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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04148521
Other study ID # IRB00081746
Secondary ID 13952Pro00038573
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date January 31, 2022

Study information

Verified date February 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Hospital admissions are common amongst those with mental illness. Significant morbidity exists for patients who are being admitted to a psychiatric hospital from the Emergency Department (ED).Additionally, commitment to a hospital setting may have adverse effects on patients psychologically, degrade relationships with therapists, and disrupt continuity of care. ED providers often decide to admit to a psychiatric hospital because of limited availability of behavioral health resources. To better enhance transitions of care for those with mental illness, Atrium Health has designed a behavioral health virtual patient navigation (BH-VPN)program that helps coordinate services and follow-up care, while facilitating the safe discharge of patients. Patients presenting to an ED that have a tele psychiatric consult who are recommended for discharge are eligible for services. The Behavioral health Service line is expanding the program to additional rural emergency departments. Using an outcomes evaluation, the investigators will inform Atrium Health on the effect of the BH-VPN program to reduce hospital admissions among patients with a tele psychiatric consult in the ED. The proposed hypothesis is that by having the BH-VPN program available in an ED, more patients will be discharged from the ED than admitted.


Recruitment information / eligibility

Status Completed
Enrollment 1089
Est. completion date January 31, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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 Exclusion Criteria:• Patients currently enrolled in the BH-VPN program upon their index ED encounter -

Study Design


Intervention

Behavioral:
Behavioral Health - Virtual Patient Navigation
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.

Locations

Country Name City State
United States Atrium Health - Stanly Albemarle North Carolina
United States Atrium Health - Kings Mountain Kings Mountain North Carolina
United States Scotland Memorial Hospital Laurinburg North Carolina
United States Atrium Health - Lincoln Lincolnton North Carolina
United States Carolinas HealthCare System - Blue Ridge - Morganton Morganton North Carolina
United States Atrium Health - Cleveland Shelby North Carolina
United States Carolinas HealthCare System - Valdese Valdese North Carolina
United States Atrium Health - Anson Wadesboro North Carolina
United States Columbus Regional Hospital Whiteville North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences The Duke Endowment

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 45-day Post Discharge Utilization Rate Comparing the 45-day utilization (ED, IP, OBS encounter) rate after the ED encounter between the 2 arms of the study 45 days
Secondary 45-day Post Discharge Utilization Rate With a Self-harm Diagnosis Compare the frequency of patients with any encounter with a self-harm diagnosis within 45 days of the ED visit between the 2 arms of the study 45 days
Secondary 45-day Post Discharge ED Utilization Rate With a Behavioral Health Crisis Compare the frequency of patients who return to the ED and have a telepsychiatric consult within 45 days of their initial ED visit between the 2 arms of the study 45 days
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