Trial Outcomes & Findings for An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health (NCT NCT05460078)

NCT ID: NCT05460078

Last Updated: 2024-10-15

Results Overview

30-day all cause non-elective acute care post discharge utilization (Emergency Department (ED), inpatient, and observation encounters)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7526 participants
• Primary outcome timeframe: day 30
• Results posted on: 2024-10-15

Participant Flow

Participant milestones

Measure	Virtual Program Seen at a location where the virtual program is being offered Virtual Psychiatric Transition of Care Program: Behavioral Health facility or units that have discharged patients meeting inclusion criteria will be randomly assigned as either an intervention or standard care site. Intervention sites will be those using the VPTC program. This evaluation design will integrate into current workflows for the measurement of outcomes. Prior to discharge, patients may be referred to the VPTC program if they report residency or shelter in North Carolina, are 18 years of age or older on the day of discharge and can access virtual care (phone/video). The VPTC program is defined by: * Psychiatric consultation * Medication management services with pharmacological consultation * following of Health Coaching participation and provide treatment recommendations * Tracking of behavioral health symptoms and provide treatment recommendations * Health coaching; Psychoeducational support * Treatment and safety planning * Assistance connecting with an outpatient care provider	Standard Care Seen at a location where standard care is offered
Overall Study STARTED	3616	3910
Overall Study COMPLETED	1382	3910
Overall Study NOT COMPLETED	2234	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health

Baseline characteristics by cohort

Measure	Virtual Program n=3616 Participants Seen at a location where the virtual program is being offered Virtual Psychiatric Transition of Care Program: Behavioral Health facility or units that have discharged patients meeting inclusion criteria will be randomly assigned as either an intervention or standard care site. Intervention sites will be those using the VPTC program. This evaluation design will integrate into current workflows for the measurement of outcomes. Prior to discharge, patients may be referred to the VPTC program if they report residency or shelter in North Carolina, are 18 years of age or older on the day of discharge and can access virtual care (phone/video). The VPTC program is defined by: * Psychiatric consultation * Medication management services with pharmacological consultation * following of Health Coaching participation and provide treatment recommendations * Tracking of behavioral health symptoms and provide treatment recommendations * Health coaching; Psychoeducational support * Treatment and safety planning * Assistance connecting with an outpatient care provider	Standard Care n=3910 Participants Seen at a location where standard care is offered	Total n=7526 Participants Total of all reporting groups
Age, Continuous	37.7 years STANDARD_DEVIATION 13.6 • n=5 Participants	37.3 years STANDARD_DEVIATION 14.5 • n=7 Participants	37.5 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	1546 Participants n=5 Participants	2011 Participants n=7 Participants	3557 Participants n=5 Participants
Sex: Female, Male Male	2070 Participants n=5 Participants	1899 Participants n=7 Participants	3969 Participants n=5 Participants
Race/Ethnicity, Customized African American	1557 participants n=5 Participants	1620 participants n=7 Participants	3177 participants n=5 Participants
Race/Ethnicity, Customized American indian	38 participants n=5 Participants	37 participants n=7 Participants	75 participants n=5 Participants
Race/Ethnicity, Customized Asian	63 participants n=5 Participants	60 participants n=7 Participants	123 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	1786 participants n=5 Participants	1970 participants n=7 Participants	3756 participants n=5 Participants
Race/Ethnicity, Customized Multi-Race	68 participants n=5 Participants	93 participants n=7 Participants	161 participants n=5 Participants
Race/Ethnicity, Customized Other	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants
Race/Ethnicity, Customized Unknown	97 participants n=5 Participants	120 participants n=7 Participants	217 participants n=5 Participants
Region of Enrollment United States	3616 participants n=5 Participants	3910 participants n=7 Participants	7526 participants n=5 Participants

PRIMARY outcome

Timeframe: day 30

30-day all cause non-elective acute care post discharge utilization (Emergency Department (ED), inpatient, and observation encounters)

