NCT06553521

Brief Summary

Often, mental health (MH) conditions are under-identified in youth with chronic health conditions, which can lead to long-term health consequences and can impact their everyday lives. Hospitalized youth often experience higher MH burdens and tend to have fewer interactions with their primary healthcare providers upon discharge, leading to overall worse health outcomes. In-hospital treatment focuses on the acute physical condition relating to the hospitalization and often neglects the mental health aspect of the patients general health problems. The American Academy of Paediatrics has advocated for the universal use of MH screening tools to detect and facilitate management of youth with psychiatric illnesses; however, this has yet to be effectively implemented. Currently, the guidelines for screening of MH related concerns in hospitalized youth vary by treating specialties. The investigators believe that having a universal psychosocial screening using an online MH self-assessment tool, MyHEARTSMAP, in hospitalized youth will allow for early screening of MH conditions and can improve their holistic biopsychosocial care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

June 12, 2024

Last Update Submit

August 9, 2024

Conditions

Keywords

screening toolrandomized control trialpsychosocial screeningin-patientuniversal mental health screeningpediatricsuniversal psychosocial screeningpediatric mental healthmental health screeningMyHEARTSMAP

Outcome Measures

Primary Outcomes (2)

  • Incorporation of mental health resources during in-patient stay

    The investigators will report the proportion of youth who received MH resources/consultation during their in-patient stay comparing participants in their randomized intervention group.

    During admission period

  • Incorporation of MH resources on discharge planning

    The investigators will compare the proportion of youth who received MH resources and recommendations for support on their discharge plans comparing participants in their randomized intervention group. The investigators will also assess whether the care team provided verbal consultation with patients/families at the time of discharge.

    Time at which participant is discharged from hospital, could be up to approximately 6 weeks from date of randomization

Secondary Outcomes (1)

  • Utilization of mental health resources following discharge

    At 3 months following discharge

Study Arms (2)

Intervention arm

OTHER

In the MyHEARTSMAP intervention group, research assistants (RAs) help with the self-administered screening using a device. Validated for ages 10-17, both self-reporting and proxy-reporting are allowed. After self- and/or parent-reports, a MyHEARTSMAP report is auto-submitted to REDCap, with one printed copy for the patient chart. if there are any mental health concerns identified in MyHEARTSMAP report, they will be addressed by the treating teams. Respondents can receive reports via email, ensuring privacy and separate reports for parents and youth. Discussions with the treating team are encouraged. Severe safety concerns during ED screening prompt immediate contact with the treating team. The admitting service manages concerns in the care plan.

Other: MyHEARTSMAP Youth Self-assessment Tool (At Admission)

Standard of care (delayed MyHEARTSMAP arm):

NO INTERVENTION

Participants receiving standard care will complete an initial data collection form for demographic and medical information. After hospital discharge, they'll get a link to complete MyHEARTSMAP. Reminder email will be sent if MyHEARTSMAP is not completed by days 3 and 7. Severe or acute safety concerns from MyHEARTSMAP trigger alerts, directing participants to crisis lines or EDs. RAs review daily for such concerns, contacting the research team for follow-up, led by a pediatric emergency physician.

Interventions

MyHEARTSMAP is a validated self-assessment tool for pediatric populations, demonstrating high sensitivity and specificity for identifying psychosocial concerns. Adapted from HEARTSMAP, it allows self- and proxy-reporting across 10 well-being domains, providing personalized recommendations. Currently, the clinician-reported HEARTSMAP is the standard of care at BC Children's Hospital ED for the initial assessment of youth with primary psychiatric concerns

Intervention arm

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and youth aged 7-17 years (and their guardians) from the emergency department (ED)
  • Primary non-psychiatric concerns
  • Admitted to the in-patient general pediatrics, cardiology, nephrology, neurology, endocrinology, gastroenterology, general surgery, urology, or orthopaedic surgery services OR from the surgical units if they have a pre-planned admission under general surgery, orthopaedic surgery, or urology for an elective surgery
  • Use of translators in the ED or surgical units will be accessed as available (ED/surgical unit staff with shared language skills) to help include families with language barrier challenges.

You may not qualify if:

  • Hospitalized with a mental health condition as the primary reason for their ED visit or surgery.
  • Requiring a sustained level of critical care
  • Aged \<7 and \>17 years at the time of ED presentation or surgery
  • Previously enrolled in the study (ie. multiple admissions)
  • No email and internet access (email and internet access is required in order to access MyHEARTSMAP if completing after discharged from hospital.)
  • No mental capacity to read, understand and agree to the assent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 12, 2024

First Posted

August 14, 2024

Study Start

August 17, 2021

Primary Completion

May 18, 2023

Study Completion

September 5, 2023

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations