Equity and local health systems: a qualitative evaluation of the experiences of local health service leads during the first two years of the NHS Low Calorie Diet programme pilot

KEVIN J DREW,¹ CATHERINE HOMER,² DUNCAN RADLEY,³ CHARLOTTE FREEMAN,⁴ KARINA KINSELLA,¹ MARIA MAYNARD,¹ CHIRAG BAKHAI,⁵ LOUISA ELLS¹

Abstract

Background: Obesity and type 2 diabetes (T2DM) can both profoundly impact health and wellbeing. Their prevalence largely follows a social gradient. The National Health Service Low Calorie Diet programme in England aims to support people to achieve T2DM remission while also reducing health inequalities. We aimed to explore the experiences of local health service leads and identify barriers and facilitators in relation to the equitable mobilisation of the Low Calorie Diet programme.

Methods: Twenty semi-structured interviews were completed with 24 locality leads across the first two years of the Low Calorie Diet programme. Interviewees were purposively sampled from the 10 localities who undertook the Low Calorie Diet programme pilot. Each interview explored a number of topics of interest, including referrals, training, communication, incentivisation, governance and engagement, before being subjected to a thematic analysis.

Results: From the data, seven core themes were identified: COVID-19 and primary care capacity and engagement; methods of communication; approaches to training; approaches to incentivisation; approaches to referrals; barriers to referrals; and the importance of collaboration. COVID-19 presented a specific challenge to the mobilisation and delivery of the Low Calorie Diet programme; however, our findings demonstrate the large variation and differences in the approaches taken when delivering the programme across 10 geographically and demographically distinct pilot sites. We also identified a lack of a recognised approach or strategy to mobilisation and delivery support for the Low Calorie Diet programme, such as proportionate universalism, which is a social policy response to tackling health inequalities by ensuring that service delivery is equitable.

Conclusions: Health inequalities remain a significant challenge, and health service leads have the potential to adopt an equity perspective from the start of programme mobilisation. In doing so, resources at their disposal can be managed equitably and can therefore contribute to efforts to reduce the potential occurrence of intervention-generated inequalities.

Br J Diabetes 2023;23:77-85 

https://doi.org/10.15277/bjd.2023.416

Key words: T2DM, obesity, Low Calorie Diet, equity, inequalities, proportionate universalism, Re:Mission study

Introduction

Obesity and type 2 diabetes (T2DM) are both prevalent non- communicable diseases which can profoundly impact health and wellbeing.¹ In England, 64% of adults live with overweight, and of these 26% live with obesity.² It is estimated that 3.8 million adults (≥16 years) in England have diabetes, and modelled projections indicate that the National Health Service (NHS) and the wider societal costs associated with obesity and diabetes will escalate unless urgent action is taken.³

Health outcomes largely follow a social gradient: prevalence of both obesity and T2DM increase with age and area-level deprivation and among people of Black and South Asian ethnicity.^1,2,4,5 Inequalities, the unjust and avoidable differences in people’s health outcomes, have been further exacerbated by the COVID-19 pandemic,^6-8 and they also exist in access to healthcare. For example, amongst people of Black and South Asian ethnicity, inequalities in diabetes treatment and metabolic control have been evidenced in the UK.⁹ Although addressing inequalities is a public health priority,¹⁰ many interventions aimed at improving health across the entire population can be markedly more beneficial for individuals of higher socio-economic status and of White ethnicity.^11-14 This has been referred to as an inequality paradox – the occurrence of intervention-generated inequalities in interventions that aim to reduce them.¹⁵

The NHS Low Calorie Diet programme

Recent systematic reviews,^16-20 and clinical trials,^21-23 show that for some people living with or at risk of obesity and T2DM a Low Calorie Diet (LCD) achieved by Total Diet Replacement (TDR) can lead to clinically significant weight loss, support remission of T2DM and improve quality of life. The NHS Long- Term Plan made a commitment to pilot an LCD programme for people living with excess weight and T2DM.²⁴ This commitment aims to significantly improve health while reducing health inequalities and associated future costs to the NHS. NHS England, partnered with Diabetes UK, commissioned the programme delivered by commercial providers across 10 geographically diverse pilot areas using integrated care systems.²⁵ Integrated care systems are partnerships between NHS bodies, local authorities and local organisations which work together on health and care services to improve the lives of people locally. Each area tested one of three different delivery models (group, 1:1 and digital) (see Additional file 1 online at www.bjd-abcd.com). The programme was available to adults aged 18-65 years with a body mass index (BMI) ≥27 kg/m² (adjusted to ≥25 kg/m² for Black, Asian and other ethnic groups) and a T2DM diagnosis within the last six years. Full eligibility criteria were given by the NHS in 2019.²⁶ The programme aims to significantly improve health by reducing glycaemic parameters, diabetes-related medication and weight, and by achieving remission.

The delivery of the NHS LCD programme gave due regard to the reduction of health inequalities by ensuring compliance with the NHS Act 2006 and the Equality Act 2010.^27,28 The promotion of equal access by all service users, and the tailoring of a programme to support those with the greatest need through a proportionate universalism approach, was also mandated in the service specification.²⁹ Thus, health equity (the state in which people have a fair and just opportunity, irrespective of their social position, to attain their full health and wellbeing from social conditions that seek to promote and support good health),³⁰ is crucial to the delivery of the NHS LCD programme. Although the programme is delivered by commercial service providers, the local health system (primary care) is responsible for referring eligible patients to the programme. The obligations set out in the service specification, and specifically the due regard to reduce inequalities, is therefore incumbent in part on local health service leads who have responsibility for the mobilisation of the programme. This paper aims to explore the experiences of local health service leads and to identify barriers and facilitators in relation to the equitable mobilisation of the service.

Methods

This study received ethical approval from the Health Research Authority (REF 21/WM/0136), and is reported using COREQ guidelines (see Additional file 2 online at www.bjd-abcd.com).³¹ Participants from each of the first 10 Integrated Care Systems (referred to from this point as ‘localities’) who undertook the pilot programme across England were sampled. Twenty four health service leads (referred to from this point as ‘locality leads’) (20 females and 4 males) with responsibility for the mobilisation of the NHS LCD programme and employed by local integrated care systems (local commissioning lead, project manager and clinical lead) were interviewed across 20 interviews (see Additional file 1 online at www.bjd-abcd.com). Semi-structured interviews (MS Teams) lasting between 60 and 90 minutes were completed between July and September 2021 (n=10), with follow-up interviews completed in July 2022 (n=10). Interviews in 2021 were carried out by two researchers (KD and CF), who each conducted five interviews. All follow-up interviews in 2022 were conducted by KD. The interviews were semi-structured in nature, giving the interviewer control over the interview, and were designed to elicit discussion on specific topics of interest. Topics were communicated to interviewees prior to interview, and included: referrals, training, communication, incentivisation, governance and engagement. These topics were pre-empted by initial programme theory,³² developed through the overarching realist informed Re:Mission evaluation,³³ to which this study contributes. Fieldnotes were recorded after each interview.

Interviews were audio recorded, transcribed verbatim, and then subjected to a thematic analysis as described by Braun et al.³⁴ KD and CF familiarised themselves with the data by undertaking multiple readings of the interview transcripts from the interviews they conducted. Transcripts were coded using a latent coding method and the interview guide as a deductive framework for analysis. This involved abductive reasoning, or the mixing of inductive and deductive reasoning which facilitated movement between participant accounts and researcher-defined topics of interest. Following initial coding, KD, CF and KK read through a sample of transcripts as second coders to search for alternative meanings in the data that had not previously been tagged. Differing interpretations of the data were discussed. NVivo software (QS International Pty Ltd. Version 12) was used to assist this process of storing and organising textual data and initial coding.

