- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465361
Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
Evaluation of Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many children in the United States have developmental or behavioral disabilities. The American Academy of Pediatrics recently published a policy statement outlining recommendations for developmental surveillance and screening of infants and young children. One of the Academy's recommendations was for inclusion of developmental surveillance during all preventive care visits. The five components of developmental surveillance include elicitation and attendance to parental concerns, maintenance of the developmental history, observation of the child through physical and developmental examinations, identification of risk and protective factors, and documentation of surveillance findings and process (referral, follow-up, etc.).
As a result of concerns expressed by the public regarding accountability in medical education and health care, the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties mandated that training programs shift to a competency based assessment system. The focus of this study will be to assess the impact of performance feedback (based upon video recorded observation) coupled with an educational module on resident demonstration of competency in regard to the physical and developmental examinations component of developmental surveillance of infants at the two month preventive care visit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospitals and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Categorical pediatric residents in their second year of training at Children's Mercy Hospitals and Clinics who are scheduled to see infants for a two month preventive care visit.
Exclusion Criteria:
- Preventive care visits for infants who have parents/guardians who do not speak English fluently
- Preventive care visits for infants who have a previously identified genetic or other medical syndrome or developmental delay
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Baseline Performance
Observation of baseline performance
|
|
|
Experimental: Post-intervention Performance
Observation of performance post-intervention
|
individual performance feedback with an educational module
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit
Time Frame: Residents were observed during each of the eligible preventive care visits. Each visit was an average of 20 minutes in length. Preventive care visits were observed over a 13 month time period.
|
Residents were observed to determine whether specific aspects of infant developmental status, as part of developmental surveillance, were assessed during the two-month preventive care visit.
The components of developmental surveillance observed were: assessment of the infant's ability to follow past midline, assessment of the infant's ability to lift his/her head off of the table in prone, assessment of the infant's ability to hold an object placed in his/her hand, assessment of the infant's ability to coo, and assessment of the infant's ability to demonstrate a social smile.
|
Residents were observed during each of the eligible preventive care visits. Each visit was an average of 20 minutes in length. Preventive care visits were observed over a 13 month time period.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah S Nyp, MD, Children's Mercy Hospital Kansas City
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07 02-027E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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