Health Knowledge, Attitudes, PracticeBFOHNCT01406366
Evaluation of a Bright Futures Oral Health Intervention
An observational study of Health Knowledge, Attitudes, Practice, run by Continuity Research Network at 1 site in United States.
Trial summary
Pediatricians serve an important role in promoting health in families. 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 in promotion of oral health and prevention of iron deficiency. Read more about this study
- Who is it for?
- Ages 12 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Group 1: Bright Futures Oral Health Curriculum and Group 2: Iron Deficiency Training Module
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2010
- Phase
- Observational
- 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
Study population: Pediatric categorical residents in continuity clinics associated with CORNET practices that volunteer to participate will be asked to participate in the study. Resident inclusion criteria will include pediatric residents in their 1st or 2nd year of categorical training. Parent-child dyad inclusion criteria include children between 12-35 months of age, accompanied by a legal guardian, who presents for a scheduled health maintenance visit with their primary care provider who is a pediatric resident. Families must have a means by which to be contacted (i.e., telephone, cell phone, or beeper number) for follow-up. At least 2 numbers for communication will need to be solicited.
Who may be able to join
- Residents
- Pediatric categorical residents
- PL-1 or PL-2 level
- Parents/Patients
- Parents/legal guardian of children 12- 35 months of age
- Legal guardian present at visit
Show all 9Show fewer
- Primary care provider is pediatric resident seeing patient at that visit
- Child presents for health maintenance visit
- English speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Hanover, New Hampshire, 03755
About this study
Official title: Evaluation of a Bright Futures Oral Health Intervention for Pediatric Residents
Pediatricians serve an important role in promoting health in families. 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 in promotion of oral health and prevention of iron deficiency. We plan to study implementing educational curriculum to pediatric residents through a randomized controlled trial. Randomization will be done through assignment at the level of pediatric training program. Residents randomized to Group 1 will receive education about Bright Futures partnership and communication skills with oral health as the main health promotion topic. Group 2 will receive educational curriculum pertaining to the topic of iron deficiency prevention. While pediatricians are positioned perfectly to partner and effectively communicate with families on these two issues, there are gaps in pediatric education addressing these topics. The CORNET continuity practices of the Ambulatory Pediatric Association provide a venue through which multiple residency programs that educate pediatric residents and whose residents provide medical care to underserved children can participate. The research hypotheses include:
- Residents in Group 1 will have greater confidence, knowledge and competence in partnership building and communication with families
- Residents in Group 1 will have greater knowledge and competence in discussing oral health promotion
- Residents in Group 2 will have greater knowledge and competence in discussing iron deficiency prevention
- Parent-child dyads in Group 1 will be more likely to have established a dental home
- Parent-child dyads in Group 1 will be more likely to be satisfied with their healthcare encounter.
Read more
Pediatric practices provide fertile ground for the provision of health promotion on oral health and iron deficiency prevention. However, evidence for the effectiveness of primary care clinician interventions of screening, referral and counseling to prevent dental caries is lacking [14]. The National Survey of America's Families [15] found 47% of children did not receive the recommended number of dental visits, with the youngest ones being least likely to receive any dental care.
Although 90% of pediatricians agreed they had important roles in identifying and counseling patients on prevention of caries, half stated they had received no previous training during medical school or residency and their knowledge of basic oral health topics was limited [13]. These studies highlight that pediatricians play important roles in oral health and are capable of being trained to complete oral screening exams, but more education and guidance is needed.
Iron deficiency is the most common childhood nutritional deficiency in the United States. Recent prevalence data have determined that 7-30% of children in the United States aged 1-2 years have iron deficiency and 3-10% have iron deficiency anemia [17, 18]. Specific goals in Health People 2010 include a reduction of iron deficiency to 5% in children less than 3 years of age.
Read the detailed description
Although health professionals must be equipped to promote healthy lifestyles and serve as resources for the public's health information, many gaps in the education and training of residents exist. Health professional students readily admit to deficiencies in their training (i.e. lack of learning principles of prevention, health promotion, behavior change and risk reduction), yet, curricular changes have been slow [1,2]. A 1997 AAMC Medical School Graduation Questionnaire revealed that almost one quarter of graduates felt instruction time devoted to health promotion and disease prevention was inadequate [3, 4, 5, 6]. Mandates for competency-based, post-graduate training by the ACGME Outcomes Project and competency expectations by the AAMC Medical Schools Objectives Project (MSOP) require all residency programs and medical schools to develop innovative approaches to teaching clinical skills.
