Growth & DevelopmentNCT00465361
Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
A study testing performance feedback with an educational module in people with Growth & Development and Child Development, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth & Development, Child Development, Internship and Residency
- What is being tested?
- performance feedback with an educational module
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: Evaluation of Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
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.
Read the 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.
- Conditions
- Growth & Development, Child Development, Internship and Residency, Education, Medical, Developmental Disabilities
- Being tested
- performance feedback with an educational module
- Keywords
- Growth and Development, Child Development, Developmental Surveillance, Medical Education, Internship and Residency
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performance feedback with an educational moduleProcedure or surgery
individual performance feedback with an educational module
| Study group | Role | What they receive |
|---|---|---|
| Baseline Performance | No intervention | Observation of baseline performance |
| Post-intervention Performance | Experimental | Observation of performance post-intervention Receives: Procedure: performance feedback with an educational module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Growth & DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Nyp, Children's Mercy Hospital Kansas City
- Investigators
- Sarah S Nyp, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465361
- Sponsor's protocol ID
- 07 02-027E
- Status last verified
- Dec 2011
- First submitted
- 23 Apr 2007
- Last updated
- 9 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
- ClinicalTrials.gov ID
- NCT00465361
- Acronym / sponsor ID
- 07 02-027E
- Conditions
- Growth & Development, Child Development, Internship and Residency, Education, Medical, Developmental Disabilities
- Keywords
- Growth and Development, Child Development, Developmental Surveillance, Medical Education, Internship and Residency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Posted 9 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Performance | No intervention | –Observation of baseline performance |
| Post-intervention Performance | Experimental | Procedure: performance feedback with an educational moduleObservation of performance post-intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| performance feedback with an educational moduleindividual performance feedback with an educational module | Procedure or surgery | Post-intervention Performance |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah S Nyp, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing performance feedback with an educational module in people with Growth & Development and Child Development, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.