Rheumatic DiseasesNCT02409251
Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests in Patients With Rheumatologic Complaints
A study testing Education and feedback in people with Rheumatic Diseases, run by Sint Maartenskliniek at 3 sites in Netherlands.
Trial summary
The aim of this study is to assess the effect of a simple intervention (a combination of education and feedback) on Antinuclear Antibody (ANA) testing. This aim was chosen because of the known overuse of many laboratory tests, of which ANA testing is one. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Education and feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesNetherlands
- Study dates
- Feb 2012to Jul 2014
- 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
- rheumatologists who are consulting patients at the rheumatology outpatient clinic of a participating centre
Who cannot join
- rheumatologists not working the full study period (pre- and post-intervention) at a participating centre
- rheumatologists not giving their consent to participate
- Inclusion Criteria patients - all patients with an ANA test requested by an included rheumatologist during the study period
- patients with an ANA test requested during a clinical admission
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Sint Maartenskliniek
Nijmegen, Gelderland, 6500 GM
Radboud University Medical Center
Nijmegen
Maartenskliniek Woerden
Woerden
About this study
Official title: Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints
The aim of this study is to assess the effect of a simple intervention (a combination of education and feedback) on Antinuclear Antibody (ANA) testing.
This aim was chosen because of the known overuse of many laboratory tests, of which ANA testing is one. As overuse of ANA tests can have negative consequences (both for patients and society), the investigators designed an intervention to see how this would influence Antinuclear Antibody testing by rheumatologists.
- Conditions
- Rheumatic Diseases
- Being tested
- Education and feedback
- Keywords
- Antinuclear antibody (ANA), Overuse, Rheumatologists, Quality of care
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and feedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Education and feedback | Experimental | The intervention consisted of a one-hour, small group educational session. During this session information on rational ANA testing was provided and feedback on current ANA testing was provided to the rheumatologists. A booster session with the same components was held 6 months after the first session. Receives: Behavioral: Education and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention)
Number of ANA tests divided by the number of new patients
Measured: Pre- and post-intervention (both 12 months)
Change from baseline (pre-intervention) % of positive ANA tests at 12 months (post-intervention)
Percentage of ANA tests reported as positive by the local laboratory. ANA tests reported as 'weakly positive' are regarded as negative.
Measured: Pre- and post-intervention (both 12 months)
Change from baseline (pre-intervention) % of repeated ANA testing at 12 months (post-intervention)
Percentage of patients with ≥1 ANA test in 12 months (pre- or post-intervention period)
Measured: Pre- and post-intervention (both 12 months)
Change from baseline (pre-intervention) % of ANA associated diagnoses at 12 months (post-intervention)
Percentage of patients, in which an ANA is done during the study period, with final diagnosis of SLE, SSc, PM/DM, MCTD or SS
Measured: Pre- and post-intervention (both 12 months)
Change from baseline (pre-intervention) APR variation between rheumatologists at 12 months (post-intervention)
Standard deviation around the mean APR, calculated from the APRs of the individual rheumatologists
Measured: Pre- and post-intervention (both 12 months)
Change from baseline (pre-intervention) reaching the of target APR at 12 months (post-intervention)
Difference (percentage) between the actual APR and the target-APR defined during the intervention
Measured: Pre- and post-intervention (both 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startFeb 2012
- Primary completionJan 2014
- Study completionJul 2014
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 Rheumatic DiseasesStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nienke Lesuis, Sint Maartenskliniek
- Investigators
- Ronald van Vollenhoven, MD, PhD, Principal investigator, Karolinska InstitutetMarlies Hulscher, PhD, Principal investigator, Scientific Institute for Quality of Healthcare, Radboud University Medical Center, Nijmegen, the NetherlandsAlfons den Broeder, MD, PhD, Principal investigator, Sint Maartenskliniek, Nijmegen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409251
- Sponsor's protocol ID
- RR-103-ANA
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lesuis N, Hulscher ME, Piek E, Demirel H, van der Laan-Baalbergen N, Meek I, van Vollenhoven RF, den Broeder AA. Choosing Wisely in Daily Practice: An Intervention Study on Antinuclear Antibody Testing by Rheumatologists. Arthritis Care Res (Hoboken). 2016 Apr;68(4):562-9. doi: 10.1002/acr.22725.
