Secondary prevention after first stroke

ISRCTN	ISRCTN35701810
DOI	https://doi.org/10.1186/ISRCTN35701810
Protocol serial number	086921
Sponsor	The Wellcome Trust (UK)
Funder	The Wellcome Trust (UK) (grant ref: 086921)

Submission date: 16/03/2010
Registration date: 17/03/2010
Last edited: 09/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Martin Gulliford
Scientific

Division of Primary Care and Public Health
King's College London
6th Floor Capital House
42 Weston Street
London
SE1 3QD
United Kingdom

Email	martin.gulliford@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional multicentre clustered randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Cluster randomised trial in a Primary Care database: utilising electronic patient records for intervention research into secondary prevention after first stroke
Study objectives	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(s)	London - Surrey Borders Research Ethics Committee approved on the 13th January 2010 (ref: 10/H0806/1)
Health condition(s) or problem(s) studied	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
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
Key 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
Completion date	31/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key 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
Key exclusion criteria	No eligible patients will be excluded from the analysis, to avoid bias.
Date of first enrolment	01/04/2010
Date of final enrolment	31/10/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Division of Primary Care and Public Health

London
SE1 3QD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014		Yes	No
Protocol article	protocol	03/10/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes