NCT03204643

Brief Summary

Patients who present to one of the participating EDs with a telepsychiatric consult performed will be treated and followed per the behavioral health virtual patient navigation pathway (BH-VPN) or usual care. The BH-VPN is inclusive of several components which will all be consistently applied to patients randomized to the intervention, as well as having access to behavioral health trained patient navigators. These key components are often deployed inconsistently as a part of usual care, but per the intervention, will be completed in totality for subjects who are assigned to and participate in the BH-VPN plan. This study includes a qualitative sub-study to measure perceptions of the impact of the BH-VPN on readmission rates and patient outcomes, experiences with the services provided by the BH-VPN, and provider and clinician ideas for how to improve the services provided by the BH-VPN.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
637

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 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

June 12, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 2, 2019

Completed
Last Updated

April 21, 2022

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

June 28, 2017

Results QC Date

July 25, 2019

Last Update Submit

April 19, 2022

Conditions

Mental Health

Outcome Measures

Primary Outcomes (1)

  • Emergency Department to Inpatient Conversion Rate

    admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.

    5 days

Secondary Outcomes (3)

  • Quality, Comfort, and Care (QCC) Defined Readmission Rate

    30 days

  • Patient-centric (Protocol Defined) Readmission Rate

    30 days

  • Utilization of Healthcare Services Post-discharge From Emergency Department

    45 days

Study Arms (2)

BH-VPN

EXPERIMENTAL

A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services.

Behavioral: BH-VPN

Usual Care

NO INTERVENTION

The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.

Interventions

BH-VPNBEHAVIORAL

A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.

BH-VPN

Eligibility Criteria

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

You may qualify if:

  • Present at a participating ED
  • Completed telepsychiatric consult as captured in the EMR
  • Completed telepsychiatric consult Monday - Friday during Navigator's potential hours of operation.

You may not qualify if:

  • None per the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Carolinas Medical Center Mercy

Charlotte, North Carolina, 28207, United States

Location

Carolinas Healthcare System - Pineville

Charlotte, North Carolina, 28210, United States

Location

Carolinas Healthcare System University

Charlotte, North Carolina, 28262, United States

Location

Carolinas Healthcare System Steele Creek

Charlotte, North Carolina, 28278, United States

Location

Carolinas Healthcare System Huntersville

Huntersville, North Carolina, 28078, United States

Location

Carolinas Healthcare System - Union

Monroe, North Carolina, 28112, United States

Location

Related Publications (1)

  • Roberge J, McWilliams A, Zhao J, Anderson WE, Hetherington T, Zazzaro C, Hardin E, Barrett A, Castro M, Balfour ME, Rachal J, Krull C, Sparks W. Effect of a Virtual Patient Navigation Program on Behavioral Health Admissions in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1919954. doi: 10.1001/jamanetworkopen.2019.19954.

    PMID: 31995214DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Results Point of Contact

Title
Dr. Jason Roberge
Organization
Atrium Health
Jason.Roberge@AtriumHealth.org
704-355-0268

Study Officials

  • Wayne Sparks, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Jason Roberge, PhD

    Wake Forest University Health Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

June 12, 2017

Primary Completion

February 14, 2018

Study Completion

March 31, 2018

Last Updated

April 21, 2022

Results First Posted

October 2, 2019

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(6)