Evaluation of Behavioral Health-Virtual Patient Navigation Team (BH-VPN)

An Evaluation of ED to Admission Conversion Among Patients With a Telepsychiatric Consult Who Are Followed by a Behavioral Health - Virtual Patient Navigation Team

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.

Study Overview

• Status: Completed
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: BH-VPN

• Study Type: Interventional
• Enrollment (Actual): 637
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Carolinas Healthcare System - Pineville
    • Charlotte, North Carolina, United States, 28207
      • Carolinas Medical Center Mercy
    • Charlotte, North Carolina, United States, 28262
      • Carolinas Healthcare System University
    • Charlotte, North Carolina, United States, 28278
      • Carolinas Healthcare System Steele Creek
    • Huntersville, North Carolina, United States, 28078
      • Carolinas Healthcare System Huntersville
    • Monroe, North Carolina, United States, 28112
      • Carolinas Healthcare System - Union

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• None per the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BH-VPN; A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services.	Behavioral: BH-VPN; A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.
NO_INTERVENTION: Usual Care; The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality, Comfort, and Care (QCC) Defined Readmission Rate	readmission within 30 days to the same facility	30 days
Patient-centric (Protocol Defined) Readmission Rate	readmission within 30 days to any facility which Carolinas Healthcare System have access to the data	30 days
Utilization of Healthcare Services Post-discharge From Emergency Department	Number of Emergency Department, inpatient, observation encounters	45 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Wayne Sparks, MD, Wake Forest University Health Sciences; Study Director: Jason Roberge, PhD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2017
• Primary Completion (ACTUAL): February 14, 2018
• Study Completion (ACTUAL): March 31, 2018

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 00021808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No