Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553521
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-12
Brief Title:
MyHEARTSMAP In-Patient Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Universal Psychosocial Screening Using MyHEARTSMAP In Hospitalized Pediatric Patients A Randomized Control Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
PurposeObjective 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 increaseaffect their holistic biopsychosocial management
HypothesisJustification 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 Childrens 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
HypothesisJustification 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 Childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None