Implementation and scalability of shared care models for chronic eye disease: a realist assessment informed by health system stakeholders in Finland, the United Kingdom, and Australia.

BACKGROUND/OBJECTIVES: Several health systems have implemented innovative models of care which share the management of patients with chronic eye diseases between ophthalmologists and optometrists. These models have demonstrated positive outcomes for health systems including increased access for patients, service efficiency and cost-savings. This study aims to understand factors which support successful implementation and scalability of these models of care. SUBJECTS/METHODS: Semi-structured interviews were conducted with 21 key health system stakeholders (clinicians, managers, administrators, policy-makers) in Finland, United Kingdom and Australia between October 2018 and February 2020. Data were analyzed using a realist framework to identify the contexts, mechanisms of action, and outcomes of sustained and emerging shared care schemes. RESULTS: Five key themes relating to successful implementation of shared care were identified as (1) clinician-led solutions, (2) redistributing teams, (3) building inter-disciplinary trust, (4) using evidence for buy-in, and (5) standardized care protocols. Scalability was found to be supported by (6) financial incentives, (7) integrated information systems, (8) local governance, and (9) a need for evidence of longer-term health and economic benefits. CONCLUSIONS: The themes and program theories presented in this paper should be considered when testing and scaling shared eye care schemes to optimize benefits and promote sustainability.

Formulating Initial Programme Theories of the Healthy Homes and Neighbourhoods Integrated Care Initiative.

Introduction: The Healthy Homes and Neighbourhoods (HHAN) integrated care initiative was designed to break intergenerational cycles of social and health inequalities and enhance access to and engagement with health and social services for vulnerable families in the Sydney Local Health District. We sought to unearth the initial programme theory of the HHAN initiative to inform rollout to other relevant areas. Methods: We conducted a critical realist evaluation using steps. (1) Exploring the events around the HHAN initiative development. (2) Explore consumer experiences. (3) Identifying the entities and associations characterising the HHAN initiative and related outcomes. (4) Searching for different theoretical perspectives and explanations (abduction). (5) Hypothesising the mechanisms and [context] conditions that might have activated the generation of the HHAN outcomes (retroduction). Results: We identified three central mechanisms; trust, buy-in and motivation, and understanding family dynamics operating across consumer, provider and systems levels of the HHAN initiative. Discussion: These programme theories reveal that to achieve the goals of HHAN, interpersonal dynamics, fostering buy-in and ensuring motivation of both the consumers and care workers should be sought and sustained at all levels. Conclusion: The programme theories unveil that integrated care initiatives should foster positive relationships at all levels to ensure favourable consumer outcomes.

Evaluating an oral health programme for the prevention of dental decay among school-aged children in China: protocol for a mixed-methods study based on the RE-AIM framework.

INTRODUCTION: The objective of the Comprehensive Intervention of Oral Disease for Children (CIODC) in China is to prevent dental decay for school-aged children and provide free prevention services in pilot areas beginning in 2008. It is a potentially affordable, acceptable and effective prevention strategy to use for more school-aged children in the future. There is a shortage of robust evidence regarding the cost-effectiveness, feasibility and scalability of prevention strategies for dental decay for school-aged children in China. This study aims to provide a comprehensive evaluation, including an economic evaluation and process evaluation, to better understand how and why the public health programme may be effective and economical. METHODS AND ANALYSIS: Mixed methods will be used in this study. Cost-effectiveness analysis (CEA) will be conducted from a societal perspective, based on a modelling study over 6 years (from age 7 to 12) in terms of the incremental cost-effectiveness ratios per dental decay averted. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework informed the process evaluation. An estimated 48-80 semistructured interviews with service providers, patient parents/caregivers and decision-makers under the logic model will be used in the progress evaluation to describe the feasibility and sustainability of CIODC. ETHICS AND DISSEMINATION: The study has all necessary ethical approvals from the Ethics Committee of Anhui Medical University (number 2021H030). All participants will provide informed consent prior to participation. Findings will be disseminated through conference presentations and scientific publications in peer-reviewed journals.

The value of process evaluation for public health interventions: field-case studies for non-communicable disease prevention and management in five countries.

Complex interventions are needed to effectively tackle non-communicable diseases. However, complex interventions can contain a mix of effective and ineffective actions. Process evaluation (PE) in public health research is of great value as it could clarify the mechanisms and contextual factors associ-ated with variation in the outcomes, better identify effective components, and inform adaptation of the intervention. The aim of this paper is to demonstrate the value of PE through five case studies that span the research cycle. The interven-tions include using digital health, salt reduction strategies, use of fixed dose combinations, and task shifting. Insights of the methods used, and the implications of the PE findings to the project, were discussed. PE of complex interventions can refute or confirm the hypothesized mechanisms of action, thereby enabling intervention refinement, and identifying implementation strategies that can address local contextual needs, so as to improve service delivery and public health outcomes.

Barriers and Facilitators to Implementing Reduced-Sodium Salts as a Population-Level Intervention: A Qualitative Study.

