NCT00465361

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

February 9, 2012

Completed
Last Updated

February 9, 2012

Status Verified

December 1, 2011

Enrollment Period

1.2 years

First QC Date

April 23, 2007

Results QC Date

February 8, 2011

Last Update Submit

February 6, 2012

Conditions

Keywords

Growth and DevelopmentChild DevelopmentDevelopmental SurveillanceMedical EducationInternship and Residency

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Baseline Performance

NO INTERVENTION

Observation of baseline performance

Post-intervention Performance

EXPERIMENTAL

Observation of performance post-intervention

Procedure: performance feedback with an educational module

Interventions

individual performance feedback with an educational module

Post-intervention Performance

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Limitations and Caveats

Long-term effects of intervention are unknown.

Results Point of Contact

Title
Sarah S. Nyp
Organization
Children's Mercy Hospitals and Clinics

Study Officials

  • Sarah S Nyp, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Physician

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Study Start

May 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 9, 2012

Results First Posted

February 9, 2012

Record last verified: 2011-12

Locations