Cardiovascular disease: background and growing prevalence

Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels such as coronary heart disease, heart failure, and stroke. It is the leading cause of death globally, accounting for an estimated 17.9 million deaths in 2019, 32% of global deaths [1]. In the UK, approximately seven million people are living with CVD, and it contributes to a quarter of UK deaths [2]. Economic costs of CVD are significant, with CVD-related health and social care costs in England estimated to be £12 billion annually, and societal costs £28 billion annually [3]. CVD is a leading cause of health inequalities [4] and the largest cause of premature mortality in deprived areas of England [5].

The incidence of CVD increases rapidly with age, is higher for males than females, and has a positive association with deprivation, the impact being greatest in the most socio-economically disadvantaged groups [6]. Cardiovascular disease (CVD) risk has also been shown to vary across ethnic groups. In the UK, South Asian individuals have been found to have an increased risk of CVD overall [7], but for specific cardiovascular diseases, reported associations with ethnicity are mixed. For instance, in a study of White, Black and South Asian patients, George et al. [8] found that, relative to the White group, there was a raised risk of angina for those in the South Asian group but a decreased risk for Black individuals. Risk of heart failure was similar for all three ethnic groups whereas stroke risk was relatively higher for individuals of both South Asian and Black ethnicities. There is a positive causal link between smoking and CVD [9].

The NHS Health Check

The NHS Health Check (NHSHC) programme was launched by the UK National Health Service (NHS) in 2009 and is a cornerstone of CVD prevention in the UK. The programme aims to assess older adults for CVD risk factors by providing people aged between 40 and 74 years, without pre-existing health conditions, with a health check free at point of access. Eligible individuals are invited to an NHSHC by their GP or local council every five years, or can self-refer [10]. Throughout this document the abbreviations NHSHC and HC will be used interchangeably to refer to the NHS Health Check.

NHSHCs are conducted by a healthcare professional, typically a healthcare assistant (HCA) or nurse, although they may also be delivered by a doctor or pharmacist. They involve the health professional taking measurements such as height, weight, waist size, blood pressure, and cholesterol. Attendees are also asked to provide details of family history of medical conditions, alcohol and tobacco consumption, and physical activity level. Results are used to calculate a CVD risk score, known as a QRISK score [11], and attendees also receive an assessment of their body mass index (BMI) and diabetes risk [10]. At the end of the NHSHC, attendees receive feedback on their health status and, where relevant, advice, guidance, and support on beneficial lifestyle changes and appropriate clinical and behavioural approaches to reduce the risk of CVD and improve overall health and wellbeing. This may include signposting or referral to a General Practitioner (GP) to consider pharmacological interventions or to ‘lifestyle’ services (such as a weight management, smoking cessation, or addiction services) [10].

Research suggests that NHSHCs may positively impact health outcomes, particularly through the identification of CVD risk. For example, Usher-Smith et al. [12] conducted a rapid synthesis of the published evidence on NHSHCs and highlighted small increases in disease detection and greater statin prescription for attendees, with a new case of raised blood pressure found in three to four health checks and a person with cardiovascular disease risk (>20%) identified in six to ten. Changes in blood pressure, cholesterol and BMI were also significantly larger in NHSHC attendees than matched non-attendees. Similarly, Tanner et al.’s, 2022 review found that NHSHCs lead to increased detection of CVD risk factors [13]. Research has also identified increased referral to health improvement services following NHSHCs [14].

However, the effect of the NHSHC on attendees’ lifestyle and health-related behaviours is unclear, with limited research examining post NHSHC behaviour change and a need for additional research in this area [13].

Encouraging uptake of NHSHCs

The NHSHC programme costs hundreds of millions of pounds per year to deliver, with the most recent cost estimate approximately £450 million annually [15]. However, encouraging uptake of health checks has proved challenging, with inequity identified in the likelihood of different groups attending. Research suggests that fewer than half of those eligible attend a health check [16–18] and uptake has been found to be higher for older people and females, and lower for those living in deprived areas [16,17,19]. Ogunlayi et al.’s recent study found that individuals from some minority ethnic backgrounds and those living in the most deprived localities were less likely to be invited to a health check or take up the invitation to attend [20].

