No registrations found.
ID
Source
Brief title
Health condition
As the procedure involves the inspection of all (abnormal) reports by a laboratory specialist, all related diseases will be subject to this investigation.
Sponsors and support
Arts Klinische Chemie, Epidemioloog
Atrium Medisch Centrum Parkstad
Klinische Chemie
Postbus 4446
6401 CX Heerlen
Intervention
Outcome measures
Primary outcome
In 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 outcome
A 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.
Background summary
Reflective 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.
Study objective
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), in a patient population, referred by general practitioners to the clinical chemistry laboratory.
Study design
Measurements will be done after a follow-up period of 6 months.
Intervention
Study 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.
Klinische Chemie
Postbus 4446
Wilhelmine Verboeket-van de Venne
Atrium Medisch Centrum Parkstad
Klinische Chemie
Postbus 4446
Heerlen 6401 CX
The Netherlands
+31 (0)45 - 5766303
wvenne@atriummc.nl
Klinische Chemie
Postbus 4446
Wilhelmine Verboeket-van de Venne
Atrium Medisch Centrum Parkstad
Klinische Chemie
Postbus 4446
Heerlen 6401 CX
The Netherlands
+31 (0)45 - 5766303
wvenne@atriummc.nl
Inclusion criteria
The study will be restricted to those cases, in which abnormal test results require additional testing and/or comments, according to the laboratory specialist.
Exclusion criteria
Cases 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1817 |
NTR-old | NTR1927 |
Other | METC Atrium Medisch Centrum, Orbis Medisch en Zorgconcern en Hogeschool Zuyd : 08-N-73 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |