Dental CariesPREDICTNCT02312921
Population-centered Risk- and Evidence-based Dental Inter-professional Care Team
An observational study of Dental Caries, run by Advantage Dental Services, LLC.
Trial summary
The main goal of the payment and delivery system reform is to reduce disparities in oral health and dental care access of low-income mothers and children living in rural Oregon counties. The target population is children, pregnant women and new mothers enrolled in Oregon Health Plan (OHP) in rural Oregon. Read more about this study
- Who is it for?
- Ages Up to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- PREDICT
- Type of treatment
- Pill or oral medicine
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2019
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 80,000 children on Medicaid nested in 14 rural Oregon Counties.
Who may be able to join
- Children less than 21 years old and women who are pregnant or up to 2 months-post-partum.
- Enrollment in Medicaid and assigned by Oregon Health Authority to receive dental care from Advantage Dental Plan.
- Home address is located in the selected counties.
Who cannot join
- None
About this study
Official title: Reducing Oral Health Disparity Through Outreach, Evidenced-Based Care, Global Budgeting and the Alternative Quality Contract
The main goal of the payment and delivery system reform is to reduce disparities in oral health and dental care access of low-income mothers and children living in rural Oregon counties. The target population is children, pregnant women and new mothers enrolled in Oregon Health Plan (OHP) in rural Oregon.
Read the detailed description
To implement a payment plan model based on global budgeting and Alternative Quality Contract (pay-for-performance) for dental providers within Advantage Dental Services, LLC with the goal of incentivizing implementation of delivery system changes aimed at reducing disparities in access and oral health for low-income mothers and children living in rural Oregon counties.
To implement delivery system changes where a team of dental providers (dentists, dental hygienists, case managers, community outreach workers and others) within Advantage Dental Services, LLC provide evidence-based screening, risk assessment and primary preventive care in non-conventional community settings (WIC, Head Start and similar settings) and seamless, timely and appropriate evidence-based care in Advantage dental clinics.
To evaluate and document the payment and delivery system changes to assess whether the changes result in (1) reductions in disparities in access for low-income mothers and children; (2) efficiency in allocation of limited resources with the application of evidence-based screening; (3) seamless and appropriate care for mothers and their child at high risk of dental caries
- Conditions
- Dental Caries
- Being tested
- PREDICT
- Keywords
- managed healthcare, child, dental care
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREDICTOther
Allied dental personnel provide screening and preventive services in community settings and case managers serve as patient navigators to arrange referrals of children who need dentist services. The intervention is paired with a compensation system for high performance (pay-for-performance) with efficient performance monitoring. PREDICT focuses on: 1) identifying eligible children and gaining caregiver consent for services in community settings (e.g., schools); 2) providing risk-based preventive and caries stabilization services efficiently at these settings; 3) providing curative care in dental clinics; and 4) incentivizing local delivery teams to meet performance benchmarks.
| Study group | Role | What they receive |
|---|---|---|
| PREDICT | Delivery system changes where a team of dental providers (dentists, dental hygienists, case managers, community outreach workers and others) within Advantage Dental Services, LLC provide evidence-based screening, risk assessment and primary and secondary preventive care in non-conventional community settings (WIC, Head Start and similar settings) and seamless, timely and appropriate evidence-based care in dental clinics.
Payment plan model based on global budgeting and Alternative Quality Contract (pay-for-performance) for dental providers within Advantage Dental Services, LLC (Advantage) with the goal of incentivizing implementation of delivery system changes aimed at reducing disparities in dental care utilization and oral health for low-income mothers and children.. Receives: Other: PREDICT | |
| Control | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Untreated dental caries
Percentage of participants with untreated dental caries
Measured: 2 years
Secondary outcomes (2)
Consumer Satisfaction
Scores on the Dental Satisfaction Questionnaire
Measured: 2 years
Dental care utilization
Percentage of participants 0-21 years of age and pregnant women who received a dental service
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advantage Dental Services, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Robert Wood Johnson Foundation, University of Chicago, University of Washington
- Responsible party
- Sponsor
- Investigators
- Peter Milgrom, DDS, Study director, Advantage Dental Services, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312921
- Sponsor's protocol ID
- RWJF
- Acronym
- PREDICT
- Status last verified
- Aug 2016
- First submitted
- 6 Dec 2014
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cunha-Cruz J, Milgrom P, Shirtcliff RM, Bailit HL, Huebner CE, Conrad D, Ludwig S, Mitchell M, Dysert J, Allen G, Scott J, Mancl L. Population-centered Risk- and Evidence-based Dental Interprofessional Care Team (PREDICT): study protocol for a randomized controlled trial. Trials. 2015 Jun 20;16:278. doi: 10.1186/s13063-015-0786-y.
