Improving Management of Patients with Acute Cough by C-reactive protein point of care testing and Communication Training

ISRCTN	ISRCTN85154857
DOI	https://doi.org/10.1186/ISRCTN85154857
Protocol serial number	NTR51
Sponsor	University Maastricht (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Submission date: 04/08/2005
Registration date: 04/08/2005
Last edited: 30/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

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

P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 388 2396
Email	geertjan.dinant@hag.unimaas.nl

Study information

Primary study design	Interventional
Study design	Randomised active-controlled factorial trial
Secondary study design	Randomised controlled trial
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
Study acronym	IMPAC3T
Study objectives	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(s)	Received from the local ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Change (decrease) in antibiotic prescription 2. Clinical recovery and return to normal work and activities
Key secondary outcome measure(s)	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
Completion date	01/08/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key 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
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	01/08/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

P.O. Box 616

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	05/05/2009		Yes	No
Results article	results	01/03/2013		Yes	No
Protocol article	protocol	29/03/2007		Yes	No