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

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ClinicalTrials.gov Identifier: NCT03204643
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Carolinas Healthcare System

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.


Condition or disease Intervention/treatment Phase
Mental Health Behavioral: BH-VPN Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Evaluation of ED to Admission Conversion Among Patients With a Telepsychiatric Consult Who Are Followed by a Behavioral Health - Virtual Patient Navigation Team
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Emergency Department to inpatient conversion rate [ Time Frame: 5 days ]
    admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.


Secondary Outcome Measures :
  1. Quality, Comfort, and Care (QCC) defined readmission rate [ Time Frame: 30 days ]
    readmission within 30 days to the same facility

  2. Patient-centric (protocol defined) readmission rate [ Time Frame: 30 days ]
    readmission within 30 days to any facility which Carolinas Healthcare System have access to the data

  3. Utilization of healthcare services post-discharge from Emergency Department [ Time Frame: 45 days ]
    Number of Emergency Department, inpatient, observation encounters



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204643


Contacts
Contact: Wayne Sparks, MD 704-631-1654 wayne.sparks@carolinashealthcare.org
Contact: Jason Roberge, PhD 704-355-0268 jason.roberge@carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Medical Center Mercy Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Wayne Sparks, MD         
Contact: Jason Roberge, PhD         
Carolinas Healthcare System - Pineville Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Wayne Sparks, MD         
Contact: Jason Roberge, PhD         
Carolinas Healthcare System University Recruiting
Charlotte, North Carolina, United States, 28262
Contact: Wayne Sparks, MD         
Contact: Jason Roberge, PhD         
Carolinas Healthcare System Steele Creek Recruiting
Charlotte, North Carolina, United States, 28278
Contact: Wayne Sparks, MD         
Contact: Jason Roberge, PhD         
Carolinas Healthcare System Huntersville Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Wayne Sparks, MD         
Contact: Jason Roberge, PhD         
Carolinas Healthcare System - Union Recruiting
Monroe, North Carolina, United States, 28112
Contact: Wayne Sparks, MD         
Contact: Jason Roberge, PhD         
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Wayne Sparks, MD Carolinas Healthcare System
Study Director: Jason Roberge, PhD Carolinas Healthcare System

Responsible Party: Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT03204643     History of Changes
Other Study ID Numbers: 00021808
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No