Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gillian O'Reilly
ORCID ID
Contact details
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
gor@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8156
Study information
Scientific title
Genomics 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
Acronym
GRACE INTRO
Study hypothesis
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 cost-effectiveness. Up to 5400 patients will take part in this study throughout Europe.
Ethics approval
Southampton and South West Hampshire Research Ethics Committee A, 13/05/2010, ref: 10/H0502/29
Study design
Multicentre randomised interventional process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention
GP 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Antibiotic prescribing, measured at baseline and after intervention
Secondary outcome measures
1. 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 trial start date
01/10/2010
Overall trial end date
01/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 19600; UK sample size: 4900
Participant exclusion criteria
Patients who are unable to properly consent or fill out the diary (dementia, psychosis, severe depression)
Recruitment start date
01/10/2010
Recruitment end date
01/05/2011
Locations
Countries of recruitment
Belgium, Netherlands, Poland, Spain, United Kingdom
Trial participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Clinical Neurosciences Division
Memory Assessment and Research Centre
Moorgreen Hospital
Botley Road
Southampton
SO30 3JB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
European Commission (Belgium) - The Sixth Framework Programme (FP6) (ref: LSHM-CT-2005-518226)
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23915885
Publication citations
-
Results
Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L, , Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial., Lancet, 2013, 382, 9899, 1175-1182, doi: 10.1016/S0140-6736(13)60994-0.