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Completed

NCT Number: NCT03820011

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

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.

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Key information

Conditions

Developmental Disability Developmental Disabilities Early Intervention (Education) Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEM+

Other

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).

Primary outcomes

  1. Mean Retention Rates

    Time frame: Following completion of two-week trial

    As an indicator of PEM+ feasibility, we used web analytics to obtain estimates of the percentage of caregivers who enrolled completed the trial.

  2. Median PEM+ Completion Time

    Time frame: Following completion of PEM+ iteration (Aim 1) and two weeks (Aim 2)

    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

  3. Percentage of Caregivers Completing PEM+ Independently

    Time frame: Following completion of two-week trial

    As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created

  4. Median Number of PEM+ Care Plans Created

    Time frame: Following completion of two-week trial

    As an indicator of PEM+ feasibility, we used web analytics estimate the number of care plans created over a two-week trial period.

  5. Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)

    Time frame: Following completion of two-week trial

    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.

  6. Caregiver Self-Efficacy to Promote Child's Participation in Activities

    Time frame: Following completion of two-week trial

    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.

Sponsors and collaborators

Lead sponsor

Mary A Khetani

Other

Collaborators

  • McGill University
  • McMaster University

Registry information

Official study title

Feasibility Test of a Pediatric Web-Based Care Planning Guide

Acronym: PEM-Plus

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jan 29, 2019
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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