Contact information
Type
Scientific
Primary contact
Prof G.J. Dinant
ORCID ID
Contact details
Maastricht University
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882396
geertjan.dinant@hag.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR398
Study information
Scientific title
Blood test ordering for unexplained complaints in general practice
Acronym
VAMPIRE
Study hypothesis
1. When patients visit their GPs with unexplained complaints it is cost effective to follow a watchful waiting strategy of four weeks before ordering laboratory tests
2. A systematically developed quality improvement strategy, based on barriers and facilitators of GPs' blood test ordering behaviour, is cost effective in supporting GPs to postpone blood test ordering
Ethics approval
Ethics approval received from the Medical Ethics Committees of:
1. The Academic Medical Center-University of Amsterdam
2. The University Hospital Maastricht
Study design
Multicentre randomised single blind parallel group controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Condition
Unexplained complaints
Intervention
1. Immediate blood test ordering versus watchful waiting of 4 weeks with blood test ordering after four weeks only if complaints remain
2. Quality improvement strategy consisting of small group meetings, practice visits, patient leaflets and waiting room videotape versus no quality improvement strategy
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Accuracy of blood tests for serious pathology (per test and in combinations relevant for general practice), related and in addition to signs and symptoms, at the moment of presentation and after postponing test ordering for four weeks
2. Adherence of GPs to instruction either to order blood tests directly or after a watchful waiting policy of four weeks
Secondary outcome measures
1. Incidence of unexplained complaints in general practice
2. Predictive value of GPs' working hypothesis
3. Duration of unexplained complaints
4. Effect of unexplained complaints on quality of life of patients
5. Effect of direct testing or watchful waiting on satisfaction with care, anxiety, medical consumption and absence from work of patients
6. Effect of direct testing or watchful waiting on satisfaction, anxiety and insecurity of GPs
7. Effect of quality improvement intervention on knowledge about the value of blood test ordering in unexplained complaints, communication skills and attitudes of GPs
8. Barriers to and facilitators of proposing a watchful waiting strategy by GPs
9. Costs of the quality improvement intervention
Overall trial start date
01/01/2002
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients of 18 years and above with:
1.1. Unexplained fatigue
1.2. Abdominal complaints
1.3. Musculoskeletal complaints
1.4. Weight changes
1.5. Itching
2. Patients have not contacted their GPs for the last six months with the same complaints
3. Patients able to speak, read and write Dutch
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5000
Participant exclusion criteria
The GP is worried that the patient has got serious pathology that makes watchful waiting unacceptable.
Recruitment start date
01/01/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
Care and Public Health Research Institute (CAPHRI) (Netherlands)
Sponsor details
University Maastricht
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882446
e.habets@caphri.unimaas.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Central Sickfund (CZ) health care insurance (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Netherlands Organization for Scientific Research (NWO) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dutch Health Care Insurance Board (CVZ, independent government organisation) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stichting 'De drie Lichten' (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dutch Heart Foundation (Netherlands)
Alternative name(s)
Heart Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Netherlands
Funder name
Stichting Volksgezondheid en Roken (STIVORO) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16553955
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19273865
Publication citations
-
Protocol
van Bokhoven MA, Koch H, van der Weijden T, Grol RP, Bindels PJ, Dinant GJ, Blood test ordering for unexplained complaints in general practice: the VAMPIRE randomised clinical trial protocol. [ISRCTN55755886]., BMC Fam Pract, 2006, 7, 20, doi: 10.1186/1471-2296-7-20.
-
Results
van Bokhoven MA, Koch H, van der Weijden T, Grol RP, Kester AD, Rinkens PE, Bindels PJ, Dinant GJ, Influence of watchful waiting on satisfaction and anxiety among patients seeking care for unexplained complaints., Ann Fam Med, 7, 2, 112-120, doi: 10.1370/afm.958.