PubMed 26091669
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Oral Health Disparity Through Outreach, Evidenced-Based Care, Global Budgeting and the Alternative Quality Contract
- ClinicalTrials.gov ID
- NCT02312921
- Acronym / sponsor ID
- PREDICT / RWJF
- Conditions
- Dental Caries
- Keywords
- managed healthcare, child, dental care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Advantage Dental Services, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Robert Wood Johnson Foundation, University of Chicago, University of Washington
- Study start
- Jan 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 9 Dec 2014 (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.
The main goal of the payment and delivery system reform is to reduce disparities in oral health and dental care access of low-income mothers and children living in rural Oregon counties. The target population is children, pregnant women and new mothers enrolled in Oregon Health Plan (OHP) in rural Oregon.
Detailed description
To implement a payment plan model based on global budgeting and Alternative Quality Contract (pay-for-performance) for dental providers within Advantage Dental Services, LLC with the goal of incentivizing implementation of delivery system changes aimed at reducing disparities in access and oral health for low-income mothers and children living in rural Oregon counties.
To implement delivery system changes where a team of dental providers (dentists, dental hygienists, case managers, community outreach workers and others) within Advantage Dental Services, LLC provide evidence-based screening, risk assessment and primary preventive care in non-conventional community settings (WIC, Head Start and similar settings) and seamless, timely and appropriate evidence-based care in Advantage dental clinics.
To evaluate and document the payment and delivery system changes to assess whether the changes result in (1) reductions in disparities in access for low-income mothers and children; (2) efficiency in allocation of limited resources with the application of evidence-based screening; (3) seamless and appropriate care for mothers and their child at high risk of dental caries
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREDICT | – | Other: PREDICTDelivery system changes where a team of dental providers (dentists, dental hygienists, case managers, community outreach workers and others) within Advantage Dental Services, LLC provide evidence-based screening, risk assessment and primary and secondary preventive care in non-conventional community settings (WIC, Head Start and similar settings) and seamless, timely and appropriate evidence-based care in dental clinics. Payment plan model based on global budgeting and Alternative Quality Contract (pay-for-performance) for dental providers within Advantage Dental Services, LLC (Advantage) with the goal of incentivizing implementation of delivery system changes aimed at reducing disparities in dental care utilization and oral health for low-income mothers and children.. |
| Control | – | –Usual care |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 80,000 children on Medicaid nested in 14 rural Oregon Counties.
Key inclusion criteria (3 listed)
- Children less than 21 years old and women who are pregnant or up to 2 months-post-partum.
- Enrollment in Medicaid and assigned by Oregon Health Authority to receive dental care from Advantage Dental Plan.
- Home address is located in the selected counties.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| PREDICTAllied dental personnel provide screening and preventive services in community settings and case managers serve as patient navigators to arrange referrals of children who need dentist services. The intervention is paired with a compensation system for high performance (pay-for-performance) with efficient performance monitoring. PREDICT focuses on: 1) identifying eligible children and gaining caregiver consent for services in community settings (e.g., schools); 2) providing risk-based preventive and caries stabilization services efficiently at these settings; 3) providing curative care in dental clinics; and 4) incentivizing local delivery teams to meet performance benchmarks. | Other | PREDICT |
Primary outcome
Untreated dental caries
Time frame: 2 years
Percentage of participants with untreated dental caries
2 secondary outcomes
Consumer Satisfaction
Time frame: 2 years
Dental care utilization
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Derived from this study: PubMed 26091669Cunha-Cruz J, Milgrom P, Shirtcliff RM, Bailit HL, Huebner CE, Conrad D, Ludwig S, Mitchell M, Dysert J, Allen G, Scott J, Mancl L. Population-centered Risk- and Evidence-based Dental Interprofessional Care Team (PREDICT): study protocol for a randomized controlled trial. Trials. 2015 Jun 20;16:278. doi: 10.1186/s13063-015-0786-y.
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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.
Peter Milgrom, DDS study director
Advantage Dental Services, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Advantage Dental Services, LLC.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2016. 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?
Results are not available in the source record.
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?
Untreated dental caries (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312921, which also lists 1 linked publication.
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 9 Aug 2016.