NCT04148521

Brief Summary

This research project is a pragmatic, randomized evaluation of a quality improvement initiative which seeks to evaluate the effects of standardizing the use of a BH-VPN program among patients with a telepsychiatric consult. The outcomes evaluation of this intervention has been designed to integrate with routine care and minimize frontline staff burden by deploying an evaluation in a real-world setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,089

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable depression

Geographic Reach
1 country

9 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

October 14, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 12, 2022

Completed
Last Updated

March 21, 2023

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

October 30, 2019

Results QC Date

February 21, 2022

Last Update Submit

March 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessing Hospital Admissions

    Compare the effectiveness of having the Behavioral Health - Virtual Patient Navigation (BH-VPN) program available compared to usual care, on admission rates among patients in the ED with a telepsychiatric consult

    Up to 2 weeks from initial ED admission

Secondary Outcomes (3)

  • 45-day Post Discharge Utilization Rate

    45 days

  • 45-day Post Discharge Utilization Rate With a Self-harm Diagnosis

    45 days

  • 45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis

    45 days

Study Arms (2)

Behavioral Health - Virtual Patient Navigation

EXPERIMENTAL

All patients who meet eligibility criteria at sites where the virtual patient navigation behavioral health program is offered will be considered exposed to the intervention.

Behavioral: Behavioral Health - Virtual Patient Navigation

Usual care Behavioral Health

NO INTERVENTION

All patients who meet eligibility criteria at sites where the virtual patient navigator behavioral health program is not offered will be considered exposed to usual care.

Interventions

Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention.

Behavioral Health - Virtual Patient Navigation

Eligibility Criteria

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

You may qualify if:

  • Eligible patients must meet each of the following criteria:
  • Present to an ED at participating sites
  • Complete a telepsychiatric consult as captured in the electronic medical record
  • Complete a telepsychiatric consult during the navigator's hours of operation
  • ≥ 18 years of age at time of ED admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Atrium Health - Stanly

Albemarle, North Carolina, 28001, United States

Location

Atrium Health - Kings Mountain

Kings Mountain, North Carolina, 28086, United States

Location

Scotland Memorial Hospital

Laurinburg, North Carolina, 28352, United States

Location

Atrium Health - Lincoln

Lincolnton, North Carolina, 28092, United States

Location

Carolinas HealthCare System - Blue Ridge - Morganton

Morganton, North Carolina, 28655, United States

Location

Atrium Health - Cleveland

Shelby, North Carolina, 28150, United States

Location

Carolinas HealthCare System - Valdese

Valdese, North Carolina, 28690, United States

Location

Atrium Health - Anson

Wadesboro, North Carolina, 28170, United States

Location

Columbus Regional Hospital

Whiteville, North Carolina, 28472, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersChemically-Induced Disorders

Results Point of Contact

Title
Jason Roberge
Organization
Atrium Health

Study Officials

  • Jason Roberge, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 1, 2019

Study Start

October 14, 2019

Primary Completion

October 31, 2021

Study Completion

January 31, 2022

Last Updated

March 21, 2023

Results First Posted

April 12, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations