Condition category
Respiratory
Date applied
22/07/2013
Date assigned
22/07/2013
Last edited
22/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Flu causes a substantial financial burden to the NHS and to the UK as a whole. The flu 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 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 consistently being met, with a third of patients missed in the 2011/12 flu season. 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. 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 are performing a trial of a text messaging flu vaccine reminder in patients aged under 65 who have a chronic condition.

Who can participate?
Practices will be eligible to participate if they currently use text messaging to contact practices, but did not send a text message to patients under 65 at clinical risk in the 2012/13 influenza season.

What does the study involve?
Our study will randomly allocate general practices to either standard care (in which practices are required to carry out their seasonal flu vaccination campaign as planned), or to receive additional resources allowing the practice to send a targeted text messaging campaign to eligible patients aged under 65 with a chronic condition. Practices in the text messaging arm will also be required to complete a short questionnaire. Vaccine uptake will be measured remotely through completely anonymised electronic patient medical records.

What are the possible benefits and risks of participating?
Practices in the intervention arm will receive additional resources to enable them to send a text message to support their seasonal influenza vaccination campaign. Practices in the intervention arm will receive a £200 incentive to participate. If the text message is effective, then it will increase uptake of flu vaccine within the practice. This will result in additional incentive payment to GPs by the government and will help them reach their Quality and Outcomes Framework targets. Practices in the control group will not receive support, but will not be required to perform any additional tasks. For individual patients, the intervention aims to increase uptake of influenza vaccine, which will offer protection against seasonal flu. Participating practices must spend time identifying eligible patients and sending a text message. We are reducing this burden in four ways. First, we are allowing practices to use established procedures and software to identify eligible patients for vaccination. This is a task that they would perform annually in non-study conditions. Second, we are including only practices that are familiar with the text messaging software, which minimises time spent in familiarisation with the software and sending messages. Third, additional support is available to any practice through a guidance document and dedicated support helpline (should the practice require this). Finally, we are providing an incentive payment to practices in the intervention group to encourage participation.
Practices may experience increased demand for influenza vaccination. Practices may therefore run out of vaccine supplies sooner than expected and may have to cope with additional demand for vaccination appointments. The increase is unlikely to be large and any increase will help the practice to achieve their Quality and Outcomes Framework target for vaccination, for which they receive payment.

Where is the study run from?
London School of Hygiene and Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
August 2013 to May 2014

Who is funding the study?
The Wellcome Trust (UK)

Who is the main contact?
Emily Herrett
emily.herrett@lshtm.ac.uk

Trial website

http://www.lshtm.ac.uk/eph/ncde/research/txt4flujabtrial/index.html

Contact information

Type

Scientific

Primary contact

Dr Emily Herrett

ORCID ID

http://orcid.org/0000-0002-9425-644X

Contact details

Keppel Street
London
WC1E 7HT
United Kingdom
-
emily.herrett@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14673

Study information

Scientific title

A text messaging intervention to increase influenza vaccine uptake in patients aged under 65 in clinical risk groups: three feasibility trials in primary care

Acronym

TXT4FLUJAB

Study hypothesis

Influenza causes a substantial burden to the NHS and the UK as a whole. Influenza vaccine is safe and effective but is required annually. In 2012, the UK government 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 targets for the elderly, they are under-performing in patients with chronic conditions, missing a third of eligible patients in 2011/12. Therefore strategies to increase flu vaccine uptake in these patients are required.

Text messaging is already being used in some practices for flu vaccine reminders but there has been no trial assessing its effectiveness. Therefore, we propose a trial of a text message flu vaccine reminder in patients aged under 65 who have a chronic condition.

This study will randomise general practices to either standard care (seasonal flu campaign as planned), or to receive additional resources allowing them to send a targeted text messaging campaign to eligible patients aged under 65 and with a chronic condition. Vaccine uptake will be ascertained through the anonymised patient medical records.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14673

Ethics approval

Surrey Borders Ethics Committee approved on 10th July, ref: 13/LO/0872

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

The practice information sheet is available at the following site: http://www.lshtm.ac.uk/eph/ncde/research/txt4flujabtrial/practice_information_sheet.pdf

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

This study will randomise general practices to either standard care (seasonal flu campaign as planned), or to receive additional resources.

Text message, Practices will be asked to send an influenza vaccine reminder text message to patients under 65 in clinical risk groups.

Follow Up Length: 9 months

Intervention type

Biological/Vaccine

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 04/11/2015:
Proportion of patients who received flu vaccine; Timepoint(s): Up to 4 months

Previous primary outcome measures:
Recruitment rate; Timepoints: 3 months after initial contact

Secondary outcome measures

Current secondary outcome measures as of 04/11/2015:
1. Recruitment rate; Timepoints: 3 months after initial contact
2. Practice delivery of text message; Timepoint(s): One month after study start
3. Proportion of practices reporting yes to difficulties; Timepoint(s): Up to 3 months
4. Were outcome data available?; Timepoint(s): Up to 9 months

Previous secondary outcome measures:
1. Practice delivery of text message; Timepoint(s): One month after study start
2. Proportion of patients who received flu vaccine; Timepoint(s): Up to 9 months
3. Proportion of practices reporting yes to difficulties; Timepoint(s): Up to 3 months
4. Were outcome data available?; Timepoint(s): Up to 9 months

Overall trial start date

01/09/2013

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Practices must use text messaging software to communicate with patients
2. Practices must not have used a text message to remind patients aged under 65 about influenza vaccine in the 2012/13 influenza season
3. Practices will send the text message to eligible patients who are aged between 18 and 65, with one of the following risk conditions: chronic respiratory disease, chronic liver disease, chronic kidney disease, chronic heart disease, chronic neurological disease, immunosuppression

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

Practices will not send the text message to pregnant women.

Recruitment start date

02/09/2013

Recruitment end date

18/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

University/education

Website

http://www.lshtm.ac.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) grant ref no: 098504/Z/12/Z

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Our trial protocol has been published. We are intending to publish the main trial results over the coming months. We will also disseminating a report to the practices involved in the trial, which will explain the results.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24793252
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26895984

Publication citations

Additional files

Editorial Notes

22/02/2016: Publication reference added.