VAgue Medical Problems In REsearch (VAMPIRE): Blood test ordering for unexplained complaints in general practice.

ISRCTN	ISRCTN55755886
DOI	https://doi.org/10.1186/ISRCTN55755886
Protocol serial number	NTR398
Sponsor	Care and Public Health Research Institute (CAPHRI) (Netherlands)
Funders	Central Sickfund (CZ) health care insurance (Netherlands), The Netherlands Organization for Scientific Research (NWO) (Netherlands), Dutch Health Care Insurance Board (CVZ, independent government organisation) (Netherlands), Stichting 'De drie Lichten' (Netherlands), Dutch Heart Foundation (Netherlands), Stichting Volksgezondheid en Roken (STIVORO) (Netherlands)

Submission date: 22/11/2005
Registration date: 22/11/2005
Last edited: 18/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof G.J. Dinant
Scientific

Maastricht University
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 3882396
Email	geertjan.dinant@hag.unimaas.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised single blind parallel group controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Blood test ordering for unexplained complaints in general practice
Study acronym	VAMPIRE
Study objectives	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(s)	Ethics approval received from the Medical Ethics Committees of: 1. The Academic Medical Center-University of Amsterdam 2. The University Hospital Maastricht
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	5000
Key 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
Key exclusion criteria	The GP is worried that the patient has got serious pathology that makes watchful waiting unacceptable.
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2004

Locations

Countries of recruitment

Netherlands

Study participating centre

Maastricht University

Maastricht
6200 MD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009		Yes	No
Protocol article	protocol	22/03/2006		Yes	No