Developmental DisabilityNCT03904797
Electronic Patient-reported Outcomes (e-PROs) in Early Intervention
A study testing Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) in people with Developmental Disability and Development Delay, run by University of Illinois at Chicago.
Trial summary
A major goal of early intervention (EI) is to employ a family-centered approach to helping children to optimally function at home and in the community. However, the effects of EI are poorly understood. Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Developmental Disability, Development Delay
- What is being tested?
- Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caregiver is at least 18 years old;
- Caregiver can read, write, and speak English or Spanish;
- Caregiver had internet access;
- Caregiver has a child between 0-3 years old who had received early intervention at RMHS for at least 3 months.
Who cannot join
- Caregiver is less than 18 years old
- Caregiver reads, speaks, and writes in a language other than English or Spanish
- Caregiver does not have internet access
- Caregiver has a child who has received EI services for less than 3 months
- Caregiver has a child older than 3 years (36 months)
About this study
Official title: Colorado Early Intervention Outcomes Research Using Innovative Patient-Reported Outcome (PRO) Measures
A major goal of early intervention (EI) is to employ a family-centered approach to helping children to optimally function at home and in the community. However, the effects of EI are poorly understood. The aims of this project are: 1) to test the feasibility, acceptability, and value of introducing novel electronic patient-reported outcome (e-PRO) measures in EI, to strengthen family-centered EI care; and 2) to obtain and pair these outcomes data with EI program data, to further determine the value of e-PRO data collection for examining links between EI service use and functional outcomes among families who are enrolled in a large, urban EI program.
Read the detailed description
Approximately 5,800 infants and toddlers with developmental disabilities (e.g., cerebral palsy, Down syndrome, complex chronic conditions) and delays access Early Intervention Colorado (EI-CO) annually. A primary goal of EI-CO is to employ a family-centered care approach to help children optimally function at home and in the community. Hence, early intervention is a common source of rehabilitation (i.e., physical, occupational, speech and language therapy) for EI-CO eligible families.
However, the effects of EI-CO are poorly understood. Numerous challenges exist with obtaining EI-CO outcomes data, including a paucity of validated and feasible functional outcome measures for use in EI outcomes reporting. These challenges have resulted in inadequate knowledge about EI service use and outcomes to guide service delivery. Despite these challenges, recent policy changes have resulted in EI-CO service providers being pressed to ensure high quality care with limited resources and evidence to guide their clinical decision-making about effective and efficient interventions. This proposal addresses the need to fill critical knowledge gaps about the adequacy of EI services with an eye toward improving care quality.
This study involves families who have/are receiving EI-CO services through Rocky Mountain Human Services (RMHS), the largest EI program in Denver Metro. The purpose of this study is to test the feasibility, acceptability, and value of collecting electronic patient-reported outcomes (e-PRO) data to engage families when their child is due for an annual evaluation of progress. To further demonstrate the value of e-PRO data collection, these data will be paired with program data to estimate the association between EI-CO service use and functional outcomes.
- Conditions
- Developmental Disability, Development Delay
- Being tested
- Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)
- Keywords
- patient-reported outcome, electronic, participation, early intervention
- Medical subject headings
- Developmental Disabilities, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)Behavioural
Participants were primary caregivers (n=149) recruited from a large, urban early intervention program. All caregivers were approached by early intervention staff the month prior to the child's annual evaluation of progress.
Each caregiver confirmed his or her eligibility online by verifying that they were at least 18 years old; could read, write, and speak English or Spanish; had internet access; and had a child between 0-3 years old who had received early intervention for at least 3 months.
Participants enrolled online and provided consent, signed a HIPAA authorization for service record release, and then proceeded to completing a demographic questionnaire and YC-PEM e-PRO to receive an online report of their responses to share with their child's EI team.
| Study group | Role | What they receive |
|---|---|---|
| e-PRO | Experimental | EI service coordinators participated in a 90-minute training on the study protocol, to gain clearance to recruit families when they were being contacted to schedule their annual reviews of progress. The recruitment protocol was later modified in response to low enrollment, such that a designated EI staff member was paired with research staff to recruit participants. Eligible and interested caregivers visited the project website to create an account, confirmed study eligibility, provided informed consent and HIPAA authorization for abstracting select EI service use data, and completed a demographic questionnaire and the Young Children's Participation and Environment Measure (YC-PEM) e-PRO. Caregivers received immediate access to an online report summarizing their e-PRO responses to share with their child's EI team Receives: Behavioral: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
YC-PEM e-PRO Feasibility as assessed by enrollment rate
Enrollment rate was estimated as the proportion of eligible participants who enrolled in the study. The success of feasibility was determined as e-PRO enrollment rates of 50% or higher based on what is known about the percentage of families who opt into family assessment as part of usual care.
