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 |
| Secondary identifying numbers | NTR51 |
- 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
Scientific
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 388 2396 |
|---|---|
| geertjan.dinant@hag.unimaas.nl |
Study information
| Study design | Randomised active-controlled factorial trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/11/2005 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
6200 MD
Netherlands
Sponsor information
University Maastricht (Netherlands)
University/education
University/education
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Website | http://www.unimaas.nl/default.asp?taal=en |
|---|---|
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (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 | 29/03/2007 | Yes | No | |
| Results article | results | 05/05/2009 | Yes | No | |
| Results article | results | 01/03/2013 | Yes | No |
