Genomics to combat Resistance against Antibiotics for Community acquired lower respiratory tract infection (LRTI) in Europe: INternet Training for Reducing antibiOtic use trial

ISRCTN ISRCTN99871214
DOI https://doi.org/10.1186/ISRCTN99871214
Secondary identifying numbers 8156
Submission date
07/07/2010
Registration date
07/07/2010
Last edited
15/04/2020
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

Study website

Contact information

Dr Gillian O'Reilly
Scientific

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

gor@soton.ac.uk

Study information

Study designMulticentre randomised interventional process of care trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleGenomics to combat Resistance against Antibiotics for Community acquired lower respiratory tract infection (LRTI) in Europe: INternet Training for Reducing antibiOtic use - a multicentre randomised interventional process of care trial
Study acronymGRACE INTRO
Study objectivesThis 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 cost-effectiveness. Up to 5400 patients will take part in this study throughout Europe.
Ethics approval(s)Southampton and South West Hampshire Research Ethics Committee A, 13/05/2010, ref: 10/H0502/29
Health condition(s) or problem(s) studiedTopic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
InterventionGP practices will be randomised into 4 intervention 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 C-reactive protein (CRP) test
4. INTRO Programme and additional CRP test

Antibiotic prescribing for LRTI will be audited for the practices pre- and post-intervention over one winter season.

Study entry: registration only
Intervention typeOther
Primary outcome measureAntibiotic prescribing, measured at baseline and after intervention
Secondary outcome measures1. Patient complications after the interventions by measuring significant deterioration of illness
2. Cost effectiveness of the interventions by measuring resource use
3. Issues behind the successes, difficulties and limitations of implementing behaviour change using GP focus groups
4. Patient perceptions of the process using patient interviews
Overall study start date01/10/2010
Completion date01/05/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participantsPlanned sample size: 19600; UK sample size: 4900
Key inclusion criteria1. Aged 18 years and over, either sex
2. An illness where a acute cough or worsened cough is the main or dominant symptom, or a clinial presentation suggesting LTRI, greater than or equal to 28 days duration
3. First consultation for this illness episode
4. Seen within normal consulting hours
5. First time in this study
6. Ability to fill out study materials
7. Written consent to participate
8. Immunocompetent
Key exclusion criteriaPatients who are unable to properly consent or fill out the diary (dementia, psychosis, severe depression)
Date of first enrolment01/10/2010
Date of final enrolment01/05/2011

Locations

Countries of recruitment

  • Belgium
  • England
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study participating centre

Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

Funders

Funder type

Government

European Commission (Belgium) - The Sixth Framework Programme (FP6) (ref: LSHM-CT-2005-518226)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/10/2013 Yes No
Results article results 01/03/2019 15/04/2020 Yes No

Editorial Notes

15/04/2020: Publication reference added.

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