Trial Outcomes & Findings for Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention (NCT NCT03820011)
NCT ID: NCT03820011
Last Updated: 2024-04-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Following completion of two-week trial
Results posted on
2024-04-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
22
|
|
Overall Study
COMPLETED
|
6
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention
Baseline characteristics by cohort
| Measure |
PEM-Plus Group (Aim 2)
n=22 Participants
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).
|
PEM-Plus Group (Aim 1)
n=6 Participants
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.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age of caregiver · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Age of caregiver · Between 18 and 65 years
|
22 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
Age of caregiver · >=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or Not Disclosed
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following completion of two-week trialPopulation: 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.
As an indicator of PEM+ feasibility, we used web analytics to obtain estimates of the percentage of caregivers who enrolled completed the trial.
Outcome measures
| Measure |
PEM-Plus Group (Aim 2)
n=22 Participants
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.
|
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.
|
|---|---|---|
|
Mean Retention Rates
|
18 Participants
|
—
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
PEM-Plus Group (Aim 2)
n=6 Participants
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.
|
PEM-Plus Group (Aim 2)
n=18 Participants
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.
|
|---|---|---|
|
Median PEM+ Completion Time
|
13.6 minutes
Interval 3.3 to 20.0
|
12.99 minutes
Interval 6.7 to 17.33
|
PRIMARY outcome
Timeframe: Following completion of two-week trialAs an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created
Outcome measures
| Measure |
PEM-Plus Group (Aim 2)
n=18 Participants
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.
|
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.
|
|---|---|---|
|
Percentage of Caregivers Completing PEM+ Independently
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: Following completion of two-week trialPopulation: 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.
As an indicator of PEM+ feasibility, we used web analytics estimate the number of care plans created over a two-week trial period.
Outcome measures
| Measure |
PEM-Plus Group (Aim 2)
n=18 Participants
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.
|
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.
|
|---|---|---|
|
Median Number of PEM+ Care Plans Created
|
2.5 care plans
Interval 1.0 to 17.0
|
—
|
PRIMARY outcome
Timeframe: Following completion of two-week trialAs 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.
Outcome measures
| Measure |
PEM-Plus Group (Aim 2)
n=18 Participants
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.
|
PEM-Plus Group (Aim 2)
n=6 Participants
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.
|
|---|---|---|
|
Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
Usefulness
|
4.41 score on a scale
Standard Deviation 1.54
|
NA score on a scale
Standard Deviation NA
This domain of the USE outcome measure was not administered to decrease response burden, and it was deemed least relevance for Aim 1 targeting ease of use, learning, and satisfaction with an abbreviated intervention (i.e., one iteration).
|
|
Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
Ease of Use
|
4.64 score on a scale
Standard Deviation 1.25
|
4.4 score on a scale
Standard Deviation 5.8
|
|
Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
Ease of Learning
|
4.97 score on a scale
Standard Deviation 1.57
|
5.4 score on a scale
Standard Deviation 6.0
|
|
Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
Satisfaction
|
3.80 score on a scale
Standard Deviation 1.97
|
4.2 score on a scale
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: Following completion of two-week trialPopulation: 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.
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.
Outcome measures
| Measure |
PEM-Plus Group (Aim 2)
n=18 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
Adverse Events
PEM-Plus Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mary Khetani, Associate Professor
Board of Trustees at University of Illinois
Phone: 312-996-0942
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place