VAgue Medical Problems In REsearch (VAMPIRE): Blood test ordering for unexplained complaints in general practice.
| ISRCTN | ISRCTN55755886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55755886 |
| Secondary identifying numbers | NTR398 |
- 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
Scientific
Maastricht University
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3882396 |
|---|---|
| geertjan.dinant@hag.unimaas.nl |
Study information
| Study design | Multicentre randomised single blind parallel group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| 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 | 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 study start date | 01/01/2002 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
6200 MD
Netherlands
Sponsor information
Care and Public Health Research Institute (CAPHRI) (Netherlands)
Research organisation
Research organisation
University Maastricht
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3882446 |
|---|---|
| e.habets@caphri.unimaas.nl | |
| Website | http://www.caphri.nl/ |
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Research organisation
Central Sickfund (CZ) health care insurance (Netherlands)
No information available
The Netherlands Organization for Scientific Research (NWO) (Netherlands)
No information available
Dutch Health Care Insurance Board (CVZ, independent government organisation) (Netherlands)
No information available
Stichting 'De drie Lichten' (Netherlands)
No information available
Dutch Heart Foundation (Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Heart Foundation
- Location
- Netherlands
Stichting Volksgezondheid en Roken (STIVORO) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/03/2006 | Yes | No | |
| Results article | results | 01/03/2009 | Yes | No |
