NCT00596856

Brief Summary

Purpose:

  1. 1.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.
  2. 2.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.
  3. 3.Evaluate the extent to which the education intervention affects physicians' screening and referral performance (use of guidelines, appropriateness and quality of referrals).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
3.2 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

January 8, 2008

Last Update Submit

March 15, 2013

Conditions

Keywords

Early childhood caries - ECCReferral behaviorOral health risk assessmentGuideline development and dissemination

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 6 months of receipt of preventive dental services from a medical practice.

Secondary Outcomes (1)

  • Implementation of developed guidelines and risk assessment tool in medical practices and identified barriers to their use.

    Pre and post guideline dissemination

Study Arms (3)

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

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

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

Interventions

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 Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Growth and Development

Intervention Hierarchy (Ancestors)

Physiological Phenomena

Study Officials

  • Richard G Rozier, DDS

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Policy & Management

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 18, 2013

Record last verified: 2013-03