Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention (PEM-Plus)

Feasibility Test of a Pediatric Web-Based Care Planning Guide

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.

Study Overview

• Status: Completed
• Conditions: Developmental Disability; Early Intervention (Education)
• Intervention / Treatment: Other: PEM+

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PEM-Plus Group; For Aim 1, 6 parents of young children were recruited to perform tasks related to navigating the PEM+ interface. Data on completion rate and time, as well as user satisfaction, were analyzed to guide PEM+ improvements. For Aim 2, we recruited 27 participants to enroll in a feasibility trial of PEM+. Caregivers who completed the YC-PEM e-PRO to evaluate their child's participation clicked on a weblink to begin PEM+, whereby they built on their YC-PEM responses for the purpose of creating a participation-focused care plan to share with their child's rehabilitation team. Caregivers were instructed to complete the PEM+ over a two-week (14 day) period because it mimics what would be provided in routine care.

Other: PEM+; PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many intervention plans for their child as needed, relative to the number of activities in which change is desired based on the YC-PEM e-PRO, 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Retention Rates	As an indicator of PEM+ feasibility, we used web analytics to obtain estimates of the percentage of caregivers who enrolled completed the trial.	Following completion of two-week trial
Median PEM+ Completion Time	As an indicator of PEM+ feasibility, we used web analytics to estimate the median time for completing the first and subsequent iterations within a two-week trial period	Following completion of PEM+ iteration (Aim 1) and two weeks (Aim 2)
Percentage of Caregivers Completing PEM+ Independently	As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created	Following completion of two-week trial
Median Number of PEM+ Care Plans Created	As an indicator of PEM+ feasibility, we used web analytics estimate the number of care plans created over a two-week trial period.	Following completion of two-week trial
Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)	As an indicator of PEM+ acceptability, the USE is a questionnaire that evaluates usefulness, ease of use, ease of learning, and satisfaction. Items are on a 7-point scale, from from [1] strongly disagree, to [7] strongly agree. There were multiple items for each domain, which were summed together and divided by the total number of items to generate a summary score for that domain. Higher scores indicate a better outcome.	Following completion of two-week trial
Caregiver Self-Efficacy to Promote Child's Participation in Activities	As an indicator of preliminary effects, we developed two items for this project to estimate caregiver self-efficacy in caring for their child, according to "what I will do next [to support child's participation]" and "how I think [about my child's participation]". Each item was rated on a 7-point scale, from [1] strongly disagree, to [7] strongly agree. Higher scores indicate a better outcome.	Following completion of two-week trial

Collaborators and Investigators

• Sponsor: Mary A Khetani
• Collaborators: McGill University; McMaster University
• Investigators: Principal Investigator: Mary A Khetani, ScD, Board of Trustees at University of Illinois

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: environment; participation; goal setting
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: 2016-0600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No