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| Name | Class |
|---|---|
| McGill University | OTHER |
| McMaster University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Aim 1 Inclusion Criteria:
Aim 1 Exclusion Criteria:
Aim 2 Inclusion Criteria:
Aim 2 Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary A Khetani, ScD | Board of Trustees at University of Illinois | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | PEM-Plus Group (Aim 1) | For Aim 1, 6 parents of young children were recruited to perform tasks related to navigating the PEM+ interface during one iteration only. Data on completion rate and time, and user satisfaction, were analyzed to guide PEM+ improvements. PEM+ is a five-step recursive process, so the caregiver can repeat the five-step process to create as many intervention plans for their child as needed, and it offers tiered support. |
| FG001 | PEM-Plus Group (Aim 2) | 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+ as many time as needed over a 14 day period because it mimics what would be provided in routine care. PEM+ is a five-step recursive process, so the caregiver can repeat the five-step process to create as many intervention plans for their child as needed, and it offers tiered support. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Following completion of two-week trial |
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We collected data on adverse events for 10 months
We did not report any adverse events in either Aim 1 or Aim 2 of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEM-Plus Group | For Aim 1, 6 parents of young children were recruited to perform tasks related to navigating the PEM+ interface during one iteration. Data on completion rate and time, and 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 to create a participation-focused care plan to share with their child's rehabilitation team. Caregivers were instructed to complete the PEM+ over a 14-day period because it mimics what would be provided in routine care. 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, and it offers tiered support to users). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Khetani, Associate Professor | Board of Trustees at University of Illinois | 312-996-0942 | mkhetani@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2017 | Jan 28, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2017 | May 26, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2017 | Jan 28, 2019 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002658 | Developmental Disabilities |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Posted | Median | Full Range | minutes | Following completion of PEM+ iteration (Aim 1) and two weeks (Aim 2) |
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| Primary | Percentage of Caregivers Completing PEM+ Independently | As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created | Posted | Count of Participants | Participants | Following completion of two-week trial |
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| 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. | 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. | Posted | Median | Full Range | care plans | Following completion of two-week trial |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Following completion of two-week trial |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Following completion of two-week trial |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| Ease of Learning |
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| Satisfaction |
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