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This is a randomized controlled trial aimed at assessing the effectiveness of a patient decision aid (PDA) and text message reminder in promoting early intervention referral completion when infants and toddlers are identified with a developmental concern in the pediatric medical home. Subjects will be randomized to one of two study arms- (1) intervention (2) control condition. Subjects in the intervention arm will watch a video PDA and will receive a text message reminder approximately 7 to 14 business days after enrollment if they agree to the early intervention referral.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Decision Aid | Experimental | After positive screen for a developmental concern the intervention group will receive the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention. |
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| Routine Care | No Intervention | After screening positive for a potential development delay those in the control arm will receive routine care, in this case, a handout explaining Early Intervention services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Decision Aid | Other | Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups | Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed. | Up to 1 year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention | Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Uncertainty About Early Intervention | Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey. | Up to 7 days |
| Parental Predisposition for Early Intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Fiks, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Manuel Jimenez, MD, MS | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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164 parent-child dyads were assessed for eligibility and 100 were excluded. Reasons for exclusion were primarily because potential subjects either not meeting eligibility criteria (i.e., already received early intervention) or they declined to participate. 64 parent-child dyads were consented and randomized.
Participants were recruited from 2 urban pediatric practice sites within the Children's Hospital of Philadelphia Pediatric Research Consortium, a primary care-based network including 31 practices in 2 states, between December 2013 and September 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Decision Aid | After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention. Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services. |
| FG001 | Routine Care | After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization/Allocation to Study Group |
| |||||||||||||
| Follow-up |
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64 parent-child dyads were enrolled, randomized and included in the final analysis. 1 parent-child dyad who completed the intervention could not be contacted for follow-up to determine early intervention (EI) disposition within 1 year of enrollment. Intervention phase data was complete and is in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Decision Aid | After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention. Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services. |
| 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, Customized | Child's Age |
| 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 | Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups | Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed. | One parent-child dyad had missing information regarding EI intake and evaluation. Given the absence of information on referral outcome, this parent-child dyad was included in the final evaluation as having not received an EI intake and evaluation. | Posted | Number | participants | Up to 1 year after randomization |
|
Adverse events were monitored for the duration of participation (up to 1 year)
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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 | Patient Decision Aid | After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention. Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services. |
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Given that the study recruited a convenience sample from one primary care network, findings may not be generalizable to all settings. Also worth noting, EI services differ by state and some of the information is not applicable in all states.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manuel Jimenez, MD, MS | Child Health Institute of New Jersey | 732-235-6230 | jimenema@rwjms.rutgers.edu |
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| Up to 7 days |
Parental predisposition for early intervention services will be measured using surveys.
| Up to 7 days |
| Feasibility of the Patient Decision Aid | The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral. | Up to 7 days |
| Acceptability of the Patient Decision Aid for Early Intervention Referral | The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention. | Up to 7 days |
| NOT COMPLETED |
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| BG001 | Routine Care | After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services. |
| BG002 | Total | Total of all reporting groups |
| participants |
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| Age, Customized | Parent's Age | Number | participants |
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| Sex: Female, Male | Child's Gender | Count of Participants | Participants |
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| Sex: Female, Male | Parent's Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Parent's Race | Number | participants |
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| Region of Enrollment | Number | participants |
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| Parent's Education | Number | participants |
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| Parent's Employment Status | Number | participants |
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| Parent's Marital Status | Number | participants |
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| OG001 | Routine Care | After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services. |
|
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| Secondary | Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention | Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention. | All parent-child dyads who were enrolled and randomized were included in the analysis. | Posted | Number | percentage of participants | Up to 7 days |
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|
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| Other Pre-specified | Parent Uncertainty About Early Intervention | Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey. | All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". A separate analysis was not completed. | Posted | Up to 7 days |
|
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| Other Pre-specified | Parental Predisposition for Early Intervention | Parental predisposition for early intervention services will be measured using surveys. | All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". A separate analysis was not completed. | Posted | Up to 7 days |
|
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| Other Pre-specified | Feasibility of the Patient Decision Aid | The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral. | Data was not collected regarding the time to complete PDA and/or number of Early Intervention referrals for the total population, thus data for this outcome measure was not able to be analyzed as outlined at the time of protocol development. | Posted | Up to 7 days |
|
|
| Other Pre-specified | Acceptability of the Patient Decision Aid for Early Intervention Referral | The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention. | Provider information was not collected as outlined in the initial protocol design. All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". This includes elements of parent acceptability. A separate analysis was not completed. | Posted | Up to 7 days |
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| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Routine Care | After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services. | 0 | 33 | 0 | 33 |
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| All learn to talk, walk, think @ same time (post) |
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| Longer to talk, walk, think may be delayed (pre) |
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| Longer to talk, walk, think may be delayed (post) |
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| All with delays get better on their own (pre) |
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| All with delays get better on their own (post) |
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| Behavior/Learning probs in school w/o help (pre) |
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| Behavior/Learning probs in school w/o help (post) |
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| Know more about child's develop than others (pre) |
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| Know more about child's develop than others (post) |
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| If delayed want to work with child on my own (pre) |
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| If delayed want to work with child on my own (pos) |
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| EI helps kids w/develop delay (pre) |
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| EI helps kids w/develop delay (post) |
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| You have to pay for EI services (pre) |
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| You have to pay for EI services (post) |
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| EI services can be in home or daycare (pre) |
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| EI services can be in home or daycare (post) |
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| EI provider must come to home (pre) |
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| EI provider must come to home (post) |
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| Once EI starts you cannot stop (pre) |
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| Once EI starts you cannot stop (post) |
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| Studies show EI helps make progress (pre) |
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| Studies show EI helps make progress (post) |
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| Resources like EI can help my family & I (pre) |
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| Resources like EI can help my family & I (post) |
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| I'm comfortable with EI staff in my home (pre) |
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| I'm comfortable w/EI staff in my home (post) |
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