Trial Outcomes & Findings for A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments (NCT NCT04148521)

Last Updated: 2023-03-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

1089 participants

Primary outcome timeframe

Up to 2 weeks from initial ED admission

Results posted on

2023-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Behavioral Health - Virtual Patient Navigation 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 Health - Virtual Patient Navigation: 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.	Usual Care Behavioral Health 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.
Overall Study STARTED	534	555
Overall Study COMPLETED	534	555
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Health - Virtual Patient Navigation n=534 Participants 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 Health - Virtual Patient Navigation: 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.	Usual Care Behavioral Health n=555 Participants 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.	Total n=1089 Participants Total of all reporting groups
Age, Continuous	41.1 years STANDARD_DEVIATION 16.0 • n=5 Participants	41.6 years STANDARD_DEVIATION 15.9 • n=7 Participants	41.4 years STANDARD_DEVIATION 16.0 • n=5 Participants
Sex: Female, Male Female	222 Participants n=5 Participants	248 Participants n=7 Participants	470 Participants n=5 Participants
Sex: Female, Male Male	312 Participants n=5 Participants	307 Participants n=7 Participants	619 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	91 Participants n=5 Participants	92 Participants n=7 Participants	183 Participants n=5 Participants
Race (NIH/OMB) White	420 Participants n=5 Participants	437 Participants n=7 Participants	857 Participants n=5 Participants
Race (NIH/OMB) More than one race	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	534 Participants n=5 Participants	555 Participants n=7 Participants	1089 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks from initial ED admission

Outcome measures

Outcome measures
Measure	Behavioral Health - Virtual Patient Navigation n=534 Participants 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 Health - Virtual Patient Navigation: 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.	Usual Care Behavioral Health n=555 Participants 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.
Assessing Hospital Admissions	332 Participants	326 Participants

SECONDARY outcome

Timeframe: 45 days

Comparing the 45-day utilization (ED, IP, OBS encounter) rate after the ED encounter between the 2 arms of the study

Outcome measures

Outcome measures
Measure	Behavioral Health - Virtual Patient Navigation n=534 Participants 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 Health - Virtual Patient Navigation: 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.	Usual Care Behavioral Health n=555 Participants 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.
45-day Post Discharge Utilization Rate	88 participants	89 participants

SECONDARY outcome

Timeframe: 45 days

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

Outcome measures

Outcome measures
Measure	Behavioral Health - Virtual Patient Navigation n=534 Participants 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 Health - Virtual Patient Navigation: 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.	Usual Care Behavioral Health n=555 Participants 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.
45-day Post Discharge Utilization Rate With a Self-harm Diagnosis	47 Participants	35 Participants

SECONDARY outcome

Timeframe: 45 days

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

Outcome measures

Outcome measures
Measure	Behavioral Health - Virtual Patient Navigation n=534 Participants 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 Health - Virtual Patient Navigation: 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.	Usual Care Behavioral Health n=555 Participants 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.
45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis	40 Participants	36 Participants

Adverse Events

Behavioral Health - Virtual Patient Navigation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Behavioral Health

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason Roberge

Atrium Health

Phone: 7043550268

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place