A 2018 systematic review to understand barriers to NHSHC attendance identified lack of awareness of the availability of NHSHCs, misunderstanding of the purpose and benefits of the health check, time and access constraints, and privacy and confidentiality concerns, among the main barriers [21]. Studies have highlighted significant variation in NHSHC invitation and delivery models and practices, and those delivering health checks have often modified practice to improve uptake or delivery [12,22,23].

The mode and content of NHSHC communications have been studied extensively and found to influence the likelihood of health check attendance. For instance, telephone and verbal invitations appear to be more effective than postal invitations [24,25], and face-to-face invitations more effective than letter or telephone [19]. Additionally, the positive impact on health check attendance, of amending invitation letters or using text messaging, is well-established [26,27]. Specifically, studies have shown that the precise framing and wording of health check invitation letters [28] and the use of text message primers or reminders [29] can positively impact NHSHC uptake.

However, the relationship between communication methods and NHSHC attendance appears far from straightforward, with studies suggesting that the effectiveness of invitation methods may vary depending on invitee characteristics [19,26]. Cook et al.’s 2016 study, for example, found that ethnicity and gender appeared to play a key role in determining invitee responses to different forms of invitation communication. They cite misunderstandings about the NHS system, language barriers, and a lack of trust as potential factors influencing the effectiveness of communication methods and lower NHSHC uptake among immigrant communities — specifically Polish migrants in this study [19]. Cook et al. are among those who suggest that tailored approaches to communicating with different population groups about health checks may be necessary to address disparities in uptake [19,30].

Beyond the invitation process itself, studies suggest that the setting in which the NHSHC is delivered may positively influence uptake, as checks undertaken in community venues such as pharmacies, retail spaces or places of worship may be more accessible or acceptable to patients than those delivered in GP practices [30–32]. It is also reasonable to expect that the practitioner or organisation delivering the NHSHC could affect health check experiences or outcomes. Existing evidence suggests that the role of the medical professional conducting the NHSHC — whether a doctor, healthcare assistant, or pharmacist — may influence outcomes such as medication prescribing and referrals to lifestyle services [33], and that delivery by trained non-clinical staff, such as healthy lifestyle advisors, is feasible and may be experienced positively by patients [34]. Research also highlights the importance of appropriate training for those delivering the health check [31]. However, there is limited research exploring the impact of who delivers the health check and no studies to date have examined differences in patient experience or outcomes between NHSHCs delivered by clinical GP practice staff, such as nurses and HCAs, and non-clinical staff.

Recognising scope for improvement of the NHSHC programme, local authorities have begun to adapt the health check intervention to better address the development of diseases and long-term conditions in their localities.

The current study

This study will evaluate the modifications made to NHSHC invitation and delivery in a large local authority area in the East Midlands region of England. The local authority has identified ‘working to support people to live healthy lives’ as a strategic priority and funds a healthy lifestyles service delivered by specialist healthy lifestyles practitioners. The service – which includes support and referrals for smoking cessation, weight management, and physical activity – is available to anyone within the locality.

In June 2022, the local authority began a pilot project in which the delivery of NHSHC was modified in ten GP practice areas. A key modification involved staff from the healthy lifestyle service, rather than GP practice staff, delivering NHSHCs (in some pilot practice areas, some delivery of NHSHCs by GP practice staff continues alongside healthy lifestyle service health check delivery). In the pilot practice areas, eligible residents who are registered with the pilot GP practice either have the option of choosing to attend a ‘GP-led’ or ‘lifestyle service’ health check, or will receive a lifestyle service health check as standard (depending on the practice). There are several differences between a GP-led health check and a lifestyle service health check:

