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

NCT02409251 | Completed

• 1 other identifier: RR-103-ANA
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Rheumatic Diseases

Keywords

Antinuclear antibody (ANA); Overuse; Rheumatologists; Quality of care

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Education and feedback

EXPERIMENTAL

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

Interventions

Education and feedback BEHAVIORAL

Education and feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• rheumatologists who are consulting patients at the rheumatology outpatient clinic of a participating centre

You may not qualify if:

• rheumatologists not working the full study period (pre- and post-intervention) at a participating centre
• rheumatologists not giving their consent to participate
• \- patients with an ANA test requested during a clinical admission

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (3)

Sint Maartenskliniek

Nijmegen, Gelderland, 6500 GM, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Maartenskliniek Woerden

Woerden, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 26414008 DERIVED

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: April 6, 2015
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 6, 2015

Record last verified: 2015-03

Locations

NL (3)