Contact information
Type
Scientific
Primary contact
Prof Martin Gulliford
ORCID ID
Contact details
Division of Primary Care and Public Health
King's College London
6th Floor Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
martin.gulliford@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
086921
Study information
Scientific title
Cluster randomised trial in a Primary Care database: utilising electronic patient records for intervention research into secondary prevention after first stroke
Acronym
Study hypothesis
We aim to provide proof of concept of the feasibility and utility of implementing cluster randomised trials utilising electronic patient records in a large national primary care database.
Ethics approval
London - Surrey Borders Research Ethics Committee approved on the 13th January 2010 (ref: 10/H0806/1)
Study design
Interventional multicentre clustered randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke
Intervention
A series of electronic prompts will be activated at each consultation by patients with previous stroke, to promote adherence with evidence-based recommendations for secondary prevention of stroke and vascular disease following the National Guidelines (Intercollegiate Stroke Working Party [ICSWP], 2008). The prompts encourage primary care professional adherence with recommended processes of care. 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 will be at the discretion of the GP. The GP will also be able to terminate display of the prompt at any time. Control practices will continue with usual care. The intervention will be implemented for 12 months at each practice.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Difference in mean systolic blood pressure (BP) between intervention and control groups at 12 months adjusted for pre-intervention mean systolic BP
Secondary outcome measures
Measured at 12 months follow-up:
1. Mean diastolic blood pressure
2. Mean cholesterol concentration
3. Proportion of patients whose eligibility for anticoagulants/antiplatelet drugs is defined
4. Proportion of eligible patients that receive anticoagulant/antiplatelet drugs
5. Prescription adherence with prescribed medicines
6. Occurrence and hospitalisation with vascular events including transient ischaemic attack (TIA)/stroke, myocardial infarction, new-onset angina and mortality
Overall trial start date
01/04/2010
Overall trial end date
31/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All stroke patients (no age limit, either sex)
2. Registered at the practice for at least three years at the trial start date
3. First diagnosis of stroke recorded in the 24 month period before the trial start date
4. Medical code for stroke is entered during the consultation
5. Patient's electronic medical record includes previous stroke medical codes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 GP practices per group (100 practices in total)
Participant exclusion criteria
No eligible patients will be excluded from the analysis, to avoid bias.
Recruitment start date
01/04/2010
Recruitment end date
31/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Primary Care and Public Health
London
SE1 3QD
United Kingdom
Sponsor information
Organisation
The Wellcome Trust (UK)
Sponsor details
Gibbs Building
215 Euston Road
London
NW1 2BE
United Kingdom
contact@wellcome.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 086921)
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
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23034059
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24903985
Publication citations
-
Protocol
Dregan A, van Staa T, McDermott L, McCann G, Ashworth M, Charlton J, Wolfe C, Rudd A, Yardley L, Gulliford M, , Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study): study protocol for a randomized controlled trial., Trials, 2012, 13, 181, doi: 10.1186/1745-6215-13-181.
-
Results
Dregan A, van Staa TP, McDermott L, McCann G, Ashworth M, Charlton J, Wolfe CD, Rudd A, Yardley L, Gulliford MC, Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records., Stroke, 2014, 45, 7, 2066-2071, doi: 10.1161/STROKEAHA.114.005713.