Outcome measures

Measure	Virtual Program n=3616 Participants Seen at a location where the virtual program is being offered Virtual Psychiatric Transition of Care Program: Behavioral Health facility or units that have discharged patients meeting inclusion criteria will be randomly assigned as either an intervention or standard care site. Intervention sites will be those using the VPTC program. This evaluation design will integrate into current workflows for the measurement of outcomes. Prior to discharge, patients may be referred to the VPTC program if they report residency or shelter in North Carolina, are 18 years of age or older on the day of discharge and can access virtual care (phone/video). The VPTC program is defined by: * Psychiatric consultation * Medication management services with pharmacological consultation * following of Health Coaching participation and provide treatment recommendations * Tracking of behavioral health symptoms and provide treatment recommendations * Health coaching; Psychoeducational support * Treatment and safety planning * Assistance connecting with an outpatient care provider	Standard Care n=3910 Participants Seen at a location where standard care is offered
Number of Participants With All Cause Non-elective Acute Care Post Discharge Utilization Within 30 Days	941 Participants	973 Participants

SECONDARY outcome

Timeframe: day 60

60-day all cause non-elective acute care utilization (ED visits, observation, and inpatient encounters)

Outcome measures

Measure	Virtual Program n=3616 Participants Seen at a location where the virtual program is being offered Virtual Psychiatric Transition of Care Program: Behavioral Health facility or units that have discharged patients meeting inclusion criteria will be randomly assigned as either an intervention or standard care site. Intervention sites will be those using the VPTC program. This evaluation design will integrate into current workflows for the measurement of outcomes. Prior to discharge, patients may be referred to the VPTC program if they report residency or shelter in North Carolina, are 18 years of age or older on the day of discharge and can access virtual care (phone/video). The VPTC program is defined by: * Psychiatric consultation * Medication management services with pharmacological consultation * following of Health Coaching participation and provide treatment recommendations * Tracking of behavioral health symptoms and provide treatment recommendations * Health coaching; Psychoeducational support * Treatment and safety planning * Assistance connecting with an outpatient care provider	Standard Care n=3910 Participants Seen at a location where standard care is offered
60-day All Cause Non-elective Acute Care Utilization	1257 Participants	1270 Participants

SECONDARY outcome

Timeframe: day 45

Population: Intent to treat analysis

45-day behavioral health acute care utilization (BH unit or BH ED)

Outcome measures

Measure	Virtual Program n=3616 Participants Seen at a location where the virtual program is being offered Virtual Psychiatric Transition of Care Program: Behavioral Health facility or units that have discharged patients meeting inclusion criteria will be randomly assigned as either an intervention or standard care site. Intervention sites will be those using the VPTC program. This evaluation design will integrate into current workflows for the measurement of outcomes. Prior to discharge, patients may be referred to the VPTC program if they report residency or shelter in North Carolina, are 18 years of age or older on the day of discharge and can access virtual care (phone/video). The VPTC program is defined by: * Psychiatric consultation * Medication management services with pharmacological consultation * following of Health Coaching participation and provide treatment recommendations * Tracking of behavioral health symptoms and provide treatment recommendations * Health coaching; Psychoeducational support * Treatment and safety planning * Assistance connecting with an outpatient care provider	Standard Care n=3910 Participants Seen at a location where standard care is offered
45-day Behavioral Health Acute Care Utilization	556 Participants	622 Participants

SECONDARY outcome

Timeframe: day 45

Population: Intent to treat analysis

45-day behavioral health acute care utilization (ED visits, observation, and inpatient encounters)

Outcome measures

Measure	Virtual Program n=3616 Participants Seen at a location where the virtual program is being offered Virtual Psychiatric Transition of Care Program: Behavioral Health facility or units that have discharged patients meeting inclusion criteria will be randomly assigned as either an intervention or standard care site. Intervention sites will be those using the VPTC program. This evaluation design will integrate into current workflows for the measurement of outcomes. Prior to discharge, patients may be referred to the VPTC program if they report residency or shelter in North Carolina, are 18 years of age or older on the day of discharge and can access virtual care (phone/video). The VPTC program is defined by: * Psychiatric consultation * Medication management services with pharmacological consultation * following of Health Coaching participation and provide treatment recommendations * Tracking of behavioral health symptoms and provide treatment recommendations * Health coaching; Psychoeducational support * Treatment and safety planning * Assistance connecting with an outpatient care provider	Standard Care n=3910 Participants Seen at a location where standard care is offered
45-day All Cause Non-elective Acute Care Utilization	1124 Participants	1138 Participants

Adverse Events

Virtual Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

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

Dr. Jason Roberge

Atrium Health

Phone: 7043550268

Email: jason.roberge@atriumhealth.org

Results disclosure agreements

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