An interventional study of Patient Decision Aid in Developmental Delays, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 2 Days to 36 Months. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by Children's Hospital of Philadelphia · Not applicable and Interventional
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.
Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Patient Decision Aid
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.
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.
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.
Time frame: Up to 1 year after randomization
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.
Time frame: Up to 7 days
Parent Uncertainty About Early Intervention
Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.
Time frame: Up to 7 days
Parental Predisposition for Early Intervention
Parental predisposition for early intervention services will be measured using surveys.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 days
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.
| Milestone | Patient Decision Aid | Routine Care |
|---|---|---|
| Started | 31 | 33 |
| Completed | 31 | 33 |
| Not completed | 0 | 0 |
| Milestone | Patient Decision Aid | Routine Care |
|---|---|---|
| Started | 31 | 33 |
| Completed | 30 | 33 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| participants | Patient Decision Aid | Routine Care |
|---|---|---|
| Early Intervention Intake | 20 | 21 |
| Early Intervention Evaluation | 17 | 17 |
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.
| percentage of participants | Patient Decision Aid: Strongly Disagree | Patient Decision Aid: Disagree | Patient Decision Aid: Somewhat Disagree | Patient Decision Aid: Somewhat Agree | Patient Decision Aid: Agree | Patient Decision Aid: Strongly Agree | Routine Care: Strongly Disagree | Routine Care: Disagree | Routine Care: Somewhat Disagree | Routine Care: Somewhat Agree | Routine Care: Agree | Routine Care: Strongly Agree |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All learn to talk, walk, think @ same time (pre) | 48 | 35 | 6 | 10 | 0 | 0 | 52 | 33 | 9 | 3 | 0 | 3 |
| All learn to talk, walk, think @ same time (post) | 42 | 35 | 3 | 6 | 3 | 9 | 52 | 30 | 9 | 6 | 3 | 0 |
| Longer to talk, walk, think may be delayed (pre) | 10 | 32 | 10 | 23 | 19 | 6 | 9 | 33 | 21 | 21 | 6 | 9 |
| Longer to talk, walk, think may be delayed (post) | 10 | 10 | 10 | 23 | 35 | 13 | 15 | 30 | 12 | 33 | 6 | 3 |
| All with delays get better on their own (pre) | 19 | 29 | 6 | 19 | 19 | 6 | 3 | 30 | 15 | 30 | 15 | 6 |
| All with delays get better on their own (post) | 16 | 39 | 10 | 29 | 3 | 3 | 18 | 21 | 21 | 24 | 9 | 6 |
| Behavior/Learning probs in school w/o help (pre) | 10 | 16 | 6 | 26 | 29 | 13 | 6 | 9 | 12 | 30 | 27 | 15 |
| Behavior/Learning probs in school w/o help (post) | 3 | 3 | 6 | 13 | 45 | 29 | 3 | 0 | 15 | 30 | 30 | 21 |
| Know more about child's develop than others (pre) | 10 | 10 | 10 | 19 | 19 | 32 | 6 | 24 | 12 | 33 | 15 | 9 |
| Know more about child's develop than others (post) | 10 | 6 | 6 | 29 | 29 | 19 | 6 | 12 | 15 | 24 | 27 | 15 |
| If delayed want to work with child on my own (pre) | 23 | 39 | 10 | 10 | 16 | 3 | 9 | 27 | 24 | 18 | 21 | 0 |
| If delayed want to work with child on my own (pos) | 23 | 35 | 16 | 16 | 3 | 6 | 6 | 27 | 21 | 9 | 18 | 18 |
| EI helps kids w/develop delay (pre) | 6 | 0 | 0 | 16 | 42 | 35 | 0 | 0 | 0 | 9 | 64 | 27 |
| EI helps kids w/develop delay (post) | 3 | 0 | 0 | 13 | 42 | 42 | 0 | 0 | 0 | 18 | 48 | 33 |
