PRACTICE INFORMATION SHEET

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1 PRACTICE INFORMATION SHEET Study title A feasibility study for a cluster randomised trial of text messaging reminders for influenza vaccine in patients under 65 in clinical risk groups in English primary care Protocol version 2.3 date 01/07/2013 What is the purpose of the study? Influenza morbidity and mortality cause a substantial financial burden to the NHS and to the UK as a whole. Influenza vaccine is safe and effective but is required annually because the circulating strain of virus changes each year. In the UK in 2012, the Chief Medical Officer (CMO) recommended that at least 75% of elderly people (aged 65+) and 75% people under 65 with certain chronic conditions (e.g. chronic heart disease, diabetes, asthma, etc) should be vaccinated. While primary care practices are achieving these targets for elderly patients, those set for younger patients with chronic conditions are not being met, with a third of patients being missed in the 2011/12 flu season and with no substantial improvements in uptake in the past decade. Therefore strategies to increase flu vaccine uptake in these patients are required. Previous trials have shown that patient reminders can increase vaccine uptake and in particular, text messaging has shown to work in some populations in the United States as a cheap, simple and effective reminder. However, whether the same is true in UK general practice is unclear. The use of text messaging in the NHS for appointment reminders is also increasing as it is cheap, quick and effective. Text messaging is already used in roughly 30% of practices to remind patients about their flu vaccine but there has been no trial addressing its effectiveness. Therefore, we propose a trial of a text messaging flu vaccine reminder in patients aged under 65 who have a chronic condition. Why has our practice been chosen? Your practice has been chosen because it uses text messaging software to communicate with patients. We are recruiting 60 practices from across the UK to take part in this feasibility trial. Page 1 of 5

2 Does our practice have to take part? No. It is up to your practice to decide whether or not to take part. If your practice does take part, you will be asked to sign a consent form. Your practice is still free to withdraw at any time and without giving a reason. What will happen to our practice if we take part? The flowchart overleaf describes what will happen to your practice if you take part in the trial. If your practice agrees to take part in this trial, then it will be randomised to one of two groups: A. the text messaging intervention group. Practices in this group will receive additional resources, which will allow them to send a text messaging campaign to eligible patients, or B. the standard care group. Practices in this group will be asked to proceed with their seasonal flu campaigns as planned. We will randomise primary care practices to either standard care or a text messaging campaign to eligible patients. Vaccine uptake in the few months after will be ascertained in order to establish the effectiveness of the text message. We plan to randomise whole practices rather than individual patients. Therefore, participating would mean that your practice had a 50:50 chance of either being randomised to usual care or to text messaging. In this kind of study, there is no requirement to obtain informed consent from patients before sending out the text message. The text messaging software in your practice will be used for this study, so your time involvement with the trial would be minimal. If the text message works, it could result in increased uptake of flu vaccine in your practice. At the end of the flu season, we will use your anonymised computer records to establish which patients were sent a text message and which were vaccinated. Expenses and payments: If you are assigned to the intervention group, we will provide the additional sum of 200. Page 2 of 5

3 Practices invited to trial Practices consenting to take part in trial are randomised Group A: Text messaging intervention Group B: Standard care (i) (ii) identify patients who are at risk of flu according to the UK Chief Medical Officer* Send text message to patients at risk who are unvaccinated Seasonal flu campaign proceeds as planned Complete a short questionnaire about intervention delivery *Includes patients with chronic respiratory disease, chronic heart disease, chronic liver disease, chronic kidney disease, immunosuppression, chronic neurological disease. What does our practice have to do? Group A (allocated additional resources) would be asked to perform three short tasks: 1. Identify patients who are under 65 and who are in clinical risk groups as defined by the chief medical officer. Identifying and targeting these patients is a QOF requirement that your practice is likely to be already doing. If you require assistance with identifying this group of patients, then please initial the appropriate box in the attached consent form. Page 3 of 5

4 2. Of the patients identified in step 1, send a text message to patients who, on this date, have not already received their seasonal flu vaccine. We will tell you what this text message should say and you should not make any changes to this. 3. At the end of your seasonal flu campaign, a named contact at your practice would be asked to fill in an online or hard copy questionnaire about the trial. Group B will be asked to carry out their seasonal flu campaign as planned, whether it includes text messaging or not. For both groups A and B, the proportion of patients who had received the text message and their vaccine would be ascertained through your practice records, which we will access remotely with your permission. What is the intervention that is being tested? We are testing a text messaging intervention to increase flu vaccine uptake. This will use the software that you already use in practice. The message aims to encourage patients to get their vaccine. What are the other possible disadvantages and risks of taking part? Since your practice already uses text messaging to communicate with patients, the time commitment of your practice staff should be minimal. If the intervention works, you may find that there is increased demand for flu vaccine. One of the outcomes that we want to look at in our study is how easy your practice can send out a text message campaign to a group of patients. Part of this evaluation involves finding out when things go wrong and so we would like you to report this to us. What are the possible benefits of taking part? We cannot promise that the study will help you but the information we get might help improve flu vaccination uptake rates in your practice. This will contribute to your QOF points and will be at no expense to your practice. What happens when the research study stops? After the trial, your practice will receive a full report describing the results of the study. Page 4 of 5

5 What if there is a problem? Any complaint about the way you have been dealt with during the study will be addressed. If you have any complaints, please contact Emily Herrett ( or telephone ). Will my taking part in the study be kept confidential? Yes. All the information about your participation in this study will be kept confidential. Who is organising and funding the research? This study is sponsored by the London School of Hygiene and Tropical Medicine, and funded by the Wellcome Trust, the Department of Health and the Cabinet Office. Who has reviewed the study? This study was given a favourable ethical opinion by the Surrey Borders Research Ethics Committee. Contact Details For any further information about the study or for concerns during the study, please contact Emily Herrett ( or telephone ). You will be given a copy of the information sheet and a signed consent form to keep. Thank you for taking the time to read this sheet Page 5 of 5

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