• A lifestyle service health check lasts for approximately 45–60 minutes, compared to the shorter GP-led health check. While the length of NHSHCs is not mandated by the NHS, NHS publicity suggests they typically last about 20–30 minutes [10] and in the study area, GPs were funded to complete an NHSHC within 30 minutes. However, although some individual GP practices record the duration of their health checks, the actual time allocated to GP-led NHSHCs is not collated at the study area level, and reliable data on their duration are therefore unavailable. Nevertheless, several published studies have identified significant variation in NHSHC duration, with some checks lasting as little as five to seven minutes [22,35].
• The additional time in a lifestyle service health check is intended to allow for further lifestyle conversations, referrals, and signposting.
• Staff delivering a lifestyle service health check are holistic lifestyle experts who have specific referral expertise and can signpost to a wide variety of wellbeing services. A standard GP-led health check may be delivered by a nurse, doctor, pharmacist, or healthcare assistant and may be just one of many clinical responsibilities.
• As standard, the lifestyle service health check offers an HbA1c test to everyone — a blood test that measures average blood glucose levels and consequently the presence or development of diabetes. In the study area, there is variation between GP practices in whether an HbA1c test is offered as part of the GP-led health NHSHC. For example, some offer an HbA1c test as standard (either prior to or during the NHSHC), while others only offer it if clinical risk symptoms are identified.
• A lifestyle service health check incorporates all GP-led checks and measures but additionally includes a ‘health and wellbeing MOT’. The MOT adopts a holistic wellbeing approach, focussing on broader domains than a standard NHSHC, including assessment of emotional wellbeing, financial and debt issues, and employability concerns. Depending on the client’s responses, they may be referred to receive additional support from the lifestyle service, NHS services, or other third-sector providers.

In addition to lifestyle service health check delivery, the local authority has made two further modifications to NHSHCs in the ten pilot areas. These will also be the focus of this evaluation. Firstly, beginning in June 2023, postal reminders sent to those eligible for an NHSHC to remind them to book an NHSHC appointment were supplemented by text message prompts and reminders. An initial text message is sent prior to an NHSHC invitation letter and a subsequent text is sent to remind the client to book an appointment. Secondly, from October 2023, those eligible for health checks have had the additional option of booking their NHSHC appointment online. The previous telephone booking option remains in place. Our evaluation will therefore focus on three NHSHC modifications:

1. Modifications to NHSHC delivery – delivery is a healthy lifestyle service rather than GP-led.
2. Modification to NHSHC invitation process – implementation of text message prompts and reminders.
3. Modification to NHSHC invitation process – implementation of an online booking option.

Fig 1 illustrates the standard NHSHC process, along with the modifications introduced to the invitation and delivery procedures as part of the current pilot.

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Fig 1. A typical NHSHC process and the modifications made to the invitation and delivery process as part of the current pilot.

https://doi.org/10.1371/journal.pone.0330368.g001

Study aims and research questions

The study aims firstly, to investigate the impact of modifications to NHSHC invitation and session delivery on health check attendance, outcomes, and resources. Secondly, to explore staff and client experiences of the modifications made to health check practice.

To address the impact of modifications to the NHSHC invite process, the study will investigate the impact of text message prompts and reminders, and the online booking option, on the uptake of the NHSHCs. We will also investigate whether the lifestyle service health checks lead to any changes in health check outcomes (e.g., numbers of referrals or new prescriptions), and outcomes data will be contrasted between the standard GP-led and lifestyle service led NHSHCs. In addition, staff and client experiences of the lifestyle service health check will be explored, as will changes to clients’ health-related knowledge and planned behaviour.

We aim to answer the following research questions:

1. Does the implementation of a) text message prompts and reminders, and b) an NHSHC online booking option, lead to changes in the proportion of those invited attending an NHSHC?
2. Does delivery of modified NHSHCs by the healthy lifestyles service, which includes Health and Wellbeing MOTs, lead to any changes in NHSHC outcomes?
3. What are staff experiences of the modified NHSHC?
4. What are clients’ experiences of the modified NHSHC and how do clients feel it has impacted their current and future health and wellbeing?
5. What are the costs and resources required for the modified NHSHC delivery and how do they compare to costs and resources for standard GP-led NHSHC delivery?

Ethical considerations and declarations

Ethical approval has been received through the University of Hertfordshire Health, Science, Engineering and Technology Ethics Committee with Delegated Authority (protocol number: LMS/SF/UH/05540). The NHS Health Research Authority (HRA) decision tool has been consulted and has confirmed that NHS Research Ethics Committee review and approval is not required as the study is ‘service evaluation’ rather than ‘research’.

Patient and public involvement (PPI)

A PPI group, known as the Public Involvement in Research group (PIRg), is an integral part of the research team conducting the current evaluation. Two ‘embedded’ PIRg members will work alongside the research team as co-researchers for the duration of the evaluation. The embedded PIRg members will attend project meetings, review project materials, and contribute to the production of project outputs. Their input will be complemented by public contributors from the pilot area locality, who will be recruited with the assistance of local voluntary and community sector organisations. These public contributors, who will meet NHSHC eligibility criteria, will provide additional local public perspective on the evaluation. They will review public-facing project materials and attend project Advisory Group (AG) meetings as full AG members. Embedded PIRg members and local public contributors will be remunerated for their time in line with NIHR guidance [36].

