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

NCT03904797 | Completed

• 1 other identifier: 2016-0139
• Study Type: interventional
• Target: 149
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Developmental Disability; Development Delay

Keywords

patient-reported outcome; electronic; participation; early intervention

Outcome Measures

Primary Outcomes (5)

• YC-PEM e-PRO Feasibility as assessed by enrollment rate

  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

  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

  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

  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

  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

Study Arms (1)

e-PRO

EXPERIMENTAL

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

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

Interventions

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

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.

e-PRO

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Rocky Mountain Human Services: collaborator
• University of Colorado, Denver: collaborator

Related Publications (2)

• 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.

  PMID: 32838772 DERIVED

• 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.

  PMID: 32620161 DERIVED

MeSH Terms

Conditions

Developmental Disabilities; Learning Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary A Khetani, ScD

  Board of Trustees at University of Illinois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 5, 2019
• Study Start: April 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: February 1, 2019
• Last Updated: April 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: The criteria for access is being developed at this time and will be updated when finalized.