Measured: up to 4 weeks
YC-PEM e-PRO Acceptability as assessed by caregiver perceptions of overall helpfulness
Caregiver responses to an open-ended item were coded into a one of three categories (yes, helpful; somewhat helpful; not helpful) to create a new variable that captured the extent to which caregivers perceived the YC-PEM e-PRO to be useful for planning EI care.
Measured: up to 4 weeks
YC-PEM e-PRO Value as assessed by proportion of participants viewing e-PRO online report
The percentage of participants who viewed a summary of their e-PRO responses via an online report was estimated.
Measured: up to 4 weeks
YC-PEM e-PRO Feasibility as assessed by completion rate
Feasibility was determined as the proportion of participants who enrolled that completed the YC-PEM e-PRO. The success of feasibility was determined as completion rates of 50% or higher based on family assessment completion rates within usual care.
Measured: up to 4 weeks
YC-PEM e-PRO Feasibility as assessed by completion time in minutes and seconds
The success of feasibility was determined as e-PRO completion time of less than 45 minutes based on family assessment completion time within usual care.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Apr 2016
- Primary completion1 Sep 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Rocky Mountain Human Services, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Mary A Khetani, ScD, Principal investigator, Board of Trustees at University of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904797
- Sponsor's protocol ID
- 2016-0139
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIH funds were secured to archive a subset of the data as a restricted use data file, and the dataset is being curated now.
Publications
Albrecht EC, Kaelin VC, Rigau BL, Dooling-Litfin JK, Scully EA, Murphy NJ, McManus BM, Khetani MA; High Value Early Intervention Research Group. Pilot implementation of an electronic patient-reported outcome measure for planning and monitoring participation-focused care in early intervention. BMC Med Inform Decis Mak. 2020 Aug 24;20(1):199. doi: 10.1186/s12911-020-01189-9.
PubMed 32838772Khetani MA, McManus BM, Albrecht EC, Kaelin VC, Dooling-Litfin JK, Scully EA; High Value Early Intervention Research Group. Early intervention service intensity and young children's home participation. BMC Pediatr. 2020 Jul 3;20(1):330. doi: 10.1186/s12887-020-02182-x.
PubMed 32620161
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorado Early Intervention Outcomes Research Using Innovative Patient-Reported Outcome (PRO) Measures
- ClinicalTrials.gov ID
- NCT03904797
- Acronym / sponsor ID
- 2016-0139
- Conditions
- Developmental Disability, Development Delay
- Keywords
- patient-reported outcome, electronic, participation, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- Rocky Mountain Human Services, University of Colorado, Denver
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A major goal of early intervention (EI) is to employ a family-centered approach to helping children to optimally function at home and in the community. However, the effects of EI are poorly understood. The aims of this project are: 1) to test the feasibility, acceptability, and value of introducing novel electronic patient-reported outcome (e-PRO) measures in EI, to strengthen family-centered EI care; and 2) to obtain and pair these outcomes data with EI program data, to further determine the value of e-PRO data collection for examining links between EI service use and functional outcomes among families who are enrolled in a large, urban EI program.
Detailed description
Approximately 5,800 infants and toddlers with developmental disabilities (e.g., cerebral palsy, Down syndrome, complex chronic conditions) and delays access Early Intervention Colorado (EI-CO) annually. A primary goal of EI-CO is to employ a family-centered care approach to help children optimally function at home and in the community. Hence, early intervention is a common source of rehabilitation (i.e., physical, occupational, speech and language therapy) for EI-CO eligible families.
However, the effects of EI-CO are poorly understood. Numerous challenges exist with obtaining EI-CO outcomes data, including a paucity of validated and feasible functional outcome measures for use in EI outcomes reporting. These challenges have resulted in inadequate knowledge about EI service use and outcomes to guide service delivery. Despite these challenges, recent policy changes have resulted in EI-CO service providers being pressed to ensure high quality care with limited resources and evidence to guide their clinical decision-making about effective and efficient interventions. This proposal addresses the need to fill critical knowledge gaps about the adequacy of EI services with an eye toward improving care quality.
