A Family Centered Intervention to Promote Optimal Child Development
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community|
- Evaluation by Early Intervention Specialists [ Time Frame: Up to 180 days ] [ Designated as safety issue: No ]The primary objective of this study is to determine the effectiveness of a patient decision aid and text message reminder on increasing early intervention referral completion. This will be measured by determining the number of subjects who receive a multi-disciplinary evaluation from the early intervention agency.
- Parental Attitudes and Knowledge of Early Intervention [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]Parental knowledge and attitudes will be measured quantitatively using Likert-scale surveys.
- Parent Uncertainty about Early Intervention [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.
- Parental Predisposition for Early Intervention [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]Parental predisposition for early intervention services will be measured using surveys.
- Feasibility of the Patient Decision Aid [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]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.
- Acceptability of the Patient Decision Aid for Early Intervention Referral [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Patient Decision Aid
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
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.
No Intervention: Routine Care
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941186
|Contact: Manuel Jimenez, MD, MSemail@example.com|
|Contact: Alexander Fiks, MD, MSCEfirstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Alexander Fiks, MD, MSCE||Children's Hospital of Philadelphia|
|Principal Investigator:||Manuel Jimenez, MD, MS||Children's Hospital of Philadelphia|