Trial Outcomes & Findings for Evaluation of Behavioral Health-Virtual Patient Navigation Team (BH-VPN) (NCT NCT03204643)

NCT ID: NCT03204643

Last Updated: 2022-04-21

Results Overview

admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 637 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2022-04-21

Participant Flow

Participant milestones

Measure	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.	Usual Care The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Overall Study STARTED	323	314
Overall Study COMPLETED	323	314
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Behavioral Health-Virtual Patient Navigation Team (BH-VPN)

Baseline characteristics by cohort

Measure	BH-VPN n=323 Participants 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.	Usual Care n=314 Participants The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.	Total n=637 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 16.8 • n=5 Participants	39.8 years STANDARD_DEVIATION 16.3 • n=7 Participants	39.7 years STANDARD_DEVIATION 16.5 • n=5 Participants
Sex: Female, Male Female	140 Participants n=5 Participants	139 Participants n=7 Participants	279 Participants n=5 Participants
Sex: Female, Male Male	183 Participants n=5 Participants	175 Participants n=7 Participants	358 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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	105 Participants n=5 Participants	90 Participants n=7 Participants	195 Participants n=5 Participants
Race (NIH/OMB) White	170 Participants n=5 Participants	182 Participants n=7 Participants	352 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	323 participants n=5 Participants	314 participants n=7 Participants	637 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: The number of patients that were admitted

admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.

Outcome measures

Measure	BH-VPN n=323 Participants 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.	Usual Care n=314 Participants The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Emergency Department to Inpatient Conversion Rate	178 participants	198 participants

SECONDARY outcome

Timeframe: 30 days

readmission within 30 days to the same facility

Outcome measures

Measure	BH-VPN n=323 Participants 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.	Usual Care n=314 Participants The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Quality, Comfort, and Care (QCC) Defined Readmission Rate	7 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

readmission within 30 days to any facility which Carolinas Healthcare System have access to the data

Outcome measures

Measure	BH-VPN n=323 Participants 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.	Usual Care n=314 Participants The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Patient-centric (Protocol Defined) Readmission Rate	28 Participants	23 Participants

SECONDARY outcome

Timeframe: 45 days

Number of Emergency Department, inpatient, observation encounters

Outcome measures

Measure	BH-VPN n=323 Participants 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.	Usual Care n=314 Participants The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Utilization of Healthcare Services Post-discharge From Emergency Department	112 Participants	89 Participants

Adverse Events

BH-VPN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason Roberge

Atrium Health

Phone: 704-355-0268

Email: Jason.Roberge@AtriumHealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place