Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-04
Brief Title:
Exploratory Trial of a Pediatric Web-Based Care Planning Guide
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Patient-Reported Outcomes Plus Care Planning Applications for Strengthening Participation on Early Intervention Care Teams
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSPECT
Brief Summary:
Infants and toddlers with developmental disabilities or delays use early intervention EI for rehabilitation services Yet poor quality of EI services is pervasive particularly for racially and ethnically diverse and socially disadvantaged families A key lever to improve EI quality is family-centered care an evidence-based approach that is grounded in family engagement for shared decision-making This project is motivated by the need to give families a smart and connected option for engaging in the design of the EI service plan for their child This project upgrades and tests an evidence-based and innovative electronic solution that helps families to organize and share their priorities for change and ideas for goal attainment with professionals so as to ensure fit of the service plan with their needs
Detailed Description:
Infants and toddlers with developmental disabilities or delays use early intervention EI for rehabilitation services Yet poor quality of EI services is pervasive particularly for racially and ethnically diverse and socially disadvantaged families A key lever to improve EI quality is family-centered care an evidence-based approach that is grounded in family engagement for shared decision-making
This project further develops and evaluates the Participation and Environment Measure PEM an electronic option for family-centered EI service design that has two parts 1 an evidence-based and promising electronic patient-reported outcome e-PRO assessment called the Young Childrens Participation and Environment Measure YC-PEM and 2 a prototypic goal setting application called Participation and and Environment Measure Plus PEM This project builds on published evidence for its feasibility acceptability and preliminary effectiveness of the YC-PEM e-PRO when paired with a program-specific decision-support tool on EI service quality EI stakeholder perspectives on salient supports barriers and strategies signal its viability for broader early intervention service system implementation One important optimization involves expanding its reach to historically minoritized families
This project will be accomplished in 3 aims 1 The PEM assessment and intervention content will be culturally adapted to amplify the assessment and consideration of racial climate on young childrens participation in activities during the design of an EI service plan ie make content more relevant for racially and ethnically diverse EI families 2 Artificial intelligence AI will be applied to personalize the user experience of the PEM intervention to a broader range of EI enrolled families ie leverage the power of natural language processing as a form of AI to individualize the PEM intervention to caregivers in two ways 3 The team will evaluate the effectiveness of the upgraded PEM electronic option to improve caregiver perceptions of family-centered service quality improve parent engagement in EI service plan implementation and increase the proportion of participation-focused EI service plans EI family and provider perspectives will be obtained on supports barriers and strategies to its broader implementation in the early intervention service system
This project further develops and evaluates the Participation and Environment Measure PEM an electronic option for family-centered EI service design that has two parts 1 an evidence-based and promising electronic patient-reported outcome e-PRO assessment called the Young Childrens Participation and Environment Measure YC-PEM and 2 a prototypic goal setting application called Participation and and Environment Measure Plus PEM This project builds on published evidence for its feasibility acceptability and preliminary effectiveness of the YC-PEM e-PRO when paired with a program-specific decision-support tool on EI service quality EI stakeholder perspectives on salient supports barriers and strategies signal its viability for broader early intervention service system implementation One important optimization involves expanding its reach to historically minoritized families
This project will be accomplished in 3 aims 1 The PEM assessment and intervention content will be culturally adapted to amplify the assessment and consideration of racial climate on young childrens participation in activities during the design of an EI service plan ie make content more relevant for racially and ethnically diverse EI families 2 Artificial intelligence AI will be applied to personalize the user experience of the PEM intervention to a broader range of EI enrolled families ie leverage the power of natural language processing as a form of AI to individualize the PEM intervention to caregivers in two ways 3 The team will evaluate the effectiveness of the upgraded PEM electronic option to improve caregiver perceptions of family-centered service quality improve parent engagement in EI service plan implementation and increase the proportion of participation-focused EI service plans EI family and provider perspectives will be obtained on supports barriers and strategies to its broader implementation in the early intervention service system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None