PubMed 26414008
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints
- ClinicalTrials.gov ID
- NCT02409251
- Acronym / sponsor ID
- RR-103-ANA
- Conditions
- Rheumatic Diseases
- Keywords
- Antinuclear antibody (ANA), Overuse, Rheumatologists, Quality of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Apr 2015 (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 aim of this study is to assess the effect of a simple intervention (a combination of education and feedback) on Antinuclear Antibody (ANA) testing.
This aim was chosen because of the known overuse of many laboratory tests, of which ANA testing is one. As overuse of ANA tests can have negative consequences (both for patients and society), the investigators designed an intervention to see how this would influence Antinuclear Antibody testing by rheumatologists.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education and feedback | Experimental | Behavioral: Education and feedbackThe intervention consisted of a one-hour, small group educational session. During this session information on rational ANA testing was provided and feedback on current ANA testing was provided to the rheumatologists. A booster session with the same components was held 6 months after the first session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- rheumatologists who are consulting patients at the rheumatology outpatient clinic of a participating centre
Key exclusion criteria (4 listed)
- rheumatologists not working the full study period (pre- and post-intervention) at a participating centre
- rheumatologists not giving their consent to participate
- Inclusion Criteria patients - all patients with an ANA test requested by an included rheumatologist during the study period
- patients with an ANA test requested during a clinical admission
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 |
|---|---|---|
| Education and feedback | Behavioural | Education and feedback |
Primary outcome
Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention)
Time frame: Pre- and post-intervention (both 12 months)
Number of ANA tests divided by the number of new patients
Change from baseline (pre-intervention) % of positive ANA tests at 12 months (post-intervention)
Time frame: Pre- and post-intervention (both 12 months)
Percentage of ANA tests reported as positive by the local laboratory. ANA tests reported as 'weakly positive' are regarded as negative.
Change from baseline (pre-intervention) % of repeated ANA testing at 12 months (post-intervention)
Time frame: Pre- and post-intervention (both 12 months)
Percentage of patients with ≥1 ANA test in 12 months (pre- or post-intervention period)
Change from baseline (pre-intervention) % of ANA associated diagnoses at 12 months (post-intervention)
Time frame: Pre- and post-intervention (both 12 months)
Percentage of patients, in which an ANA is done during the study period, with final diagnosis of SLE, SSc, PM/DM, MCTD or SS
Change from baseline (pre-intervention) APR variation between rheumatologists at 12 months (post-intervention)
Time frame: Pre- and post-intervention (both 12 months)
Standard deviation around the mean APR, calculated from the APRs of the individual rheumatologists
Change from baseline (pre-intervention) reaching the of target APR at 12 months (post-intervention)
Time frame: Pre- and post-intervention (both 12 months)
Difference (percentage) between the actual APR and the target-APR defined during the intervention
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 6 Apr 2015.
- Derived from this study: PubMed 26414008Lesuis N, Hulscher ME, Piek E, Demirel H, van der Laan-Baalbergen N, Meek I, van Vollenhoven RF, den Broeder AA. Choosing Wisely in Daily Practice: An Intervention Study on Antinuclear Antibody Testing by Rheumatologists. Arthritis Care Res (Hoboken). 2016 Apr;68(4):562-9. doi: 10.1002/acr.22725.
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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.
Ronald van Vollenhoven, MD, PhD principal investigator
Karolinska Institutet
Marlies Hulscher, PhD principal investigator
Scientific Institute for Quality of Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands
Alfons den Broeder, MD, PhD principal investigator
Sint Maartenskliniek, Nijmegen, the Netherlands
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and feedback in people with Rheumatic Diseases, run by Sint Maartenskliniek at 3 sites in Netherlands.
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 4 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 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention) (time frame: Pre- and post-intervention (both 12 months)). The study lists 6 primary outcomes in all. 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 NCT02409251, 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 6 Apr 2015.