Developmental Disability, Early Intervention (Education)
Conditions
Keywords
participation, environment, goal setting
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.
Interventions
OTHERPEM+
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).
Sponsors
McGill University
McMaster University
Mary A Khetani
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Retention Rates | 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. |
| Median PEM+ Completion Time | 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 |
| Percentage of Caregivers Completing PEM+ Independently | Following completion of two-week trial | As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created |
| Median Number of PEM+ Care Plans Created | 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. |
| Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | 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. |
| Caregiver Self-Efficacy to Promote Child's Participation in Activities | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEM-Plus Group (Aim 2) For Aim 2, caregivers who completed the YC-PEM e-PRO clicked on a weblink to begin PEM+, whereby they built on their YC-PEM responses to create care plans to share with their child's rehabilitation team. Caregivers were instructed to complete the PEM+ over a 14-day period because it mimics routine care. PEM+ is a five-step recursive process (i.e., the caregiver repeats the process to create as many intervention 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). | 22 |
| PEM-Plus Group (Aim 1) 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 and user satisfaction were analyzed to guide PEM+ improvements. | 6 |
| Total | 28 |
Baseline characteristics
| Characteristic | Total | PEM-Plus Group (Aim 2) | PEM-Plus Group (Aim 1) |
|---|---|---|---|
| Age, Categorical Age of caregiver <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age of caregiver >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age of caregiver Between 18 and 65 years | 28 Participants | 22 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Other or Not Disclosed | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 14 Participants | 3 Participants |
| Sex: Female, Male Female | 26 Participants | 20 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
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.
Time frame: Following completion of two-week trial
Population: This Outcome Measure was pre-specified to be only assessed under Aim 2 of the study, to identify clinical outcomes to include in a future efficacy trial of the PEM+ intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEM-Plus Group (Aim 2) | Caregiver Self-Efficacy to Promote Child's Participation in Activities | PEM+ influenced what I think can be done | 4.72 score on a scale | Standard Deviation 2.24 |
| PEM-Plus Group (Aim 2) | Caregiver Self-Efficacy to Promote Child's Participation in Activities | PEM+ influenced what I will do | 4.61 score on a scale | Standard Deviation 1.85 |
Primary
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.
Time frame: Following completion of two-week trial
Population: As stated in our published article, a total of 22 of the 27 participants recruited confirmed their eligibility, and 18 of the 22 participants who confirmed study eligibility continued with PEM+ use. This outcome is specific to Aim 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PEM-Plus Group (Aim 2) | Mean Retention Rates | 18 Participants |
Primary
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.
Time frame: Following completion of two-week trial
Population: This Outcome Measure was pre-specified to be only assessed under Aim 2 of the study. Aim 1 only required caregivers to complete a single iteration of PEM+, so all participants completed it one time. Aim 2 required caregivers to complete as many iterations of PEM+ as possible over 2 weeks, so participants could complete PEM+ one or more times.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEM-Plus Group (Aim 2) | Median Number of PEM+ Care Plans Created | 2.5 care plans |
Primary
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
Time frame: Following completion of PEM+ iteration (Aim 1) and two weeks (Aim 2)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEM-Plus Group (Aim 2) | Median PEM+ Completion Time | 13.6 minutes |
| PEM-Plus Group (Aim 2) | Median PEM+ Completion Time | 12.99 minutes |
Primary
Percentage of Caregivers Completing PEM+ Independently
As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created
Time frame: Following completion of two-week trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PEM-Plus Group (Aim 2) | Percentage of Caregivers Completing PEM+ Independently | 17 Participants |
Primary
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.
Time frame: Following completion of two-week trial
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEM-Plus Group (Aim 2) | Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | Ease of Learning | 4.97 score on a scale | Standard Deviation 1.57 |
| PEM-Plus Group (Aim 2) | Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | Usefulness | 4.41 score on a scale | Standard Deviation 1.54 |
| PEM-Plus Group (Aim 2) | Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | Satisfaction | 3.80 score on a scale | Standard Deviation 1.97 |
| PEM-Plus Group (Aim 2) | Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | Ease of Use | 4.64 score on a scale | Standard Deviation 1.25 |
| PEM-Plus Group (Aim 2) | Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | Satisfaction | 4.2 score on a scale | Standard Deviation 5.7 |
| PEM-Plus Group (Aim 2) | Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | Usefulness | NA score on a scale | — |
| PEM-Plus Group (Aim 2) | Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | Ease of Learning | 5.4 score on a scale | Standard Deviation 6 |
| PEM-Plus Group (Aim 2) | Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) | Ease of Use | 4.4 score on a scale | Standard Deviation 5.8 |