The use of thematic analysis allowed for the identification of patterns (‘themes’) in the data. The identification, reviewing, defining and naming of themes was conducted by KD, who used inequalities as a theoretical lens for interpretation. This involved the organisation of codes by clustering them to identify what Braun etal. call ‘higher-level’ patterns in the data. Twelve and 10 themes, respectively, emerged from the data collected in 2021 and 2022. These themes were then subjected to a further interrogation by KD to consolidate themes into clusters that represented broader patterns in the data. A fourth researcher (CH) provided a greater depth of meaning in the analysis, which led to the refinement and consolidation of themes and the development of recommendations.

Findings

Upon completion of the analysis, seven core themes were constructed out of the data from both years. The following section presents these core themes, along with exemplar quotes. Further supporting quotations can be found in Additional file 3 online at www.bjd-abcd.com.

COVID-19 and primary care capacity and engagement (theme 1)
The NHS LCD programme was mobilised when primary care was experiencing COVID-19-related pressures, such as the pausing of governance processes, the vaccine rollout, and the deferral and alteration of annual diabetes reviews. By year two of the programme, interviewees discussed Covid-19-related backlogs and staffing challenges.

In this context of Covid pressures, the engagement of GP practices was mixed and variably defined. Engagement was discussed in relation to the generation of referrals in the healthcare system where, by year two, the percentages of referring practices fell between 42% and 85%. Engagement was also deduced from the number of practices that had taken part in LCD training.

Interviewees also discussed referrals being generated by a small number of practices, or even single referrers. Specifically, the capacity of referrers and their interest and passion for the NHS LCD programme were important aspects of engagement.

The engagement of practices was not only dependent on referral staff, such as GPs, practice nurses or pharmacists. Interviewees discussed the important contributions of other colleagues from the wider community, including nurse or diabetes champions, dietitians, clinical leads and care coordinators. Thus, the engagement of practices was dependent on the wider team across the whole health system.

Methods of communication (theme 2)
Interviewees discussed a multitude of methods used to communicate information about the NHS LCD programme to the local health system. These methods included internal communication channels, which typically relied on written communication such as bulletins, newsletters or emails. It was, however, ubiquitous across all interviews that these more formal means of written communication did not always reach their intended audience, either because the right gatekeepers in GP practices had not been identified, the information wasn’t passed on or because primary care staff often suffered from “bulletin blindness” (LL3 – Y1).

Methods of communication also included synchronous information sessions, either via means of attendance at existing forums, such as practice or health system meetings, or via LCD- specific sessions such as drop-in sessions or diabetes education events. Information sessions were predominantly delivered remotely via video conferencing, with in-person sessions starting by July 2022. The use of existing forums was seen as the most successful method of communication.

Interviewees were unanimous about the need to find as many methods of communication as possible; three localities discussed using more informal and unstructured methods of communication, such as an MS Teams channel, WhatsApp group or lunch and learn session. These methods of communication were seen as successful because they dealt with the issues of “bulletin blindness” while providing a means of reaching referral staff via more unstructured and informal means.

During mobilisation, communication was focused on practices. However, in year two, five localities reported communicating directly to patients, including via Facebook, press releases, audio visuals in GP waiting rooms, diabetes events and at the end of structured education for diabetes.

Approaches to training (theme 3)
Interviewees discussed their localised approach to the adoption of training to support the mobilisation and delivery of the NHS LCD programme. Nine localities made training available - defined as a resource additional to the dissemination of written information – by providing synchronous webinars and their recordings for asynchronous viewing. One locality did not make training available since it was not thought necessary.

Training was typically delivered by a team, including locality leads, IT support staff, providers and clinical leads, with an emphasis on clinical leads being important for addressing the concerns of referral staff. The frequency of training varied but was overall provided infrequently across both years of data collection, with fewer synchronous sessions provided in year two.

The aim of training varied between localities. It was made mandatory by four localities because it was perceived to lead to a higher proportion of eligible referrals and thought to be better for referral staff and patient safety. Conversely, training was made optional by five localities because participation in the programme was voluntary, and because mandatory training was seen as a barrier to generating referral numbers. The need for training overall coalesced around the needs to address referrals barriers, ineligible referrals and to improve engagement amongst GP practices.

There were no national requirements on the use of training, and therefore training was managed based on local resources (time of key stakeholders), the views and experiences of locality leads and clinical leads, and in line with local approaches to training more broadly. Moreover, any training that was put in place and described by locality leads did not address inequalities.

Approaches to incentivisation (theme 4)
Reimbursement systems are intended to create incentives to achieve policy objectives or health-related targets.35 During mobilisation of the NHS LCD programme, four localities deployed incentivisation while a further two had their plans to incentivise delayed by COVID-19. As a result, by the second year of data collection, six localities were offering localised incentivisation, which varied in the amount and the time of payment. For example, one locality paid £200 per practice for attendance at LCD training. Three localities paid between £10.30 and £75 for each referral; one locality also paid £41.20 for patients starting TDR while a second paid an additional £10 for programme completion. A fifth locality paid £90 for starting TDR. A sixth locality introduced a local improvement scheme and paid GP practices a one-off sum of £150 for making a referral to the programme, as well as £20 at six and 12 months for the completion of GP reviews.

There was also variation in the reasons for incentivising. For some localities, incentivisation was deployed as a means of increasing the number and eligibility of referrals. Other interviewees discussed incentivising as a means of just remittance for the increased work of referral to the programme. There was an element of opportunism to incentivisation locally, and plans were devised in line with other services, or because the money was available.

The remaining four localities reasoned that incentivisation did not increase the number or improve the quality of referrals, or stated that they did not have sufficient funds to incentivise.

During the second year of the programme, the NHS added the NHS LCD programme to the national weight management incentivisation scheme.36 To maximise referrals to weight management services, during the second year the programme was included in the Weight Management Enhanced Service which enabled practices to claim a payment of £11.50 for each individual referred who was eligible for the enhanced service payment, and within an allocation limit of 20% of the number of patients on the practice’s obesity register. Thus, all 10 localities had a form of incentivisation as well as their localised approaches to incentivisation.

Approaches to referrals (theme 5)
Five localities staggered the rollout of participating practices over a period of 1 to 12 months due to capacity issues and the need to provide training before practices could refer. Yet, despite these differing approaches taken during mobilisation, all localities were required to adopt an open referral policy, namely that any eligible patients could be referred within the referral limits at any time. The main reasons given for this approach were that an open referral policy facilitates high referral numbers and is considered fair or provides an equality of opportunity.

In the first year of the programme, five localities allocated referral places at either a practice or area level, thus putting some caps on referral numbers. These allocations were typically based on diabetes prevalence locally: for example, one locality initially allowed practices to refer 1% of their registered population with T2DM. The remaining localities did not allocate referral places since they did not want to add barriers to the generation of referrals. However, all five localities that initially used a referral allocation had removed that cap to encourage increased referral numbers by the second year of the programme.

During the second year of data collection, a greater number of localities subsequently discussed monitoring referrals to see who refers before taking action to target individuals or areas where the number of referrals were low or not representative of the population. Given this practice of monitoring referral numbers, inequalities or inequities were not considered or addressed in the management of referrals by all localities from the start of the programme or were only starting to be considered during the latter stages of the programme. Some localities discussed a focus on inequalities as taking time, not being conducive to referral generation and an aspect to have been discussed only following the first year of the programme.

Barriers to referrals (theme 6)

By the second year of the programme the majority of locality leads reflected that referral numbers were below their referral trajectories. This resulted in frustrations: it was felt that referral numbers did not reflect the work locality leads were putting into the programme, which in turn resulted in a sense that some localities just did not know what worked to generate increased referrals.

