Clinical trial NCT02409251: Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests in Patients With Rheumatologic Complaints
Official title: Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Diseases
Keywords: Antinuclear antibody (ANA)
Overuse
Rheumatologists
Quality of care
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


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

Primary outcomes:
measure: Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention)
timeFrame: Pre- and post-intervention (both 12 months)
measure: Change from baseline (pre-intervention) % of positive ANA tests at 12 months (post-intervention)
timeFrame: Pre- and post-intervention (both 12 months)
measure: Change from baseline (pre-intervention) % of repeated ANA testing at 12 months (post-intervention)
timeFrame: Pre- and post-intervention (both 12 months)
measure: Change from baseline (pre-intervention) % of ANA associated diagnoses at 12 months (post-intervention)
timeFrame: Pre- and post-intervention (both 12 months)
measure: Change from baseline (pre-intervention) APR variation between rheumatologists at 12 months (post-intervention)
timeFrame: Pre- and post-intervention (both 12 months)
measure: Change from baseline (pre-intervention) reaching the of target APR at 12 months (post-intervention)
timeFrame: Pre- and post-intervention (both 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Woerden
country: Netherlands
facility: Maartenskliniek Woerden
Study officials:
affiliation: Karolinska Institutet
name: Ronald van Vollenhoven, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific Institute for Quality of Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands
name: Marlies Hulscher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sint Maartenskliniek, Nijmegen, the Netherlands
name: Alfons den Broeder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.