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

NCT ID: NCT03204643

Last Updated: 2022-04-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

637 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BH-VPN

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

Group Type EXPERIMENTAL

BH-VPN

Intervention Type BEHAVIORAL

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

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BH-VPN

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wayne Sparks, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Jason Roberge, PhD

Role: STUDY_DIRECTOR

Wake Forest University Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Carolinas Medical Center Mercy

Charlotte, North Carolina, United States

Site Status

Carolinas Healthcare System - Pineville

Charlotte, North Carolina, United States

Site Status

Carolinas Healthcare System University

Charlotte, North Carolina, United States

Site Status

Carolinas Healthcare System Steele Creek

Charlotte, North Carolina, United States

Site Status

Carolinas Healthcare System Huntersville

Huntersville, North Carolina, United States

Site Status

Carolinas Healthcare System - Union

Monroe, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31995214 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00021808

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Remote Training in Rural Schools
NCT05034198 COMPLETED NA