In this context of low referral numbers, multiple referral barriers were discussed by interviewees. They include process-based barriers such as ineligible referrals, the time needed for a referral and the fact that it was considered complicated.

Referrer-based barriers were also discussed, such as staff turnover in the local health system and referrer confidence and expertise.

Some locality leads also discussed a lack of database searches to identify eligible patients. Instead, and to varying degrees, all localities relied on opportunistic referral touch points, such as annual reviews, to identify eligible patients. However, with COVID-19-related disruption and the reliance on staff engagement in the local health system, localities discussed a lack of opportunistic referral touch points.

A number of localities had started to address these barriers, and in doing so made the referral process easier for referral staff. At the time of data collection, at least one locality had developed a referral pop-up and had shared it amongst several other localities. The referral pop-up maximised opportunistic touch points by prompting referral staff to discuss the programme with eligible patients, whilst also alleviating the need to run searches. Another locality was potentially providing additional staff to run searches, whilst three other localities were trying to increase referral touch points by involving clinical pharmacists, dietitians and care coordinators in the referral process.

The importance of collaboration (theme 7)
Locality leads discussed the importance and positive impact of collaboration with fellow public health colleagues in mobilising and supporting the delivery of the NHS LCD programme. Steering groups, and to a degree programme boards, which was protected leadership time, enabled oversight of the programme and brought together a broad representation of people who could share ideas and converse constructively about the challenges of delivering the programme. Despite some COVID-19 disruption, these governance structures were largely unchanged across the two years of the programme.

The notion of collaboration also includes the role of the provider and their contributions towards the mobilisation and delivery of the programme. Provider representatives attended LCD engagement events, contributed to the delivery of training and sat on steering groups. Overwhelmingly, the relationship between the locality leads and providers was discussed positively. These views of the providers are held in a context where the locality lead role has been filled by a number of different staff with different levels of experience, and where those in post have reported having numerous other responsibilities. Locality leads reported having other pressures which limited the time they could spend on the NHS LCD programme but overall the support and time put in from the provider enabled delivery to progress.

Discussion

In this paper we have provided insights from the evaluation of the NHS LCD programme (which will be renamed NHS Type 2 Diabetes Path to Remission Programme when rolled out nationally in June 2023) by exploring the experiences of NHS staff involved in the mobilisation within the wider local health system. A significant investment for the NHS, the NHS LCD programme is based on outcomes from two recent UK clinical trials.^21,22 However, translating controlled clinical trials into routine service delivery remains a significant challenge. The data presented in this paper elucidate this challenge by highlighting the approaches and context in which the NHS LCD programme is being delivered, and contribute to a larger programme evaluation (Re:Mission study).^33,37

At its most fundamental level, our findings demonstrate the variation and differences in the approaches taken when mobilising the NHS LCD programme. Key aspects of these approaches, such as training, incentivisation and management of referrals (allocation, rollout to practices), and the human and financial resource they depend on, were utilised, and were justified differently across the 10 pilot localities. COVID-19 presented a specific challenge, which meant the programme was mobilised and delivered in a context that undoubtedly had a constraining influence on the capacity and capability of the local health system. The findings also highlight a lack of focus on proportionate universalism, and although delivery is ultimately the responsibility of the service providers, local health systems could play a more prominent role in driving this agenda through the mobilisation process.

Despite an ongoing debate about the use of targeted and universal strategies to address health inequities,³⁸ proportionate universalism is an example of a policy approach or strategy considered appropriate for tackling the social gradient in health. Marmot defines proportionate universalism as universal actions “with a scale and intensity that is proportionate to the level of disadvantage” and calls for a combination of universal and targeted actions.⁵ Proportionate universalism, therefore, is conceived as a social policy response to inequities – the state in which people do not have a fair and just opportunity to attain health. This is important because it is inequities that create, perpetuate and exacerbate inequalities: inequalities or the social gradient in health are the manifestation of inequities.^10,30

An equity perspective from the start
During the first year of data collection, five of the 10 localities adopted referral allocations based on the size of eligible populations. While these localities did not explicitly target specific populations, by considering how eligibility was distributed they adopted a ‘secondary’ level of targeting within their referral policy. This level of targeting is considered secondary because it ensures that areas or practices with the highest need are given more opportunities to refer but does not take measures to ensure that certain groups within these areas or practices subsequently receive referrals.

Our findings show that the targeting, or the equitable distribution of referrals, was not something adopted by all localities. For localities that started with referral allocations, there was a tension between generating referrals and doing so equitably. Specifically, despite the best intentions of some localities, there was a tension between generating referrals equitably and utilising all the places available, and therefore maximising the benefit from the NHS LCD programme for the whole population. While the lack of a referral allocation may result in referrals coming from a small number of practices, it is possible these referrals are generated equitably. Nonetheless, referral allocations adopted in year one were later changed in order to meet overall referral numbers, which often relied on a small number of practices or referral staff. A lack of commitment to concrete action to reduce inequalities in local systems has previously been reported.³⁹ Yet, following the ratification of the Health and Social Care Act 2012, local health systems have had an increased responsibility to address inequalities in access to health and health outcomes.⁴⁰

To address inequalities, or achieve equitability, there is a need for a suite of measures at varying levels, including at a national or policy level, organisational or planning level (local health systems), service delivery level and at lifestyle level.^41-45 By implication, there is also a need to adopt an equity perspective from the start, as a degree of responsibility for identifying and addressing the inequities in healthcare falls upon those doing public health work.⁴⁶ The organisation and planning of resources at a local health systems level can be managed within a proportionate universalism approach. As a result, the decisions that locality leads make regarding the organisation and planning of resources at a local health system level have an impact on the equitability of programme delivery and should be duly considered.

A health equity impact assessment (HEIA), a process of exploring or mitigating the impacts of decisions on inequalities during decision making, is one such tool that encourages an equity perspective from the start.⁴² A HEIA can act as a catalyst to equity-focused organisational change and can improve health equity by promoting and encouraging considerations of health equity in policies and programmes, such as the deployment of resources at the disposal of local health systems. The local completion of an HEIA has been recommended by Public Health England,⁴⁴ who advocated positioning health equity at the heart of all strategies and policies across local health systems. Doing this can reduce the negative impact of policy and programmes that could further widen health inequalities.⁴²

Managing resources equitably
Overall, our findings demonstrate the importance of training for addressing referral barriers and ineligible referrals and for improving engagement amongst GP practices. The use of information sessions proved effective at communicating information about the programme to the local health system, especially in light of the phenomenon of “bulletin blindness”, where written communications do not always reach referral staff. Therefore, training and/or synchronous information sessions can be considered important in enabling the effective referral of eligible patients to the NHS LCD programme. For example, our findings show that barriers to referrals include referrer-based barriers, many of which can be addressed by providing appropriate training. The depth of knowledge of participating stakeholders in the health system, and the subsequent need for training, have been shown to be important for the effective delivery of large diabetes programmes.⁴⁷

There is also a need to consider the proportionality of service resourcing and provision when delivering health-based interventions. Time could be distributed differentially at a planning or organisational level, for example, by delivering training amongst GP practices proportionate to their need, judged by the prevalence of T2DM in their population or their level of engagement across multiple programmes. However, our results show that time was not managed equitably by all participating localities, because training and synchronous information sessions were delivered variably.

