Health care utilization and the associated costs attributable to cardiovascular disease in Ireland: a cross-sectional study.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality and disability globally. We examined healthcare service utilization and costs attributable to CVD in Ireland in the period before the introduction of a major healthcare reform in 2016. METHODS: Secondary analysis of data from 8 113 participants of the first wave of The Irish Longitudinal Study on Ageing. CVD was defined as having a self-reported doctor's diagnosis of myocardial infarction, angina, heart failure, stroke, atrial fibrillation or transient ischaemic attack. Participants self-reported the utilization of healthcare services in the year preceding the interview. Negative binomial regression with average marginal effects (AME) was used to estimate the incremental number of general practitioner (GP) and outpatient department (OPD) visits, accident and emergency department attendances and hospitalisations in population with CVD relative to population without CVD. We calculated the corresponding costs at individual and population levels, by gender and age groups. RESULTS: The prevalence of CVD was 18.2% (95% CI: 17.3, 19.0) Participants with CVD reported higher utilization of all healthcare services. In adjusted models, having CVD was associated with incremental 1.19 (95% CI: 0.99, 1.39) GP and 0.79 (95% CI: 0.65, 0.93) OPD visits. There were twice as many incremental hospitalisations in males with CVD compared to females with CVD (AME (95% CI): 0.20 (0.16, 0.23) vs 0.10 (0.07, 0.14)). The incremental cost of healthcare service use in population with CVD was an estimated €352.2 million (95% CI: €272.8, €431.7), 93% of which was due to use of secondary care services. CONCLUSION: We identified substantially increased use of healthcare services attributable to CVD in Ireland. Continued efforts aimed at CVD primary prevention and management are required.

Enablers and barriers to accessing self-management support services for those living with and beyond cancer: A qualitative study using the theoretical domains framework.

BACKGROUND: Supporting those living with and beyond cancer to self-manage their health can optimise health-related quality of life and reduce symptom burden. Self-management support (SMS) programmes have been shown to be effective, but uptake is often low. This qualitative study aimed to identify experienced and perceived enablers and barriers to accessing SMS services among those who had completed primary cancer treatment and were living with and beyond cancer. METHODS: Participants were recruited through social media and cancer advocacy groups. Semi-structured telephone and online interviews were conducted. Transcripts were coded inductively based on participants' reported experiences. Statements related to factors that enable or inhibit access to SMS were then mapped to the Theoretical Domains Framework (TDF). RESULTS: Twenty-six people participated. Six themes explain the factors that act as barriers and enablers which mapped to 11 TDF domains. Lack of knowledge of available SMS was a prominent barrier, as well as inaccessible services due to timing and place of delivery. Lack of confidence and emotional factors including fear were barriers to seeking SMS. Social influences shaped knowledge, attitudes and readiness to access SMS. Perceptions of SMS service goals and if in alignment with self-identity, intentions and goals also shaped decisions around accessing support. CONCLUSIONS: While lack of knowledge and provider signposting were common barriers, findings suggest that other psychosocial and emotional factors may be barriers, even if SMS services are accessible. Findings are relevant for oncology healthcare services developing strategies to increase reach of SMS for those living with and beyond cancer.

What works to recruit general practices to trials? A rapid review.

