Development and Evaluation of a Medical Intervention for Early Childhood Caries (IMB-RCT)

This study has been completed.
Sponsor:
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
  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
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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 October 01, 2014