Many localities were reactive in allocating additional time and resources to support practices or areas with lower rates of referral. There was less evidence of proactive allocation of time and resources at the initial stages of mobilisation to avoid potential development of intervention-generated inequalities in referral rates at the outset. Many localities did not use resources and time proportionately from the start, thus missing a potential opportunity to adopt an equity perspective in service resourcing and provision. Indeed, where local health systems have allocated resources that are proportionate to need, instead of simply supporting those who are easiest to support, proportionate universalism has been an effective policy approach.⁴⁴

The introduction of incentivisation has been associated with an improvement in quality of primary care for people living with diabetes.⁴⁸ However, we found that economic resource, used as an incentive, missed a potential opportunity to use financial incentives to address inequalities.⁴⁹ As a consequence, the actions of locality leads run the inherent risk of exacerbating existing inequalities if patients who are more likely to achieve favourable outcomes are selected.⁵⁰ There is limited evidence to support the use of incentives to address inequalities, and it has been suggested that resource allocation matched to increased needs might have a greater impact on health inequalities than incentivisation.³⁵ Nonetheless, the approaches to incentivisation have the potential to contribute to a more equitable programme and should be considered through an equity lens. This is important, because any programme that does not take due diligence towards equities runs the risk of becoming an inequality paradox, becoming markedly more beneficial for individuals of higher socio-economic status and of White ethnicity.

The importance of collaboration within the local health system was also demonstrated in this study. A close working relationship with providers,⁵¹ and community involvement to identify services users,⁴⁷ have also been reported by others. The presence of a Steering Group was more often than not discussed as an important part of the NHS LCD programme, which presented an ideal location for the equitable management of resources. Findings from this work help to build a comprehensive picture of the programme mobilisation, which will be further supported by insights from NHS staff responsible for patient referral to the programme.

Limitations

This is the first study to explore the experiences of local health service leads with the responsibility for the mobilisation of a national Low Calorie Diet programme of this nature in real-world settings. However, there are a number of limitations to the current study. 1) The programme was mobilised in the middle of the COVID-19 pandemic, which placed significant strain on the health system and will have undoubtedly impacted programme mobilisation. 2) The wider health system, including the position of locality lead, experienced a high turnover of staff during this tumultuous period, meaning that follow-up interviews were often conducted with different personnel, which will have impacted consistency in the findings between the first and second years. 3) These findings alone do not permit us to conclude which approaches and methods are the most successful when judged against their impact on the identification and generation of referrals. Instead, we have attempted to share the perspectives of locality leads, and as we move away from first order constructs, we have shared our interpretations of the data using inequalities as a lens for interpretation. 4) There is also a need to consider the impact on equity at a national or policy level, which in the case of the current study precedes the actions of locality leads and therefore has not been considered. This is important as an equity perspective from the start needs to consider policy, which has not always been presented convincingly.^52,53

Recommendations

Based on our findings, the following recommendations may help inform the equitable mobilisation of the NHS LCD (and similar) programmes at a local health system level in the future.

1. Localities could consider an approach to addressing inequalities at the start of programme mobilisation, such as a local HEIA, and review it regularly to ensure it remains fit for purpose.
2. Training and/or information sessions could be delivered equitably, for example by prioritising delivery to parts of the local health system with a high proportion of eligible patients and/or low engagement.
3. Financial incentivisation can be used to increase the equity of the NHS LCD programme, but should be measured to ensure this is For example, outcome incentives, whereby practices receive payment for the number of patients referred, have been shown to stimulate more participation.⁵⁴ However, they could also adopt an equitable perspective, or be proportionate to the prevalence of T2DM locally, by paying more to areas with a greater need.
4. Built on the collaboration within the wider health system, a means of regularly monitoring uptake in addition to adopting an equity perspective from the start is reasonable, as is responding to this data in a timely manner to address any emerging inequalities.

Conclusions

Health inequalities remain a significant challenge. While the healthcare system may not be able to remedy inequalities that transcend healthcare, such as socioeconomic inequalities, we should expect that the healthcare system does not exacerbate existing inequalities. It is important that health service leads adopt an equity perspective from the start of any new service mobilisation, and in doing so manage resources equitably. This will help to reduce the potential occurrence of intervention- generated inequalities and avoid the possibility of programmes becoming an inequality paradox. Perhaps only when inequities are considered at a planning or organisational level can we expect to see more favourable outcomes in health and access to healthcare between different socio-demographic groups.

Conflict of interest Dr Chirag Bakhai is a primary care advisor to the national diabetes programme for NHS England and NHS Improvement.

Funding This work was supported by the National Institute for Health Research, Health Services and Delivery Research [NIHR 132075]. The NHS England Low-Calorie Diet Pilot is funded by NHS England.

Author contributions LE secured funding for the Re:Mission study, and with CH, DR and KD designed the outline for the current work and managed access with NHS England. KD and CF conducted fieldwork. KD, CF, KK and CH contributed to the analysis of data. All authors contributed to drafts of this paper and have reviewed and agreed this final draft that is submitted for publication.

Editorial note Acknowledgements, references and additional files can be viewed online.

ORCID ID: Kevin Drew - https://orcid.org/0000-0003-0149-2521

Acknowledgement The authors would like to acknowledge Clare Helm from NHS England, who has worked on the coproduction of this study; identification of study aims, gatekeeper to participants who were previously unknown to the interviewers and provided feedback on an earlier draft of this manuscript.

The authors would also like to acknowledge the Patient and Public Involvement team that have worked on the coproduction of the Re:Mission study, including Ken Clare, Abimbola Ojo, Jennifer Teke, Mike Willis, Gulsoom Akhtar, Beth Clegg and Clair Goddard.

Members of the steering and oversight groups are also acknowledged by the authors for their input and involvement in the Re:Mission study, including the clinical leads Dr Mark Ashton and Dr Chirag Bakhai.

The Re:Mission study includes a multidisciplinary team of academics from across the North of England. The authors would like to acknowledge all members of the team including Dr Jamie Matu, Prof Jim McKenna, Dr Susan Jones, Pat Watson, Dr Simon Rowlands, Dr Tanefa Apekay, Dr Stuart Flint, Prof Janet Cade, Dr Adam Martin, Dr Maria Bryant, Dr Jordan Marwood, Dr Tamara Brown, Dr Wendy Burton, Mick Martson, Pooja Dhir and Tamla Evans.

Declarations The views expressed in this paper are those of the authors and not necessarily those of the NHS or the National Institute for Health Research.

Ethics approval and consent to participate All methods were carried out in accordance with relevant guidelines and regulations. The Re:Mission study was granted ethical approval by the Health Research Authority (HRA) on 5 July 2021, REC ref: 21/WM/0136. Participants provided both oral and written informed consent to participate in the Re:Mission study, including consent for publication.

Consent for publication Not applicable.

Availability of data and materials The datasets generated during this current study are not publicly available for reasons of privacy and confidentiality, and because of the inability to de-identify the data. Additional knowledge about the data can be available from the corresponding author on reasonable request.

Additional File 1 presents an overview of pilot areas, delivery models and programme structure. Additional File 2 provides an overview of the COREQ checklist. Additional File 3 provides further quotations from the data. These additional files can be viewed online.

