Early Childhood Dental CariesPORRTNCT00596856
Development and Dissemination of Oral Health Risk Assessment and Referral Guidelines
A study testing Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT in people with Early Childhood Dental Caries, run by University of North Carolina, Chapel Hill.
Trial summary
Purpose: 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early Childhood Dental Caries
- What is being tested?
- Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Licensed and practicing pediatricians in North Carolina who see at least 10 Medicaid children under 3 years of age per month.
Who cannot join
None listed.
About this study
Official title: Development and Dissemination of Oral Health Risk Assessment and Referral Guidelines - PORRT
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).
Read more
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.
Read the detailed description
The project "Development and Dissemination of a Priority Oral Health Risk Assessment and Referral Tool - PORRT" is designed as an education and training intervention in medical and dental practices statewide. Various evaluation activities, the purpose of the subcontract, will take place during the four years (see attached timeline). The project will collect data statewide on use of guidelines and changes occurring in medical and dental practices in adopting the guidelines. In addition through a RCT in 75 sites, we will measure the adoption rate of guideline use and the quality and effectiveness of referrals occurring as a result of guideline adoption. This multi-phase project is the logical next step in our work with IMB medical practices throughout the state as it seeks to incorporate dental providers by increasing referrals for those children whose dental care cannot be managed in a medical home. And it seeks to revise through a systematic review of the literature the risk assessment form used by all IMB practices.
The planning phase of the project will focus on the development and refinement of the risk assessment and referral tool (PORRT). This will be accomplished through a systematic review of the literature to provide the scientific evidence for risk factors for ECC, and if sufficient information can be derived from the literature, we will develop a three-state (normal, non-cavitated and cavitated lesions) Markov-model to enable comparisons of ECC incidence rates among children with different risk factors.
A revised PORRT with supporting evidence and guidance on its use will then be pilot tested in five medical practices during year 1 of the project (sites to be selected once the tool is completed). This pilot will be conducted by the OHS. Results from the pilot will be incorporated into the development of a final tool and the accompanying documentation (the guidelines) and used in the implementation of the education intervention in the selected 75 RCT sites. (The education intervention is the responsibility of the OHS.)
Prior to the initiation of the RCT, a statewide baseline survey will be carried out during year 2 with all primary care medical providers who see at least 10 Medicaid patients under three years of age per month. This self-completed, mail survey will assess oral health knowledge regarding infants and toddlers, and the likelihood of adoption of the PORRT instrument in the medical practices. (The questionnaire is not yet developed but will be submitted at a later date for IRB approval along with its accompanying consent form.) Data entry and analysis will take place at UNC and will follow all normal procedures for maintaining confidentiality and protection of human subjects.
The randomized controlled trial will begin during year 2. The education intervention and the dissemination of the PORRT tool and guidelines will occur only in the selected 75 RCT practices. 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. We hypothesize that effect measures (guideline implementation, and referral quantity, quality and effectiveness) will be most favorable in those practices with the intense intervention, least favorable in those practices that have not participated in the IMB program and somewhat effective for those practices that are participating in IMB but only receive the passive dissemination of guidelines.
Six months following the initiation of the education intervention, site visits to all RCT practices will take place to collect copies of the completed PORRT forms and to conduct brief interviews with practice managers on the use and adoption of the tool. The OHS will be responsible for these visits as they are the implementing agency in the grant. Copies of the completed PORRTs will be sent to UNC for data entry and analysis. Data from the forms will be entered by project staff in an ACCESS based data entry system, which will be password protected. No personal identifiers will be entered. All PORRT forms will be stored in locked filing cabinets. PORRT data will be used to measure the quantity of referral activity among the RCT practices (percent of patients with PORRTs, number of referrals made, percent of forms with referrals, completeness of forms).
Beginning at three months following the start of the education intervention a dental record review of referred patients will take place in one geographic area (county) pertaining to the more intense intervention site of the RCT. The OHS will be responsible for conducting these record reviews in the dental offices located in the geographic catchment area of the medical practices. The objective of the records review is to collect information on referrals received from participating medical providers, and on the treatment provided in dental offices to these referred patients. The evaluation of this data will look at the risk and disease status of patients referred for care. The records review data will be analyzed by UNC. The data will allow us to evaluate the quality of referral activity occurring as a result of the intense education intervention and PORRT distribution. Referral effectiveness will be evaluated by looking at pre and post treatment Medicaid claims from this geographic area to ascertain the portion of patients with a dental visit.
The follow-up provider survey will be conducted statewide during year 3 of the project. The results from this survey will allow us to look at use of guidelines and barriers to implementation, comparing RCT with non-RCT practices.
The final phase of the project will focus on data analysis and manuscript preparation. The statewide implementation of the education intervention will be determined by the results of the RCT.
