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

NCT03820011 | Completed Results

• 1 other identifier: 2016-0600
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Developmental Disability; Early Intervention (Education)

Keywords

participation; environment; goal setting

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

PEM-Plus Group

EXPERIMENTAL

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+

Interventions

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).

PEM-Plus Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Mary A Khetani: lead
• McGill University: collaborator
• McMaster University: collaborator

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

There were sampling limitations, as condition severity may impact PEM+ feasibility and the effect on caregiver confidence. There is a need to include a validated measure of caregiver confidence and/or self-efficacy in future PEM+ testing.

Results Point of Contact

• Title: Dr. Mary Khetani, Associate Professor
• Organization: Board of Trustees at University of Illinois

mkhetani@uic.edu

312-996-0942

Study Officials

• Mary A Khetani, ScD

  Board of Trustees at University of Illinois

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 29, 2019
• Study Start: July 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2020
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share