Widespread use of reduced-sodium salts can potentially lower excessive population-level dietary sodium intake. This study aimed to identify key barriers and facilitators to implementing reduced-sodium salt as a population level intervention. Semi-structured interviews were conducted with key informants from academia, the salt manufacturing industry, and government. We used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to inform our interview guides and data analysis. Eighteen key informants from nine countries across five World Health Organization regions participated in the study from January 2020 to July 2020. Participants were concerned about the lack of robust evidence on safety for specific populations such as those with renal impairment. Taste and price compared to regular salt and an understanding of the potential health benefits of reduced-sodium salt were identified as critical factors influencing the adoption of reduced-sodium salts. Higher production costs, low profit return, and reduced market demand for reduced-sodium salts were key barriers for industry in implementation. Participants provided recommendations as potential strategies to enhance the uptake. There are presently substantial barriers to the widespread use of reduced-sodium salt but there are also clear opportunities to take actions that would increase uptake.

Availability, Formulation, Labeling, and Price of Low-sodium Salt Worldwide: Environmental Scan.

BACKGROUND: Regular salt is about 100% sodium chloride. Low-sodium salts have reduced sodium chloride content, most commonly through substitution with potassium chloride. Low-sodium salts have a potential role in reducing the population's sodium intake levels and blood pressure, but their availability in the global market is unknown. OBJECTIVE: The aim of this study is to assess the availability, formulation, labeling, and price of low-sodium salts currently available to consumers worldwide. METHODS: Low-sodium salts were identified through a systematic literature review, Google search, online shopping site searches, and inquiry of key informants. The keywords "salt substitute," "low-sodium salt," "potassium salt," "mineral salt," and "sodium reduced salt" in six official languages of the United Nations were used for the search. Information about the brand, formula, labeling, and price was extracted and analyzed. RESULTS: A total of 87 low-sodium salts were available in 47 out of 195 (24%) countries worldwide, including 28 high-income countries, 13 upper-middle-income countries, and 6 lower-middle-income countries. The proportion of sodium chloride varied from 0% (sodium-free) to 88% (as percent of weight; regular salt is 100% sodium chloride). Potassium chloride was the most frequent component with levels ranging from 0% to 100% (potassium chloride salt). A total of 43 (49%) low-sodium salts had labels with the potential health risks, and 33 (38%) had labels with the potential health benefits. The median price of low-sodium salts in high-income, upper-middle-income, and lower-middle-income countries was US $15.00/kg (IQR 6.4-22.5), US $2.70/kg (IQR 1.7-5.5), and US $2.90/kg (IQR 0.50-22.2), respectively. The price of low-sodium salts was between 1.1 and 14.6 times that of regular salts. CONCLUSIONS: Low-sodium salts are not widely available and are commonly more expensive than regular salts. Policies that promote the availability, affordability, and labeling of low-sodium salts should increase uptake, helping populations reduce blood pressure and prevent cardiovascular diseases. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1111/jch.14054.

The cost of providing a community-based model of care to people with spinal cord injury, and the healthcare costs and economic burden to households of spinal cord injury in Bangladesh.

DESIGN: Descriptive. SETTING: Community, Bangladesh. OBJECTIVES: To determine the costs associated with providing a community-based model of care delivered as part of the CIVIC trial to people discharged from hospital with recent spinal cord injury (SCI), and to determine the economic burden to households. METHODS: Records were kept of the costs of providing a community-based model of care to participants of the CIVIC trial. Data were also collected at discharge and 2 years post discharge to capture out-of-pocket healthcare costs over the preceding 2 years, and the number of participants suffering catastrophic health expenditure and illness-induced poverty. RESULTS: The mean cost of providing the community-based model of care to participants assigned to the intervention group (n = 204) was US$237 per participant. The mean out-of-pocket healthcare cost over the first 2 years post discharge was US$472 per participant (n = 410), and US$448 per control participant (n = 206). Median (IQR) equivalent annual household incomes prior to SCI and at 2 years post discharge were US$721 (US$452-1129) and US$464 (US$214-799), respectively. Of the 378 participants alive at 2 years, 324 (86%) had catastrophic health expenditure, and 161 of 212 participants who were not in poverty prior to injury (76%) were pushed into illness-induced poverty within 2 years of injury. CONCLUSION: The cost of providing community-based support to people with SCI for 2 years post discharge in Bangladesh is relatively inexpensive but an overwhelming majority of households rapidly experience financial catastrophe, and most fall into poverty.

Patient-level and system-level barriers associated with treatment delays for ST elevation myocardial infarction in China.

