An Evaluation of Virtual Psychiatric Transition of Care O... | NCT05460078

Status Module

Name	Class
The Duke Endowment	OTHER

Oversight Module

Description Module

Detailed Description

The foundational idea for the Virtual Psychiatric Transition of Care (VPTC) program came from the Atrium Health Hospital at Home care model which has garnered wide acclaim and financial support in the acute care world. A behavioral health care team comprised of licensed clinicians (Behavioral Health Professionals), health coaches, a consulting psychiatric pharmacist and psychiatric providers follow patients for 45 days or more depending on patient need after their acute care encounter. Patient enrolled in the VPTC program will receive the following core components: Introduction to the patient follow-up process, psychosocial assessment, tracking and treatment recommendations for (residential movement, nutrition, sleep hygiene, stress management, pain management, perinatal/postpartum mood disorders, substance abuse), tracking and treatment recommendations for behavioral health symptoms (depression, anxiety, suicidal ideation, etc.), placement into an appropriate case management program if needed, navigation to additional psychiatric or substance use services if needed, and motivational interviewing and brief therapeutic recommendations if needed.

For patients that have attempted suicide, they will begin the VPTC program following the zero suicide pathway. The Atrium Health Behavioral Health Service Line created the 'Zero Suicide pathway', in 2019 for those patients identified as "high risk" for suicide when leaving inpatient units. Zero Suicide is a national movement sponsored by the 2012 National Strategy for Suicide Prevention, National Alliance for Suicide Prevention, Suicide Prevention Resource Center and the Substance Abuse and Mental Health Services Administration (SAMHSA). It is a programmatic approach to keep patients from falling through the cracks in a fragmented and disconnected healthcare system and is based on the belief that suicide is preventable, and suicide deaths are not fated. Since access to mental health services is constrained in our community, patients often fall through the cracks when transitioning between points of care.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual program	Experimental	Seen at a location where the virtual program is being offered	Behavioral: Virtual Psychiatric Transition of Care Program
Standard care	No Intervention	Seen at a location where standard care is offered

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Psychiatric Transition of Care Program	Behavioral	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With All Cause Non-elective Acute Care Post Discharge Utilization Within 30 Days	30-day all cause non-elective acute care post discharge utilization (Emergency Department (ED), inpatient, and observation encounters)	day 30

Secondary Outcomes

Measure	Description	Time Frame
60-day All Cause Non-elective Acute Care Utilization	60-day all cause non-elective acute care utilization (ED visits, observation, and inpatient encounters)	day 60
45-day Behavioral Health Acute Care Utilization

Eligibility Module

Name	Affiliation	Role
Jason Roberge, PhD	Wake Forest University Health Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Atrium Health Behavioral Health Davidson - Mountain Laurel		Charlotte	North Carolina	28036	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Oct 8, 2021

Arm/Group Information

ID	Title	Description
BG000	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
BG001	Standard Care	Seen at a location where standard care is offered
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0003616 BG0013910 BG0027526

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.7± 13.6 BG00137.3± 14.5 BG00237.5± 13.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001546 BG0012011 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

African American

Title	Measurements
	BG0001557 BG0011620 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0003616 BG0013910 BG002

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

Number of Participants With All Cause Non-elective Acute Care Post Discharge Utilization Within 30 Days

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

Posted

Count of Participants

Participants

day 30

ID	Title	Description
OG000	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
OG001	Standard Care	Seen at a location where standard care is offered

Units	Counts
Participants	OG0003616 OG0013910

Title

Denominators

Categories

Title	Measurements
	OG000941 OG001973

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		<0.001		Odds Ratio (OR)	1.39			2-Sided	95	1.16	1.68					Superiority

Secondary

60-day All Cause Non-elective Acute Care Utilization

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

Posted

Count of Participants

Participants

day 60

ID	Title	Description
OG000	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
OG001	Standard Care	Seen at a location where standard care is offered

Secondary

45-day Behavioral Health Acute Care Utilization

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

Intent to treat analysis

Posted

Count of Participants

Participants

day 45

ID	Title	Description
OG000	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
OG001	Standard Care	Seen at a location where standard care is offered

Secondary

45-day All Cause Non-elective Acute Care Utilization

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

Intent to treat analysis

Posted

Count of Participants

Participants

day 45

ID	Title	Description
OG000	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
OG001	Standard Care	Seen at a location where standard care is offered

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	3,616	0	3,616	0	3,616
EG001	Standard Care	Seen at a location where standard care is offered	0	3,910	0	3,910	0	3,910