Improving uptake of cervical screening in people with severe mental illness using tailored text message reminders
| ISRCTN | ISRCTN12558681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12558681 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 323832 |
| Protocol serial number | 202223 23 Sniehotta, IRAS 323832 |
| Sponsor | Newcastle University |
| Funder | National Institute for Health and Care Research |
- Submission date
- 05/10/2023
- Registration date
- 22/10/2024
- Last edited
- 08/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
In the United Kingdom, there's a program called the Cervical Screening program that offers cervical screening to women and individuals with cervixes aged 25 to 65. They get invited for this screening every three years if they're between 25 and 49 years old, or every five years if they're between 50 and 64 years old. These invitations usually come in the form of a letter and, in most cases, a text message reminder.
However, a study from 2018 discovered that people with severe mental illness (SMI), especially those aged 45 to 64, were 20% more likely to miss their cervical screening within the recommended timeframe compared to those without SMI.
To help boost the participation of individuals with anxiety about attending cervical screening, mental health service users and healthcare professionals have created an informative tool, like a pamphlet. You can find it on the government's official website (gov.uk), as a downloadable pamphlet on the Jo's Cervical Cancer Trust website, and as an animation on YouTube. The current invitation letter or text message reminders don't include links to these helpful resources.
The study aims to test if it is possible to run a trial where people receive either an enhanced text message reminder with a link to the tool or the standard text message that they usually get and see if this increases the number of people who read the information and attend screening.
Who can participate?
People with SMI who are overdue for cervical screening aged 24 - 64 years
What does the study involve?
Participants will be randomly assigned to receive either an enhanced text message reminder with a link to the tool (that's the intervention), or the standard text message that they usually get (that's the control). This pilot trial will be overseen by a company called iPLATO, which the NHS has hired to do research and send out text messages.
Local doctor's offices will identify people who are eligible for this trial and give the names to iPLATO. Then, iPLATO will randomly assign these participants to either the intervention or control group and send the appropriate text message accordingly. Within these text messages, participants will have the option to opt out of the study. Additionally, participating local doctor's offices and local charities will alert patients to the study so that they can opt out if they wish. After the study is done, local doctor's offices will add extra data about participants (e.g. age and ethnicity) to the data and send it to the research team.
If participants in the intervention group go for screening, they'll be asked if they used the information and what they thought of it. For the control group, since the information is already publicly available on the NHS screening website and provided on the invitation letters sent to patients who are due for their cervical screening, they'll be asked if they looked it up before attending screening.
This pilot trial will last for 9 months and is being funded by the National Institute of Health and Social Care Research Policy Research Unit in Behavioral and Social Sciences. Its purpose is to help decide whether this improved cervical screening reminder can increase participation among people with SMI.
What are the possible benefits and risks of participating?
Possible benefits are that this text message reminder may help people with SMI to attend for cervical screening reducing their risk of cervical cancer. This is a very low-risk intervention. The information leaflet is already available in the public domain and text message reminders are widely used by GP practices for cervical screening.
Where is the study run from?
Newcastle University (UK)
When is the study starting and how long is it expected to run for?
March 2023 to August 2025
Who is funding the study?
National Institute of Health and Social Care Research Policy Research Unit in Behavioural and Social Sciences (UK)
Who is the main contact?
