- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06616701
The Impact of Routine Follow-up Contacts After a Pediatric ED Visit for Youth With Suicide Risk
The Impact of Routine Follow-up Contacts After a Pediatric ED Visit for Youth With Suicide Risk: a Randomized Controlled Trial
The goal of this clinical trial is to learn if a social work led follow up program helps caregivers of youths with suicide risk access mental health resources.
Primary aims include:
- To formalize a mental health follow up protocol that assists youths with engagement of mental health services after a hospital visit.
- To evaluate and standardize the optimal timing for the follow up phone calls.
- To assess the proportion of patients with suicide risk who connect with community mental health care within a month after a pediatric emergency department (ED) visit at Johns Hopkins Hospital.
- To assess the proportion of patients with suicide risk who have repeat ED visits within 3 and 6 months.
The primary outcome of interest is the proportion of youths referred to a community provider who successfully connect to community mental health resources 5 to 10 business days after an ED visit. The secondary outcome will involve repeat ED visits within 3 and 6 months.
Study Overview
Detailed Description
The month following an ED discharge is a high-risk period for suicide for patients recovering from a suicide attempt and/or experiencing suicidal ideation, making referrals and follow up critically important. Very few hospital systems, if any, have been able to implement policies and practices that ensure patients at risk for suicide are getting the follow up care they need. Patient navigator interventions have demonstrated success in improving health outcomes across a range of conditions including mental health, and moreover, they have been effective in providing practical support and encouragement to aid patients in accessing community mental health services. Navigators are trained and supervised frontline public health personnel who are hired from the same communities as patients and aid patients in accessing health care and social services. They have shared experiences and nuanced understanding of the communities they serve to help facilitate developing rapport and trust with families, which can help mitigate health care inequities. To the investigator's knowledge, there are no published studies that have evaluated the implementation of patient navigators in the pediatric ED to help caregivers of suicidal youths access community mental health resources after an ED visit.
In the pediatric ED at Johns Hopkins, an ad hoc clinical initiative led by social work (SW) was started in September 2022 with efforts focused on following up with caregivers of patients with mental health emergencies who are discharged from the hospital. SW staff have been calling caregivers a few days after an ED visit or hospitalization to assist with barriers such as challenges in connecting with community mental health resources and accessing prescribed medications.
For this research, this follow up program will be standardized and consistent data collection will be implemented. A randomized controlled trial will be conducted to evaluate the efficacy of this intervention. If the results are promising, evaluation of this program would provide preliminary data for a future study for implementation of a patient navigation program to improve mental health service engagement for youths with suicide risk who are discharged from the pediatric ED.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients ages 8 to 21 years old;
- Who present to the emergency department (ED) and are assessed with suicide risk;
- Who are discharged from the Johns Hopkins Hospital (Pediatric inpatient psychiatric unit, Pediatric Day Hospital, or Pediatric ED) with a mental health referral
Exclusion Criteria:
- Patients who were directly transferred to the inpatient psychiatry unit or the Day Hospital from an outside hospital, bypassing the hospital's ED
- Direct admissions, bypassing the hospital's ED
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Follow up call within 5 days
|
As part of the standard of care, caregivers of youths who present to the hospital with suicidal risk receive a follow up call approximately 5-10 business days after the hospital discharge to assist them with any challenges they may encounter in accessing mental health care, including medication access.
The intervention group will receive a call 5 days after discharge.
The non-intervention group will receive a call 10 days after discharge.
|
|
No Intervention: Follow up call within 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of youths accessing community mental health resources
Time Frame: From enrollment up to 6 months
|
The primary outcome of interest is the proportion of youths referred to a community provider who successfully connect to community mental health resources 5 to 10 business days after an ED visit.
|
From enrollment up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency department revisits
Time Frame: From enrollment up to 6 months
|
The secondary outcome will involve repeat ED visits within 3 and 6 months.
|
From enrollment up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hanae Fujii-Rios, MD MPH, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00396477
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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