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

January 28, 2010 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27955
        • UNC-CH, School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pediatric or family physician Medicaid practice in North Carolina

Exclusion Criteria:

  • participation in related pilot study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of preventive dental services provision per 100 well-child visits.
Time Frame: One year following initial training.
One year following initial training.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of practices providing 20 or more preventive dental visits.
Time Frame: One year following initial training.
One year following initial training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

April 1, 2002

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

April 19, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimate)

April 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 29, 2010

Last Update Submitted That Met QC Criteria

January 28, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-P-91251/4-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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