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

April 4, 2019 updated by: University of Illinois at Chicago

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: e-PRO
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
YC-PEM e-PRO Feasibility as assessed by enrollment rate
Time Frame: up to 4 weeks
Enrollment rate was estimated as the proportion of eligible participants who enrolled in the study. The success of feasibility was determined as e-PRO enrollment rates of 50% or higher based on what is known about the percentage of families who opt into family assessment as part of usual care.
up to 4 weeks
YC-PEM e-PRO Acceptability as assessed by caregiver perceptions of overall helpfulness
Time Frame: up to 4 weeks
Caregiver responses to an open-ended item were coded into a one of three categories (yes, helpful; somewhat helpful; not helpful) to create a new variable that captured the extent to which caregivers perceived the YC-PEM e-PRO to be useful for planning EI care.
up to 4 weeks
YC-PEM e-PRO Value as assessed by proportion of participants viewing e-PRO online report
Time Frame: up to 4 weeks
The percentage of participants who viewed a summary of their e-PRO responses via an online report was estimated.
up to 4 weeks
YC-PEM e-PRO Feasibility as assessed by completion rate
Time Frame: up to 4 weeks
Feasibility was determined as the proportion of participants who enrolled that completed the YC-PEM e-PRO. The success of feasibility was determined as completion rates of 50% or higher based on family assessment completion rates within usual care.
up to 4 weeks
YC-PEM e-PRO Feasibility as assessed by completion time in minutes and seconds
Time Frame: up to 4 weeks
The success of feasibility was determined as e-PRO completion time of less than 45 minutes based on family assessment completion time within usual care.
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mary A Khetani, ScD, Board of Trustees at University of Illinois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (ACTUAL)

April 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NIH funds were secured to archive a subset of the data as a restricted use data file, and the dataset is being curated now.

IPD Sharing Time Frame

The subset of data are expected to become publicly available as of June 2019, but it not yet known for how long the data will be available.

IPD Sharing Access Criteria

The criteria for access is being developed at this time and will be updated when finalized.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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