported | 7 | 8 | 15 |
| Region of Enrollment(Participants) | Behavioral Health - Virtual Patient Navigation | Usual Care Behavioral Health | Total |
|---|---|---|---|
| United States | 534 | 555 | 1089 |
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Wake Forest University Health Sciences