| You have to pay for EI services (pre) | 23 | 45 | 13 | 13 | 6 | 0 | 27 | 39 | 21 | 6 | 6 | 0 |
| You have to pay for EI services (post) | 55 | 35 | 0 | 6 | 3 | 0 | 39 | 45 | 9 | 3 | 3 | 0 |
| EI services can be in home or daycare (pre) | 6 | 3 | 3 | 6 | 51 | 29 | 0 | 0 | 3 | 6 | 48 | 42 |
| EI services can be in home or daycare (post) | 3 | 3 | 0 | 6 | 35 | 52 | 0 | 0 | 0 | 15 | 45 | 39 |
| EI provider must come to home (pre) | 13 | 16 | 16 | 23 | 19 | 13 | 9 | 36 | 18 | 15 | 12 | 9 |
| EI provider must come to home (post) | 10 | 23 | 10 | 23 | 23 | 13 | 12 | 7 | 15 | 21 | 18 | 6 |
| Once EI starts you cannot stop (pre) | 32 | 35 | 16 | 3 | 13 | 0 | 45 | 36 | 6 | 3 | 3 | 6 |
| Once EI starts you cannot stop (post) | 48 | 32 | 6 | 6 | 3 | 3 | 39 | 42 | 9 | 0 | 6 | 3 |
| Studies show EI helps make progress (pre) | 6 | 3 | 0 | 13 | 45 | 32 | 0 | 0 | 6 | 18 | 58 | 18 |
| Studies show EI helps make progress (post) | 3 | 0 | 0 | 10 | 42 | 45 | 0 | 0 | 6 | 9 | 58 | 27 |
| Resources like EI can help my family & I (pre) | 6 | 0 | 3 | 13 | 35 | 42 | 0 | 0 | 0 | 9 | 52 | 39 |
| Resources like EI can help my family & I (post) | 3 | 0 | 0 | 10 | 35 | 52 | 0 | 0 | 0 | 12 | 58 | 30 |
| I'm comfortable with EI staff in my home (pre) | 6 | 3 | 3 | 16 | 29 | 42 | 0 | 3 | 3 | 12 | 48 | 33 |
| I'm comfortable w/EI staff in my home (post) | 3 | 0 | 6 | 10 | 39 | 42 | 0 | 0 | 6 | 12 | 45 | 36 |
Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.
No measurements were reported for this outcome.
Parental predisposition for early intervention services will be measured using surveys.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.
No measurements were reported for this outcome.
Collected over Adverse events were monitored for the duration of participation (up to 1 year). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Decision Aid | — | 0/31 (0%) | 0/31 (0%) |
| Routine Care | — | 0/33 (0%) | 0/33 (0%) |
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.
| Age, Customized(participants) | Patient Decision Aid | Routine Care | Total |
|---|---|---|---|
| Child: Age 1-12 months | 3 | 4 | 7 |
| Child: Age 13-24 months | 20 | 22 | 42 |
| Child: Age 25-36 months | 8 | 7 | 15 |
| Age, Customized(participants) | Patient Decision Aid | Routine Care | Total |
|---|---|---|---|
| Parent: 20 years and Under | 2 | 3 | 5 |
| Parent: 21-30 Years | 15 | 18 | 33 |
| Parent: 31-40 Years | 10 | 6 | 16 |
| Parent: Over 40 Years | 2 | 2 | 4 |
| Parent: Unknown Age | 2 | 4 | 6 |
| Sex: Female, Male(Participants) | Patient Decision Aid | Routine Care | Total |
|---|---|---|---|
| Female | 13 | 12 | 25 |
| Male | 18 | 21 | 39 |
| Sex: Female, Male(Participants) | Patient Decision Aid | Routine Care | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 26 | 28 | 54 |
| Race/Ethnicity, Customized(participants) | Patient Decision Aid | Routine Care | Total |
|---|---|---|---|
| Black/African American | 24 | 32 | 56 |
| Other | 7 | 1 | 8 |
| Region of Enrollment(participants) | Patient Decision Aid | Routine Care | Total |
|---|---|---|---|
| United States | 31 | 33 | 64 |
| Parent's Education(participants) | Patient Decision Aid | Routine Care | Total |
|---|---|---|---|
| Less than High School | 1 | 4 | 5 |
| High School Graduate | 23 | 27 | 50 |
| Post Secondary Education | 7 | 2 | 9 |
| Parent's Employment Status(participants) | Patient Decision Aid | Routine Care | Total |
|---|---|---|---|
| Employed | 17 | 20 | 37 |
| Unemployed | 14 | 13 | 27 |
1 further baseline measures are reported on the registry.
Plan to share: No
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