Background: Recruitment challenges are a barrier to the conduct of trials in general practice, yet little is known about which recruitment strategies work best to recruit practices for randomised controlled trials (RCTs). We aimed to describe the types of strategies used to recruit general practices for trials and synthesize any available evidence of effectiveness. Methods: We conducted a rapid evidence review in line with guidance from Tricco et al. Eligible studies reported or evaluated any strategy to improve practice recruitment to participate in clinical or implementation RCTs. PubMed, Embase, and Cochrane Central Library were searched from inception to June 22 nd, 2021. Reference lists of included studies were screened. Data were synthesized narratively. Results: Over 9,162 articles were identified, and 19 studies included. Most (n=13, 66.7%) used a single recruitment strategy. The most common strategies were: in-person practice meetings/visits by the research team (n=12, 63.2%); phone calls (n=10, 52.6%); financial incentives (n=9, 47.4%); personalised emails (n=7, 36.8%) or letters (n=6, 52.6%) (as opposed to email 'blasts' or generic letters); targeting practices that participated in previous studies or with which the team had existing links (n=6, 31.6%) or targeting of practices within an existing practice or research network (n=6, 31.6%).  Three studies reporting recruitment rates >80%, used strategies such as invitation letters with a follow-up phone call to non-responders, presentations by the principal investigator and study coordinator, or in-person meetings with practices with an existing affiliation with the University or research team.  Conclusions: Few studies directly compared recruitment approaches making it difficult to draw conclusions about their comparative effectiveness. However, the role of more personalised letter/email, in-person, or phone contact, and capitalising on existing relationships appears important. Further work is needed to standardise how recruitment methods are reported and to directly compare different recruitment strategies within one study . PROSPERO registration: CRD42021268140 (15/08/2021).

Cohort profile update: The Cork and Kerry Diabetes and Heart Disease Study.

Background: The Cork and Kerry Diabetes and Heart Disease Study was established to investigate the prevalence of diabetes and cardiovascular disease among middle-aged adults in Ireland. The Mitchelstown cohort was recruited from a single large primary care centre between 2010-2011. A rescreen of this cohort was conducted in 2015. Methods: Data were collected on cardiovascular health and associated risk factors. In addition, the rescreen incorporated new measures which included information on cognition and frailty, medication adherence, dietary factors and the collection of stool samples with RNA sequencing of the gut microbiome. Results: Of 2047 participants in the original cohort, 237 (11.6%) were deceased, too ill to participate or were lost to follow-up. Of the remaining 1810 baseline study participants, 1378 men and women aged 51-77 years agreed to take part in the rescreen (response rate of 76.1%). The prevalence of hypertension was high, ranging from 50% to 64% depending on the measurement method. An investigation of the association of gut microbiota with metabolic syndrome and obesity indicated greater microbiome diversity in metabolically healthy non-obese individuals relative to their unhealthy counterparts. Analysis of prescribing data over time demonstrated a high prevalence of potentially inappropriate prescribing among older-aged people in primary care which increased as they progressed to more advanced old age. Conclusions: The rescreen has provided new insights into cardiovascular health. In addition, this study is embedded in a single primary care centre, enabling passive follow-up of study participants through electronic health records. All data collected at baseline and rescreen are maintained and stored at the School of Public Health, University College Cork and specific proposals for future collaborations are welcome.

Implementing a community specialist team to support the delivery of integrated diabetes care: experiences in Ireland during the COVID-19 pandemic.

Background: While models of integrated care for people with chronic conditions have demonstrated promising results, there are still knowledge gaps about how these models are implemented in different contexts and which strategies may best support implementation. We aimed to evaluate the implementation of a multidisciplinary diabetes Community Specialist Team (CST) to support delivery of integrated type 2 diabetes care during COVID-19 in two health networks. Methods: A mixed methods approach was used. Quantitative data included administrative data on CST activity and caseload, and questionnaires with GPs, practice nurses (PN) and people with type 2 diabetes. Qualitative data were collected using semi-structured interviews and focus groups about the service from CST members, GPs, PNs and people with type 2 diabetes. We used the Consolidated Framework for Implementation Research framework to explain what influences implementation and to integrate different stakeholder perspectives. Results: Over a 6-month period (Dec 2020-May 2021), 516 patients were seen by podiatrists, 435 by dieticians, and 545 by CNS. Of patients who had their first CST appointment within the previous 6 months (n=29), 69% (n=20) waited less than 4 weeks to see the HCP. During initial implementation, CST members used virtual meetings to build ' rapport' with general practice staff, supporting ' upskilling' and referrals to the CST. Leadership from the local project team and change manager provided guidance on how to work as a team and ' iron out' issues. Where available, shared space enhanced networking between CST members and facilitated joint appointments. Lack of administrative support for the CST impacted on clinical time. Conclusions: This study illustrates how the CST benefited from shared space, enhanced networking, and leadership. When developing strategies to support implementation of integrated care, the need for administrative support, the practicalities of co-location to facilitate joint appointments, and relative advantages of different delivery models should be considered.

