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

University of Illinois

Status: Completed

Conditions: Development Delay; Developmental Disability

Treatments: Behavioral: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)

Study type: Interventional

Funder types: Other

Identifiers

NCT03904797

2016-0139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 1 to 36 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Caregiver is at least 18 years old;
• Caregiver can read, write, and speak English or Spanish;
• Caregiver had internet access;
• Caregiver has a child between 0-3 years old who had received early intervention at RMHS for at least 3 months.

Exclusion criteria

• Caregiver is less than 18 years old
• Caregiver reads, speaks, and writes in a language other than English or Spanish
• Caregiver does not have internet access
• Caregiver has a child who has received EI services for less than 3 months
• Caregiver has a child older than 3 years (36 months)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

e-PRO

Experimental group

Description:

EI service coordinators participated in a 90-minute training on the study protocol, to gain clearance to recruit families when they were being contacted to schedule their annual reviews of progress. The recruitment protocol was later modified in response to low enrollment, such that a designated EI staff member was paired with research staff to recruit participants. Eligible and interested caregivers visited the project website to create an account, confirmed study eligibility, provided informed consent and HIPAA authorization for abstracting select EI service use data, and completed a demographic questionnaire and the Young Children's Participation and Environment Measure (YC-PEM) e-PRO. Caregivers received immediate access to an online report summarizing their e-PRO responses to share with their child's EI team

Treatment:

Behavioral: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)