To determine the effect of point of care (PoC) C-reactive protein (CRP) testing and delayed prescribing on antibiotic prescribing for acute lower respiratory tract infections (LRTI) and acute rhinosinusitis in general practice.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prescribing rates at index consultation (day 0), defined as immediate, delayed
or no antibiotics
Secondary outcome
- Total antibiotic exposure over a period of 28 days, defined as the number of
patients receiving immediate antibiotics or filling a delayed prescription for
antibiotics within 28 days of index consultation (day 0)
- Clinical recovery
- Patient satisfaction and enablement
- Reconsultation within 28 days
- Evaluation of GPs' estimation of CRP value based on usual diagnostic work-up
(medical history and physical examination) compared to actual CRP test result.
- CRP value on day 0 and day 7 in relation to perceived degree of illness (VAS,
Visual Analogue Scale).
Background summary
About 85-90% of all antimicrobials are prescribed in primary care and up to 80%
of these are for respiratory tract indications. Most of these antibiotic
prescriptions are of questionable value. This unnecessary prescribing leads to
antimicrobial resistance, described as one of the most serious public health
issues of our time.
The usual diagnostic work-up (history and physical examination) by general
practitioners (GPs) is not accurate to diagnose or rule out pneumonia in
patients with acute cough. In a previous study we found that a C-reactive
protein (CRP) test result of less than 20 reduced the absolute risk of a
pneumonia to less than 2%. Since the test results are available in four minutes
(using a finger prick blood sample), a low CRP test result at hand is useful in
reassuring both the doctor and the patient that prescribing antibiotics are not
indicated in most cases.
In recent years the additional value op CRP for LRTI and rhinosinusitis has
been widely proven, but GPs in the Netherlands are still relatively unfamiliar
with point of care (PoC) CRP testing. We are currently investigating the effect
of PoC CRP testing, with or without communication skills training for GPs, on
antibiotic prescribing rates for LRTI. The results will be available at the end
of 2007. Delayed prescribing of antibiotics is another method that has proven
to decrease prescribing rates for RTI in recent years. In this fashion the GP
hands out the prescription, but the patient will only collect the antibiotic if
symptoms do not resolve within a certain time.
These two promising strategies in combating unnecessary prescribing for
self-limiting respiratory tract infections have not been combined in a trial
so far. Moreover, since GPs may need assistance in building confidence,
specific guidance on interpretation of the CRP test results and management may
be helpful in (further) reducing unwarranted antibiotic prescriptions.
Study objective
To determine the effect of point of care (PoC) C-reactive protein (CRP) testing
and delayed prescribing on antibiotic prescribing for acute lower respiratory
tract infections (LRTI) and acute rhinosinusitis in general practice.
Study design
Randomised controlled trial in general practice
Intervention
PoC CRP assisted antibiotic prescribing including delayed prescribing compared
to usual care
Study burden and risks
The subjects will not have any direct advantages, or disadvantages, by
participating in the project. The management (including decisions about
additional investigations and treatment) will be at the discretion of the GP.
Patients will undergo two finger pricks (at day 0 and day 7 of the study). This
procedure is comparable to the daily pricks in diabetic patients or the finger
prick used to measure hemoglobin.
There are no recognized risks associated with the CRP test. No adverse events
were recorded in a previous trial of our group of 431 patients, in which CRP
PoC was performed at index consultation. Complications, side effects and
adverse events therefore are highly unlikely. The same holds for the strategy
of delayed antibiotic prescribing. The GP remains fully responsible for
management and may change management at any time.
P.O. Box 83
FI-02101 Espoo
Finland
P.O. Box 83
FI-02101 Espoo
Finland
Listed location countries
Age
Inclusion criteria
LRTI:
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
Rhinosinusitis:
First consultation of current episode of rhinosinusitis (duration <4 weeks)
At time of consultation both of the following signs / symptoms:
1. purulent nasal discharge by self-report or by physical examination
2. unilateral or bilateral frontal or maxillary pain
Exclusion criteria
Patients who require immediate admission to hospital
Patients who have no understanding of written and/or Dutch language
Patients who previously participated in the study
Patients who currently use antibiotic or have taken an antibiotic in the past 2 weeks
Patients who have been hospitalized in the past 2 weeks
Severely immuno-compromised patients
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19561.060.07 |