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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health Settings
- ClinicalTrials.gov ID
- NCT05460078
- Acronym / sponsor ID
- VPTC / IRB00082500
- Conditions
- Mental Health Issue
- Keywords
- behavioral health symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,526 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Duke Endowment
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Virtual program | Experimental | Behavioral: Virtual Psychiatric Transition of Care ProgramSeen at a location where the virtual program is being offered |
| Standard care | No intervention | –Seen at a location where standard care is offered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Psychiatric Transition of Care ProgramBehavioral 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 | Behavioural | Virtual program |
Primary outcome
Number of Participants With All Cause Non-elective Acute Care Post Discharge Utilization Within 30 Days
Time frame: day 30
30-day all cause non-elective acute care post discharge utilization (Emergency Department (ED), inpatient, and observation encounters)
3 secondary outcomes
60-day All Cause Non-elective Acute Care Utilization
Time frame: day 60
45-day Behavioral Health Acute Care Utilization
Time frame: day 45
45-day All Cause Non-elective Acute Care Utilization
Time frame: day 45
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Roberge, PhD principal investigator
Wake Forest University Health Sciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With All Cause Non-elective Acute Care Post Discharge Utilization Within 30 Days (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.