We believe the resident continuity experience is the perfect venue to implement and practice clinical guidelines and Bright Futures concepts. Past studies have documented that residents in academic, hospital-based sites, similar to those in CORNET, experience the most continuity and longitudinal relationships with their patients [7, 8, 9]. Longitudinal learning is a basic tenet of successful interventions and is easily accomplished during resident continuity practice. Pediatrics in Practice provides key resources for enhancing knowledge in family-centered oral health promotion and responding to the present gaps in medical education and training. Both residents and pediatricians in practice have limited knowledge of Bright Futures and its tenets. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents represents the framework of providing contextual care to children that fosters partnerships among families, health professionals, and communities and increases knowledge about health education and prevention [10, 11, 12]. Although more competency-based curricula are being designed to promote skills and knowledge in health promotion and preventive services, there has been very little research into their efficacy in trainees.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Group 1: Bright Futures Oral Health Curriculum, Group 2: Iron Deficiency Training Module
- Keywords
- Pediatric oral health, Bright Futures, Health promotion
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Bright Futures Oral Health CurriculumBehavioural
Residents who are randomized to Group 1 will receive a resident curriculum that exposes them to Bright Futures concepts of health promotion, including partnership building, communication and oral health. Group 1 residents will complete 7 modules, 3 on Bright Futures concepts (health, partnership building and communication), and 4 on oral health promotion. These modules have been developed in collaboration with the Pediatrics in Practice workgroup and the Open Wide modules endorsed by the American Academy of Pediatrics and the Maternal and Child Health Bureau. The oral health modules address dental caries development and prevention, importance of identifying maternal oral health status, duration of bottle-feeding or breastfeeding and discouraging both during sleep.
Group 2: Iron Deficiency Training ModuleBehavioural
Our study team opted to include a single 1-hour educational module addressing the identification and prevention of iron deficiency created by the AAP on Pedialink® to the active control group. This educational module addresses screening for and assessing risk for iron deficiency.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1: 16 programs / 148 residents Receives: Behavioral: Group 1: Bright Futures Oral Health Curriculum | |
| Group 2 | Group 2: 16 programs / 142 residents Receives: Behavioral: Group 2: Iron Deficiency Training Module |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startSep 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Continuity Research Network
- Sponsor type
- Research network
- Investigators
- Henry H Bernstein, DO, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406366
- Sponsor's protocol ID
- R40MC05267-01-00
- Other IDs
- R40MC05267-01-00
- Acronym
- BFOH
- Status last verified
- Aug 2010
- First submitted
- 29 Jul 2011
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Bright Futures Oral Health Intervention for Pediatric Residents
- ClinicalTrials.gov ID
- NCT01406366
- Acronym / sponsor ID
- BFOH / R40MC05267-01-00
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- Pediatric oral health, Bright Futures, Health promotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Continuity Research NetworkResearch network
- Study start
- Sep 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Aug 2011 (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.
Pediatricians serve an important role in promoting health in families. 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 in promotion of oral health and prevention of iron deficiency. We plan to study implementing educational curriculum to pediatric residents through a randomized controlled trial. Randomization will be done through assignment at the level of pediatric training program. Residents randomized to Group 1 will receive education about Bright Futures partnership and communication skills with oral health as the main health promotion topic. Group 2 will receive educational curriculum pertaining to the topic of iron deficiency prevention. While pediatricians are positioned perfectly to partner and effectively communicate with families on these two issues, there are gaps in pediatric education addressing these topics. The CORNET continuity practices of the Ambulatory Pediatric Association provide a venue through which multiple residency programs that educate pediatric residents and whose residents provide medical care to underserved children can participate. The research hypotheses include:
- Residents in Group 1 will have greater confidence, knowledge and competence in partnership building and communication with families
- Residents in Group 1 will have greater knowledge and competence in discussing oral health promotion
- Residents in Group 2 will have greater knowledge and competence in discussing iron deficiency prevention
- Parent-child dyads in Group 1 will be more likely to have established a dental home
- Parent-child dyads in Group 1 will be more likely to be satisfied with their healthcare encounter.
Pediatric practices provide fertile ground for the provision of health promotion on oral health and iron deficiency prevention. However, evidence for the effectiveness of primary care clinician interventions of screening, referral and counseling to prevent dental caries is lacking [14]. The National Survey of America's Families [15] found 47% of children did not receive the recommended number of dental visits, with the youngest ones being least likely to receive any dental care.