References

1. Gatineau M, Hancock C, Holman N, etal. Adult obesity and type 2 diabetes. London: Public Health England, 2014: 5-14.
2. NHS Digital. Health Survey for England, 2021 part 1. London: National Statistics, https://digital.nhs.uk/data-and-information/publications/statistical/health-survey-for-england/2021
3. Public Health England. Diabetes prevalence model. London: Public Health England, 2016. https://assets.publishing.service.gov.uk
4. Marmot The Health Gap: the challenge of an Unequal World. London: Bloomsbury, 2015.
5. Marmot M. The Marmot review: Fair society, healthy lives. The Strategic Review of Health Inequalities in England Post-2010. London: The Marmot Review, PublicHealth 2012;126 (Suppl 1): S4-S10. https://doi.org/10.1016/j.puhe.2012.05.014
6. Green H, Fernandez R, MacPhail The social determinants of health and health outcomes among adults during the COVID‐19 pandemic: A systematic review. Public Health Nursing 2021;38(6):942-52. https://doi.org/10.1111/phn.12959
7. Marmot M, Allen J, Goldblatt P, etal. Build Back Fairer - The COVID-19 Marmot Review. The Pandemic, Socioeconomic and Health Inequalities in England. London: Institute of Health Equity, 2020.
8. Khunti K, Feldman EL, Laiteerapong N, et al. The impact of the COVID-19 pandemic on ethnic minority groups with diabetes. Diabetes Care 2023;46(2):228-36.
9. Ricci‐Cabello I, Ruiz‐Perez I, De Labry‐Lima AO, et al. Do social inequalities exist in terms of the prevention, diagnosis, treatment, control and monitoring of diabetes? A systematic review. Health Soc Care Community 2010;18(6):572-87. https://doi.org/10.1111/j.1365-2524.2010.00960.x
10. Bleich SN, Jarlenski MP, Bell CN, et al. Health inequalities: trends, progress, and AnnuRevPublicHealth 2012;33:7-40. https://doi.org/10.1146/annurev-publhealth-031811-124658
11. Cleland CL, Tully MA, Kee F, et al. The effectiveness of physical activity interventions in socio-economically disadvantaged communities: a systematic Prev Med 2012;54(6):371-80. https://doi.org/10.1016/j.ypmed.2012.04.004
12. Lorenc T, Oliver Adverse effects of public health interventions: a conceptual framework. J Epidemiol Community Health 2014;68(3):288-90. https://doi.org/10.1136/jech-2013-203118
13. Alvaro C, Jackson L, Kirk S, et al. Moving Canadian governmental policies beyond a focus on individual lifestyle: some insights from complexity and critical Health Promotion International 2010;26(1):91-9. https://doi.org/10.1093/heapro/daq052
14. Whyte MB, Hinton W, McGovern A, et al. Disparities in glycaemic control, monitoring, and treatment of type 2 diabetes in England: a retrospective cohort PLoS Medicine 2019;16(10):e1002942. https://doi.org/10.1371/journal.pmed.1002942
15. Frohlich KL, Potvin L. Transcending the known in public health practice: the inequality paradox: the population approach and vulnerable populations. Am J Public Health 2008;98(2):216-21. https://doi.org/10.2105/AJPH.2007.114777
16. Castellana M, Conte E, Cignarelli A, etal. Efficacy and safety of very low calorie ketogenic diet (VLCKD) in patients with overweight and obesity: a systematic review and meta-analysis. Rev Endocr Metabolic Dis 2020;21(1):5-16. https://doi.org/10.1007/s11154-019- 09514-y
17. Sellahewa L, Khan C, Lakkunarajah S, etal. A systematic review of evidence on the use of very low calorie diets in people with Curr Diabetes Reviews 2017;13(1):35-46. https://doi.org/10.2174/1573399812666151005123431
18. Caprio M, Infante M, Moriconi E, et al. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest 2019;42(11):1365-86. https://doi.org/10.1007/s40618-019-01061-2
19. Rehackova L, Arnott B, Araujo-Soares V, et al. Efficacy and acceptability of very low energy diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta‐analyses. DiabeticMed 2016;33(5):580-91. https://doi.org/10.1111/dme.13005
20. Astbury NM, Piernas C, Hartmann-Boyce J, etal. A systematic review and meta-analysis of the effectiveness of meal replacements for weight loss. Obesity Rev 2019;20(4):569-87. https://doi.org/1111/obr.12816
21. Lean ME, Leslie WS, Barnes AC, etal. Durability of a primary care- led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster- randomised trial. Lancet Diabetes Endocrinol 2019;7(5):344-55. https://doi.org/10.1016/S2213-8587(19)30068-3
22. Astbury NM, Aveyard P, Nickless A, et al. Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial.BMJ 2018;362: k3760 https://doi.org/10.1136/bmj.k3760
23. Ard JD, Lewis KH, Rothberg A, et al. Effectiveness of a total meal replacement program (OPTIFAST program) on weight loss: results from the OPTIWIN Obesity (Silver Spring) 2019;27(1):22-9. https://doi.org/10.1002/ony.22303
24. NHS The NHS Long Term Plan. NHS, 2019.
25. Bhat K, Easwarathasan R, Jacob M, et al. Identifying and under- standing the factors that influence the functioning of integrated healthcare systems in the NHS: a systematic literature BMJ Open 2022;12(4):e049296. https://doi.org/10.1136/bmjopen-2021-049296
26. Low calorie diets to treat obesity and type 2 diabetes. 2019 [Available from: https://www.england.nhs.uk/diabetes/treatment-care/low-calorie-diets/.
27. National Health Service Act 2006, Stat. c41 (2006). https://legislation.gov.uk
28. Equality Act 2010, c15 (2010). https://www.legislation.gov.uk
29. NHS England and NHS Improvement. NHS Low Calorie Diet Programme – face to face [one to one/group] delivery model - Service Specification. England, 2019. https://www.england.nhs.uk
30. Williams O, Coen SE, Gibson Comment on: “Equity in physical activity: a misguided goal”. Sports Med 2019;49:637-9. https://doi.org/10.1007/s40279-018-01047-9
31. Tong A, Sainsbury P, Craig Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007;19(6):349-57. https://doi.org/10.1093/iintqhc/mzm042
32. Pawson R. The science of evaluation: a realist manifesto. Sage Publications, https://doi.org/10.4135/9781473913820
33. Ells L, Radley D, Homer A coproduced mixed method evaluation of the NHS England Low-Calorie Diet implementation pilot. Protocol 2021, 12th March 2021. https://fundingawards.nihr.ac.uk/award/NIHR132075
34. Braun V, Clarke V, Weate Using thematic analysis in sport and exercise research. In: Smith B, Sparkes AC, editors. Routledge Handbook of Qualitative Research in Sport and Exercise. London: Routledge, 2016, 191-205.
35. Tao W, Agerholm J, Burström B. The impact of reimbursement systems on equity in access and quality of primary care: a systematic literature review. BMC Health Services Res 2016;16(1):1-10. https://doi.org/10.1186/s12913-016-1805-8
36. NHS Enhanced Service Specification Weight management 2022/23 - Version 1. NHS; 2022. https://www.england.nhs.uk
37. Re:Mission. Re:Mission - An Evaluation of the NHS Low Calorie Diet Programme 2020 [Available from: https://www.remission.study/.
38. Fisher M, Harris P, Freeman T, et al. Implementing universal and targeted policies for health equity: lessons from Int J Health Policy Manage 2022;11(10):2308-18. https://doi.org/10.34172/ijhpm.2021.157
39. Olivera JN, Ford J, Sowden S, et al. Conceptualisation of health inequalities by local healthcare systems: a document analysis. Health Soc Care Community 2022;30(6):e3977-e3984 https://doi.org/10.1111/hsc.13791
40. Health and Social Care Act 2012. [Available from: legislation.gov.uk/ukpga/2012/7/contents/enacted.
41. Ford J, Sowden S, Olivera J, etal. Transforming health systems to reduce health FutureHealthcJ 2021;8(2):e204-e209. https://doi.org/10.7861/fhj.2021-0018
42. Sadare O, Williams M, Simon Implementation of the Health Equity Impact Assessment (HEIA) tool in a local public health setting: challenges, facilitators, and impacts. Can J Public Health 2020;111(2):212-19. https://doi.org/10.17269/s41997-019-00269-2
43. Peeters A, Backholer How to influence the obesity landscape using health policies. Int J Obesity 2017;41(6):835-9. https://doi.org/10.1038/ijo.2017.24
44. Public Health Local action on health inequalities: tackling health inequalities through action on the social determinants of health: lessons from experience. London: Public Health England, 2014.
45. Mackenzie M, Hastings A, Babbel B, et al. Proportionate universalism as a route to mitigating health inequalities? Exploring political, policy and practice uncertainties in times of In: Fee D, Kober-smith A, editors. Inequalities in the UK. Bingley: Emerald Publishing Limited; 2017. ISBN:978-1-78714-480-4
46. Brassolotto J, Raphael D, Baldeo N. Epistemological barriers to addressing the social determinants of health among public health professionals in Ontario, Canada: a qualitative CriticalPublic Health 2014;24(3):321-36. https://doi.org/10.1080/09581596.2013.820256
47. Rodrigues AM, Haste A, Penn L, et al. Stakeholders’ perceptions and experiences of the National Health Service diabetes prevention programme in England: qualitative study with service users, intervention providers and deliverers, commissioners and BMC Health Services Res 2020;20:1-13. https://doi.org/10.1186/s12913-020-05160-2
48. Kontopantelis E, Reeves D, Valderas JM, et al. Recorded quality of primary care for patients with diabetes in England before and after the introduction of a financial incentive scheme: a longitudinal observational study. BMJ Quality Safety 2013;22(1):53-64. https://doi.org/10.1136/bmjqs-2012-001033
49. Oliver A, Brown A consideration of user financial incentives to address health inequalities. JHealthPolPolicyLaw 2012;37(2):201-26. https://doi.org/10.1215/03616878-153602
50. Koshy E, Millett The ‘Quality and Outcomes Framework’: improving care, but are all patients benefiting? SAGE Publications Sage UK: London, England; 2008, 432-3.
51. Shaw SE, Smith JA, Porter A, et The work of commissioning: a multisite case study of healthcare commissioning in England’s NHS. BMJ Open 2013;3(9):e003341. https://doi.org/10.1136/bmjopen-2013-003341
52. Carey G, Crammond B, De Leeuw EJ. Towards health equity: a framework for the application of proportionate Int J Equity Health 2015;14(1):81. https://doi.org/10.1186/s12939-015-0207-6
53. Coggon J, Adams ‘Let them choose not to eat cake...’: Public health ethics, effectiveness and equity in government obesity strategy. Future Healthc J 2021;8(1):49-52. https://doi.org/10.7861/fhj.2020-0246
54. McManus E, Elliott J, Meacock R, et al. The effects of structure, process and outcome incentives on primary care referrals to a national prevention Health Economics 2021;30(6):1393-416. https://doi.org/10.1002/hec.4262

