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

March 31, 2015 updated by: Nienke Lesuis, Sint Maartenskliniek

Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Medical Center
      • Woerden, Netherlands
        • Maartenskliniek Woerden
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 GM
        • Sint Maartenskliniek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre- and post-intervention (both 12 months)
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.
Pre- and post-intervention (both 12 months)
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)
Pre- and post-intervention (both 12 months)
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
Pre- and post-intervention (both 12 months)
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
Pre- and post-intervention (both 12 months)
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
Pre- and post-intervention (both 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sint Maartenskliniek

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 6, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RR-103-ANA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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