Condition category
Mental and Behavioural Disorders
Date applied
22/11/2005
Date assigned
22/11/2005
Last edited
18/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.caphri.nl/

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)

Dutch Heart Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes