An interventional study of PEM+ in Developmental Disability and Early Intervention (Education), sponsored by Mary A Khetani. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Mary A Khetani · Not applicable, Interventional, and Treatment
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.
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.
291 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 202 interventional studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →This is the only study on the registry with Mary A Khetani as lead sponsor.
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Aim 1 Inclusion Criteria:
Aim 1 Exclusion Criteria:
Aim 2 Inclusion Criteria:
Aim 2 Exclusion Criteria:
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).
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
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)
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
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
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
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
| Milestone | PEM-Plus Group (Aim 1) | PEM-Plus Group (Aim 2) |
|---|---|---|
| Started | 6 | 22 |
| Completed | 6 | 18 |
| Not completed | 0 | 4 |
As an indicator of PEM+ feasibility, we used web analytics to obtain estimates of the percentage of caregivers who enrolled completed the trial.
| Participants | PEM-Plus Group (Aim 2) |
|---|---|
| Mean Retention Rates | 18 |
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
| minutes | PEM-Plus Group (Aim 1) | PEM-Plus Group (Aim 2) |
|---|---|---|
| Median PEM+ Completion Time | 13.6 (3.3 to 20) | 12.99 (6.70 to 17.33) |
As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created
| Participants | PEM-Plus Group (Aim 2) |
|---|---|
| Percentage of Caregivers Completing PEM+ Independently | 17 |
As an indicator of PEM+ feasibility, we used web analytics estimate the number of care plans created over a two-week trial period.
| care plans | PEM-Plus Group (Aim 2) |
|---|---|
| Median Number of PEM+ Care Plans Created | 2.5 (1 to 17) |
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.
| score on a scale | PEM-Plus Group (Aim 2) | PEM-Plus Group (Aim 1) |
|---|---|---|
| Usefulness | 4.41 ± 1.54 | NA ± NA |
| Ease of Use | 4.64 ± 1.25 | 4.4 ± 5.8 |
| Ease of Learning | 4.97 ± 1.57 | 5.4 ± 6.0 |
| Satisfaction | 3.80 ± 1.97 | 4.2 ± 5.7 |
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.
| score on a scale | PEM-Plus Group (Aim 2) |
|---|---|
| PEM+ influenced what I will do | 4.61 ± 1.85 |
| PEM+ influenced what I think can be done | 4.72 ± 2.24 |
Collected over We collected data on adverse events for 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PEM-Plus Group | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Categorical(Participants) | PEM-Plus Group (Aim 2) | PEM-Plus Group (Aim 1) | Total |
|---|---|---|---|
| Age of caregiver — <=18 years | 0 | 0 | 0 |
| Age of caregiver — Between 18 and 65 years | 22 | 6 | 28 |
| Age of caregiver — >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | PEM-Plus Group (Aim 2) | PEM-Plus Group (Aim 1) | Total |
|---|---|---|---|
| Female | 20 | 6 | 26 |
| Male | 2 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | PEM-Plus Group (Aim 2) | PEM-Plus Group (Aim 1) | Total |
|---|---|---|---|
| Asian | 3 | 1 | 4 |
| Black or African American | 2 | 0 | 2 |
| White | 14 | 3 | 17 |
| Other or Not Disclosed | 3 | 2 | 5 |
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