Improving the quality of care for men with Abdominal Aortic Aneurysms (AAA) who undergo regular screening: reducing the psychosocial consequences of screening and developing a patient-centred Exit Strategy from surveillance
| ISRCTN | ISRCTN17240424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17240424 |
| IRAS number | 321528 |
| Secondary identifying numbers | CPMS 55062, NIHR135031 |
- Submission date
- 26/01/2023
- Registration date
- 09/02/2023
- Last edited
- 10/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Abdominal Aortic Aneurysm (AAA) is a swelling in the aorta, a vessel that runs from the heart down through the chest and stomach. AAA can increase in size and burst. Most people who have a burst AAA die before they get to hospital or do not survive emergency surgery. 4000 people die each year in England and Wales from a burst AAA. Screening can pick up an AAA before it bursts. It saves lives and is cost-effective. The National AAA Screening Programme (NAAASP) offers screening to all men aged 65. It invites 300,000 men for scans each year. Some men have a small AAA and are checked each year to see how much it has grown. Some men have a medium AAA and are checked every three months. There are now 15,000 men ‘in surveillance’, that is, having scans regularly. When men have a large AAA they are offered surgery to stop it bursting.
There are two challenges to ensure that the benefits of screening outweigh harms. First, men and their partners can suffer anxiety, distress, burden from protecting others from worrying, guilt, helplessness, and uncertainty. We need to find ways to reduce these problems. Second, as men get older, they may become unfit for surgery and cannot have treatment. We need to understand men’s preferences for leaving the surveillance programme.
The study aims to improve the quality of care for men who have regular screening to check on the growth of their Abdominal Aortic Aneurysm.
Who can participate?
Adult men who are in AAA screening.
What does the study involve?
There are several components to the study. We will do a survey of 1200 men in the surveillance programme to find out who is anxious and when this is worse. We will identify 20 men with problems and interview them and their partners about what might help them manage anxiety. Then staff, men and their partners will co-design an intervention. We will make this intervention and assess if men use it and like it.
What are the possible benefits and risks of participating?
The benefits would be having the opportunity to have input into improving the support of men in the screening programme and being able to support the development of an intervention.
The risks may be that for participants who might already be highly anxious, talking about the issue may create further anxiety. There are specific plans for this eventuality. The interviewees are experienced in speaking to men with AAA. The interview/group may be stopped (temporarily or permanently) and the participant may be directed to speak to their AAA nurse or GP.
Where is the study run from?
University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
February 2022 to September 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Prof Alicia O'Cathain, a.ocathain@sheffield.ac.uk
Contact information
Scientific
ScHARR
University of Sheffield
Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 114 222 0770 |
|---|---|
| a.ocathain@sheffield.ac.uk |
Study information
| Study design | Mixed methods |
|---|---|
| Primary study design | Observational |
| Secondary study design | Mixed methods |
| Study setting(s) | Community, Home, Internet/virtual, Telephone, University/medical school/dental school |
| Study type | Other, Quality of life, Screening, Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Person centred abdominal aortic aneurysm study (PCAAAS) |
| Study acronym | PCAAAS |
| Study objectives | Overall aim - To improve the quality of care for men in the surveillance programme within NAAASP. |
| Ethics approval(s) |
Approved 26/04/2023, Wales REC 6 (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2922 940911; wales.REC6@wales.nhs.uk), ref: 23/WA/0019 |
| Health condition(s) or problem(s) studied | Abdominal aortic aneurysm screening |
| Intervention | Current interventions as of 13/02/2025: In the first work package we will develop a new intervention to reduce the psychological consequences of screening. We will do a survey of men ‘in surveillance’ to measure who has problems and when this is worse (n=1200). We will identify men with problems and interview them (n=20-24) and their partners/family (n=12-20) about what might help them manage anxiety. Then service providers, men and their partners/family will co-design an intervention to reduce the potential negative effects of being in surveillance. We will create this intervention and assess its feasibility and acceptability. Its effectiveness would be measured in a future study if appropriate. In the second work package we will interview men (n=20-24) ‘in surveillance’ and their partners (n=12-20) about their preferences for exiting surveillance under different circumstances. Then