Development and Evaluation of a Medical Intervention for Early Childhood Caries (IMB-RCT)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00464009
First received: April 19, 2007
Last updated: January 28, 2010
Last verified: September 2009
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Purpose
This study aimed to evaluate the effect of three forms of continuing medical education (CME) on provision of preventive dental services to Medicaid-enrolled children by medical personnel in primary care physician offices.
| Condition | Intervention |
|---|---|
|
Early Childhood Dental Caries |
Behavioral: Continuing medical education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Development and Evaluation of a Medical Intervention for Early Childhood Caries |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Rate of preventive dental services provision per 100 well-child visits. [ Time Frame: One year following initial training. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent of practices providing 20 or more preventive dental visits. [ Time Frame: One year following initial training. ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | February 2001 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | April 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish.
|
Behavioral: Continuing medical education
Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application. Group B practices received the same as group A and additionally were offered support through telephone conference calls using "learning collaborative" methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices. The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices. Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist.
|
|
Active Comparator: B
Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support.
|
Behavioral: Continuing medical education
Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application. Group B practices received the same as group A and additionally were offered support through telephone conference calls using "learning collaborative" methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices. The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices. Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist.
|
|
Active Comparator: C
Group C practices (n=41) received the same as Group B and were also offered in-office follow-up visits providing hands-on advice and support.
|
Behavioral: Continuing medical education
Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application. Group B practices received the same as group A and additionally were offered support through telephone conference calls using "learning collaborative" methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices. The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices. Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist.
|
Detailed Description:
Practice-based, randomized controlled trial. Setting: 1,400 pediatric and family physician practices in North Carolina providing care to an estimated 240,000 Medicaid-eligible children aged 0-3 years. Interventions: Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support. Group C practices (n=41) received the same as Group B and were offered in-office visit providing hands-on advice and support. Outcome measures were computed from reimbursement claims submitted to NC Division of Medical Assistance. Primary outcome measure: rate of preventive dental services provision per 100 well-child visits. Secondary outcome measure: % of practices providing 20 or more preventive dental visits.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- pediatric or family physician Medicaid practice in North Carolina
Exclusion Criteria:
- participation in related pilot study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464009
Locations
| United States, North Carolina | |
| UNC-CH, School of Public Health | |
| Chapel Hill, North Carolina, United States, 27955 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | Richard G Rozier, DDS | UNC-CH, School of Public Health, Department of Health Policy and Administration |
More Information
Additional Information:
Publications:
| Responsible Party: | R. Gary Rozier, DDS, UNC-CH School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00464009 History of Changes |
| Other Study ID Numbers: | 11-P-91251/4-02 |
| Study First Received: | April 19, 2007 |
| Last Updated: | January 28, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
Early childhood caries - ECC Prevention Continuing medical education Randomized controlled trial |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013