Condition category
Respiratory
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
30/05/2013
Prospective/Retrospective
Prospectively 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

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

http://www.unimaas.nl/default.asp?taal=en

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes