Clinical trial NCT03904797: Electronic Patient-reported Outcomes (e-PROs) in Early Intervention
Official title: Colorado Early Intervention Outcomes Research Using Innovative Patient-Reported Outcome (PRO) Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Disability
Development Delay
Keywords: patient-reported outcome
electronic
participation
early intervention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Rocky Mountain Human Services
name: University of Colorado, Denver
First posted: 2019-04-05
Enrollment: 149
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: YC-PEM e-PRO Feasibility as assessed by enrollment rate
timeFrame: up to 4 weeks
measure: YC-PEM e-PRO Acceptability as assessed by caregiver perceptions of overall helpfulness
timeFrame: up to 4 weeks
measure: YC-PEM e-PRO Value as assessed by proportion of participants viewing e-PRO online report
timeFrame: up to 4 weeks
measure: YC-PEM e-PRO Feasibility as assessed by completion rate
timeFrame: up to 4 weeks
measure: YC-PEM e-PRO Feasibility as assessed by completion time in minutes and seconds
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Board of Trustees at University of Illinois
name: Mary A Khetani, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albrecht EC, Kaelin VC, Rigau BL, Dooling-Litfin JK, Scully EA, Murphy NJ, McManus BM, Khetani MA; High Value Early Intervention Research Group. Pilot implementation of an electronic patient-reported outcome measure for planning and monitoring participation-focused care in early intervention. BMC Med Inform Decis Mak. 2020 Aug 24;20(1):199. doi: 10.1186/s12911-020-01189-9.
citation: Khetani MA, McManus BM, Albrecht EC, Kaelin VC, Dooling-Litfin JK, Scully EA; High Value Early Intervention Research Group. Early intervention service intensity and young children's home participation. BMC Pediatr. 2020 Jul 3;20(1):330. doi: 10.1186/s12887-020-02182-x.