Understanding tailoring to support the implementation of evidence-based interventions in healthcare: The CUSTOMISE research programme protocol.

Although there are effective evidence-based interventions (EBIs) to prevent, treat and coordinate care for chronic conditions they may not be adopted widely and when adopted, implementation challenges can limit their impact.  Implementation strategies are "methods or techniques used to enhance the adoption, implementation, and sustainment of a clinical program or practice". There is some evidence to suggest that to be more effective,  strategies should be tailored; that is, selected and designed to address specific determinants which may influence implementation in a given context. Despite the growing popularity of tailoring the concept is ill-defined, and the way in which tailoring is applied can vary across studies or lack detail when reported. There has been less focus on the part of tailoring where stakeholders prioritise determinants and select strategies, and the way in which theory, evidence and stakeholders' perspectives should be combined to make decisions during the process. Typically, tailoring is evaluated based on the effectiveness of the tailored strategy, we do not have a clear sense of the mechanisms through which tailoring works, or how to measure the "success" of the tailoring process. We lack an understanding of how stakeholders can be involved effectively in tailoring and the influence of different approaches on the outcome of tailoring. Our research programme, CUSTOMISE (Comparing and Understanding Tailoring Methods for Implementation Strategies in healthcare) will address some of these outstanding questions and generate evidence on  the feasibility, acceptability, and efficiency of different tailoring approaches, and build capacity in implementation science in Ireland, developing and delivering training and supports for, and network of, researchers and implementation practitioners. The evidence generated across the studies conducted as part of CUSTOMISE will bring greater clarity, consistency, coherence, and transparency to tailoring, a key process in implementation science.

Adoption and Initial Implementation of a National Integrated Care Programme for Diabetes: A Realist Evaluation.

Background: The implementation of models of integrated care for chronic conditions is not well understood. We conducted a realist evaluation to determine how and why the implementation of the National Diabetes Programme in Ireland worked (or not). Methods: Documentary analysis and qualitative interviews with a purposive sample of national stakeholders (n = 19), were used to develop an initial theory on expected programme delivery. We refined this theory using semi-structured interviews (n = 38) with professionals from different clinical disciplines involved in programme implementation. Results: Locally important contexts facilitating implementation included staff experience of delivering diabetes care, capacity, and familiarity with the intended purpose of new clinical posts. The extent to which integrated care was adopted and implemented depended on judgements made by professionals working in these contexts; specifically, judging the relative advantage of the programme and whether to engage in negotiations to legitimize their new roles in diabetes care. Conclusions: Our results highlight the need for adequate preparatory work to raise awareness of and support new roles to implement integrated care, clarification on the core components of new care models, and the development of local service infrastructures to support integrated care.

Conceptual tensions and practical trade-offs in tailoring implementation interventions.

Tailored interventions have been shown to be effective and tailoring is a popular process with intuitive appeal for researchers and practitioners. However, the concept and process are ill-defined in implementation science. Descriptions of how tailoring has been applied in practice are often absent or insufficient in detail. This lack of transparency makes it difficult to synthesize and replicate efforts. It also hides the trade-offs for researchers and practitioners that are inherent in the process. In this article we juxtapose the growing prominence of tailoring with four key questions surrounding the process. Specifically, we ask: (1) what constitutes tailoring and when does it begin and end?; (2) how is it expected to work?; (3) who and what does the tailoring process involve?; and (4) how should tailoring be evaluated? We discuss these questions as a call to action for better reporting and further research to bring clarity, consistency, and coherence to tailoring, a key process in implementation science.

What and how do different stakeholders contribute to intervention development? A mixed methods study.

