Contact information
Type
Scientific
Primary contact
Prof G J Dinant
ORCID ID
Contact details
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2396
geertjan.dinant@hag.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR51
Study information
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
Acronym
IMPAC3T
Study hypothesis
1. 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?
2. To what extent are these reductions cost-effective?
Ethics approval
Received from the local ethics committee
Study design
Randomised active-controlled factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute cough, respiratory tract infection
Intervention
Randomisation at the level of practice. Factorial randomisation into four groups:
1. Access to and training in Point of Care (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 Simulated Patient in Clinical Encounter (SPICE) method.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Change (decrease) in antibiotic prescription
2. Clinical recovery and return to normal work and activities
Secondary outcome measures
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
Overall trial start date
01/11/2005
Overall trial end date
01/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. First consultation of current episode of acute cough (duration less than four weeks)
2. Regarded by the General Practitioner (GP) to be caused by an acute lower respiratory tract infection
3. At least one out of following four:
3.1. Shortness of breath
3.2. Wheezing
3.3. Chest pain
3.4. Auscultation abnormalities
4. At least one of the following five:
4.1. Fever
4.2. Perspiring
4.3. Headache
4.4. Myalgia
4.5. Feeling generally unwell
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Patients who require immediate admission to hospital
2. Patients who have no understanding of written and/or spoken Dutch language
3. Patients who previously participated in the study
4. Patients who currently use antibiotic or have taken an antibiotic in the past two weeks
5. Patients who have been hospitalised in the past six weeks
Recruitment start date
01/11/2005
Recruitment end date
01/08/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 616
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
University Maastricht (Netherlands)
Sponsor details
P.O. Box 616
Maastricht
6200 MD
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (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. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17394651
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19416992
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23508603
Publication citations
-
Results
Cals JW, Butler CC, Hopstaken RM, Hood K, Dinant GJ, Effect of point of care testing for C reactive protein and training in communication skills on antibiotic use in lower respiratory tract infections: cluster randomised trial., BMJ, 2009, 338, b1374.
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Results
Cals JW, de Bock L, Beckers PJ, Francis NA, Hopstaken RM, Hood K, de Bont EG, Butler CC, Dinant GJ, Enhanced communication skills and C-reactive protein point-of-care testing for respiratory tract infection: 3.5-year follow-up of a cluster randomized trial., Ann Fam Med, 11, 2, 157-164, doi: 10.1370/afm.1477.
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Cals JW, Hopstaken RM, Butler CC, Hood K, Severens JL, Dinant GJ, Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial., BMC Fam Pract, 2007, 8, 15, doi: 10.1186/1471-2296-8-15.