GRACE (Genomics to combat Resistance against Antibiotics for Community acquired LRTI in Europe) INTRO (INternet TRaining for antibiOtic use) Trial

This study is part of a programme of research into cough due to chest and other
infections across 15 European countries, called GRACE. This part of the GRACE
study will be carried out in 6 European countries and aims to improve
antibiotic prescribing for acute cough in primary care.

Acute cough /lower respiratory tract infection (LRTI) is one of the commonest
reasons why people seek health care and take antibiotics. The implications for
use of precious health care resources and antibiotic resistance are
considerable. There is a wide variation in antibiotic prescription in Europe,
and based on what is known about how comparable patients are investigated and
treated in different European countries, there is a need to identify
educational programmes directed at clinicians and patients to determine whether
they improve the management of acute cough.

This study will compare antibiotic prescribing levels for practices trained via
the GRACE INTRO programme (a self directed web based learning package combined
with patient booklets), with those not trained, and in addition will determine
whether the use of CRP tests (a test that can be performed in the surgery to
help GPs decide who to give antibiotics to) are useful in targeting
prescriptions to the correct patients. The aim is to see whether GP antibiotic
prescribing behavior can be improved so that only those patients with chest
infections that will really benefit from
antibiotics are prescribed them. We will assess antibiotic use, complications
and costeffectiveness.

Up to 16.800 (maximum) patients will take part in this study throughout Europe.

GP practices will be randomised into 4 groups
1. routine care
2. routine care plus GP training into optimal antibiotic use and Patient
education with booklet (INTRO Programme)
3. routine care and additional training about the use of CRP tests
4. INTRO Programme and training about the use of CRP tests

Practices will be invited to participate in the study across 8 European networks

Baseline Data Collection:
Prior to the intervention practices will provide an audit of antibiotic use for
a minimum of 30 consecutive patients with
Lower Respiratory Tract Infection (LRTI) presenting to participating
clinicians, using a very brief case report form. Prior
to their participation in the research each patient will be informed about the
research and consented. A minimum of 5 consecutive patients who have other RTIs
will also be assessed to document whether relabeling LRTI could account for
reduced antibiotic prescribing.

For the intervention, practices will be randomised into four groups and trained
according to their randomisation group.

Post Intervention Data collection:
Practices will provide an audit for a minimum of 30 consecutive patients with
LRTI presenting to participating clinicians using a case report form which will
document use of antibiotics, of delayed prescription, of near patient tests
(and why used), and the use of a booklet. Prior to their participation in the
research each patient will be informed about the research and consented. All
patients will be asked to complete a diary recording symptom duration and
severity. A minimum of 5 consecutive patients who have other RTIs will also be
assessed to document whether relabeling LRTI could account for reduced
antibiotic prescribing.

Note Review:
One month after data collection we will also ask participating practices to
allow local research staff to perform a note review of the patients to monitor
complications, antibiotic use and hospital admission data.

Focus Groups:
After the intervention, patient and GP focus groups (and/or individual
interviews) will be convened with a selection of
participating doctors to explore issues behind the successes, difficulties and
limitations of implementing behavior
change in practices using the GRACE INTRO Programme with or without CRP tests.

GP practices will be randomised into 4 groups
1. routine care
2. routine care plus GP training into optimal antibiotic use and Patient
education with booklet (INTRO Programme)
3. routine care and additional training about the use of CRP tests
4. INTRO Programme and training about the use of CRP tests

Patients with LRTI will not suffer any greater risk than if they were managed
in routine care.