Health EducationRCDENT2017NCT03051295
Dentists' Understanding of Diagnostic Test Results and Treatment Efficacy.
A study testing Dental health information form in people with Health Education, run by Rio de Janeiro State University.
Trial summary
There is little evidence on how best to present diagnostic and treatment effect information to dentists and whether this makes any difference to their understanding of the information given and clinical management. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Education
- What is being tested?
- Dental health information form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 8 Jun 2016to 13 Dec 2016
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Graduated dentist undergoing a postgraduate course in a public university in Rio de Janeiro.
Who cannot join
- None.
About this study
Official title: The Influence of Different Formats for Presenting Diagnostic Test Results and Treatment Efficacy on Dentists' Understanding and on Their Reported Clinical Management.
There is little evidence on how best to present diagnostic and treatment effect information to dentists and whether this makes any difference to their understanding of the information given and clinical management. The objective of this study is to assess the influence of different formats for presenting diagnostic test results and treatment efficacy on dentists' understanding and on their reported clinical management. The hypothesis is that presenting diagnostic test and treatment effectiveness results using natural frequencies influences the threshold for treatment and improves interpretation of tests results compared to conditional probabilities and percentage differences. A group of dentists recruited from postgraduate courses were randomized to two of four arms, being two arms of a hypothetical realistic diagnostic scenario (a) and two arms of a hypothetical realistic treatment scenario (b): a1) diagnostic test results presented in conditional probabilities; a2) diagnostic test results presented in natural frequencies; b1) treatment efficacy presented in percentages; b2) treatment efficacy presented in natural frequencies. The main outcome measures were the correct answer as to whether disease was actually present (post-test probability) and the correct answer as the number of patients that would benefit from the treatment (efficacy). Secondary outcome measures included the decision whether to treat or not treat the hypothetical patient.
- Conditions
- Health Education
- Being tested
- Dental health information form
- Keywords
- Communication Barriers, Persuasive Communication, Risk
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental health information formOther
The format in which dentists receive information about diagnostic test results and efficacy of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic percentages. | Active comparator | Dentist receives diagnostic test results presented in conditional probabilities. Receives: Other: Dental health information form |
| Diagnostic frequencies | Experimental | Dentist receives diagnostic test results presented in natural frequencies. Receives: Other: Dental health information form |
| Treatment percentages. | Active comparator | Dentist receives treatment efficacy presented in percentages. Receives: Other: Dental health information form |
| Treatment frequencies. | Experimental | Dentist receives treatment efficacy presented in natural frequencies. Receives: Other: Dental health information form |
What is being measured
The primary outcome is the main question the study is designed to answer.
The probability that a patient will have a dental cavity as assessed by a dentist.
The assessement by the dentist was based on a questionnarie containing a clinical hypothetical situation and the result of a bite-wing radiographic exam.
Measured: Up to 20 minutes
The number of patients that will benefit from systemic antibiotics adjunct to periodontal treatment as assessed by a dentist.
The assessement by the dentist was based on a questionnarie containing a clinical hypothetical situation and the information about the usual efficacy of systemic antibiotics adjunct to periodontal treatment.
Measured: Up to 20 minutes
Secondary outcomes (1)
The number of dentists that would recommend the use of systemic antibiotics adjunct to periodontal treatment in the clinical management of a patient with periodontal disease.
The recommendation by the dentist was based on a questionnarie containing a clinical hypothetical situation and the information about the usual efficacy of systemic antibiotics adjunct to periodontal treatment.
Measured: Up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start8 Jun 2016
- Primary completion13 Dec 2016
- Study completion13 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health EducationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Nadanovsky, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051295
- Sponsor's protocol ID
- riskcommunicationdentist2017
- Acronym
- RCDENT2017
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Formats for Presenting Diagnostic Test Results and Treatment Efficacy on Dentists' Understanding and on Their Reported Clinical Management.
- ClinicalTrials.gov ID
- NCT03051295
- Acronym / sponsor ID
- RCDENT2017 / riskcommunicationdentist2017
- Conditions
- Health Education
- Keywords
- Communication Barriers, Persuasive Communication, Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 13 Dec 2016 (actual)
- First posted
- 13 Feb 2017 (actual)
- 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.
There is little evidence on how best to present diagnostic and treatment effect information to dentists and whether this makes any difference to their understanding of the information given and clinical management. The objective of this study is to assess the influence of different formats for presenting diagnostic test results and treatment efficacy on dentists' understanding and on their reported clinical management. The hypothesis is that presenting diagnostic test and treatment effectiveness results using natural frequencies influences the threshold for treatment and improves interpretation of tests results compared to conditional probabilities and percentage differences. A group of dentists recruited from postgraduate courses were randomized to two of four arms, being two arms of a hypothetical realistic diagnostic scenario (a) and two arms of a hypothetical realistic treatment scenario (b): a1) diagnostic test results presented in conditional probabilities; a2) diagnostic test results presented in natural frequencies; b1) treatment efficacy presented in percentages; b2) treatment efficacy presented in natural frequencies. The main outcome measures were the correct answer as to whether disease was actually present (post-test probability) and the correct answer as the number of patients that would benefit from the treatment (efficacy). Secondary outcome measures included the decision whether to treat or not treat the hypothetical patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diagnostic percentages. | Active comparator | Other: Dental health information formDentist receives diagnostic test results presented in conditional probabilities. |
| Diagnostic frequencies | Experimental | Other: Dental health information formDentist receives diagnostic test results presented in natural frequencies. |
| Treatment percentages. | Active comparator | Other: Dental health information formDentist receives treatment efficacy presented in percentages. |
| Treatment frequencies. | Experimental | Other: Dental health information formDentist receives treatment efficacy presented in natural frequencies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Graduated dentist undergoing a postgraduate course in a public university in Rio de Janeiro.
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 |
|---|---|---|
| Dental health information formThe format in which dentists receive information about diagnostic test results and efficacy of treatment. | Other | Diagnostic frequencies, Diagnostic percentages., Treatment frequencies., Treatment percentages. |
Primary outcome
The probability that a patient will have a dental cavity as assessed by a dentist.
Time frame: Up to 20 minutes
The assessement by the dentist was based on a questionnarie containing a clinical hypothetical situation and the result of a bite-wing radiographic exam.
The number of patients that will benefit from systemic antibiotics adjunct to periodontal treatment as assessed by a dentist.
Time frame: Up to 20 minutes
The assessement by the dentist was based on a questionnarie containing a clinical hypothetical situation and the information about the usual efficacy of systemic antibiotics adjunct to periodontal treatment.
1 secondary outcome
The number of dentists that would recommend the use of systemic antibiotics adjunct to periodontal treatment in the clinical management of a patient with periodontal disease.
Time frame: Up to 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dental health information form in people with Health Education, run by Rio de Janeiro State University.
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 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: finished, as of the sponsor's last update on 13 Feb 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The probability that a patient will have a dental cavity as assessed by a dentist. (time frame: Up to 20 minutes). The study lists 2 primary outcomes in all. 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 13 Feb 2017.