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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00465361
Other study ID # 07 02-027E
Secondary ID
Status Completed
Phase N/A
First received April 23, 2007
Last updated February 6, 2012
Start date May 2007
Est. completion date July 2008

Study information

Verified date December 2011
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of individualized performance feedback coupled with an educational module in improving resident performance of the physical and developmental examination component of developmental surveillance of infants at the two month preventive care visit.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Procedure:
performance feedback with an educational module
individual performance feedback with an educational module

Locations

Country Name City State
United States Children's Mercy Hospitals and Clinics Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit 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. No
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