Background: UK Medical Research Council guidelines recommend end-user involvement in intervention development. There is limited evidence on the contributions of different end-users to this process. The aim of this Study Within A Trial (SWAT) was to identify and compare contributions from two groups of end-users - people with diabetes' (PWD) and healthcare professionals' (HCPs), during consensus meetings to inform an intervention to improve retinopathy screening uptake. Methods: A mixed method, explanatory sequential design comprising a survey and three semi-structured consensus meetings was used. PWD were randomly assigned to a diabetes only or combined meeting. HCPs attended a HCP only or combined meeting, based on availability. In the survey, participants rated intervention proposals on acceptability and feasibility. Survey results informed the meeting topic guide. Transcripts were analysed deductively to compare feedback on intervention proposals, suggestions for new content, and contributions to the final intervention. Results: Overall, 13 PWD and 17 HCPs completed the survey, and 16 PWD and 15 HCPs attended meetings. For 31 of the 39 intervention proposals in the survey, there were differences (≥10%) between the proportion of HCPs and PWD who rated proposals as acceptable and/or feasible. End-user groups shared and unique concerns about proposals; both were concerned about informing but not scaring people when communicating risk, while concerns about resources were mostly unique to HCPs and concerns about privacy were mostly unique to PWD.  Fewer suggestions for new intervention content from the combined meeting were integrated into the final intervention as they were not feasible for implementation in general practice. Participants contributed four new behaviour change techniques not present in the original proposals: goal setting (outcome), restructuring the physical environment, material incentive (behaviour) and punishment. Conclusions: Preferences for intervention content may differ across end-user groups, with feedback varying depending on whether end-users are involved simultaneously or separately.

Characterising processes and outcomes of tailoring implementation strategies in healthcare: a protocol for a scoping review.

Background: Tailoring strategies to target the salient barriers to and enablers of implementation is considered a critical step in supporting successful delivery of evidence based interventions in healthcare. Theory, evidence, and stakeholder engagement are considered key ingredients in the process however, these ingredients can be combined in different ways. There is no consensus on the definition of tailoring or on a single method for tailoring strategies to optimize impact, ensure transparency, and facilitate replication. Aim: The purpose of this scoping review is to describe how tailoring has been undertaken within healthcare to answer questions about how it has been conceptualised, described, and conducted in practice, and to identify research gaps. Methods: The review will be conducted in accordance with best practice guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for scoping reviews (PRISMA-ScR) will be used to guide the reporting. Searches will be conducted of MEDLINE, Embase, Web of Science, Scopus, from 2005 to present. Reference lists of included articles will be searched. Grey literature will be searched on Google Scholar. Screening and data extraction will be conducted by two or more members of the research team, with any discrepancies resolved by consensus discussion with a third reviewer. Initial analysis will be quantitative involving a descriptive numerical summary of the characteristics of the studies and the tailoring process. Qualitative content analysis aligned to the research questions will also be conducted, and data managed using NVivo where applicable. This scoping review is pre-registered with the Open Science Framework. Conclusions: The findings will serve as a resource for implementation researchers and practitioners to guide future research in this field and facilitate systematic, transparent, and replicable development of tailored implementation strategies.

Evaluation of the impact and implementation of a national clinical programme for the management of self-harm in hospital emergency departments: study protocol for a natural experiment.

BACKGROUND: A National Clinical Programme for the Management of Hospital-Presenting Self-Harm (NCP-SH) was introduced in Ireland in 2014. This involved the development of a model of care to standardise the management of self-harm in emergency departments, to be delivered by dedicated clinical nurse specialists. The core components of the programme were to: ensure an empathic and timely response, conduct a biopsychosocial assessment, involve family members in assessment and discharge planning, and provide a bridge to next care. The overall aim of the programme was to reduce the rate of repeat self-harm. This multistage study will evaluate the impact of the NCP-SH on hospital-presenting self-harm and to identify determinants influencing its implementation. METHODS: Employing a sequential mixed methods design, the first stage will use data from the National Self-Harm Registry Ireland to examine the impact of the NCP-SH on self-harm repetition, along with other aspects of care, including provision of psychosocial assessments and changes in admissions and postdischarge referrals. A cost-effectiveness analysis will assess the cost per repeat self-harm attendance avoided as a result of the NCP-SH. The second stage will identify the influences of implementation fidelity-adherence to the programme's core components-using a combination of document analysis and semistructured interviews with staff of the programme, guided by the Consolidated Framework for Implementation Research. ETHICS AND DISSEMINATION: This study has received full ethical approval and will run until August 2023. This study is novel in that it will identify important factors influencing successful implementation of complex programmes. It is expected that the findings will provide important learnings for the integration of mental health services in general hospital settings and will be disseminated via peer-review publications along with reports for clinicians and policy-makers.

