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OpenTrials
Completed

NCT Number: NCT02409251

Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests 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.

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Key information

Conditions

Rheumatic Diseases Connective Tissue Diseases Musculoskeletal Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education and Feedback

Behavioral

Primary outcomes

  1. 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

  2. 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.

  3. 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)

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Registry information

Official study title

Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 6, 2015
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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