Mental Health IssueVPTCNCT05460078
An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health
A study testing Virtual Psychiatric Transition of Care Program in people with Mental Health Issue, run by Wake Forest University Health Sciences at 7 sites in United States.
Trial summary
The primary objective is to evaluate the effectiveness of a post inpatient discharge virtual psychiatric care team compared to standard care, to reduce 30-day all cause non-elective acute care utilization (Emergency Department (ED), observation, and inpatient encounters). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Virtual Psychiatric Transition of Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,526 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Nov 2021to 20 Oct 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Atrium Health Behavioral Health Davidson - Mountain Laurel
Charlotte, North Carolina, 28036
Atrium Health Behavioral Health Davidson - River Birch
Charlotte, North Carolina, 28036
Carolinas Medical Center Main - 6B
Charlotte, North Carolina, 28203
Atrium Health Behavioral Health Charlotte - ED Obs
Charlotte, North Carolina, 28211
Atrium Health Behavioral Health Charlotte - North and South
Charlotte, North Carolina, 28211
Atrium Health Behavioral Health Davidson - Frasier Fur
Davidson, North Carolina, 28036
Atrium Health Kings Mountain Psychiatry
Kings Mountain, North Carolina, 28086
About this study
Official title: An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health Settings
The primary objective is to evaluate the effectiveness of a post inpatient discharge virtual psychiatric care team compared to standard care, to reduce 30-day all cause non-elective acute care utilization (Emergency Department (ED), observation, and inpatient encounters).
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- Virtual Psychiatric Transition of Care Program
- Keywords
- behavioral health symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Psychiatric Transition of Care ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Virtual program | Experimental | Seen at a location where the virtual program is being offered Receives: Behavioral: Virtual Psychiatric Transition of Care Program |
| Standard care | No intervention | Seen at a location where standard care is offered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 30
Secondary outcomes (3)
60-day All Cause Non-elective Acute Care Utilization
60-day all cause non-elective acute care utilization (ED visits, observation, and inpatient encounters)
Measured: day 60
45-day Behavioral Health Acute Care Utilization
45-day behavioral health acute care utilization (BH unit or BH ED)
Measured: day 45
45-day All Cause Non-elective Acute Care Utilization
45-day behavioral health acute care utilization (ED visits, observation, and inpatient encounters)
Measured: day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Nov 2021
- Primary completion22 Aug 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- stepped-wedge
- Masking
- None (open label)
- Enrolment
- 7,526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment
- Responsible party
- Sponsor
- Investigators
- Jason Roberge, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460078
- Sponsor's protocol ID
- IRB00082500
- Acronym
- VPTC
- Status last verified
- May 2024
- First submitted
- 12 Jul 2022
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No