Condition category
Circulatory System
Date applied
16/03/2010
Date assigned
17/03/2010
Last edited
09/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.wellcome.ac.uk/

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

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23034059
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24903985

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes