Contact information
Type
Scientific
Primary contact
Prof Martin Gulliford
ORCID ID
Contact details
Division of Health and Social Care Research
Division of Primary Care and Public Health
King's College London
6th Floor Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
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martin.gulliford@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
086921; UKCRN ID: 7412
Study information
Scientific title
Cluster randomised trial in a Primary Care database: utilising electronic patient records for intervention research into reducing antibiotic prescribing in respiratory illness
Acronym
Study hypothesis
To test the effectiveness of an electronic record-based intervention at achieving a reduction in antibiotic prescribing at consultations for respiratory illness between the ages of ages 18 and 59 years in intervention practices as compared with controls.
Ethics approval
London - Surrey Borders Research Ethics Committee, 21/12/2009, ref: 09/H0806/81
Study design
Interventional multicentre cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Respiratory tract infection
Intervention
Electronic prompts have been developed based on recommended clinical practice guidelines to be activated during consultations for respiratory tract infection (RTI) in the selected age range. During consultations with patients presenting with symptoms of RTI, primary care professionals will see the prompts which remind them of recommended standards of care in RTI. The prompts will also provide them with supporting information and links to evidence that supports the recommendations. The decision on whether to follow the treatment suggestions included in the prompt, or whether to prescribe antibiotics, will be at the discretion of the GP. The GP will also be able to terminate display of the prompt at any time. As indicated above, the prompts will only be activated during consultations by patients aged 18 to 59 years. There will be no intervention at control practices. The intervention phase will continue for 12 months at each practice.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Proportion of RTI consultations with antibiotics prescribed over 12 months
Secondary outcome measures
Measured at 12 months follow-up:
1. Age- and sex-specific rates of RTI consultation
2. Age- and sex-specific proportion of RTI consultations with antibiotics prescribed
3. Occurrence of RTI complications
Overall trial start date
01/04/2010
Overall trial end date
31/10/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients aged 18 - 59 years, either sex
2. Registered at the practice for at least 3 years at the trial start date
3. First diagnosis of stroke recorded in the 24-month period before the trial start date
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 GP practices per group (100 practices in total)
Participant exclusion criteria
Younger than 18 years and over the age of 59 years
Recruitment start date
01/04/2010
Recruitment end date
31/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Health and Social Care Research
London
SE1 3QD
United Kingdom
Sponsor information
Organisation
The Wellcome Trust (UK)
Sponsor details
Gibbs Building
215 Euston Road
London
NW1 2BE
United Kingdom
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contact@wellcome.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
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
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21569237
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24919485
2014 process evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/25700144
Publication citations
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Protocol
Gulliford MC, van Staa T, McDermott L, Dregan A, McCann G, Ashworth M, Charlton J, Grieve AP, Little P, Moore MV, Yardley L, , Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study)., Trials, 2011, 12, 115, doi: 10.1186/1745-6215-12-115.
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Results
Gulliford MC, van Staa TP, McDermott L, McCann G, Charlton J, Dregan A, , Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)., Trials, 2014, 15, 220, doi: 10.1186/1745-6215-15-220.
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Results
McDermott L, Yardley L, Little P, van Staa T, Dregan A, McCann G, Ashworth M, Gulliford M; eCRT research team, Process evaluation of a point-of-care cluster randomised trial using a computer-delivered intervention to reduce antibiotic prescribing in primary care, BMC Health Serv Res, 2014, 14, 1, 594, doi: 10.1186/s12913-014-0594-1.