Additional file 1 Drew et al

Overview of the first 10 localities commissioned by NHSE

Geographical locations of the ten pilot sites; updated to April 2021 Integrated Care System configurations: taken from the Strategic Health Asset Planning Evaluation tool (SHAPE)

The NHS Low Calorie Diet programme delivery structure

The four providers used different total diet replacement (TDR) product brands with large differences in range of products and flavours available. One provider provided six different options (soups and shakes) while a second provided 89 different options (soups, shakes, smoothies, bars, breakfasts and pre-prepared meals). The other two providers provided 15 (soups, shakes, smoothies and porridge) and seven (soups, shakes and bars) options, respectively.

Interviewees in 2021 and 2022

Additional file 2 Drew et al

Consolidated criteria for reporting qualitative studies (COREQ): 32-item checklist

Developed from:

Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Intl J Quality in Health Care 2007; 19(6): 349 – 57.

Personal characteristics:

Dr Kevin J Drew PhD (Male). Post-doctoral Research Fellow with 7 years’ experience of conducting qualitative evaluations of health-based interventions.

Dr Catherine Homer PhD (Female). Senior Research Fellow with experience working in academia and extensive experience working in public health.

Dr Duncan Radley PhD (Male). Reader with 25 years’ experience conducting obesity research, and previously research manager in weight management service providers.

Charlotte Freeman (Female). Project Research Assistant with experience of evaluating interventions in academia and experience of working in public health.

Karina Kinsella MRes (Female). Research Officer for the Re:Mission study with experience of evaluating interventions.

Dr Maria Maynard (Female). Professor of Health Inequalities, specialising in the patterning of health by ethnicity and migrant status, with extensive experience of programme evaluation.

Dr Chirag Bakhai (Male). General Practitioner, Clinical Lead on the Re:Mission study oversight group and Primary Care Advisor to the NHS Diabetes Programme.

Dr Louisa Ells (Female). Professor of Obesity with a specialist interest in multi- disciplinary, cross-sector applied obesity research, with extensive experience of leading programme evaluations.

Additional file 3 Drew et al

Additional quotations

Covid 19 and primary care capacity and engagement (theme 1)

Year one – theme 1: Covid-19 added pressures to primary care
“I think, to be honest I think a lot of it depends on what the asks of primary care at the time are. So obviously you know when they're doing the Covid vaccination programme, then that's going to be, you know top priority and then as we kind of go into the flu season and the booster programme, then you know that that is a primary focus so” (LL2 – Y1).

“They, it might affect take up by the patient and over the last year diabetic reviews have been a bit different in, in not so much of it has been face-to-face, where there might not be quite so many opportunities for those face-to-face conversations” (LL5 – Y1).

“We would see the, you know, oh great, I get 75 pounds if I do this here, you know I'll call all of my diabetics in. It hasn't been about that. GPs have not had the headspace. They've been flat out doing you know all sorts of things around Covid” (LL13 – Y1).

“A lot of response I’ve had back is that Covid priorities in primary care has just kicked this to the back of the queue” (LL15 – Y1).

Year one – theme 10: mixed engagement with the LCD programme
“We then see probably at the moment a 50% drop off, which obviously means we're only having about 25% of an area train and refer” (LL9 – Y1).

“And then what we found was actually not every practice wants to be involved. Perhaps just over 50, 60% of practices are keen, the others for whatever reason, are short staffed or whatever with the pandemic, so they haven't got involved” (LL11 – Y1).

Year one – theme 11: staff on the ground matter for the engagement of pilot sites
“Recently I've been in contact with a couple of the dietitians in [sub-area 2], [sub- area 3], [sub-area 4] and [sub-area 5]. They've got dieticians in their PCN supporting them, so they've run searches. So, they're doing it on behalf of the practice” (LL15 – Y1).

“We had a very outspoken GP even before we’d actually got, been appointed successfully as a pilot site who was copying in GPs all over the county saying, well, this is really dangerous, everyone’s gonna die of heart attacks and strokes and all sorts and raising a lot of fear I think. So he's taken a bit of managing but we've got him sorted” (LL11 – Y1).

Year two – theme 1: the continued impact of Covid to primary care
“I think our referrals haven't been amazing and it's disappointing because I think as a steering group, [LL18], I'm sure you'd agree like we come up with amazing ideas and we've got a great team around us and kind of we're doing as much as you know we think we could do and we've still not seen like a significant increase in the referrals. But I do, we obviously can't blame everything on Covid, but I do think that that has been a, a significant kind of factor to that” (LL17 – Y2).

“Well, the continuing impact is you know, the pressure on primary care to increase access, you know for patients to be able to get into them and that's taken their priority really. So the fact that we got so many practices that actually signed up to it this, signed up to do it this year is, is good. I think you know that it shows that perhaps they're coming out of totally focusing on Covid and starting to look at other areas” (LL19 – Y2).

“We're still on the catch up programme and ensuring that the people we do know about are treated well. But the case finding hasn't even started and obviously the more people that are identified, the more people that are eligible for the programme” (LL20 – Y2).

