Web-Based Care Planning for Developmental Disabilities

(PROSPECT+ Trial)

Overseen By Mary A Khetani

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Non-English speakers, No internet access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new web-based tool called PEM+ to enhance early intervention (EI) services for young children with developmental disabilities or delays. The goal is to help families communicate their needs and priorities more effectively to create personalized service plans with professionals. The trial compares this new tool to the usual care process. It suits parents or legal guardians who have a child in EI services for at least three months, can read and write in English, and have internet and phone access.

As an unphased trial, this study provides a unique opportunity for families to contribute to innovative solutions in early intervention services.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this web-based care planning method is safe for infants and toddlers with developmental disabilities?

Research shows that PEM+ is designed to assist families with children who have developmental disabilities by simplifying care planning and organization. Studies have found that caregivers find PEM+ easy to use and learn, which enhances safety by reducing the chance of mistakes. Caregivers report that the tool is effective and user-friendly, indicating positive reception.

While specific information about negative effects from using PEM+ is not available, testing for ease of use and effectiveness suggests it is safe. This tool enhances communication between families and professionals, potentially leading to better care plans and outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PEM+ approach because it leverages a web-based platform to enhance care planning for individuals with developmental disabilities. Unlike traditional methods that may involve in-person consultations and paperwork, PEM+ offers a more accessible and efficient way to manage care plans online. This digital approach is designed to streamline communication between caregivers and healthcare providers, potentially leading to more personalized and timely interventions. By utilizing technology, PEM+ aims to improve the quality of care and empower families with more control and flexibility in managing developmental disability care.

What evidence suggests that PEM+ is effective for improving early intervention services for developmental disabilities?

Research has shown that PEM+, which participants in this trial may receive, is a helpful tool for families with young children who have developmental disabilities. Studies found that 72% of caregivers using PEM+ create several care plans, and 83% make at least one plan that is complete and focused on participation. This indicates that most families find it useful for organizing and communicating their needs and goals. Additionally, the tool receives high ratings for effectiveness, scoring between 5.7 and 6.3 out of 7.0. These findings suggest that PEM+ effectively involves families in the care planning process, potentially leading to better outcomes for children receiving early intervention services. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for parents or legal guardians of children enrolled in early intervention (EI) services for over 3 months. Participants must be able to read, write, and speak English and have access to the internet and a telephone.

Inclusion Criteria

Have internet and telephone access

Identify as a parent/legal guardian of a child enrolled in EI for 3+ months

Exclusion Criteria

I cannot read, write, or speak English.

Do not have internet and phone access

Do not identify as a parent/legal guardian of a child enrolled in EI for 3+ months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the PEM+ electronic solution to engage in the design of the EI service plan for their child

3 months

Ongoing virtual engagement

Follow-up

Participants are monitored for changes in caregiver perceptions of family-centered service quality and parent engagement

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PEM+

Trial Overview

The trial is testing PEM+, an innovative web-based guide designed to help families engage in creating EI service plans that match their needs by sharing priorities and ideas with professionals.

How Is the Trial Designed?

Group I: PEM+ Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Rocky Mountain Human Services

Collaborator

Trials

4

Recruited

750+

Rocky Mountain Human Services

Collaborator

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03820011

Participation and Environment Measure-Plus (PEM-Plus) Care ...

Specifically, PEM+ enables parents to build on their baseline assessment of their child using the Young Children's Participation and Environment Measure (YC-PEM) ...

2.

researchgate.net

researchgate.net/publication/333690965_Usability_of_the_Participation_and_Environment_Measure_Plus_PEM_for_Client-Centered_and_Participation-Focused_Care_Planning

Usability of the Participation and Environment Measure ...

Mean technical effectiveness ratings ranged from 5.7 to 6.3 out of 7.0, and mean ease of use, ease of learning, and user satisfaction ratings were 4.4, 5.4, and ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31313843/

Caregiver creation of participation-focused care plans ...

Results: Multiple care plans were created by 72% of the caregivers, 83% caregivers created at least one care plan that was complete and participation-focused ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10981057/

Impact of family-centered care in families with children ...

Research indicates that families of children with intellectual and developmental disabilities often experience increased rates of stress (e.g., high medical ...

5.

researchgate.net

researchgate.net/publication/334527204_Caregiver_creation_of_participation-focused_care_plans_using_Participation_and_Environment_Measure_Plus_PEM_an_electronic_health_tool_for_family-centred_care

Caregiver creation of participation‐focused care plans ...

Results Multiple care plans were created by 72% of the caregivers, 83% caregivers created at least one care plan that was complete and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03820011

Participation and Environment Measure-Plus (PEM ...

Specifically, PEM+ enables parents to build on their baseline assessment of their child using the Young Children's Participation and Environment Measure (YC-PEM) ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8137174/

Exploring patient safety outcomes for people with learning ...

People with learning disabilities appear to experience poorer patient safety outcomes in hospital. The involvement of family and carers, and understanding and ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405844024042725

Impact of family-centered care in families with children with ...

Transforming coercive processes in family routines: family functioning outcomes for families of children with developmental disabilities. J ...

9.

aspe.hhs.gov

aspe.hhs.gov/reports/os-pcortf-2023-disability-outcomes-federal-data-infrastructure

Assessing Outcomes Relevant for Patient-Centered ...

This report and dataset inventory identifies individual-level measures for conducting patient-centered outcomes research (PCOR) relevant to adults with ...