Condition category
Circulatory System
Date applied
21/02/2013
Date assigned
25/02/2013
Last edited
14/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Atrial fibrillation is a heart condition that causes an irregular and often abnormally fast heart rate. Patients with atrial fibrillation (AF) can be 5 times more likely to suffer a stroke. Oral anticoagulants (blood thinning agents) reduce this risk by up to 70 percent. Despite this benefit to the patients, anticoagulants remain under-prescribed in UK primary care. Recent estimates place prescribing at 53 percent of those potentially eligible, whilst over 30 percent of patients remain both without a prescription, and without a recorded reason. We aim to see whether an automated software system, operating within general practices' electronic medical records, will improve management of atrial fibrillation by identifying patients eligible for anticoagulation and increasing prescriptions.

Who can participate?
The study aims to recruit 46 general practices operating the EMIS-Web clinical system, which will be included in the main phase of the trial. Before this, we will carry out a pilot study including 3 practices. Within the study, we will interview 30 patients in the participating practices and 10 general practitioners.

What does the study involve?
We will randomly allocate practices to use an electronic software tool or to continue with usual care. The tool will a) produce (and continually refresh) a list of patients with atrial fibrillation eligible for therapy - practices will invite these patients to discuss treatment at the start of the trial; b) generate electronic on-screen reminders in the medical records of those eligible, appearing throughout the trial. We will run the tool for 6 months, in 23 of the practices. The other 23 practices will manage their atrial fibrillation register as usual. We will find out how many eligible patients with atrial fibrillation have been prescribed anticoagulation therapy after six months. We will also look at incidence of stroke, transient ischaemic attack, other major thromboembolism, major haemorrhage (bleed) and reports of inappropriate anticoagulant prescribing. We will also look at patient and practitioner views of the intervention; its impact on care and the general practice - notably its time implications.

What are the possible benefits and risks of participating?
Participating practices will, if allocated to the treatment arm, have use of a software tool designed to assist them in improving care in an important clinical area. If the intervention is found to be effective and safe, control practices will also be offered the opportunity to use it after the trial. Depending on the results of the trial, the intervention could be made available to all UK primary care centres.
We foresee two main potential risks for practices; harm from the electronic reminder system to the consultation process, such as negative impacts on the length and flow of consultations and reducing patient choice. Secondly, there is a risk of prescribing anticoagulants in patients who are unsuitable for anticoagulation, despite being apparently eligible. We will monitor these carefully during the trial.

Where is the study run from?
The Department of Primary Health Care Sciences at the University of Oxford with local support from the Universities of Birmingham and Nottingham

When is the study starting and how long is it expected to run for?
We propose to begin the 3 month pilot study on 1st April 2013, recruiting practices in the month before to this. We shall recruit practices for the main-phase from March to May 2013, aiming to begin the 6 month intervention period on 1st July 2013. The trial is expected to end by 30th June 2014.

Who is funding the study?
NIHR School for Primary Care research

Who is the main contact?
Dr. Andrew R H Dalton
andrew.dalton@phc.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Dalton

ORCID ID

Contact details

Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
-
andrew.dalton@phc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13972

Study information

Scientific title

Automated Risk Assessment for Stroke in Atrial Fibrillation: A cluster randomised controlled trial of an electronic reminder intervention to promote anticoagulation and reduce stroke risk (AURAS-AF)

Acronym

AURAS-AF

Study hypothesis

We hypothesise that an automated software system, operating within electronic medical records in primary care, that identifies patients with atrial fibrillation who are eligible for oral anticoagulant therapy, will increase the uptake of therapy.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13972

Ethics approval

NRES Committee South Central - Berkshire, 11/02/2013, ref: 13/SC/0026

Study design

Cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised 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

Intervention will have a piece of software activated in their primary carer databases. The software will generate a list of all patients registered in the practice diagnosed with atrial fibrillation, who are deemed eligible for anticoagulation (based on criteria in NICE TA249) but not currently prescribed it. Practices will invite these patients (excluding those clearly unsuitable) for a consultation to discuss anticoagulation. They will include an information sheet about anticoagulation, provided by the study team, in the invite. Practices will send reminders to non-attenders one month into the study.
The tool will also produce pop-up reminders whenever patients’ (on the list above) medical records are opened. These remind the member of the practice team to discuss anticoagulation. The reminders will appear throughout the trial until they are resolved. Pop-ups must be addressed in order to continue using the medical record, with one of 5 options taken.

Control practices will manage patients on their atrial fibrillation register in the normal manner, in line with the quality and outcomes framework and clinical guidelines.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proportion of patients with diagnosed AF and eligible for anticoagulation under recent guidelines (NICE TA249) who are prescribed this therapy six months after the start of the intervention

Secondary outcome measures

Main phase
1. Proportion of patients with CHADS2 score ≥2 who are prescribed anticoagulants
2. Record of inappropriate care or prescribing decisions related to anticoagulation in patients with AF
3. Incidence of stroke, transient ischaemic attack (TIA), other major thromboembolism or major haemorrhage during the trial
4. Outcomes of the discussion of/ decisions about the prescription of anticoagulants - including number of patients eligible /invited for a discussion about anticoagulation /reasons for not inviting patients /number attending discussion /outcomes of discussion / reasons for not to using OAC

Pilot study:
1. Limitations to usability and appropriateness of intervention and trial material [to improve the intervention, not directly answer objectives
2. Ease of adoption of electronic system by primary care team

Process evaluation:
1. Responses to screen reminders
2. Patient views on opportunistic (using the electronic reminders) and systematic (from the invitation of the eligible list) approaches to anticoagulant prescribing, and views on the appropriateness and usefulness of electronic reminders
3. Practitioner views on the use of electronic reminders and audit lists of eligible patients to promote anticoagulant prescribing, and of their impact on the consultation process

Overall trial start date

01/04/2013

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Practices using clinical software compatible with the intervention (i.e. the EMIS-Web system)
2. Within the study region, namely covering the South East of England, Central England and East Midland & South Yorkshire Primary Care Research Networks (PCRNs)
3. Within participant practices, outcome data will be recorded in patients with diagnosed atrial fibrillation, who justify anticoagulation according to the criteria in NICE guidance TA249

For the pilot study the above criteria (as well as the exclusion criteria below) apply, simply confined to the Thames Valley research partnership area.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

UK Sample Size: 49 general practices (46 in the main phase, with a further 3 pilot practices)

Participant exclusion criteria

The practice may not enter the study if ANY of the following apply:
1. Practices using other clinical software systems than EMIS-Web
2. Practices have recently (within the last 2 years) carried out a major audit of OAC prescribing in eligible patients, including the systematic invitation of patients, using bespoke software tool such as GRASP-AF
3. Practices previously involved in a trial concerning anticoagulation in AF.
4. For the main phase of the trial, practices participating in the pilot will be excluded

Recruitment start date

01/04/2013

Recruitment end date

31/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Department of Primary Health Care
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - School for Primary Care Research

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24220602

Publication citations

  1. Protocol

    Holt TA, Fitzmaurice DA, Marshall T, Fay M, Qureshi N, Dalton AR, Hobbs FD, Lasserson DS, Kearley K, Hislop J, Jin J, AUtomated Risk Assessment for Stroke in Atrial Fibrillation (AURAS-AF)--an automated software system to promote anticoagulation and reduce stroke risk: study protocol for a cluster randomised controlled trial., Trials, 2013, 14, 385, doi: 10.1186/1745-6215-14-385.

Additional files

Editorial Notes