|
ISRCTN
|
ISRCTN35701810
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Secondary prevention after first stroke
|
|
Scientific title
|
Cluster randomised trial in a Primary Care database: utilising electronic patient records for intervention research into secondary prevention after first stroke
|
|
Acronym
|
N/A
|
|
Serial number at source
|
086921
|
|
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.
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Stroke
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
No eligible patients will be excluded from the analysis, to avoid bias.
|
|
Anticipated start date
|
01/04/2010
|
|
Anticipated end date
|
31/10/2011
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
50 GP practices per group (100 practices in total)
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Difference in mean systolic blood pressure (BP) between intervention and control groups at 12 months adjusted for pre-intervention mean systolic BP
|
|
Secondary outcome measure(s)
|
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
|
|
Sources of funding
|
The Wellcome Trust (UK) (grant ref: 086921)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Martin
Gulliford
|
|
Address
|
Division of Primary Care and Public Health
King's College London
6th Floor Capital House
42 Weston Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 3QD
|
|
Country
|
United Kingdom
|
|
Email
|
martin.gulliford@kcl.ac.uk
|
|
Sponsor
|
The Wellcome Trust (UK)
|
|
Address
|
Gibbs Building
215 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2BE
|
|
Country
|
United Kingdom
|
|
Email
|
contact@wellcome.ac.uk
|
|
Sponsor website:
|
http://www.wellcome.ac.uk/
|
|
Date applied
|
16/03/2010
|
|
Last edited
|
17/03/2010
|
|
Date ISRCTN assigned
|
17/03/2010
|