Epidemiology of undiagnosed depression in people with diabetes mellitus: a comparative analysis of Ireland, England and the USA.

OBJECTIVES: Improving detection of depression in people with diabetes is recommended. However, little is known about how different health systems compare in depression detection. We estimated and compared the (1) prevalence of depression detection in people with and without diabetes, and (2) association between diabetes and undiagnosed depression across three health systems. DESIGN: Cross-sectional analysis of three nationally representative studies: The Irish Longitudinal Study on Ageing, the English Longitudinal Study on Ageing and the Health and Retirement Study. SETTING: Community-dwelling adults in Ireland, England and the USA. PARTICIPANTS: Adults aged ≥50 years. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was depression diagnosis. The secondary outcome was any depression. Any depression was defined by the presence of self-reported doctor-diagnosed depression or current depression symptoms on the Centre for Epidemiological Studies-Depression scale. Depression diagnosis was categorised as: undiagnosed, symptomatic and diagnosed, and asymptomatic and diagnosed. We estimated age-standardised prevalence of depression diagnosis by country and diabetes status. Anyone who self-reported having ever received a doctor diagnosis of diabetes was classified as having diabetes. Among respondents with depression, we estimated the association between diabetes and undiagnosed depression by country using multivariable logistic regression. RESULTS: The prevalence of depression (diagnosed and undiagnosed) was higher in people with diabetes in each country with absolute rates varying by country; undiagnosed prevalence (Ireland: diabetes 10.1% (95% CI 7.5% to 12.8%) vs no diabetes 7.5% (95% CI 6.8% to 8.2%), England: diabetes 19.3% (95% CI 16.5% to 22.2%) vs no diabetes 11.8% (95% CI 11.0% to 12.6%), USA: diabetes 7.4% (95% CI 6.4% to 8.4%) vs no diabetes 6.1% (95% CI 5.7% to 6.6%)). In the fully adjusted model, there was no clear pattern of association between diabetes status and undiagnosed depression; Ireland: OR=0.82 (95% CI 0.5 to 1.3), England: OR=1.47 (95% CI 1.0 to 2.1), USA: OR=0.80 (95% CI 0.7 to 1.0). CONCLUSIONS: Although undiagnosed depression was more prevalent among people with diabetes, the relationship between diabetes and undiagnosed depression differed by country. Targeted efforts are needed to improve depression detection among community-dwelling older adults, particularly those with diabetes.

Feasibility of a multifaceted implementation intervention to improve attendance at diabetic retinopathy screening in primary care in Ireland: a cluster randomised pilot trial.

OBJECTIVES: Diabetic retinopathy screening (DRS) uptake is suboptimal in many countries with limited evidence available on interventions to enhance DRS uptake in primary care. We investigated the feasibility and preliminary effects of an intervention to improve uptake of Ireland's national DRS programme, Diabetic RetinaScreen, among patients with type 1 or type 2 diabetes. DESIGN/SETTING: We conducted a cluster randomised pilot trial, embedded process evaluation and cost analysis in general practice, July 2019 to January 2020. PARTICIPANTS: Eight practices participated in the trial. For the process evaluation, surveys were conducted with 25 staff at intervention practices. Interviews were conducted with nine staff at intervention practices, and 10 patients who received the intervention. INTERVENTIONS: The intervention comprised practice reimbursement, an audit of attendance, electronic prompts targeting professionals, General Practice-endorsed patient reminders and a patient information leaflet. Practices were randomly allocated to intervention (n=4) or wait-list control (n=4) (usual care). OUTCOMES: Staff and patient interviews explored their perspectives on the intervention. Patient registration and attendance, including intention to attend, were measured at baseline and 6 months. Microcosting was used to estimate intervention delivery cost. RESULTS: The process evaluation identified that enablers of feasibility included practice culture and capacity to protect time, systems to organise care, and staff skills, and workarounds to improve intervention 'fit'. At 6 months, 22/71 (31%) of baseline non-attenders in intervention practices subsequently attended screening compared with 15/87 (17%) in control practices. The total delivery cost across intervention practices (patients=363) was €2509, averaging €627 per practice and €6.91 per audited patient. Continuation criteria supported proceeding to a definitive trial. CONCLUSIONS: The Improving Diabetes Eye screening Attendance intervention is feasible in primary care; however, consideration should be given to how best to facilitate local tailoring. A definitive trial of clinical and cost-effectiveness is required with preliminary results suggesting a positive effect on uptake. TRIAL REGISTRATION NUMBER: NCT03901898.