This study involves families who have/are receiving EI-CO services through Rocky Mountain Human Services (RMHS), the largest EI program in Denver Metro. The purpose of this study is to test the feasibility, acceptability, and value of collecting electronic patient-reported outcomes (e-PRO) data to engage families when their child is due for an annual evaluation of progress. To further demonstrate the value of e-PRO data collection, these data will be paired with program data to estimate the association between EI-CO service use and functional outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| e-PRO | Experimental | Behavioral: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)EI service coordinators participated in a 90-minute training on the study protocol, to gain clearance to recruit families when they were being contacted to schedule their annual reviews of progress. The recruitment protocol was later modified in response to low enrollment, such that a designated EI staff member was paired with research staff to recruit participants. Eligible and interested caregivers visited the project website to create an account, confirmed study eligibility, provided informed consent and HIPAA authorization for abstracting select EI service use data, and completed a demographic questionnaire and the Young Children's Participation and Environment Measure (YC-PEM) e-PRO. Caregivers received immediate access to an online report summarizing their e-PRO responses to share with their child's EI team |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Caregiver is at least 18 years old;
- Caregiver can read, write, and speak English or Spanish;
- Caregiver had internet access;
- Caregiver has a child between 0-3 years old who had received early intervention at RMHS for at least 3 months.
Key exclusion criteria (5 listed)
- Caregiver is less than 18 years old
- Caregiver reads, speaks, and writes in a language other than English or Spanish
- Caregiver does not have internet access
- Caregiver has a child who has received EI services for less than 3 months
- Caregiver has a child older than 3 years (36 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)Participants were primary caregivers (n=149) recruited from a large, urban early intervention program. All caregivers were approached by early intervention staff the month prior to the child's annual evaluation of progress. Each caregiver confirmed his or her eligibility online by verifying that they were at least 18 years old; could read, write, and speak English or Spanish; had internet access; and had a child between 0-3 years old who had received early intervention for at least 3 months. Participants enrolled online and provided consent, signed a HIPAA authorization for service record release, and then proceeded to completing a demographic questionnaire and YC-PEM e-PRO to receive an online report of their responses to share with their child's EI team. | Behavioural | e-PRO |
Primary outcome
YC-PEM e-PRO Feasibility as assessed by enrollment rate
Time frame: up to 4 weeks
Enrollment rate was estimated as the proportion of eligible participants who enrolled in the study. The success of feasibility was determined as e-PRO enrollment rates of 50% or higher based on what is known about the percentage of families who opt into family assessment as part of usual care.
YC-PEM e-PRO Acceptability as assessed by caregiver perceptions of overall helpfulness
Time frame: up to 4 weeks
Caregiver responses to an open-ended item were coded into a one of three categories (yes, helpful; somewhat helpful; not helpful) to create a new variable that captured the extent to which caregivers perceived the YC-PEM e-PRO to be useful for planning EI care.
YC-PEM e-PRO Value as assessed by proportion of participants viewing e-PRO online report
Time frame: up to 4 weeks
The percentage of participants who viewed a summary of their e-PRO responses via an online report was estimated.
YC-PEM e-PRO Feasibility as assessed by completion rate
Time frame: up to 4 weeks
Feasibility was determined as the proportion of participants who enrolled that completed the YC-PEM e-PRO. The success of feasibility was determined as completion rates of 50% or higher based on family assessment completion rates within usual care.
YC-PEM e-PRO Feasibility as assessed by completion time in minutes and seconds
Time frame: up to 4 weeks
The success of feasibility was determined as e-PRO completion time of less than 45 minutes based on family assessment completion time within usual care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 32838772Albrecht EC, Kaelin VC, Rigau BL, Dooling-Litfin JK, Scully EA, Murphy NJ, McManus BM, Khetani MA; High Value Early Intervention Research Group. Pilot implementation of an electronic patient-reported outcome measure for planning and monitoring participation-focused care in early intervention. BMC Med Inform Decis Mak. 2020 Aug 24;20(1):199. doi: 10.1186/s12911-020-01189-9.
- Derived from this study: PubMed 32620161Khetani MA, McManus BM, Albrecht EC, Kaelin VC, Dooling-Litfin JK, Scully EA; High Value Early Intervention Research Group. Early intervention service intensity and young children's home participation. BMC Pediatr. 2020 Jul 3;20(1):330. doi: 10.1186/s12887-020-02182-x.
- Individual participant dataSharing planned: Yes. NIH funds were secured to archive a subset of the data as a restricted use data file, and the dataset is being curated now.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary A Khetani, ScD principal investigator
Board of Trustees at University of Illinois
Questions about this trial
What is this clinical trial studying?
A study testing Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) in people with Developmental Disability and Development Delay, run by University of Illinois at Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YC-PEM e-PRO Feasibility as assessed by enrollment rate (time frame: up to 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03904797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.