Title: Cardiovascular Risk reduction In the NHS abdominal aortic aneurysm (AAA) Screening Programme: a co-developed cardiovascular prevention intervention (the CRISP study)
Funder: Department of Health and Social Care

Abstract: Research question What is the best way to integrate cardiovascular-risk reduction into existing Abdominal Aortic Aneurysm (AAA) screening/surveillance pathways? Background All 65 year-old men in the UK are invited for an ultrasound (US) to screen for AAA. The vast majority of those with AAA enter a disease-surveillance programme, undergoing regular repeat US. There are 11,601 men in AAA-surveillance, spending an average 4-7 years in follow-up. Screening has minimal effect on all-cause mortality. The principal preventable cause of mortality in AAA-surveillance is cardiovascular disease. Regular attendance at surveillance clinics represents an excellent opportunity to address cardiovascular-risk. Unfortunately, AAA-surveillance was not designed to deliver cardiovascular-risk modification. Consequently, uptake of cardiovascular-risk management in AAA-surveillance is poor and does not follow National Institute for Health and Care Excellence (NICE) guidance in most instances. Main objective To develop and test a cardiovascular-risk reduction intervention for the specific needs of individuals with AAA. Specific aims: Develop a cardiovascular-risk reduction intervention for AAA-surveillance based on evidence, NICE-guidance, and co-created with service users/providers Assess intervention acceptability to users/providers Assess feasibility of recruitment, measurement procedures, and retention for a future definitive trial to guide intervention adoption across the NHS.Methods There will be two distinct stages. In Stage 1, a cardiovascular-risk reduction intervention tailored for AAA-surveillance will be established, based on Medical Research Council guidance on intervention-development. Using 'intervention mapping' and through extensive interaction with patients/stakeholders, the intervention will be grounded in the needs of patients and caregivers and informed by latest evidence. Involvement of service-providers will ensure that it can be delivered by staff within existing AAA surveillance pathways. Stage 2 will be a prospective feasibility study. Individuals with an AAA measuring 3.0-5.0 cm will be recruited from the Midlands AAA screening units. Participants will receive the intervention alongside AAA-surveillance. The key outcome measures will be recruitment/retention rate, intervention uptake and acceptability. These will inform a future definitive trial to guide adoption nationally. TimelinesAfter a six-month set-up period, Stage 1 will commence, lasting for nine months and followed by a six-month analysis period to finalise the intervention and four months to train the nurses in intervention-delivery. I will also visit two centres in the United States to gain experience in delivering large-scale cardiovascular-research. A feasibility study will then commence (Stage 2) to test the fully-developed intervention (nine months recruitment and six months follow-up). Analysis and dissemination will last six months. Overall duration: 48 months. Impact/dissemination Patients in AAA-surveillance have exceedingly high cardiovascular-risk and their unique characteristics make the adoption of preventive interventions developed for other populations challenging. This research will produce a cardiovascular-risk reduction intervention tailored for AAA-surveillance and data that will support a future definitive trial to guide wider adoption. Subsequent roll out across the NHS will be relatively quick, given the involvement of key service leads in the study. Even a very modest adoption of the intervention by men in AAA-surveillance can lead to significant reductions in cardiovascular mortality/morbidity. Outputs will be disseminated to Public Health England, AAA screening programmes, scientific and lay audiences.

Lay abstract: BackgroundAbdominal Aortic Aneurysm or AAA is an abnormal swelling of the aorta, the biggest artery in the body. It usually occurs in men aged over 65. An AAA can occasionally burst, leading to life-threatening bleeding. An AAA can be easily detected using a simple ultrasound scan. AAA screening programmes are now available across the UK through the NHS. These programmes invite all men at the age of 65 to have an ultrasound scan to check for AAA. Most of the men found to have an AAA in screening do not need surgery as their AAA is small in size. These men are, however, offered regular ultrasound scans to check the growth of the AAA. We already know that if someone has even a small AAA, they are far more likely to develop heart attacks and strokes compared to people without AAA. In fact, most people who have a small AAA will not die because of their AAA but because of a heart attack or a stroke. Despite this, individuals with AAAs in the UK AAA screening programmes do not receive adequate help and support to prevent these problems. This is an important missed opportunity. Simple things like taking an aspirin, lowering cholesterol, lowering blood pressure and improving one's diet can greatly decrease the chances of heart attacks and strokes. Unfortunately there hasn't been much research in this area and we do not know how to best support people with AAA to help them take advantage of these treatments. Aim The existing NHS AAA screening programmes can be used to improve the treatment of people with small AAAs by offering them medication, diet support, and other help to prevent heart attacks and strokes. The aim of this research is to develop and then test a health intervention specifically for men with AAA, which will improve their health and reduce their chances of heart attacks and strokes. Design, Methods, Patient & Public Involvement This research will consist of two stages: 1) In the first stage, patients with AAA, their relatives, and experts in this area will work together to develop the health intervention aimed to improve the heart health of those with AAA. First, patients with AAAs and their families will be approached and invited to take part in the research. Experts including General Practitioners (GPs), public health doctors, surgeons who treat AAA, NHS staff from NHS AAA screening programmes and psychologists will also be invited. The first step will be to identify the barriers that prevent good heart care in people with AAA. Then, the patients and experts will discuss how these barriers can be overcome. The health intervention will eventually be designed using the information from those discussions. 2) In the second stage, the intervention will be tested in the Leicestershire AAA screening unit to assess how many men with AAA will take it up. Eventually, a national study will confirm whether it works and whether it offers value-for-money in the NHS. Benefits of the researchIf this study is successful, the existing NHS AAA screening programmes will be used as a platform to offer people with small AAAs better medical care and reduce the chance of heart attacks and strokes. This will benefit thousands of patients across the UK and prevent hundreds of admissions and deaths every year. It will bring significant cost savings to the NHS as the treatment of these health problems is very expensive. Dissemination The results of the study will be published in medical journals, media, posted to patients and presented to those in charge of AAA screening as well as health-policy makers.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;7.1 INDIVIDUAL CARE NEEDS
Health categories: CARDIOVASCULAR