Plain English Summary
Background and study aims
The average cervical screening attendance rate across England is 73%, while Greater Manchester’s screening rate is below this national average at 65%. In this context, Greater Manchester Health & Social Care Partnership would like to increase the cervical screening rate within Greater Manchester. The study will be undertaken by the Behavioural Insights Team in collaboration with the Greater Manchester Health & Social Care Partnership and the screening programme of Primary Care Support England, delivered on behalf of NHS England by Capita plc. This study tests the impact of adapting the cervical screening invitation letter. This study aims to test whether it is possible to increase attendance rates for cervical screening by adapting the invitation letters sent to eligible women.
Who can participate?
Woman aged 35 to 64 who are due to be invited to a breast screening appointment.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive a letter with a loss-framed message and presenting the cervical screening as a detection behaviour. Those in the second group receive a letter with a gain-framed message and present the cervical screening as a prevention behaviour. Those in the last group receive a letter that contains an enhanced active choice message, making the benefits and losses of the options more salient. The attendance rates at cervical screenings are used to assess which type of letter leads participants to attend their appointments.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Greater Manchester Health and Social Care Partnership (UK)
When is the study starting and how long is it expected to run for?
March 2017 to November 2017
Who is funding the study?
Greater Manchester Health and Social Care Partnership (UK)
Who is the main contact?
Ms Kristina Londakova (Public)
kristina.londakova@bi.team
Trial website
Contact information
Type
Public
Primary contact
Ms Kristina Londakova
ORCID ID
Contact details
The Behavioural Insights Team
4 Matthew Parker Street
London
SW1H 9NP
United Kingdom
+44 7729 016501
kristina.londakova@bi.team
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2017014
Study information
Scientific title
Behaviorally informed invitation letters potential to increase cervical screening attendance
Acronym
Study hypothesis
The aim of this study is to assess whether a behaviourally-informed invitation letter, compared to standard letters, could increase attendance of routine cervical screening appointments.
Ethics approval
Not provided at time of registration
Study design
Single-centre four-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
No participant information sheet available
Condition
Cervical cancer screening
Intervention
Women who are due to receive a letter will be randomly assigned to one of the three arms of the trial, based on the random middle three digits of each invitees’ NHS number. This process will be undertaken by CDIS, a department of Capita pls., specialising in the printing and distribution of postal communications the invitation letters on behalf of Primary Care Support England. Women will receive either the standard invitation letters that is currently sent or one of the three new behaviourally informed letters. All the intervention letters will be simplified to include only the key information (NB. the standard leaflets detailing the pros and cons will be attached). All the intervention letters will also include a visually attractive tear-off slip to encourage women’s planning, based the the successful experience from the ‘First Invitations to Breast Screen Victoria’ trial conducted by BIT in Australia.
The first intervention letter will contain loss-framed message and present the cervical screening as a detection behaviour.This is motivated by behavioural research showing when faced with a risky situation (such as illness detection), people may be more sensitive to a message stressing the potential losses associated with not performing a behaviour (e.g. ‘A failure to detect prostate cancer can cost a man his life’).
The second intervention letter will contain gain-framed message and present the cervical screening as a prevention behaviour. Behavioural research suggests that when faced with a riskless situation (sunscreen use, physical exercise), a gain framed message focussing on potential benefits of a behaviour may be more effective (e.g. ‘Regular exercise can help you prevent heart disease and stroke’).
The third intervention letter will contain an enhanced active choice message. The aim of active choice approach is to encourage people to actively make a decision in a binary choice. In other words, the idea is to remove the ease of inaction by presenting a lack of action as an active choice, as well. ‘Enhanced active choice’ method goes one step further - it not only reframes a situation as requiring an active choice but also makes the consequences (benefits and losses) of the options more salient.
The screening invitation contains all the relevant information about the appointment and of the letters will be sent alongside the NHS cervical screening leaflet which details the benefits and risks of cervical screening, as well as any other information routinely send out by each of the screening services.
Attendance rates at cervical screening appointments will be used to assess whether those who received the adapted letters (treatment groups) were more likely to attend their appointments, compared to those who received the standard letter.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Attendance rate within 18 weeks of receiving an invitation letter of routine cervical screening appointments is assessed through medical record review.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
20/03/2017
Overall trial end date
01/11/2017
Reason abandoned (if study stopped)
The trial did not gain approval from the Cervical Screening Research Advisory Committee of Public Health England.
Eligibility
Participant inclusion criteria
1. Women
2. Aged between 25 and 64
3. Registered with a GP in Greater Manchester
4. Who are due to be invited for a breast screening appointment during the period of the trial
Participant type
All
Age group
Adult
Gender
Female
Target number of participants
125000
Participant exclusion criteria
1. Registered with a GP outside of Greater Manchester
2. In Greater Manchester who are not due to be screened during the period of the trial or not registered with a GP practice
3. Under 25 years old or over 64
4. Already diagnosed with cancer and are currently undergoing treatment
Recruitment start date
20/03/2017
Recruitment end date
31/07/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Greater Manchester Health and Social Care Partnership
3 Piccadilly Place
Manchester
M1 3BN
United Kingdom
Sponsor information
Organisation
Greater Manchester Health & Social Care Partnership
Sponsor details
3 Piccadilly Place
Manchester
M1 3BN
United Kingdom
+44 113 825 5346
siu-ann.pang@nhs.net
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
Greater Manchester Health and Social Care Partnership
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in an internal report, on BIT's website and potentially, in a high-impact peer reviewed journal, in 2018.
IPD Sharing plan:
For evaluation purposes, researchers will receive anonymised data from the screening centres, based on a mutual data sharing agreement. The data will not include information on patients' names, addresses, date of births or any information on medical conditions. During the study personal identifiable data will remain within GP practice and screening centre records (Capita on behalf of the Primary Care Support England). Personal data for the trial purposes will be collected and stored by the screening centre, in charge of sending letters and recording attendance at appointments. The researchers will only receive non-personal data, to be stored on secure hard drives accessible only to the staff of the Behavioural Insights Team (BIT).
Intention to publish date
31/12/2018
Participant level data
Stored in repository
Basic results (scientific)
Publication list