SAFER

The SAFER Trial –
Screening for Atrial Fibrillation with ECG to Reduce stroke

SAFER is a project for patients aged 70 and over.

Why are we doing this trial?
Atrial fibrillation (AF) is a heart condition that causes an irregular heartbeat. It affects over 1 in 10 people over the age of 70 but does not necessarily cause symptoms.
Having atrial fibrillation increases the risk of having a stroke 5-fold, but treatment with medication can significantly lower this risk as well as lowering your risk of having a heart attack.
We want to find out whether screening people aged 70 and over for atrial fibrillation and treating them with medication:
1. is possible/achievable in GP practices (no GP practice visit needed);
2. prevents the number of strokes we think it will;
3. is good value for money for the NHS.
The results will help the NHS decide whether to start a national screening programme for atrial fibrillation to reduce the number of strokes.

You do not need to have a computer, a mobile phone or access to the internet to take part.
You do not need to travel anywhere: all trial activities are done by post / phone.

I have a heart condition. Can I take part? Yes you can still take part.

You can also take part:

• If you have atrial fibrillation and are not taking anticoagulation medication like apixaban, warfarin, rivaroxaban or edoxaban. These medicines are sometimes called “blood thinners”.
•  If you have a pacemaker
• If you are taking antiplatelet medication like aspirin, clopidogrel or
  ticagrelor

Do I have to take part?
No. You do not have to take part. If you decide not to take part, or change your mind at any stage, your care at your GP practice will not be affected.

What will I have to do?

We will ask you to confirm your consent to take part.

We are asking you to give permission for specific information from your medical records to be shared with the research team at various points over the next few years. This information will be collected from your GP practice records and from other health-related records. The kind of information we will collect will include the medications you take, your use of health care services and stroke and cardiovascular disease related factors (for example weight, age, blood pressure, other medical conditions, and how well your kidneys and liver work). You will not need to do anything to provide this information. We will collect this information from everyone who consents to be part of the trial, whether they are screened for atrial fibrillation or not. Collecting this information will help us to understand whether screening for atrial fibrillation makes a difference, by comparing information about people who do and do not undergo this screening. We do not routinely acknowledge receipt of consent forms, and not everyone will be invited to take part in the trial activities listed below. Therefore after returning your completed consent form you may not hear from us again. However you are still part of the trial and making a valuable contribution to helping us answer the research question.

What else might I be invited to do?
Possibly take part in screening for atrial fibrillation
You may be invited to be screened for atrial fibrillation. You would be sent the ECG recording device and instructions to your home address. There would be no need to attend an appointment at your GP practice or for anyone to visit you at home. Screening involves simply holding a small, safe, non-invasive recording device in your hands for 30 seconds at a time over a period of 3 weeks.

We will send you more information about what is involved and the potential benefits and harms of screening at the time, if you are invited. You are under no obligation to take part.
Not all participants that are taking part in the trial will be offered atrial fibrillation screening. Whether you are is determined by chance, so it may be that you are
not invited to take part in screening.

Possibly complete questionnaires
On up to 3 separate occasions we may send you a questionnaire to complete and return in a Freepost envelope (or complete online). You are under no obligation to complete these questionnaires.
Possibly be invited to take part in other studies Some people may be invited to take part in optional interviews and/or other studies related to atrial fibrillation and / or screening. If this is the case, you will be given further information about what these would involve. You will be free to decide at that point whether or not you want to do them.
Not everyone will be invited to do these things. If you return your consent form and do not hear from us again, do not be concerned. You are still part of the trial.

Are there any benefits of taking part?
There may not be any direct benefit to you of taking part. However, you may find it rewarding to know that you are contributing to research that aims to prevent stroke and heart attacks in the future.

Are there any risks involved in taking part?
Identifiable medical data from your practice will be shared with the research team. All our data collection, storage and handling processes will comply with the relevant security policies and regulations. Every effort will be made to ensure the security and confidentiality of your data. Your usual medical care will not be affected by your participation in the trial.

What if I change my mind about giving access to my medical and health-related records?
If you change your mind about taking part you can withdraw your consent at any time. If this is the case, please telephone us or email us using the contact details in part 4 of this information sheet. Any of your information that has been collected up to that point will be kept and used for the purposes described in this information sheet. We will not collect any further health related information about you. Your medical care at your GP practice will not be affected.