Dental HealthNCT00658489
Implementation and Evaluation of Bright Futures Curriculum Within CORNET Continuity Practice
A study testing Education in people with Dental Health and Iron Deficiency, run by Christiana Care Health Services.
Trial summary
The purpose of "Bright Futures" is to promote and improve infant, child, and adolescent health within the context of family and community. CORNET (COntinuity Research NETwork of the Ambulatory Pediatric Association) is a national practice-based research network of resident continuity practices, whose mission is to… Read more about this study
- Who is it for?
- Ages 12 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Health, Iron Deficiency
- What is being tested?
- Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 12-35 months
Who cannot join
- None
About this study
The purpose of "Bright Futures" is to promote and improve infant, child, and adolescent health within the context of family and community. CORNET (COntinuity Research NETwork of the Ambulatory Pediatric Association) is a national practice-based research network of resident continuity practices, whose mission is to establish a self-sustaining collaborative research network among pediatric continuing clinic clinicians who will produce quality research in primary care, health care delivery, and education.
Read the detailed description
"Bright Futures" offers a child and family-centered approach to health promotion in incorporating partnership and communication skills of providers. Two areas of importance are promotion of oral health and prevention of iron deficiency. Residents will be randomized to one of these two groups and will receive web-based education about that particular topic. Residents randomized to group 1 will receive training consisting of 7 modules: 3 on the Bright Futures concepts and 4 on oral health promotion. They will be trained in performing an oral health assessment, identifying caries, and encouraged to establish a dental home for patients. They must communicate with at least one dental practice in the community to determine barriers to care, issues regarding insurance, potential solutions to improve referral, and access to dental care. Residents in group 2 will complete a single educational module on the identification and prevention of iron deficiency. They will be trained to identify iron deficiency and iron deficiency anemia, understand risk prevention strategies, improved methods of identification, and treatment.
Each resident will recruit 3 patients, children between the ages of 12-35 months, for whom he/she is the primary care provider. Each parent-child dyad will participate in one well-child care visit. Each visit will be observed by a faculty preceptor.
This study design was chosen to compare a more sophisticated and time-intensive curriculum to a more modest one. By having a curriculum with minimal overlap between the two groups, the investigators hope to examine the knowledge obtained by the residents, which health promotion aspects they address during their encounters, and to compare the establishment of a dental home in the two groups of patients.
- Conditions
- Dental Health, Iron Deficiency
- Being tested
- Education
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
One group of residents will receive extensive web-based training in the promotion of oral health. The second group of residents will complete a single training module in the prevention of iron deficiency. The third arm consists of parent-child dyads, who will participate in one well-child care visit.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Residents randomized to the promotion of oral health group will receive training consisting of 7 modules (3 on the Bright Futures curriculum and 4 on oral health promotion). They will then enroll 3 patient-child dyads from their practice who present for a well child care visit. Outcomes will be obtained by completing pre- and post-study surveys. Residents will be observed by a faculty preceptor during 3 different patient encounters, and will receive feedback at the end of the 6 month study period. Receives: Behavioral: Education |
| 2 | Active comparator | Residents randomized to the prevention of iron deficiency group will complete one web-based module. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residents will receive the direct benefit of exposure to a new curriculum and feedback on performance by their preceptor. Parents will benefit from greater access to their primary care providers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental HealthStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Responsible party
- Sponsor
- Investigators
- Shirley Klein, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658489
- Sponsor's protocol ID
- 27092
- Other IDs
- DDD#504887
- Status last verified
- Nov 2011
- First submitted
- 11 Apr 2008
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Bright Futures Curriculum Within CORNET Continuity Practice
- ClinicalTrials.gov ID
- NCT00658489
- Acronym / sponsor ID
- 27092
- Conditions
- Dental Health, Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Not posted in the source record
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 "Bright Futures" is to promote and improve infant, child, and adolescent health within the context of family and community. CORNET (COntinuity Research NETwork of the Ambulatory Pediatric Association) is a national practice-based research network of resident continuity practices, whose mission is to establish a self-sustaining collaborative research network among pediatric continuing clinic clinicians who will produce quality research in primary care, health care delivery, and education.
Detailed description
"Bright Futures" offers a child and family-centered approach to health promotion in incorporating partnership and communication skills of providers. Two areas of importance are promotion of oral health and prevention of iron deficiency. Residents will be randomized to one of these two groups and will receive web-based education about that particular topic. Residents randomized to group 1 will receive training consisting of 7 modules: 3 on the Bright Futures concepts and 4 on oral health promotion. They will be trained in performing an oral health assessment, identifying caries, and encouraged to establish a dental home for patients. They must communicate with at least one dental practice in the community to determine barriers to care, issues regarding insurance, potential solutions to improve referral, and access to dental care. Residents in group 2 will complete a single educational module on the identification and prevention of iron deficiency. They will be trained to identify iron deficiency and iron deficiency anemia, understand risk prevention strategies, improved methods of identification, and treatment.
Each resident will recruit 3 patients, children between the ages of 12-35 months, for whom he/she is the primary care provider. Each parent-child dyad will participate in one well-child care visit. Each visit will be observed by a faculty preceptor.
This study design was chosen to compare a more sophisticated and time-intensive curriculum to a more modest one. By having a curriculum with minimal overlap between the two groups, the investigators hope to examine the knowledge obtained by the residents, which health promotion aspects they address during their encounters, and to compare the establishment of a dental home in the two groups of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: EducationResidents randomized to the promotion of oral health group will receive training consisting of 7 modules (3 on the Bright Futures curriculum and 4 on oral health promotion). They will then enroll 3 patient-child dyads from their practice who present for a well child care visit. Outcomes will be obtained by completing pre- and post-study surveys. Residents will be observed by a faculty preceptor during 3 different patient encounters, and will receive feedback at the end of the 6 month study period. |
| 2 | Active comparator | Behavioral: EducationResidents randomized to the prevention of iron deficiency group will complete one web-based module. |
Who may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ages 12-35 months
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| EducationOne group of residents will receive extensive web-based training in the promotion of oral health. The second group of residents will complete a single training module in the prevention of iron deficiency. The third arm consists of parent-child dyads, who will participate in one well-child care visit. | Behavioural | 1, 2 |
Primary outcome
Residents will receive the direct benefit of exposure to a new curriculum and feedback on performance by their preceptor. Parents will benefit from greater access to their primary care providers.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2011.
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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.
Shirley Klein, MD principal investigator
Christiana Care Health Services
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Dental Health and Iron Deficiency, run by Christiana Care Health Services.
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 1 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 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Residents will receive the direct benefit of exposure to a new curriculum and feedback on performance by their preceptor. Parents will benefit from greater access to their primary care providers. (time frame: 6 months). 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 11 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.