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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05460078
Other study ID # 11-21-02E
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date June 2024

Study information

Verified date May 2024
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to evaluate the effectiveness of a post inpatient discharge virtual psychiatric care team compared to standard care, to reduce 30-day all cause non-elective acute care utilization (Emergency Department (ED), observation, and inpatient encounters).


Description:

The foundational idea for the Virtual Psychiatric Transition of Care (VPTC) program came from the Atrium Health Hospital at Home care model which has garnered wide acclaim and financial support in the acute care world. A behavioral health care team comprised of licensed clinicians (Behavioral Health Professionals), health coaches, a consulting psychiatric pharmacist and psychiatric providers follow patients for 45 days or more depending on patient need after their acute care encounter. Patient enrolled in the VPTC program will receive the following core components: Introduction to the patient follow-up process, psychosocial assessment, tracking and treatment recommendations for (residential movement, nutrition, sleep hygiene, stress management, pain management, perinatal/postpartum mood disorders, substance abuse), tracking and treatment recommendations for behavioral health symptoms (depression, anxiety, suicidal ideation, etc.), placement into an appropriate case management program if needed, navigation to additional psychiatric or substance use services if needed, and motivational interviewing and brief therapeutic recommendations if needed. For patients that have attempted suicide, they will begin the VPTC program following the zero suicide pathway. The Atrium Health Behavioral Health Service Line created the 'Zero Suicide pathway', in 2019 for those patients identified as "high risk" for suicide when leaving inpatient units. Zero Suicide is a national movement sponsored by the 2012 National Strategy for Suicide Prevention, National Alliance for Suicide Prevention, Suicide Prevention Resource Center and the Substance Abuse and Mental Health Services Administration (SAMHSA). It is a programmatic approach to keep patients from falling through the cracks in a fragmented and disconnected healthcare system and is based on the belief that suicide is preventable, and suicide deaths are not fated. Since access to mental health services is constrained in our community, patients often fall through the cracks when transitioning between points of care.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1082
Est. completion date June 2024
Est. primary completion date August 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Residency or shelter in North Carolina - 18 years of age or older on the day of discharge - Access virtual care (phone/video) - Discharged from a behavioral health hospital or a behavioral health unit Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Psychiatric Transition of Care Program
Behavioral Health facility or units that have discharged patients meeting inclusion criteria will be randomly assigned as either an intervention or standard care site. Intervention sites will be those using the VPTC program. This evaluation design will integrate into current workflows for the measurement of outcomes. Prior to discharge, patients may be referred to the VPTC program if they report residency or shelter in North Carolina, are 18 years of age or older on the day of discharge and can access virtual care (phone/video). The VPTC program is defined by: Psychiatric consultation Medication management services with pharmacological consultation following of Health Coaching participation and provide treatment recommendations Tracking of behavioral health symptoms and provide treatment recommendations Health coaching; Psychoeducational support Treatment and safety planning Assistance connecting with an outpatient care provider

Locations

Country Name City State
United States Atrium Health Behavioral Health Charlotte - ED Obs Charlotte North Carolina
United States Atrium Health Behavioral Health Charlotte - North and South Charlotte North Carolina
United States Atrium Health Behavioral Health Davidson - Mountain Laurel Charlotte North Carolina
United States Atrium Health Behavioral Health Davidson - River Birch Charlotte North Carolina
United States Carolinas Medical Center Main - 6B Charlotte North Carolina
United States Atrium Health Behavioral Health Davidson - Frasier Fur Davidson North Carolina
United States Atrium Health Kings Mountain Psychiatry Kings Mountain 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
Other Percent of patients - Depression reduction Percent of patients with a 5 point reduction of their Patient Health Questionnaire (PHQ-9) score who had an initial PHQ-9 score = 10, intervention arm only day 60
Other Change in Patient Health Questionnaire (PHQ-9) scores Show the distribution of PHQ-9 score reduction among participants, intervention arm only day 60
Other Percent of patients - report no suicide ideation Percent of patients with a PHQ-9, Question 9=0 upon graduation among patients with an initial Q9>0, intervention arm only day 60
Primary 30-day all cause non-elective acute care post discharge utilization 30-day all cause non-elective acute care post discharge utilization (Emergency Department (ED), inpatient, and observation encounters) day 30
Secondary 60-day all cause non-elective acute care utilization 60-day all cause non-elective acute care utilization (ED visits, observation, and inpatient encounters) day 60
Secondary 30-day behavioral health acute care utilization 30-day behavioral health acute care utilization (ED visits, observation, and inpatient encounters) day 30
Secondary Number of Subjects with Behavioral Health office visit Examine the percent of patients that had a behavioral health office visit within 7 days of discharge day 7
Secondary Count of unavoidable Emergency Department (ED) visits Examine the count of avoidable ED visits within 30 days of discharge day 30
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