Year two – theme 10: engagement with practices has been mixed, as the capacity, interest and passion of staff on the ground make a difference
“I think it's probably dependent on the GPs and kind of what their kind of specialist interests are. We've got kind of GP champions for diabetes across different patches. And so, you can almost guarantee that where there's a diabetes champion, there's gonna be uptake” (LL17 – Y2).

“90 out of 160 signed up. But of those, nine have made 51% of the referrals” (LL 19 – Y2).

“We have some more practices that have joined, but just to give you an estimate, yeah it's about 42% of practices” (LL14 – Y2).

Methods of communication (theme 2)

Year one – theme 7: finding as many ways to communicate with practices as possible
“I guess we, we needed to think about what communication channels are available to us. The GP Bulletin is sort of like the agreed mainstay of how we communicate with our practices because there was a time before where Practice Managers would get multiple communications from various bits of the CCG” (LL12 – Y1).

“Yeah I mean you’ll get some practices that will monitor their generic inbox every day and they’ll cascade it because they use it. There might be other practices that don't use it as, as more frequently. It's just, I guess it's difficult because every practice has their own process for this sort of thing and they all work differently. So it's just finding as many ways to get into, get into that as possible I guess” (LL15 – Y1).

Year one – theme 8: unstructured and informal means of communication support the reach of disseminated information
“Yeah, it's every other month for the GP bulletin. Again, we want to avoid like sending out too many and people just sort of then just skimming over it, I don’t know, bulletin blindness, but and then I think it will be a case by case basis or keeping an

eye on referral numbers and then do some targeted trying to go to local meetings when we can” (LL3 – Y1).

“The lunch and learn sessions have been quite popular and I think that's because they're informal, and they can just drop in and out of them. So you know sometimes when you go to training and you think I know all this, but you've got to sit through it anyway. I think that informal setting has been helpful because you know, they're time limited as well, so I think if they know they only need to be in a call for five minutes to ask a question I think that would encourage someone to just pop in and ask a question” (LL15 – Y1).

Year two – theme 7: continue, as in the first year, to find as many ways to communicate information about LCD as possible
“Other than that, we haven't really done anything outside of what I would class as kind of normal communications, so that's kind of been through CCG newsletters. We’ve done some social media work. So it was diabetes week couple of weeks ago” (LL16 – Y2).

“No, because we used the standard, the standard channels which was the newsletter and and where we've had an opportunity, or the providers had an opportunity getting a nurse forum or practice manager meeting just to publicise. And that's just like I say a short presentation saying this is the programme, these are the outcomes we're getting, this is how to refer in. So, it's it's just using those same channels and just repeating really” (LL12 – Y2).

“No, only that we talk about it at the end of all our structured education for diabetes. So every patient who gets referred, which is a significant number at the end of every session, we talk about the LCD and how to get referral and if they're interested, we give them information to go away with. So again just they at least they then go back, can go back to their GP surgery, and even if they've not mentioned it, at least the patient’s got the control of that, whether they bring it up or not” (LL18 – Y2).

Year two – theme 8: unstructured and informal means of communication support the reach of disseminated information
“I think it's really hard to say. I think one of the things that I think could possibly happen, so if there's any kind of e-mail comms, it goes to one e-mail inbox. But you know how the practices, how the practices themselves manage and you know comms within a practice and how that information filters down to different roles. You know, I don't know how that happens and I, based on some individuals reaching out to be like oh, I'd love my practice to sign up to LCD, and actually they're already signed up. It kind of shows a bit of a breakdown of communication within the practice I think” (LL14 – Y2).

“We also drip feed so we have as part of the training session we ask people if they want to become part of the [area] WhatsApp group which is run by our clinical lead. So [colleague] would have” (LL20 – Y2).

“More recently [provider] have actually set up drop in sessions. We've advertised those to primary care and that's kind of a live session with a Microsoft Teams link that GPs can just log on, ask questions and get a bit of training. So I've not had any feedback from those yet, but kind of that's a newer one that we're trying and hopefully all that will be successful” (LL18 – Y2).

Approaches to training (theme 3)

Year one – theme 9: training was managed differently between pilot sites
“Know in some other areas they've had to do the training in order to refer, and obviously I think that that was seen as obviously that would have been a barrier potentially to people actually referring in, so I think again, we've just gone for that really open approach” (LL7 – Y1).

“So that was one of the reasons why I think going out to all areas at one time felt a little bit mad and a bit too much to handle to try and roll that out. So that's why we did those information sessions. And that's where we had quite a good uptake at those information sessions, and that's when we put that offer out to say any practice who wants to train now and is ready and keen and eager to do so can do so” (LL10 – Y1).

“What we wanted to ensure, although I'm not sure we've been able to really do it, is we were really clear that we felt that training would support the, would basically ensure that we had high quality referrals” (LL14 – Y1).

Year two – theme 9: training managed differently between pilot sites, but always remotely and to address referral barriers
“It's not scheduled in that way, it's more ad hoc when you know a new area’s, a new PCN is coming on board” (LL14 – Y2).

“It was a webinar really to try and address some barriers and kind of encourage practices to refer, especially those who've trained but haven't referred” (LL16 – Y2).

“Yeah I think I might hopefully have found it. Let's see. I think the other challenge with LCD and I guess any programme though it's first, it's getting all of the practices engaged, but then it's also getting all of the staff engaged. And I think it's been really interesting because one of the things that like our clinical lead’s feeding back is that yeah like staff turnover is like a really big issue. So you know, we worked with our provider to get like time at various forums for practice managers, nurses, you know even with GPs, social prescribers. But the turnover is so high so it's almost as if we need to do that on a constant basis” (LL14 – Y2).

“Yeah, you know when she says things like “what I do when I'm referring is”, you know, “when I've struggled to identify someone”, “when I've found it difficult to know which medications to stop.” And I think it really does increase the confidence and, you know, no question is a silly question to her. Because it, you know, as some nurses may have, may not be prescribed as they may not sort of start medications, but yet they can stop them (LL20 – Y2).

Approaches to incentivisation (theme 4)

Year one – theme 6: incentivisation was managed differently between pilot sites
“We talked about it. We talked about it in the mobilisation planning phase and we decided that we've done incentivisation on other programmes in the past, and I have to say, as a canny Scotsman, I don't like spending money and getting no return for it” (LL6 – Y1).

“it's just a nice bonus, but it's not incentivised you. So we're trying to, so the plan is it's, it's on the brink of its very, very last layer of governance for the second time running and then once that gets approved we're going to do a big push to practice managers because practice nurses you can inspire them on the basis of good clinical care” (LL11 – Y1).

“And secondly we had some implementation money from NHSE and we felt that it would be beneficial to use some of that money to put directly to frontline so that we, we did actually access and get the engagement” (LL13 – Y1)

Year two – theme 6: incentivisation was managed differently between pilot sites but used more in second year
“Yeah. So we've kind of jumped on the back of the weight management service spec. So LCD is attracts a payment of £11.50 per eligible patient. So we've kind of stuck with that. There seems to be mixed messages again. We've floated the idea. I know some areas have had real success with payment. And for us, it just again feels really inconsistent” (LL10 – Y2).

“If the referral is correct because we get quite a few referrals that they don't meet the criteria for, so then they get bounced back. So, it's only if they're the right patient, trying to encourage them to give us the right patient” (LL18 – Y2).

“So, we now for £10.30 per patient referred onto the programme and then £41.20 per patient who's accepted” (LL17 – Y2).

“Because it was deemed a complex referral and it was remunerating practices for the the time that would be required for a referral. I'm not quite sure how much impact it's

had. I don't feel like we're further ahead than those that didn't incentivise” (LL20 – Y2).

