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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820011
Recruitment Status : Active, not recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
McGill University
McMaster University
Information provided by (Responsible Party):
Mary A Khetani, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Developmental Disability Early Intervention (Education) Other: PEM+ Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Test of a Pediatric Web-Based Care Planning Guide
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : February 1, 2018
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


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 26 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).




Primary Outcome Measures :
  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 two-week trial ]
    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.

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For Aim 1, participants met the following inclusion criteria: the caregiver is at least 18 years old; reads, writes, and speaks English; has access to broadband internet; resides in the U.S; and has a child between 0 and 3 years old who is receiving services for developmental delay.
  • For Aim 2, caregivers were eligible for inclusion if they: 1) were 18 years or older; 2) spoke and write English; 3) had a child aged 0-5 years old who was receiving rehabilitation services; 4) had broadband internet access; and 5) denoted at least one area of desired change during participation assessment.

Exclusion Criteria:

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Responsible Party: Mary A Khetani, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03820011    
Other Study ID Numbers: 2016-0600
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary A Khetani, University of Illinois at Chicago:
participation
environment
goal setting
Additional relevant MeSH terms:
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Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders