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

Rheumatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409251
• Other study ID #: RR-103-ANA
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: March 31, 2015
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Sint Maartenskliniek
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Rheumatic Diseases

Intervention

Behavioral:
• Education and feedback

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Sint Maartenskliniek	Nijmegen	Gelderland
Netherlands	Maartenskliniek Woerden	Woerden

Sponsors (1)

Lead Sponsor	Collaborator
Sint Maartenskliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre- and post-intervention (both 12 months)	No
Primary	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.	Pre- and post-intervention (both 12 months)	No
Primary	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)	Pre- and post-intervention (both 12 months)	No
Primary	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	Pre- and post-intervention (both 12 months)	No
Primary	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	Pre- and post-intervention (both 12 months)	No
Primary	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	Pre- and post-intervention (both 12 months)	No