Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests in Patients With Rheumatologic Complaints
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|ClinicalTrials.gov Identifier: NCT02409251|
Recruitment Status : Completed
First Posted : April 6, 2015
Last Update Posted : April 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatic Diseases||Behavioral: Education and feedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||July 2014|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409251
|Nijmegen, Gelderland, Netherlands, 6500 GM|
|Radboud University Medical Center|
|Principal Investigator:||Ronald van Vollenhoven, MD, PhD||Karolinska Institutet|
|Principal Investigator:||Marlies Hulscher, PhD||Scientific Institute for Quality of Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands|
|Principal Investigator:||Alfons den Broeder, MD, PhD||Sint Maartenskliniek, Nijmegen, the Netherlands|