- Conditions
- Early Childhood Dental Caries
- Being tested
- Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT
- Keywords
- Early childhood caries - ECC, Referral behavior, Oral health risk assessment, Guideline development and dissemination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development and dissemination of priority oral health risk assessment and referral guidelines - PORRTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Behavioral: Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre and post guideline dissemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Why it stopped: Published study provided evidence that intervention would provide little effect; study not approved by provider community.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Dental CariesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, North Carolina Department of Health and Human Services
- Responsible party
- Principal investigator, Gary Rozier, DDS, University of North Carolina, Chapel Hill
- Investigators
- Richard G Rozier, DDS, Principal investigator, UNC-CH, School of Public Health, Department of Health Policy and Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596856
- Sponsor's protocol ID
- 07-1942
- Other IDs
- 1H47MC08654-01-00
- Acronym
- PORRT
- Status last verified
- Mar 2013
- First submitted
- 8 Jan 2008
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Dissemination of Oral Health Risk Assessment and Referral Guidelines - PORRT
- ClinicalTrials.gov ID
- NCT00596856
- Acronym / sponsor ID
- PORRT / 07-1942
- Conditions
- Early Childhood Dental Caries
- Keywords
- Early childhood caries - ECC, Referral behavior, Oral health risk assessment, Guideline development and dissemination
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Published study provided evidence that intervention would provide little effect; study not approved by provider community.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, North Carolina Department of Health and Human Services
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The project "Development and Dissemination of a Priority Oral Health Risk Assessment and Referral Tool - PORRT" is designed as an education and training intervention in medical and dental practices statewide. Various evaluation activities, the purpose of the subcontract, will take place during the four years (see attached timeline). The project will collect data statewide on use of guidelines and changes occurring in medical and dental practices in adopting the guidelines. In addition through a RCT in 75 sites, we will measure the adoption rate of guideline use and the quality and effectiveness of referrals occurring as a result of guideline adoption. This multi-phase project is the logical next step in our work with IMB medical practices throughout the state as it seeks to incorporate dental providers by increasing referrals for those children whose dental care cannot be managed in a medical home. And it seeks to revise through a systematic review of the literature the risk assessment form used by all IMB practices.
The planning phase of the project will focus on the development and refinement of the risk assessment and referral tool (PORRT). This will be accomplished through a systematic review of the literature to provide the scientific evidence for risk factors for ECC, and if sufficient information can be derived from the literature, we will develop a three-state (normal, non-cavitated and cavitated lesions) Markov-model to enable comparisons of ECC incidence rates among children with different risk factors.
A revised PORRT with supporting evidence and guidance on its use will then be pilot tested in five medical practices during year 1 of the project (sites to be selected once the tool is completed). This pilot will be conducted by the OHS. Results from the pilot will be incorporated into the development of a final tool and the accompanying documentation (the guidelines) and used in the implementation of the education intervention in the selected 75 RCT sites. (The education intervention is the responsibility of the OHS.)
Prior to the initiation of the RCT, a statewide baseline survey will be carried out during year 2 with all primary care medical providers who see at least 10 Medicaid patients under three years of age per month. This self-completed, mail survey will assess oral health knowledge regarding infants and toddlers, and the likelihood of adoption of the PORRT instrument in the medical practices. (The questionnaire is not yet developed but will be submitted at a later date for IRB approval along with its accompanying consent form.) Data entry and analysis will take place at UNC and will follow all normal procedures for maintaining confidentiality and protection of human subjects.
The randomized controlled trial will begin during year 2. The education intervention and the dissemination of the PORRT tool and guidelines will occur only in the selected 75 RCT practices. 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. We hypothesize that effect measures (guideline implementation, and referral quantity, quality and effectiveness) will be most favorable in those practices with the intense intervention, least favorable in those practices that have not participated in the IMB program and somewhat effective for those practices that are participating in IMB but only receive the passive dissemination of guidelines.
Six months following the initiation of the education intervention, site visits to all RCT practices will take place to collect copies of the completed PORRT forms and to conduct brief interviews with practice managers on the use and adoption of the tool. The OHS will be responsible for these visits as they are the implementing agency in the grant. Copies of the completed PORRTs will be sent to UNC for data entry and analysis. Data from the forms will be entered by project staff in an ACCESS based data entry system, which will be password protected. No personal identifiers will be entered. All PORRT forms will be stored in locked filing cabinets. PORRT data will be used to measure the quantity of referral activity among the RCT practices (percent of patients with PORRTs, number of referrals made, percent of forms with referrals, completeness of forms).
Beginning at three months following the start of the education intervention a dental record review of referred patients will take place in one geographic area (county) pertaining to the more intense intervention site of the RCT. The OHS will be responsible for conducting these record reviews in the dental offices located in the geographic catchment area of the medical practices. The objective of the records review is to collect information on referrals received from participating medical providers, and on the treatment provided in dental offices to these referred patients. The evaluation of this data will look at the risk and disease status of patients referred for care. The records review data will be analyzed by UNC. The data will allow us to evaluate the quality of referral activity occurring as a result of the intense education intervention and PORRT distribution. Referral effectiveness will be evaluated by looking at pre and post treatment Medicaid claims from this geographic area to ascertain the portion of patients with a dental visit.
The follow-up provider survey will be conducted statewide during year 3 of the project. The results from this survey will allow us to look at use of guidelines and barriers to implementation, comparing RCT with non-RCT practices.
The final phase of the project will focus on data analysis and manuscript preparation. The statewide implementation of the education intervention will be determined by the results of the RCT.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT25 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) |
| 2 | Experimental | Behavioral: Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT25 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) |
| 3 | Experimental | Behavioral: Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT25 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Licensed and practicing pediatricians in North Carolina who see at least 10 Medicaid children under 3 years of age per month.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development and dissemination of priority oral health risk assessment and referral guidelines - PORRTThe 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. | Behavioural | 1, 2, 3 |
Primary outcome
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.
1 secondary outcome
Implementation of developed guidelines and risk assessment tool in medical practices and identified barriers to their use.
Time frame: Pre and post guideline dissemination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard G Rozier, DDS principal investigator
UNC-CH, School of Public Health, Department of Health Policy and Administration
Questions about this trial
What is this clinical trial studying?
A study testing Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT in people with Early Childhood Dental Caries, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2013.