OBJECTIVE: This study aims to understand the current ST elevated myocardial infarction (STEMI) treatment process in Guangdong Province and explore patient-level and system-level barriers associated with delay in STEMI treatment, so as to provide recommendations for improvement. METHODS: This is a qualitative study. Data were collected using semistructured, face-to-face individual interviews from April 2018 to January 2019. Participants included patients with STEMI, cardiologists and nurses from hospitals, emergency department doctors, primary healthcare providers, local health governors, and coordinators at the emergency medical system (EMS). An inductive thematic analysis was adopted to generate overarching themes and subthemes for potential causes of STEMI treatment delay. The WHO framework for people-centred integrated health services was used to frame recommendations for improving the health system. RESULTS: Thirty-two participants were interviewed. Patient-level barriers included poor knowledge in recognising STEMI symptoms and not calling EMS when symptoms occurred. Limited capacity of health professionals in hospitals below the tertiary level and lack of coordination between hospitals of different levels were identified as the main system-level barriers. Five recommendations were provided: (1) enhance public health education; (2) strengthen primary healthcare workforce; (3) increase EMS capacity; (4) establish an integrated care model; and (5) harness government's responsibilities. CONCLUSIONS: Barriers associated with delay in STEMI treatment were identified at both patient and system levels. The results of this study provide a useful evidence base for future intervention development to improve the quality of STEMI treatment and patient outcomes in China and other countries in a similar situation.

Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh.

INTRODUCTION: People with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective. METHODS AND ANALYSIS: Our process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome. ETHICS AND DISSEMINATION: Ethics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12615000630516.

Exploring the use of economic evidence to inform investment in disease prevention - a qualitative study.

OBJECTIVE: In the context of growing financial pressures on health budgets, cost-effective prevention strategies are needed to address the burden from non-communicable disease in Australia. We explored how decision makers use economic evidence to inform such investment and how such evidence generated can more effectively meet the needs of end users. METHODS: Thematic analysis of in-depth interviews with 15 high level stakeholders (Treasury, state health departments and the insurance industry), supplemented by documentary analysis. RESULTS: Types of prevention approaches and economic evidence relevant to decision makers differed by organisational perspective. Capacity building in understanding economic evaluations and research evidence that addresses the differing criteria for investment used by different organisations is needed. The task of determining investment priorities in disease prevention comes with significant challenges including ideological barriers, delayed outcome measures, and implementation uncertainties. Conclusions and Implications for public health: Promoting the greater use of economic evidence in prevention requires more work on two fronts: tailoring the methods used by economists to better match the organisational imperatives of end users; and promoting greater consideration of broader societal and health sector perspectives among end users. This will require significant infrastructure development, monitoring and evaluation, stronger national leadership and a greater emphasis on evidence coproduction.

Clinical stroke research in resource limited settings: Tips and hints.

Background Most stroke research is conducted in high income countries, yet most stroke occurs in low- and middle-income countries. There is an urgent need to build stroke research capacity in low- and middle-income countries. Aims To review the global health literature on how to improve research capacity in low- and middle-income countries, provide additional data from the recently completed ATTEND Trial and provide examples from our own experience. Summary of review The main themes from our literature review were: manpower and workload, research training, research question and methodology and research funding. The literature and our own experience emphasized the importance of local stakeholders to ensure that the research was appropriate, that there were robust local ethics and regulatory processes, and research was conducted by trained personnel. Research training opportunities can be developed locally, or internationally, with many international schemes available to help support new researchers from low- and middle-income country settings. International collaboration can successfully leverage funding from high income countries that not only generate data for the local country, but also provide new data appropriate to high income countries. Conclusions Building stroke research capacity in low- and middle-income countries will be vital in improving global health given the huge burden of stroke in these countries.

Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India.

INTRODUCTION: We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting. METHODS AND ANALYSIS: The realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation. ETHICS AND DISSEMINATION: The process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation. TRIAL REGISTRATION NUMBER: CTRI/2013/04/003557.

Factors influencing the implementation of chronic care models: A systematic literature review.

BACKGROUND: The increasing prevalence of chronic disease faced by both developed and developing countries is of considerable concern to a number of international organisations. Many of the interventions to address this concern within primary healthcare settings are based on the chronic care model (CCM). The implementation of complex interventions such as CCMs requires careful consideration and planning. Success depends on a number of factors at the healthcare provider, team, organisation and system levels. METHODS: The aim of this systematic review was to systematically examine the scientific literature in order to understand the facilitators and barriers to implementing CCMs within a primary healthcare setting. This review focused on both quantitative and qualitative studies which included patients with chronic disease (cardiovascular disease, chronic kidney disease, chronic respiratory disease, type 2 diabetes mellitus, depression and HIV/AIDS) receiving care in primary healthcare settings, as well as primary healthcare providers such as doctors, nurses and administrators. Papers were limited to those published in English between 1998 and 2013. RESULTS: The search returned 3492 articles. The majority of these studies were subsequently excluded based on their title or abstract because they clearly did not meet the inclusion criteria for this review. A total of 226 full text articles were obtained and a further 188 were excluded as they did not meet the criteria. Thirty eight published peer-reviewed articles were ultimately included in this review. Five primary themes emerged. In addition to ensuring appropriate resources to support implementation and sustainability, the acceptability of the intervention for both patients and healthcare providers contributed to the success of the intervention. There was also a need to prepare healthcare providers for the implementation of a CCM, and to support patients as the way in which they receive care changes. CONCLUSION: This systematic review demonstrated the importance of considering human factors including the influence that different stakeholders have on the success or otherwise of the implementing a CCM.

Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst indigenous and non indigenous people at high cardiovascular risk.

BACKGROUND: The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. METHODS/DESIGN: The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. DISCUSSION: The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.