- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904797
Electronic Patient-reported Outcomes (e-PROs) in Early Intervention
Colorado Early Intervention Outcomes Research Using Innovative Patient-Reported Outcome (PRO) Measures
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Mary A Khetani, ScD, Board of Trustees at University of Illinois
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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