|- candidate number||0|
|- NTR Number||NTR51|
|- Date ISRCTN created||5-aug-2005|
|- date ISRCTN requested||28-jul-2005|
|- Date Registered NTR||12-mei-2005|
|- Secondary IDs||N/A |
|- Public Title||Improving Management of Patients with Acute Cough by CRP point of care testing and Communication Training.|
|- Scientific Title||Point of care C-reactive protein test and enhanced communication skills for managing acute cough due to lower respiratory tract infection in general practice; cost-effectiveness and effect on diagnostic testing, antibiotic prescribing and recovery: a randomised controlled trial.|
|- hypothesis||To what extent will the introduction of the C-Reactive Protein (CRP) point of care test and enhanced communication skills for managing lower respiratory tract infection (LRTI) in general practice, either separately or combined, lead to
1. an enhancement of patient recovery, |
2. a reduction in other diagnostic testing
3. and a reduction in antibiotic prescribing?
4. To what extent are these reductions cost-effective?
|- Healt Condition(s) or Problem(s) studied||Acute cough, Lower respiratory tract infection|
|- Inclusion criteria||First consultation of current episode of acute cough (duration <4 weeks).
Regarded by the GP to be caused by an acute lower respiratory tract infection
- At least one out of following 4: Shortness of breath / wheezing / chest pain / auscultation abnormalities
- At least one of the following 5:
Fever / perspiring / headache / myalgia / feeling generally unwell.|
|- Exclusion criteria||1. Patients who require immediate admission to hospital;
2.Patients who have no understanding of written and/or Dutch language;
3. Patients who previously participated in the study;
4. Patients who currently use antibiotic or have taken an antibiotic in the past 2 weeks;
5. Patients who have been hospitalized in the past 6 weeks.|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-nov-2005|
|- planned closingdate||1-aug-2008|
|- Target number of participants||400|
|- Interventions||Randomisation at the level of practice. Factorial randomisation into four groups:
1. Access to and training in PoC CRP plus communication training. |
2. Access to and training in PoC CRP alone.
3. Communication training alone.
4. Usual care.
Point of Care CRP: Access to and training in use of automatic CRP test device.
Sample is one drop of whole blood from a finger prick.
Communication training: Shared decision making using SPICE method (Simulated Patient in Clinical Encounter).
|- Primary outcome||1. Change (decrease) in antibiotic prescription; |
2. Clinical recovery and return to normal work and activities.
|- Secondary outcome||1. Cost-effectiveness of PoC CRP and communication training;|
2. Use of medical services, including re-consultation;
3. Change (decrease) in diagnostic testing other than PoC CRP.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Jochen Cals|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. G.J. Dinant|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Male and Female > 18 years old.|
To what extent will the introduction of the C-Reactive Protein (CRP) point of care test and enhanced communication skills for managing lower respiratory tract infection (LRTI) in general practice, either separately or combined, lead to an enhancement of patient recovery, a reduction in other diagnostic testing, use of other medical services and a reduction in antibiotic prescribing? To what extent are these reductions cost-effective?
Study design: factorial design with randomisation on practice level. Control group follows pathways of usual care.
|- Main changes (audit trail)|
|- RECORD||20-jul-2005 - 7-dec-2006|