A micro costing analysis of the development of a primary care intervention to improve the uptake of diabetic retinopathy screening.

BACKGROUND: The application of economic analysis within implementation science is still developing and the cost of intervention development, which differs markedly from the costs of initial implementation and maintenance, is often overlooked. Our aim was to retrospectively cost the development of a multifaceted intervention in primary care to improve attendance at diabetic retinopathy screening. METHODS: A retrospective micro costing of developing the intervention from the research funder perspective was conducted. It was based on a systematic intervention development process involving analysis of existing audit data and interviews with patients and healthcare professionals (HCPs), conducting consensus meetings with patients and HCPs, and using these data together with a rapid review of the effectiveness of interventions, to inform the final intervention. Both direct (non-personnel, e.g. travel, stationary, room hire) and indirect (personnel) costs were included. Data sources included researcher time logs, payroll data, salary scales, an online financial management system, invoices and purchase orders. Personnel involved in the intervention development were consulted to determine the activities they conducted and the duration of their involvement. Sensitivity and scenario analyses were conducted to estimate uncertainty around parameters and scope. RESULTS: The total cost of intervention development (July 2014-January 2019) was €40,485 of which 78% were indirect (personnel) costs (€31,451). In total, personnel contributed 1368 h to intervention development. Highest cost activities were the patient interviews, and consensus process, contributing 23% and 34% of the total cost. Varying estimated time spent on intervention development activities by + 10% increased total intervention development cost by 6% to €42,982. CONCLUSIONS: Our results highlight that intervention development requires a significant amount of human capital input, combining research experience, patient and public experience, and expert knowledge in relevant fields. The time committed to intervention development is critical but has a significant opportunity cost. With limited resources for research on developing and implementing interventions, capturing intervention development costs and incorporating them as part of assessment of cost-effective interventions, could inform research priority and resource allocation decisions.

Acceptability and feasibility of conducting a pilot trial in Irish primary care: lessons from the IDEAs study.

Introduction Understanding primary care practices' 'readiness' to engage in trials and their experience is important to inform trial procedures and supports. Few studies report on the feasibility of study procedures though this is a central part of pilot trials. We explored the acceptability and feasibility of study procedures of a cluster randomised pilot trial of an intervention in primary care to improve uptake of Ireland's national diabetic retinopathy programme.  Methods As part of the embedded mixed-methods process evaluation, quantitative and qualitative data were gathered across four general practices participating in the intervention. Interviews were conducted with a purposive sample of staff. Research logs on time spent on intervention delivery, staff assignment, resources, problems/changes, and reasons for drop-outs, were maintained over the course of intervention rollout, and practice audit data were analysed. Quantitative outcomes included recruitment, retention, completion, and data quality and completeness. Qualitative data on perceptions and experience of the pilot trial procedures were analysed using the Framework Method. Findings Nine staff (3 GPs, 4 nurses, 2 administrators) were interviewed. An interest in the topic area or in research motivated practices to take part in the trial. Reimbursement meant they could ' afford' to participate. Staff valued the researcher briefing at the start of the trial, to avoid ' going in slightly blind'. While staff varied in audit skills and confidence, and some found this aspect of data collection challenging, a ' step-by-step' audit manual and regular researcher contact, helped them stay on track and troubleshoot during data collection. Audit quality was acceptable overall, however there were some issues, incorrect assignment of patient status being most common. Conclusion The IDEAs trial procedures were acceptable and feasible for primary care staff, however, challenges with conducting the audit may reflect staff skills gaps and the need for greater guidance and support from researchers.

