Clinical trial NCT03820011: Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention
Official title: Feasibility Test of a Pediatric Web-Based Care Planning Guide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Disability
Early Intervention (Education)
Keywords: participation
environment
goal setting
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: McGill University
name: McMaster University
First posted: 2019-01-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the proposed research is to achieve a major advance in promoting effective and efficient delivery of pediatric rehabilitation services for young children with developmental disabilities and delays. The investigative team will examine the usability, feasibility, acceptability, and preliminary effects of PEM+, an innovative web-based (mobile friendly) guide for care planning by parents of young children with developmental disabilities and delays. PEM+ is designed in partnership with parents and providers to support more collaborative and efficient clinical care planning with individual families who typically access pediatric occupational therapy services. Specifically, PEM+ enables parents to build on their baseline assessment of their child using the Young Children's Participation and Environment Measure (YC-PEM) to design specific solutions to their young child's participation-related problems. PEM+ affords parents the opportunity to do this in their own space and on their own schedule, as well as electronically share their proposed written solutions with their child's provider(s) and/or other important individuals in their young child's life.

Detailed description: Participation and Environment Measure Plus (PEM+) is a new electronic health application that facilitates family-centered and participation-focused intervention planning for young children receiving rehabilitation therapies. PEM+ design was informed by caregiver and provider input. It is a web-based intervention planning application that is designed for use by caregivers of young children receiving rehabilitation therapies. Caregivers who complete the Young Children's Participation and Environment Measure (YC-PEM), an electronic patient-reported outcome measure, evaluate their child's participation and then can click on a weblink to begin the PEM+ application, whereby they build on their YC-PEM responses for the purpose of creating a participation-focused care plan to share with their child's rehabilitation team. PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many care plans for their child as needed), and it offers tiered support to the user during completion (tier 1: frequently asked questions available in the application, tier 2: support provided by email, tier 3: support provided by phone). For the first aim of this study, caregivers completed one iteration of PEM+ to complete user tasks for the purpose of evaluating PEM+ usability. For the second aim of this study, caregivers were instructed to complete the PEM+ over a two-week (14 day) period. This time frame was selected by the research team as it mimics what would be provided in the routine care planning processes of early intervention and early childhood education.

Eligibility criteria: Aim 1 Inclusion Criteria:

* at least 18 years old
* reads, writes, and speaks English
* has access to broadband internet
* resides in the U.S
* has a child between 0 and 3 years old who is receiving services for developmental delay.

Aim 1 Exclusion Criteria:

* has a child over 3 years old
* does not have internet access
* has a child who is not receiving rehabilitation services for developmental delay
* does not reside in the U.S.

Aim 2 Inclusion Criteria:

* 18 years or older
* reads, writes, and speaks in English
* has a child aged 0-5 years old who was receiving rehabilitation services
* has broadband internet access
* denotes at least one area of desired change during participation assessment.

Aim 2 Exclusion Criteria:

* has a child over 5 years old
* does not have internet access
* has a child who is not receiving rehabilitation services for developmental delay
* does not reside in the U.S.

Primary outcomes:
measure: Mean Retention Rates
timeFrame: Following completion of two-week trial
measure: Median PEM+ Completion Time
timeFrame: Following completion of PEM+ iteration (Aim 1) and two weeks (Aim 2)
measure: Percentage of Caregivers Completing PEM+ Independently
timeFrame: Following completion of two-week trial
measure: Median Number of PEM+ Care Plans Created
timeFrame: Following completion of two-week trial
measure: Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
timeFrame: Following completion of two-week trial
measure: Caregiver Self-Efficacy to Promote Child's Participation in Activities
timeFrame: Following completion of two-week trial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Board of Trustees at University of Illinois
name: Mary A Khetani, ScD
role: PRINCIPAL_INVESTIGATOR
References: