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

Primary Purpose

Early Childhood Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuing medical education
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Early Childhood Dental Caries focused on measuring Early childhood caries - ECC, Prevention, Continuing medical education, Randomized controlled trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • pediatric or family physician Medicaid practice in North Carolina

Exclusion Criteria:

  • participation in related pilot study

Sites / Locations

  • UNC-CH, School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

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 also offered in-office follow-up visits providing hands-on advice and support.

Outcomes

Primary Outcome Measures

Rate of preventive dental services provision per 100 well-child visits.

Secondary Outcome Measures

Percent of practices providing 20 or more preventive dental visits.

Full Information

First Posted
April 19, 2007
Last Updated
January 28, 2010
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT00464009
Brief Title
Development and Evaluation of a Medical Intervention for Early Childhood Caries
Acronym
IMB-RCT
Official Title
Development and Evaluation of a Medical Intervention for Early Childhood Caries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Childhood Dental Caries
Keywords
Early childhood caries - ECC, Prevention, Continuing medical education, Randomized controlled trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support.
Arm Title
C
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Continuing medical education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of preventive dental services provision per 100 well-child visits.
Time Frame
One year following initial training.
Secondary Outcome Measure Information:
Title
Percent of practices providing 20 or more preventive dental visits.
Time Frame
One year following initial training.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pediatric or family physician Medicaid practice in North Carolina Exclusion Criteria: participation in related pilot study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard G Rozier, DDS
Organizational Affiliation
UNC-CH, School of Public Health, Department of Health Policy and Administration
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC-CH, School of Public Health
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27955
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18179471
Citation
Quinonez RB, Pahel BT, Rozier RG, Stearns SC. Follow-up preventive dental visits for Medicaid-enrolled children in the medical office. J Public Health Dent. 2008 Summer;68(3):131-8. doi: 10.1111/j.1752-7325.2007.00055.x.
Results Reference
background
PubMed Identifier
12959161
Citation
Rozier RG, Sutton BK, Bawden JW, Haupt K, Slade GD, King RS. Prevention of early childhood caries in North Carolina medical practices: implications for research and practice. J Dent Educ. 2003 Aug;67(8):876-85.
Results Reference
result
PubMed Identifier
17980021
Citation
Slade GD, Rozier RG, Zeldin LP, Margolis PA. Training pediatric health care providers in prevention of dental decay: results from a randomized controlled trial. BMC Health Serv Res. 2007 Nov 2;7:176. doi: 10.1186/1472-6963-7-176.
Results Reference
result
PubMed Identifier
16317972
Citation
Rozier RG, Slade GD, Zeldin LP, Wang H. Parents' satisfaction with preventive dental care for young children provided by nondental primary care providers. Pediatr Dent. 2005 Jul-Aug;27(4):313-22.
Results Reference
result

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Development and Evaluation of a Medical Intervention for Early Childhood Caries

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