ClinicalTrials.gg
CompletedNCT02409251Updated Apr 6, 2015

Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests in Patients With Rheumatologic Complaints

An interventional study of Education and feedback in Rheumatic Diseases, sponsored by Sint Maartenskliniek. Completed at 3 sites in Netherlands. Per ClinicalTrials.gov, last updated 2015-04-06.

Sponsored by Sint Maartenskliniek · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Sex
All
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Study 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. 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.

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Conditions studied

  • Rheumatic Diseases

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Keywords

  • Antinuclear antibody (ANA)
  • Overuse
  • Rheumatologists
  • Quality of care
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In context

Rheumatic Diseases

380 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.

This study's enrollment of 29 is below the median of 73 across 213 interventional studies indexed under Rheumatic Diseases.

Browse Rheumatic Diseases studies →

Lead sponsor

Sint Maartenskliniek is the lead sponsor of 29 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria rheumatologists:

  • rheumatologists who are consulting patients at the rheumatology outpatient clinic of a participating centre

Exclusion Criteria rheumatologists:

  • 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

Exclusion Criteria patients

- patients with an ANA test requested during a clinical admission

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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Education and feedback

    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.

    Behavioral: Education and feedback

Interventions

  • BehavioralEducation and feedback
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What researchers measure

Primary outcomes

  1. 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

    Time frame: Pre- and post-intervention (both 12 months)

  2. 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.

    Time frame: Pre- and post-intervention (both 12 months)

  3. 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)

    Time frame: Pre- and post-intervention (both 12 months)

  4. 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

    Time frame: Pre- and post-intervention (both 12 months)

  5. 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

    Time frame: Pre- and post-intervention (both 12 months)

  6. 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

    Time frame: Pre- and post-intervention (both 12 months)

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Study locations

3 sites
  • Sint Maartenskliniek
    Nijmegen, Gelderland 6500 GM, Netherlands
  • Radboud University Medical Center
    Nijmegen, Netherlands
  • Maartenskliniek Woerden
    Woerden, Netherlands
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02409251
Lead sponsor
Sint Maartenskliniek
Responsible party
Nienke Lesuis (MD, Sint Maartenskliniek) — Principal investigator
First posted
Apr 6, 2015
Start date
Feb 2012
Primary completion
Jan 2014
Completion
Jul 2014
Last update
Apr 6, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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