Condition category
Respiratory
Date applied
07/07/2010
Date assigned
07/07/2010
Last edited
14/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.grace-lrti.org/portal/en-GB

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 measures

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

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

http://www.soton.ac.uk/

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23915885

Publication citations

  1. 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.

Additional files

Editorial Notes