Beth Nichol, beth.nichol@newcastle.ac.uk
Contact information
Principal investigator
Population Health Sciences
Newcastle University
Baddiley Clark Building
Richardson Road
Newcastle
NE2 4AX
United Kingdom
 ORCID ID |
0000-0002-7642-1448 |
|---|---|
| Phone | +44 191 208 3031 |
| Beth.Nichol@newcastle.ac.uk |
Public, Scientific
Population Health Sciences Institute
NIHR Policy Research Unit in Behavioural Science
Baddiley Clark Building
Newcastle Upon Tyne
NE2 4AX
United Kingdom
| ORCID ID |
0000-0001-5828-0955 |
|---|---|
| Phone | +44 7511046947 |
| fiona.graham@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Behavioural SMS reminders with link to decision tool to improve uptake of cervical screening amongst people with severe mental illness (SMI) that are overdue: a pilot randomised controlled trial |
| Study acronym | OPTIMISE |
| Study objectives | To establish the feasibility of conducting a randomized controlled trial (RCT) that compares enhanced SMS cervical screening reminders with usual SMS reminders to increase screening uptake among people with SMI that are overdue i.e. did not attend (DNA)/non-responders. |
| Ethics approval(s) |
Approved 23/03/2023, West Midlands - Edgbaston Research Ethics Committee (3rd Floor, Barlow House, Manchester, M1 3DZ, United Kingdom; +44 207 104 8357; edgbaston.rec@hra.nhs.uk), ref: 23/WM/0037 |
| Health condition(s) or problem(s) studied | Prevention of cervical cancer in patients with severe mental illness |
| Intervention | Participants randomised to the intervention arm will receive a text message reminder that has been developed with wording framed around social norms (informed with the input of patient representatives and their carers). It will include a link to an information leaflet that has been tailored to and developed by patients with SMI and an animation explaining the leaflet. Participants randomised to the control arm will receive the usual standard text message reminder about booking an appointment for cervical screening. Participants will be randomised using a random number generator. Participants will be allocated intervention group 1:1, stratified by age. |
| Intervention type | Behavioural |
| Primary outcome measure(s) | 1. Number of eligible participants per practice identified from a search of GP records (searched for and screened by practice staff) 2. Number of participants that opt out of the study within 14 days of the study invitation and research information sheet recorded by iPLATO 3. Number of invalid phone numbers recorded in GP records during the recruitment window recorded by iPLATO 4. Number of missing phone numbers recorded in GP records during recruitment window recorded by iPLATO 5. Number of participants where Cervical Screening status is missing in GP records at 18 weeks post-intervention recorded by iPLATO 6. SMS delivery status (recorded by iPLATO) recorded at the intervention date 7. Number of participants who access the tool/ click on the link in the text (and the no. times they click on the link) recorded at the intervention date 8. Costs incurred recorded via resource use proforma completed by iPLATO and GP staff at the end of the study |
| Key secondary outcome measure(s) | Proportion of women in each arm who arrange and attend a CS appointment within 18 weeks of the SMS reminder being sent. Age, gender, ethnicity and index of multiple deprivation (IMD) decile, date of last CS, will be measured as co-variates |
| Completion date | 14/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 24 Years |
| Upper age limit | 64 Years |
| Sex | Female |
| Target sample size at registration | 88 |
| Total final enrolment | 150 |
| Key inclusion criteria | 1. Women and people with a cervix who are diagnosed as having severe mental illness and are overdue their cervical screening test. 2. Aged 24 - 64 years |
| Key exclusion criteria | 1. People who are exempt from cervical screening and have declined to receive the usual SMS text message reminders will be excluded 2. Those the general practitioner considers it inappropriate to approach 3. Patients inappropriate to approach (patients who are receiving palliative care, have declined screening when offered by their GP in the last 12 months, and have submitted a cervical screening opt-out form) |
| Date of first enrolment | 25/11/2024 |
| Date of final enrolment | 28/02/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
160 Tooley Street
London
SE1 2QH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and or analysed during the current study are not expected to be made available as we are not obtaining consent from participants to do so. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Patient notification poster version 2 |
08/10/2024 | 14/10/2024 | No | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol (other) | Version 5 | 08/11/2024 | 14/11/2024 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 44366 Patient notification poster V2 BN 08Oct2024.pdf
- Patient notification poster
Editorial Notes
08/07/2025: The completion date was changed from 31/07/2025 to 14/08/2025. Total final enrolment added.
24/01/2025: The recruitment end date was changed from 06/01/2025 to 28/02/2025.
14/11/2024: The following changes were made:
1. The recruitment start date was changed from 01/11/2024 to 25/11/2024.
2. Links to protocol (not peer-reviewed) and website added.
19/10/2023: Trial's existence confirmed by NHS HRA.