we will undertake two Deliberative Engagement Workshops with around 20-40 men and their supporters, healthcare professionals and PPI members to evaluate the intervention and develop it further. We will then conduct a phone survey of men in surveillance (n=20) to measure their preferences and the intensity of their preferences. We will feed this into NAAASP to help them develop a patient-centred Exit Strategy. _____ Previous interventions: In the first work package we will develop a new intervention to reduce the psychological consequences of screening. We will do a survey of men ‘in surveillance’ to measure who has problems and when this is worse (n=1200). We will identify men with problems and interview them (n=20-24) and their partners/family (n=12-20) about what might help them manage anxiety. Then service providers, men and their partners/family will co-design an intervention to reduce the potential negative effects of being in surveillance. We will create this intervention and assess its feasibility and acceptability. Its effectiveness would be measured in a future study if appropriate. In the second work package we will interview men (n=20-24) ‘in surveillance’ and their partners (n=12-20) about their preferences for exiting surveillance under different circumstances. Then we will undertake a survey of men in surveillance (n=500) to measure their preferences and the intensity of their preferences. We will feed this into NAAASP to help them develop a patient-centred Exit Strategy. |
| Intervention type | Other |
| Primary outcome measure | Identification of predictors of psychosocial problems - measures will include standardised measures such as the EQ5D-L, COS-AAA and e-PAQ-VAS as well as project-specific questions, qualitative interviews and focus groups. |
| Secondary outcome measures | Identify preferences for exit strategies. Measures will include a project-specific survey, focus groups and qualitative interviews. |
| Overall study start date | 11/02/2022 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 64 Years |
| Sex | Male |
| Target number of participants | 1,350 |
| Total final enrolment | 812 |
| Key inclusion criteria | 1. Initially men in AAA surveillance will be approached 2. For later work their partners/family will also be approached 3. For some parts of the study only men in surveillance who also describe anxiety will be included |
| Key exclusion criteria | Men who have not consented to be approached by researchers |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
University/education
Western Bank
Sheffield
S10 2TN
England
United Kingdom
| j.a.burr@sheffield.ac.uk | |
| Website | http://www.sheffield.ac.uk/ |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We will undertake academic dissemination by publishing a synopsis of the study in the NIHR Libraries Journal, publishing articles in academic journals targeted at the vascular clinical community (e.g. British Journal of Surgery), and presenting the research at relevant conferences and meetings. We will send summaries of findings to AAA Regional Screening Centres in England, and all national AAA screening programmes e.g. Scotland, Sweden. We will use social media to disseminate our results to other relevant screening programmes. That is, we will look for relevant Twitter accounts and emails so we can send our results. We will write Plain English summaries of findings and send them to interview, workshop and survey participants who indicate that they would like to see the findings. We will work with our PPI members and screening centre staff to identify how to disseminate findings to men in surveillance e.g. posters, summaries in paper format available at the screening centres, giving talks at ‘information days’ held by NAAASP for patients and their families |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Professor Alicia O'Cathain a.ocathain@sheffield.ac.uk. Fully anonymised quantitative data will be available to be shared after the study ends on 30/09/2025. The data will be available for 5 years. Access will be considered on an individual request basis, dependent on whether the researcher requesting the data fulfils the ethical and legal requirements of the PCAAAS study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.1 | 04/04/2023 | 15/05/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3.0 | 19/03/2024 | 13/02/2025 | No | No |
Additional files
Editorial Notes
10/09/2025: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The IPD sharing plan was added.
16/06/2025: The overall end date was changed from 31/01/2025 to 30/09/2025.
13/02/2025: The following changes were made to the trial record:
1. The interventions were changed.
2. The recruitment end date was changed from 31/01/2025 to 30/06/2025.
3. Uploaded protocol v3.0 (not peer-reviewed) as an additional file.
04/06/2024: The target number of participants was changed from 1200 to 1350.
15/05/2023: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The ethics approval was added.
13/03/2023: The recruitment start date has been changed from 01/03/2023 to 01/05/2023.
26/01/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
