Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT00465361
Collaborator
(none)
7
1
2
14
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: performance feedback with an educational module
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Evaluation of Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Baseline Performance

Observation of baseline performance

Experimental: Post-intervention Performance

Observation of performance post-intervention

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

Outcome Measures

Primary Outcome Measures

  1. Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108

Sponsors and Collaborators

  • Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Sarah S Nyp, MD, Children's Mercy Hospital Kansas City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sarah Nyp, Medical Physician, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00465361
Other Study ID Numbers:
  • 07 02-027E
First Posted:
Apr 25, 2007
Last Update Posted:
Feb 9, 2012
Last Verified:
Dec 1, 2011
Keywords provided by Sarah Nyp, Medical Physician, Children's Mercy Hospital Kansas City
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Recruitment Period: August 2007-July 2008 Location: Academic medical center
Pre-assignment Detail Seven participants were enrolled. Four participants did not complete the study due to personal issues.
Arm/Group Title Intervention
Arm/Group Description Performance after receiving feedback and educational module
Period Title: Baseline Assessment
STARTED 7
COMPLETED 3
NOT COMPLETED 4
Period Title: Baseline Assessment
STARTED 3
COMPLETED 3
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Intervention
Arm/Group Description Performance after receiving feedback and educational module
Overall Participants 7
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
7
100%
>=65 years
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
28
(2)
Sex: Female, Male (Count of Participants)
Female
5
71.4%
Male
2
28.6%
Region of Enrollment (participants) [Number]
United States
7
100%

Outcome Measures

1. Primary Outcome
Title Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit
Description 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.
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.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Arm/Group Description Performance after receiving feedback and educational module
Measure Participants 3
Number [Participants]
3
42.9%

Adverse Events

Time Frame May 2007-July 2008
Adverse Event Reporting Description No serious or non-serious adverse events were assessed.
Arm/Group Title Intervention
Arm/Group Description Performance after receiving feedback and educational module
All Cause Mortality
Intervention
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
Intervention
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Intervention
Affected / at Risk (%) # Events
Total 0/0 (NaN)

Limitations/Caveats

Long-term effects of intervention are unknown.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Sarah S. Nyp
Organization Children's Mercy Hospitals and Clinics
Phone 816-234-3000
Email ssnyp@cmh.edu
Responsible Party:
Sarah Nyp, Medical Physician, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00465361
Other Study ID Numbers:
  • 07 02-027E
First Posted:
Apr 25, 2007
Last Update Posted:
Feb 9, 2012
Last Verified:
Dec 1, 2011