Approaches to referrals (theme 5)

Year one – theme 3: open referrals to all eligible clients but referral allocation and rollout was managed differently
“We didn't want there to be a monopoly in some areas where, for example, they may have really engaged practices and to use up a lot of those places. So, we thought as a, as a starting point what we would do is divvy up the number of those 500 places equally across [Area]. So, we looked at the eligibility criteria and created an EMIS search which would give us per practice the number of eligible patients, approximate number, so we could see the spread across [Area]. And then we used those figures to essentially assign […] those 500 places fairly across [Area]” (LL3 – Y1).

“I think it as well, it's a bit of capacity because if you open the floor up to 432 GP practices, that's a lot for somebody to manage and the, what we were very keen to do is to have eyes on who they were that were coming through because you know, coming out of Covid” (LL10 – Y1).

“To clarify that, you know we have left it open that if practices wanna refer in they can” (LL15 - Y1).

Year one – theme 4: we wait to see who refers then do some targeting
“I think as we progress through the project, and as [LL1] said, we do some of the analysis about the numbers of referrals against that initial kind of target allocation, which did take into account kind of areas of higher deprivation and ethnic minority communities, if we can see that the referral numbers are lower in those areas, then we'll do some more targeted engagement work with those specific practices” (LL2 – Y1).

“We didn't know when we set upon this course what the uptake would be in terms of engagement with practices. So based on that and we, we've very much been with our provider looking at the data, so we've had some practices, and we have like a weekly check in, or they send us the figures, so we have a spreadsheet we get each

week saying what the allocation of places is and when I say allocation of places that's not referrals, that's actually TDR starts” (LL12 – Y1).

Year one – theme 5: referral allocation opened up and increased during year one
“So we've had the four referral windows and then we were realising part way through, by about referral three, we could open it up to 2%. And then on the day we went live with referral window number four, so that's essentially every practice in [area] has had the opportunity, we increased it to 3% of your diabetes list” (LL11 – Y1).

“We had a challenging, a bit of a challenging conversation with [ICP 1], probably in July I would say [LL14] and actually over the last couple of you know, couple of weeks, whatever we then have pushed and we've now got where we wanted to get to, which was our ultimate aim of trying to get them to open up, but they've done that on their own volition. So I think at the moment what we have to think about is this is one program” (LL14 – Y1)

Year two – theme 4: the duality of generating referral numbers and doing so equitably
“I think the difficulty I have is which is gonna take priority, which is more important? Is it getting people through the programme that enhances the evaluation that gives NHS England a better overview of how that works on a larger scale population? Or do I sort of put that to one side and do I look at some inequalities work and maybe get far less referrals, but understand those different communities?” (LL10 – Y2).

“I have started talking to our engagement officer about actually how are we going to target with that inequalities lens. Because now that I've got access to the connected care data, we can start to kind of unpick where are our highest prevalence and then overlay that with deprivation and actually look at her workload and say right for the next year of this pilot we're gonna really target those PCNs which have got that cohort of patients that really would benefit from something like this. So, I think as

we're kind of going through this year we'll definitely put an inequalities lens on that and that's something I'm really keen to do” (LL24 – Y2).

Barriers to referrals (theme 6)

Year two – theme 5:
“Late last year we started working on a clinical system pop up. So, these pre-runs the searches and caches them in a report. Then when the patient's record is opened by an appropriate clinician […] [LCD] will pop up. Then through, it's done the pre- search so it's looked across the things which are retrievable by coding […] And then it leaves you with about half a dozen questions around the things that can't be gleaned from coding, the key ones being the retinopathy state […] it asks half a dozen quick questions. It takes about two to three minutes to fill it in. […] When they get to the end, what they’re presented with is about 95, 98% populated referral form. So, as it's gone along it prepopulates and the only things that they’re left to do are any free text that the field needs to go on to support the referral and medication changes” (LL6 – Y2).

“I tend to go via the PCNs these days because the PCNs in [town 1] are trying to identify care coordinators with an interest in weight management. So, I go through that rather than the individual practices, but [city] might be different” (LL4 – Y2).

“Some others are enthusiastic, but operationally, they just don't have the time to kind of perhaps replicate what our clinical lead’s put into her practice” (LL8 – Y2).

The importance of collaboration (theme 7)

Year one – theme 2: coming together was key for mobilisation
“Because it's the first programme of its kind and it is such a unique offer for patients it's quite, you know, it's an amazing opportunity for patients, and I think that was recognised by a lot of our clinical leads and they were very engaged with helping it roll out, which was brilliant. And we still have that momentum going with our monthly steering group, and there's I mean every meeting there will be so many actions that

come out from ideas of things that we could be doing that you almost think we need, we need some more CCG capacity to do some of these things” (LL3 – Y1).

“it's led by our diabetes clinical lead [colleague 2] obviously, obviously I sit on there, [provider] sit on that group, then we've got a practice nurse lead, we've got our pharmacy lead for LCD. So yeah, it has been helpful because, and we've got the digital team, I won't forget them because they've been like one of the most important people. But yeah, because we've had the people that we needed, yeah, I would say it’s been useful” (LL15 – Y1).

Year one – theme 12: an engaged provider facilitates mobilisation
“I have to, so just from a mobilisation point of view from sort of when we found out that we were going live, so we found out in the July and obviously the like, the go live date for two of the areas was September and the provider kind of pulled together all of the time frame that they could work to, what the kind of the materials that they thought would be helpful” (LL8 – Y1).

“Quite a lot of it was front ended before we launched. I’d say ongoing, probably more from our provider perspective what they now do is they do weekly updates for

practice, sorry, monthly updates for practices on the programme” (LL12 – Y1).

Year two – theme 2: coming together, including with an engaged provider, is key for the continued delivery of LCD
“Yeah, it is useful. And just to get different perspectives, isn't it? And from different backgrounds as well, which helps to drive it forward (LL18 – Y2)”.

“I think in terms of kind of coming up with new ideas to increase referrals, I think it's kind of a really dynamic group and it's, yeah, everyone kind of pulls their weight and comes up with great ideas. And yeah, definitely feels like we work as a team (LL17 – Y2).

“So the LCD has a has a steering group which is comprised of [provider] the provider, me, our clinical lead and a couple of other clinical representatives from across [area 1]. We and a colleague from public health as well from the local authority side of things, we get together on a monthly basis to look at our reports, oh

and colleagues from NHS England region also join in that one. We get together on a monthly basis to look at our monthly report, suggest areas of potential improvement in intervention. There's an action log that's maintained. That feeds into our wider diabetes and weight management network where again we'll look at particular trends in the number of referrals. Talk about any escalations that we might make. Our diabetes and weight management network feeds into a long term conditions steering group, which is where the clinical leads for each of the boroughs come together to talk about wider population health initiatives” (LL21 – Y2).

Year two – theme 3: locality leads, despite their variable nature and many responsibilities, have very little time to keep LCD ticking over
“Yeah. Yeah, it was. And my actual role is I’m a senior integration manager and I cover diabetes. So, the umbrella of diabetes work comes under me. So, the low calorie diet programme, the transformation programme and the diabetes prevention programme” (LL19 – Y2).

“Oh, that's already hard one because I've just got so many other things I do as well. I suppose the, some other things, I do read the weekly reports that come through.

Yeah, so that there's that time to do just that a week. There it's, it ebbs and flows cause you know when I'm trying to get them into practice manager meetings and that I have to do a bit of legwork to speak to colleagues to try and get an agenda slot etcetera. And sometimes we've done a sort of like a sort of like a tag team on that. In other, in other times they’re just doing it on their own so that varies. And I guess it's the steering group meeting that's as I say once, yeah what was once a month and that would be like a hour and a half, two hour meeting” (LL12 – Y2).