NCT03904797

Electronic Patient-reported Outcomes (e-PROs) in Early Intervention

Colorado Early Intervention Outcomes Research Using Innovative Patient-Reported Outcome (PRO) Measures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 1 Month – 36 Months
• Healthy volunteers: Not accepted

Summary

A major goal of early intervention (EI) is to employ a family-centered approach to helping children to optimally function at home and in the community. However, the effects of EI are poorly understood. The aims of this project are: 1) to test the feasibility, acceptability, and value of introducing novel electronic patient-reported outcome (e-PRO) measures in EI, to strengthen family-centered EI care; and 2) to obtain and pair these outcomes data with EI program data, to further determine the value of e-PRO data collection for examining links between EI service use and functional outcomes among families who are enrolled in a large, urban EI program.

Detailed description

Approximately 5,800 infants and toddlers with developmental disabilities (e.g., cerebral palsy, Down syndrome, complex chronic conditions) and delays access Early Intervention Colorado (EI-CO) annually. A primary goal of EI-CO is to employ a family-centered care approach to help children optimally function at home and in the community. Hence, early intervention is a common source of rehabilitation (i.e., physical, occupational, speech and language therapy) for EI-CO eligible families. However, the effects of EI-CO are poorly understood. Numerous challenges exist with obtaining EI-CO outcomes data, including a paucity of validated and feasible functional outcome measures for use in EI outcomes reporting. These challenges have resulted in inadequate knowledge about EI service use and outcomes to guide service delivery. Despite these challenges, recent policy changes have resulted in EI-CO service providers being pressed to ensure high quality care with limited resources and evidence to guide their clinical decision-making about effective and efficient interventions. This proposal addresses the need to fill critical knowledge gaps about the adequacy of EI services with an eye toward improving care quality. This study involves families who have/are receiving EI-CO services through Rocky Mountain Human Services (RMHS), the largest EI program in Denver Metro. The purpose of this study is to test the feasibility, acceptability, and value of collecting electronic patient-reported outcomes (e-PRO) data to engage families when their child is due for an annual evaluation of progress. To further demonstrate the value of e-PRO data collection, these data will be paired with program data to estimate the association between EI-CO service use and functional outcomes.

Conditions

• Developmental Disability
• Development Delay

Interventions

Type	Name	Description
BEHAVIORAL	Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)	Participants were primary caregivers (n=149) recruited from a large, urban early intervention program. All caregivers were approached by early intervention staff the month prior to the child's annual evaluation of progress. Each caregiver confirmed his or her eligibility online by verifying that they were at least 18 years old; could read, write, and speak English or Spanish; had internet access; and had a child between 0-3 years old who had received early intervention for at least 3 months. Participants enrolled online and provided consent, signed a HIPAA authorization for service record release, and then proceeded to completing a demographic questionnaire and YC-PEM e-PRO to receive an online report of their responses to share with their child's EI team.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-09-01
• Completion: 2019-02-01
• First posted: 2019-04-05
• Last updated: 2019-04-05