- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460078
An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health (VPTC)
An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health Settings
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jason Roberge, PhD
- Phone Number: 704-355-0268
- Email: jason.roberge@atriumhealth.org
Study Contact Backup
- Name: Whitney Rossman
- Phone Number: 704-446-2104
- Email: Whitney.rossman@atriumhealth.org
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28036
- Atrium Health Behavioral Health Davidson - Mountain Laurel
-
Charlotte, North Carolina, United States, 28036
- Atrium Health Behavioral Health Davidson - River Birch
-
Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center Main - 6B
-
Charlotte, North Carolina, United States, 28211
- Atrium Health Behavioral Health Charlotte - ED Obs
-
Charlotte, North Carolina, United States, 28211
- Atrium Health Behavioral Health Charlotte - North and South
-
Davidson, North Carolina, United States, 28036
- Atrium Health Behavioral Health Davidson - Frasier Fur
-
Kings Mountain, North Carolina, United States, 28086
- Atrium Health Kings Mountain Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Residency or shelter in North Carolina
- 18 years of age or older on the day of discharge
- Access virtual care (phone/video)
- Discharged from a behavioral health hospital or a behavioral health unit
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual program
Seen at a location where the virtual program is being offered
|
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:
|
No Intervention: Standard care
Seen at a location where standard care is offered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day all cause non-elective acute care post discharge utilization
Time Frame: day 30
|
30-day all cause non-elective acute care post discharge utilization (Emergency Department (ED), inpatient, and observation encounters)
|
day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
60-day all cause non-elective acute care utilization
Time Frame: day 60
|
60-day all cause non-elective acute care utilization (ED visits, observation, and inpatient encounters)
|
day 60
|
30-day behavioral health acute care utilization
Time Frame: day 30
|
30-day behavioral health acute care utilization (ED visits, observation, and inpatient encounters)
|
day 30
|
Number of Subjects with Behavioral Health office visit
Time Frame: day 7
|
Examine the percent of patients that had a behavioral health office visit within 7 days of discharge
|
day 7
|
Count of unavoidable Emergency Department (ED) visits
Time Frame: day 30
|
Examine the count of avoidable ED visits within 30 days of discharge
|
day 30
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients - Depression reduction
Time Frame: day 60
|
Percent of patients with a 5 point reduction of their Patient Health Questionnaire (PHQ-9) score who had an initial PHQ-9 score ≥ 10, intervention arm only
|
day 60
|
Change in Patient Health Questionnaire (PHQ-9) scores
Time Frame: day 60
|
Show the distribution of PHQ-9 score reduction among participants, intervention arm only
|
day 60
|
Percent of patients - report no suicide ideation
Time Frame: day 60
|
Percent of patients with a PHQ-9, Question 9=0 upon graduation among patients with an initial Q9>0, intervention arm only
|
day 60
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jason Roberge, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11-21-02E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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