NCT05460078

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,526

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

July 12, 2022

Results QC Date

May 31, 2024

Last Update Submit

October 7, 2024

Conditions

Mental Health Issue

Keywords

behavioral health symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • 60-day All Cause Non-elective Acute Care Utilization

    day 60

  • 45-day Behavioral Health Acute Care Utilization

    day 45

  • 45-day All Cause Non-elective Acute Care Utilization

    day 45

Study Arms (2)

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

Virtual Psychiatric Transition of Care ProgramBEHAVIORAL

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

Virtual program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residency or shelter in North Carolina
  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Atrium Health Behavioral Health Davidson - Mountain Laurel

Charlotte, North Carolina, 28036, United States

Location

Atrium Health Behavioral Health Davidson - River Birch

Charlotte, North Carolina, 28036, United States

Location

Carolinas Medical Center Main - 6B

Charlotte, North Carolina, 28203, United States

Location

Atrium Health Behavioral Health Charlotte - ED Obs

Charlotte, North Carolina, 28211, United States

Location

Atrium Health Behavioral Health Charlotte - North and South

Charlotte, North Carolina, 28211, United States

Location

Atrium Health Behavioral Health Davidson - Frasier Fur

Davidson, North Carolina, 28036, United States

Location

Atrium Health Kings Mountain Psychiatry

Kings Mountain, North Carolina, 28086, United States

Location

Results Point of Contact

Title
Dr. Jason Roberge
Organization
Atrium Health
jason.roberge@atriumhealth.org
7043550268

Study Officials

  • Jason Roberge, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: stepped-wedge
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start

November 1, 2021

Primary Completion

August 22, 2023

Study Completion

October 20, 2023

Last Updated

October 15, 2024

Results First Posted

October 15, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(7)