Development and Dissemination of Oral Health Risk Assessment and Referral Guidelines - Full Text View

Sponsor:	The University of North Carolina, Chapel Hill
Collaborators:	Department of Health and Human Services North Carolina Department of Health and Human Services
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00596856

Purpose

Purpose:

Revise the existing oral health risk assessment tool (known as the Encounter Form in the IRB-approved project DENT-1527) and develop accompanying guidelines for its use and distribution.
Evaluate the education intervention to accompany the distribution of the new risk assessment tool - the Priority Oral Health Risk Assessment and Referral Tool - PORRT and guidelines.
Evaluate the extent to which the education intervention affects physicians' screening and referral performance (use of guidelines, appropriateness and quality of referrals).

Participants: Primary care medical and dental providers in North Carolina.

Procedures (methods): UNC will engage in a systematic literature review of dental caries risk and a simulation analysis in order to finalize the design of the PORRT referral tool and its accompanying guidelines. Medical providers will be surveyed statewide regarding their oral health screening practices with children under three years of age, and a randomized controlled trial will be implemented in 75 of these practices to evaluate guideline dissemination and effectiveness. Referral behavior will be evaluated through an analysis of the completed PORRT forms and a record review in dental practices serving as referral sites. Medicaid claims analysis will determine referral effectiveness for the RCT sites compared to the state as a whole.

Condition	Intervention
Early Childhood Dental Caries	Behavioral: Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Development and Dissemination of Oral Health Risk Assessment and Referral Guidelines - PORRT

Resource links provided by NLM:

MedlinePlus related topics: Dental Health

U.S. FDA Resources

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Referral rate defined as the proportion of children of the target age seen in participating medical practices who receive preventive dental services and are referred to an area dentist. [ Time Frame: Within 6 months of receipt of preventive dental services from a medical practice. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Implementation of developed guidelines and risk assessment tool in medical practices and identified barriers to their use. [ Time Frame: Pre and post guideline dissemination ] [ Designated as safety issue: No ]

Estimated Enrollment:	225
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 25 randomly selected pediatric practices that have never participated in IMB will receive the newly developed risk assessment forms and guidelines through the mail with instructions on how to implement them in the practice. (Passive dissemination to non-participating practices)	Behavioral: Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT The RCT will compare passive distribution of guidelines by mail to an in-office intervention consisting of guideline distribution combined with educational outreach providing training in guideline use and patient mediated information provided by the risk and referral assessment tool (PORRT). The three-arm trial will consist of 25 medical practices that have never participated in IMB and 25 practices that are currently participating, both of which will receive the guidelines through the mail, and 25 practices currently participating in IMB that will receive the more intense in-office training intervention.
2: Experimental 25 randomly selected pediatric practices currently participating in IMB will receive the newly developed risk assessment forms and guidelines through the mail with instructions on how to implement them in the practice. (Passive dissemination to participating practices)	Behavioral: Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT The RCT will compare passive distribution of guidelines by mail to an in-office intervention consisting of guideline distribution combined with educational outreach providing training in guideline use and patient mediated information provided by the risk and referral assessment tool (PORRT). The three-arm trial will consist of 25 medical practices that have never participated in IMB and 25 practices that are currently participating, both of which will receive the guidelines through the mail, and 25 practices currently participating in IMB that will receive the more intense in-office training intervention.
3: Experimental 25 randomly selected pediatric practices currently participating in IMB will receive the newly developed risk assessment forms and guidelines through an intense in-office intervention. (Intense intervention with participating practices)	Behavioral: Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT The RCT will compare passive distribution of guidelines by mail to an in-office intervention consisting of guideline distribution combined with educational outreach providing training in guideline use and patient mediated information provided by the risk and referral assessment tool (PORRT). The three-arm trial will consist of 25 medical practices that have never participated in IMB and 25 practices that are currently participating, both of which will receive the guidelines through the mail, and 25 practices currently participating in IMB that will receive the more intense in-office training intervention.

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Licensed and practicing pediatricians in North Carolina who see at least 10 Medicaid children under 3 years of age per month.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596856

Locations

United States, North Carolina
UNC-CH, School of Public Health	Recruiting
Chapel Hill, North Carolina, United States, 27955
Contact: Leslie P Zeldin, MSUP, MPH 919-843-4998 leslie_zeldin@dentistry.unc.edu
Principal Investigator: Richard G Rozier, DDS

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

Department of Health and Human Services

North Carolina Department of Health and Human Services

Investigators

Principal Investigator:

Richard G Rozier, DDS

UNC-CH, School of Public Health, Department of Health Policy and Administration

More Information

No publications provided

Responsible Party:	UNC-CH School of Public Health ( R. Gary Rozier, DDS )
Study ID Numbers:	07-1942, 1H47MC08654-01-00
Study First Received:	January 8, 2008
Last Updated:	June 22, 2009
ClinicalTrials.gov Identifier:	NCT00596856 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

Early childhood caries - ECC
Referral behavior
Oral health risk assessment
Guideline development and dissemination

Additional relevant MeSH terms:

Tooth Diseases
Stomatognathic Diseases
Tooth Demineralization
Dental Caries

ClinicalTrials.gov processed this record on February 08, 2010