Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00596856 |
| Other study ID # |
07-1942 |
| Secondary ID |
1H47MC08654-01-0 |
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
January 8, 2008 |
| Last updated |
March 15, 2013 |
| Start date |
April 2011 |
| Est. completion date |
April 2012 |
Study information
| Verified date |
March 2013 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical 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. 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. 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.
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.