Correction to: Development of an intervention to facilitate implementation and uptake of diabetic retinopathy screening.

An amendment to this paper has been published and can be accessed via the original article.

Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial.

BACKGROUND: Diabetic retinopathy screening (DRS) leads to the earlier detection of retinopathy and treatment that can prevent or delay the development of diabetes-related blindness. However, uptake continues to be sub-optimal in many countries, including Ireland. Routine management of type 2 diabetes largely takes place in primary care. As such, there may be an opportunity in primary care to introduce interventions to improve DRS uptake. However, few studies test the feasibility of interventions to enhance DRS uptake in this context. Our aim is to investigate the feasibility of an implementation intervention (IDEAs (Improving Diabetes Eye screening Attendance)) delivered in general practice to improve the uptake of the national DRS programme, RetinaScreen. METHODS: The IDEAs study is a cluster randomised pilot trial with an embedded process evaluation and economic evaluation. Following stratification by practice size, eight general practices (clusters) will be randomly allocated to intervention (n = 4) or wait-list control groups (n = 4). The intervention will be delivered for 6 months, after which, it will be administered to wait-list control practices. The intervention is multi-faceted and comprises provider-level components (training, audit and feedback, health care professional prompt, reimbursement) and patient-level components (GP-endorsed reminder with information leaflet delivered opportunistically face-to-face, and systematically by phone and letter). Patient inclusion criteria are type 1 or type 2 diabetes and DRS programme non-attendance. A multi-method approach will be used to determine screening uptake, evaluate the trial and study procedures and examine the acceptability and feasibility of the intervention from staff and patient perspectives. Quantitative and qualitative data will be collected on intervention uptake and delivery, research processes and outcomes. Data will be collected at the practice, health professional and patient level. A partial economic evaluation will be conducted to estimate the cost of delivering the implementation intervention in general practice. Formal continuation criteria will be used to determine whether IDEAs should progress to a definitive trial. DISCUSSION: Findings will determine whether IDEAsis feasible and acceptable and will be used to refine the intervention and study procedures. A definitive trial will determine whether IDEAs is a cost-effective intervention to improve DRS uptake and reduce diabetes-related blindness. TRIAL REGISTRATION: ClinicalTrials.gov NCT03901898. Registered 3rd April 2019.

Development of an intervention to facilitate implementation and uptake of diabetic retinopathy screening.

BACKGROUND: 'Implementation interventions' refer to methods used to enhance the adoption and implementation of clinical interventions such as diabetic retinopathy screening (DRS). DRS is effective, yet uptake is often suboptimal. Despite most routine management taking place in primary care and the central role of health care professionals (HCP) in referring to DRS, few interventions have been developed for primary care. We aimed to develop a multifaceted intervention targeting both professionals and patients to improve DRS uptake as an example of a systematic development process combining theory, stakeholder involvement, and evidence. METHODS: First, we identified target behaviours through an audit in primary care of screening attendance. Second, we interviewed patients (n = 47) and HCP (n = 30), to identify determinants of uptake using the Theoretical Domains Framework, mapping these to behaviour change techniques (BCTs) to develop intervention content. Thirdly, we conducted semi-structured consensus groups with stakeholders, specifically users of the intervention, i.e. patients (n = 15) and HCPs (n = 16), regarding the feasibility, acceptability, and local relevance of selected BCTs and potential delivery modes. We consulted representatives from the national DRS programme to check intervention 'fit' with existing processes. We applied the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects, and equity) to select the final intervention components, drawing on findings from the previous steps, and a rapid evidence review of operationalised BCT effectiveness. RESULTS: We identified potentially modifiable target behaviours at the patient (consent, attendance) and professional (registration) level. Patient barriers to consent/attendance included confusion between screening and routine eye checks, and fear of a negative result. Enablers included a recommendation from friends/family or professionals and recognising screening importance. Professional barriers to registration included the time to register patients and a lack of readily available information on uptake in their local area/practice. Most operationalised BCTs were acceptable to patients and HCPs while the response to feasibility varied. After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients. CONCLUSIONS: Using the example of an intervention to improve DRS uptake, this study illustrates an approach to integrate theory with user involvement. This process highlighted tensions between theory-informed and stakeholder suggestions, and the need to apply the Theoretical Domains Framework (TDF)/BCT structure flexibly. The final intervention draws on the trusted professional-patient relationship, leveraging existing services to enhance implementation of the DRS programme. Intervention feasibility in primary care will be evaluated in a randomised cluster pilot trial.