Although 90% of pediatricians agreed they had important roles in identifying and counseling patients on prevention of caries, half stated they had received no previous training during medical school or residency and their knowledge of basic oral health topics was limited [13]. These studies highlight that pediatricians play important roles in oral health and are capable of being trained to complete oral screening exams, but more education and guidance is needed.
Iron deficiency is the most common childhood nutritional deficiency in the United States. Recent prevalence data have determined that 7-30% of children in the United States aged 1-2 years have iron deficiency and 3-10% have iron deficiency anemia [17, 18]. Specific goals in Health People 2010 include a reduction of iron deficiency to 5% in children less than 3 years of age.
Detailed description
Although health professionals must be equipped to promote healthy lifestyles and serve as resources for the public's health information, many gaps in the education and training of residents exist. Health professional students readily admit to deficiencies in their training (i.e. lack of learning principles of prevention, health promotion, behavior change and risk reduction), yet, curricular changes have been slow [1,2]. A 1997 AAMC Medical School Graduation Questionnaire revealed that almost one quarter of graduates felt instruction time devoted to health promotion and disease prevention was inadequate [3, 4, 5, 6]. Mandates for competency-based, post-graduate training by the ACGME Outcomes Project and competency expectations by the AAMC Medical Schools Objectives Project (MSOP) require all residency programs and medical schools to develop innovative approaches to teaching clinical skills.
We believe the resident continuity experience is the perfect venue to implement and practice clinical guidelines and Bright Futures concepts. Past studies have documented that residents in academic, hospital-based sites, similar to those in CORNET, experience the most continuity and longitudinal relationships with their patients [7, 8, 9]. Longitudinal learning is a basic tenet of successful interventions and is easily accomplished during resident continuity practice. Pediatrics in Practice provides key resources for enhancing knowledge in family-centered oral health promotion and responding to the present gaps in medical education and training. Both residents and pediatricians in practice have limited knowledge of Bright Futures and its tenets. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents represents the framework of providing contextual care to children that fosters partnerships among families, health professionals, and communities and increases knowledge about health education and prevention [10, 11, 12]. Although more competency-based curricula are being designed to promote skills and knowledge in health promotion and preventive services, there has been very little research into their efficacy in trainees.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Group 1: Bright Futures Oral Health CurriculumGroup 1: 16 programs / 148 residents |
| Group 2 | – | Behavioral: Group 2: Iron Deficiency Training ModuleGroup 2: 16 programs / 142 residents |
Who may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric categorical residents in continuity clinics associated with CORNET practices that volunteer to participate will be asked to participate in the study. Resident inclusion criteria will include pediatric residents in their 1st or 2nd year of categorical training. Parent-child dyad inclusion criteria include children between 12-35 months of age, accompanied by a legal guardian, who presents for a scheduled health maintenance visit with their primary care provider who is a pediatric resident. Families must have a means by which to be contacted (i.e., telephone, cell phone, or beeper number) for follow-up. At least 2 numbers for communication will need to be solicited.
Key inclusion criteria (9 listed)
- Residents
- Parents/Patients
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Group 1: Bright Futures Oral Health CurriculumResidents who are randomized to Group 1 will receive a resident curriculum that exposes them to Bright Futures concepts of health promotion, including partnership building, communication and oral health. Group 1 residents will complete 7 modules, 3 on Bright Futures concepts (health, partnership building and communication), and 4 on oral health promotion. These modules have been developed in collaboration with the Pediatrics in Practice workgroup and the Open Wide modules endorsed by the American Academy of Pediatrics and the Maternal and Child Health Bureau. The oral health modules address dental caries development and prevention, importance of identifying maternal oral health status, duration of bottle-feeding or breastfeeding and discouraging both during sleep. | Behavioural | Group 1 |
| Group 2: Iron Deficiency Training ModuleOur study team opted to include a single 1-hour educational module addressing the identification and prevention of iron deficiency created by the AAP on Pedialink® to the active control group. This educational module addresses screening for and assessing risk for iron deficiency. | Behavioural | Group 2 |
Primary outcome
Not reported in the source record.
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 1 Aug 2011.
- A Bright-Futures based website supporting faculty in health promotionLink provided by the sponsor.
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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.
Henry H Bernstein, DO principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Knowledge, Attitudes, Practice, run by Continuity Research Network 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 9 inclusion and 0 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 1 Aug 2011. 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?
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.
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 1 Aug 2011.