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

Primary Purpose

Rheumatic Diseases

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Education and feedback

About this trial

This is an interventional health services research trial for Rheumatic Diseases focused on measuring Antinuclear antibody (ANA), Overuse, Rheumatologists, Quality of care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sint Maartenskliniek
Radboud University Medical Center
Maartenskliniek Woerden

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Education and feedback

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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.

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)

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02409251

First Posted

March 9, 2015

Last Updated

March 31, 2015

Sponsor

Sint Maartenskliniek

1. Study Identification

Unique Protocol Identification Number

NCT02409251

Brief Title

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

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sint Maartenskliniek

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatic Diseases

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Education and feedback

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Education and feedback

Primary Outcome Measure Information:

Title

Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention)

Description

Number of ANA tests divided by the number of new patients

Time Frame