A qualitative study with potential future quantitative feasibility study (mixed methodology)

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. In this study we are therefore going to develop and test a cardiovascular-risk reduction intervention for the specific needs of individuals with AAA.

Participants

Men with an abdominal aortic aneurysm identified through the existing NHS Abdominal Aortic Aneurysm (AAA) Screening Programme (NAAASP), and any healthcare professional involved in the care of individuals with an abdominal aortic aneurysm. The target number of participants is 15 patients and 30 stakeholders.

Intervention

An intervention will be developed that will help patients with an abdominal aortic aneurysm improve their heart health. Data will be collected in remote focus groups  and, if necessary, in one hour long interviews with patients with aneurysms (or carers/partners) as well as healthcare professionals. Once we have the necessary data from the participants, we will finalise the structure of the intervention. Then we will test whether the intervention can be used in current NHS care and within aneurysm screening programmes. We will invite patients from phase 1 and additional patients with aneurysms to use the intervention for six months. We will record their cardiovascular health when they are invited to take part and after six months. We will also assess how easy it was to use the intervention.

The CRISP intervention aims to address the following areas of best medical care/therapy in individuals who have an abdominal aortic aneurysm and are having surveillance using ultrasound scans:
1. Smoking cessation: A clear and easy to follow pathway, including patient-centred discussion of barriers and referral to existing NHS smoking cessation services available locally and regionally.
2. Lifestyle modifications: physical activity and diet assessed when one is diagnosed with an aneurysm in screening programmes and then the individual (if needed) is supported in setting and achieving specific targets for change (lose weight, eat healthy based on current guidance).
3. Antiplatelet agents: Aspirin 75mg (or Clopidogrel 75mg if Aspirin is contra-indicated) offered to all individuals and their primary care doctor is updated via direct communication.
4. Lipid control: Atorvastatin 80mg offered to all individuals regardless of baseline lipid levels and their primary care doctor is updated via direct communication.
5. Blood pressure control: A target of 140/90mmHg should be achieved; the primary care doctor is contacted via direct communication in order to achieve that target with appropriate pharmacotherapy

The intervention will include:
1. One initial face-to-face consultation (to assess and discuss risk-factors, address motivation and barriers and decide what actions and specific risk-factors to initially target)
2. Telephone-based remote follow-up (potentially with further face to face catch-up meetings)

Outcome measures
1. Proportion of patients agreeing to take part out of all patients invited at six months (recruitment rate) measured using case report forms
2. Proportion of people recruited who provide data at the end of the intervention period i.e. at six months (retention rate) measured using case report forms
3. Percentage of intervention sessions that participants complete at six months (intervention uptake) measured using case report forms
4. Intervention acceptability to patients (assessed qualitatively using semi-structured interviews and a satisfaction questionnaire) and service providers (assessed qualitatively)

The study is run from the NHS Abdominal Aortic Aneurysm Screening Programme.