search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effectiveness of adding additional tests and/or comments to laboratory reports in a patient population, referred by general practitioners to the clinical chemistry laboratory.


- candidate number6129
- NTR NumberNTR1927
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2009
- Secondary IDs08-N-73 METC Atrium Medisch Centrum, Orbis Medisch en Zorgconcern en Hogeschool Zuyd
- Public TitleEffectiveness of adding additional tests and/or comments to laboratory reports in a patient population, referred by general practitioners to the clinical chemistry laboratory.
- Scientific TitleEffectiveness of reflective testing in primary care.
- ACRONYMN/A
- hypothesisThe goal of this project is the investigation of the effectiveness of reflective testing (the intervention: adding additional test results and/or comments to the test report) compared with routine care (the traditional report, without additional testing or comments), in a patient population, referred by general practitioners to the clinical chemistry laboratory.
- Healt Condition(s) or Problem(s) studiedPrimary care, Reflective testing, Clinical chemistry laboratory
- Inclusion criteriaThe study will be restricted to those cases, in which abnormal test results require additional testing and/or comments, according to the laboratory specialist.
- Exclusion criteriaCases in which there is substantial risk for the patient and normally (following the existing protocol) the lab would either send an urgent fax message to the practice or the laboratory specialist would directly make a telephone call to the general practitioner.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate
- Target number of participants400
- InterventionsStudy design: a randomised clinical trial with reports with reflective testing vs. traditional reports. The randomisation of reports will be performed after the laboratory specialist has done the additional testing and commenting. All selected laboratory results will be subject to reflective testing but only in half of the cases the general practitioners will receive the report. After a follow-up period of 6 months, the differences in diagnostic and therapeutic actions of the general practitioners will be investigated.
- Primary outcomeIn every case where a report with comments is generated (both in control and study groups), the following data will be collected:
1. Following laboratory reports;
2. Following treatments, referrals;
3. Other additional diagnostic procedures and patient data from the general practitioner.
- Secondary outcomeA panel (consisting of medical specialists) will be asked to answer the following questions:
1. How useful were the additional tests and comments for the patient?;
2. What was the benefit for the patient in terms of health improvement?;
3. Was the treatment adequate in the control group, without additional information reported to the general practitioner? This will be graded from negative to positive.
- TimepointsMeasurements will be done after a follow-up period of 6 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Wilhelmine Verboeket-van de Venne
- CONTACT for SCIENTIFIC QUERIESDr. Wilhelmine Verboeket-van de Venne
- Sponsor/Initiator Atrium Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Stichting Kwaliteitsgelden Medisch Specialisten, Vereniging Artsen Laboratoriumdiagnostiek
- PublicationsN/A
- Brief summaryReflective testing is not a routine in the Netherlands. It is common practice in the UK, where such post-analytical processing is integral to the provision of a quality service, and as such is a requirement for laboratory accreditation there. However, evidence of the effectiveness of this procedure is very limited. In the present situation, the laboratories in the Netherlands do deliver extra services additional to reporting of test results. It is common practice to report strongly abnormal results directly by phone to the physician. In some special test procedures (e.g. bone marrow investigation, flow cytometry, hemoglobinopathies) the laboratory professional is more involved in the diagnostic procedure, and test results are supplemented with an interpretative comment. Reflective testing would add a new dimension to the service of the clinical chemistry laboratory to primary health care. It is a potential powerful tool for completing the diagnostic process.
Most of the reports of patients in general practice do not have abnormal test results, or have minor abnormal results not needing special attention. About 15 % of the reports do have abnormal results that need the attention of a laboratory professional. About 3 % of all reports are subject to reflective testing.
The goal of this project is the investigation of the effectiveness of reflective testing (the intervention: adding additional test results and/or comments to the test report) compared with routine care (the traditional report, without additional testing or comments being sent to the general practitioner), in a patient population referred by general practitioners to the clinical chemistry laboratory.
- Main changes (audit trail)
- RECORD21-jul-2009 - 11-okt-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl