MyHEARTSMAP In-Patient Study

NCT ID: NCT06553521

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-17
• Study Completion Date: 2023-09-05

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.

Detailed Description

Purpose/Objective: The goal of this project is to investigate if implementing universal psychosocial screening using the MyHEARTSMAP instrument in hospitalized pediatric patients admitted for non primary psychiatric concerns increase/affect their holistic biopsychosocial management.

Hypothesis/Justification: Mental health conditions represent an increasingly substantial burden of illness in the pediatric population. Especially among youth who are hospitalized or experiencing chronic illness, there is a disproportionate burden of mental health concerns. However, large proportion of children who screen positive for mental health concerns while in hospital have never been identified as having a mental health concern, or have received health or social services related to such concerns.

The American Academy of Paediatrics has advocated for the universal use of efficient, culturally sensitive, and age-appropriate mental health screening tools to detect and facilitate management of youth with psychiatric illnesses; however, this has yet to be effectively implemented. Currently, in Canada, anecdotal evidence suggests that the standard of care for screening mental health related concerns in hospitalized youth typically varies by treating specialty. The lack of a consistent, systematic approach to screening youth coupled with reduced screening among those with higher medical needs may result in vulnerable pediatric populations falling through gaps of care in medical systems. In order to address the issue of under-identification of mental health illness in youth requiring hospitalization, this study proposes to implement a universal mental health screening using an online self-assessment tool, MyHEARTSMAP, in hospitalized youth to allow for early screen of mental health conditions and to improve their holistic biopsychosocial care.

MyHEARTSMAP has been validated as a universal screening tool and, when compared to clinician reports, has high sensitivity and specificity to identify youth with psychosocial concerns that warrant further follow-up. Upon completion of the tool, MyHEARTSMAP produces triggered recommendations that are consistent with clinician assessment. This tool has been adapted from HEARTSMAP, a clinical assessment tool used by British Columbia (BC) Children's Hospital Paediatric ED clinicians for mental health assessment and management of youth presenting with mental health concerns. Designed for self-assessment and universal screening, MyHEARTSMAP allows children and their parents to efficiently self- and proxy-report across multiple domains of mental health. MyHEARTSMAP allows for the comprehensive evaluation of 10 areas of wellbeing that makeup the 'HEARTSMAP' acronym: Home, Education and activities, Alcohol and drugs, Relationships and bullying, Thoughts and anxiety, Safety, sexual health, Mood, Abuse, and Professional resources.

Study Design, Population and Setting: The investigators propose to conduct a prospective randomized controlled study to evaluate the impact of standardized psychosocial screening using MyHEARTSMAP upon admission to an in-patient ward, on the frequency of psychosocial intervention during the hospitalization or mental health resource referrals upon discharge.

Statistical Analysis: The investigators will use descriptive statistics to summarize our study population demographic distributions. Our primary objective of comparing the proportion of participants receiving psychosocial interventions as part of their in-patient care or at discharge will be analysed using a test of proportions. Our secondary and exploratory analyses will include: comparing the proportion of youth who receive psychosocial interventions or mental health resources during the three-month period following discharge. The investigators will additionally report why or why not resources were accessed in the community, including barriers reported. The investigators will use NVivo to analyze descriptive responses and code by theme to describe barriers to mental health resource access and include representative quotes.

Sample Size: The investigators know from previous studies that approximately 40% of youth who present to the ED will screen positive in at least one domain of HEARTSMAP with recommendations to follow-up with specific resources. The investigators presume that at least 80% of those will receive services within their hospital stay or referrals at the time of discharge, or 30% of participants randomized to screening with MyHEARTSMAP. Given these factors, to achieve a power of 80% and 95% confidence, to detect an absolute difference of 15% (or relative difference of 50%) in proportion of youth who receive psychosocial interventions between study arms, the investigators would need to recruit 135 participants per arm. Accounting for 30% attrition (25% in previous MyHEARTSMAP studies), a sample size of 175 per arm is required.

Conditions

Mental Health Issue; Psychosocial Functioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intervention arm

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.

Group Type: OTHER

MyHEARTSMAP Youth Self-assessment Tool (At Admission)

Intervention Type: OTHER

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

Standard of care (delayed MyHEARTSMAP arm):

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MyHEARTSMAP Youth Self-assessment Tool (At Admission)

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Quynh Doan

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BC Children Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H21-01221

Identifier Type: -

Identifier Source: org_study_id