'I've always done what I was told by the medical people': a qualitative study of the reasons why older adults attend multifactorial falls risk assessments mapped to the Theoretical Domains Framework.

OBJECTIVES: Multifactorial falls risk assessments reduce the rate of falls in older people and are recommended by international guidelines. Despite their effectiveness, their potential impact is often constrained by barriers to implementation. Attendance is an issue. The aim of this study was to explore why older people attend community-based multifactorial falls risk assessment clinics, and to map these reasons to a theoretical framework. DESIGN: This is a qualitative study. Semi-structured interviews were conducted and analysed thematically. Each theme and subtheme were then mapped onto the Theoretical Domains Framework (TDF) to identify the determinants of behaviour. PARTICIPANTS: Older adults (aged 60 and over) who attended community-based multifactorial falls risk assessments. RESULTS: Sixteen interviews were conducted. Three main themes explained participants' reasons for attending the multifactorial risk assessment; being that 'type of person', being 'linked in' with health and community services and having 'strong social support'. Six other themes were identified, but these themes were not as prominent during interviews. These were knowing what to expect, being physically able, having confidence in and being positive towards health services, imagining the benefits given previous positive experiences, determination to maintain or regain independence, and being 'crippled' by the fear of falling. These themes mapped on to nine TDF domains: 'knowledge', 'skills', 'social role and identity', 'optimism', 'beliefs about consequences', 'goals', 'environmental context and resources', 'social influences' and 'emotion'. There were five TDF domains that were not relevant to the reasons for attending. CONCLUSIONS: These findings provide theoretically based factors that influence attendance which can be used to inform the development of interventions to improve attendance to falls prevention programmes.

'Sink or Swim': A Qualitative Study to Understand How and Why Nurses Adapt to Support the Implementation of Integrated Diabetes Care.

BACKGROUND: Integrated care, organising care delivery within and between services, is an approach to improve the quality of care. Existing specialist roles have evolved to work across settings and services to integrate care. However, there is limited insight into how these expanded roles are implemented, including how they may be shaped by context. This paper examines how new diabetes nurse specialists working across care boundaries, together with hospital-based diabetes nurse specialists, adapt to support the implementation of integrated care. METHODS: We conducted semi-structured focus groups and interviews with diabetes nurse specialists purposively sampled by work setting and health service region (n = 30). Analysis was data-driven, coding actions or processes to stay closer to the data and using In Vivo codes to preserve meaning. FINDINGS: Community nurse specialists described facing a choice of "sink or swim" when appointed with limited guidance on their role. To 'swim' and implement their role, required them to use their initiative and adapt to the local context. When first appointed, both community and hospital nurse specialists actively managed misconceptions of their role by other staff. To establish clinics in general practices, community nurse specialists capitalised on professional contacts to access GPs who might utilise their role. They built GP trust by adopting practice norms and responding to individual needs. They adapted to the lack of a multidisciplinary team "safety net" in the community, by "practicing at a higher level", working more autonomously. Developing professional links and pursuing on-going education was a way to create an alternative 'safety net' so as to feel confident in their clinical decision-making when working in the community. Workarounds facilitated information flow (i.e. patient blood results, treatment, and appointments) between settings in the absence of an electronic record shared between general practices and hospital settings. CONCLUSIONS: Flexibility and innovation facilitates a new way of working across boundaries. Successful implementation of nurse specialist-led integrated care requires strategies to address elements in the inner (differences in practice organisation, role acceptance) and outer (information systems) context.