Study design overview

The study will adopt a mixed methods design, incorporating analysis of routinely collected quantitative data, alongside qualitative data collection and analysis. A convergent, parallel mixed methods approach will be utilised [37], applying both methods concurrently, and bringing them together at the interpretation stage. The mixed method approach will allow for complementarity in the analysis process [38].

We will use the six APEASE criteria [39] as a framework for evaluating the NHSHC modifications. The criteria, summarised in Table 1, can be utilised for a range of evaluation purposes including for formal evaluation of existing interventions [39] and offer a thorough and methodical framework for evaluating health interventions [40]. They will be used here as a framework through which to interpret, understand and report our findings; the criteria encompass the key components and concepts unpinning our research aims, and all our data collection and analysis will inform one or more of them.

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Table 1. Summary of APEASE criteria (adapted from West et al., 2019 [39]).

https://doi.org/10.1371/journal.pone.0330368.t001

The project has been divided into six distinct workstreams (WSs). Each seeks to answer specific research questions (RQs) or address RQs in a different way to provide for a well-rounded and robust evaluation. Table 2 provides a summary of each workstream and the study research question/s that it informs.

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Table 2. Study workstreams (WSs) mapped to research questions (RQs).

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WS1: Quantitative analysis of client NHSHC records

WS2: Focus groups with healthy lifestyle service health check staff involved in coordinating and delivering the modified health check sessions

WS3: Individual or joint interviews with staff from pilot GP practices whose roles involve the coordination or delivery of NHSHCs

WS4: Interviews with clients who have attended a healthy lifestyle service NHSHC

WS5: Health economic resource and cost evaluation

WS6: Data analysis, synthesis, and dissemination

All interview and focus group data will be transcribed verbatim and uploaded into NVivo 14 software (QSR International) for coding and analysis.

Following transcription, all qualitative data will be analysed using Framework Analysis [46]. This approach offers a structured and systematic approach to managing qualitative data analysis across multiple researchers [47], which will help facilitate the involvement of PIRg members in the analytic process. We will use the following staged Framework Analysis process: familiarization with the data; coding; development of an analytical framework; applying the analytical framework, charting, and mapping and interpretation [47–49].

We will conduct both inductive and deductive coding to enable us to understand findings in terms of the APEASE criteria, while also allowing for exploration of staff and client experiences and providing scope for the identification of unanticipated themes relevant to the research questions. Our initial coding will utilise pre-selected codes related to the APEASE criteria while simultaneously allowing for inductive coding of transcripts. After Framework Analysis ‘charting’ has been conducted, themes will be identified under each APEASE criterion, with space allowed for identification of themes that lie outside the scope of APEASE but are relevant to our research questions.

Qualitative and quantitative data will be integrated at the ‘interpretation and reporting’ stage [50]. Qualitative research data collected during Workstreams 2, 3, and 4, and quantitative data from Workstreams 1 and 5, will be separately analysed as standalone workstreams before being brought together [51]. A mixed contiguous/weaving approach will be used for qualitative and quantitative data integration [52], allowing the research team to integrate findings from the quantitative outcomes and health economic analyses with qualitative analysis of staff and clients’ interview and focus group data. During the interpretation and reporting stage, the APEASE criteria will act as a framework through which we will interpret and report findings.

Our dissemination and knowledge mobilisation work will involve close collaboration with a broad range of stakeholders including: local authority representatives; public health practitioners; NHSHC specialists; policy experts; service users; and academics. This will enable us to understand how we can frame and communicate findings most effectively. We anticipate disseminating findings through multiple routes, including blogs, presentations, summary reports, academic journal articles, infographics, video, and social media posts. Recommendations will be similarly co-produced through collaborative work with multiple project stakeholders.

Status and timeline of the study

We anticipate the following timelines for the study:

• Workstreams 1 and 5 completed by November 2024
• Workstreams 2, 3 and 4 completed by July 2024
• Workstream 6 completed by February 2025
• Study end date: March 2025