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This is the first in a series of papers reporting Sustainability in Health care by Allocating Resources Effectively (SHARE). The SHARE Program is an investigation of concepts, opportunities, methods and implications for evidence-based investment and disinvestment in health technologies and clinical practices in a local healthcare setting. The papers in this series are targeted at clinicians, managers, policy makers, health service researchers and implementation scientists working in this context. This paper presents an overview of the organisation-wide, systematic, integrated, evidence-based approach taken by one Australian healthcare network and provides an introduction and guide to the suite of papers reporting the experiences and outcomes. [ABSTRACT FROM AUTHOR]

Background: Well-organised and managed workplaces can be a source of wellbeing. The construction, healthcare and information and communication technology sectors are characterised by work-related stressors (e.g. high workloads, tight deadlines) which are associated with poorer mental health and wellbeing. The MENTUPP intervention is a flexibly delivered, multi-level approach to supporting small- and medium-sized enterprises (SMEs) in creating mentally healthy workplaces. The online intervention is tailored to each sector and designed to support employees and leaders dealing with mental health difficulties (e.g. stress), clinical level anxiety and depression, and combatting mental health-related stigma. This paper presents the protocol for the cluster randomised controlled trial (cRCT) of the MENTUPP intervention in eight European countries and Australia. Methods: Each intervention country will aim to recruit at least two SMEs in each of the three sectors. The design of the cRCT is based on the experiences of a pilot study and guided by a Theory of Change process that describes how the intervention is assumed to work. SMEs will be randomly assigned to the intervention or control conditions. The aim of the cRCT is to assess whether the MENTUPP intervention is effective in improving mental health and wellbeing (primary outcome) and reducing stigma, depression and suicidal behaviour (secondary outcome) in employees. The study will also involve a process and economic evaluation. Conclusions: At present, there is no known multi-level, tailored, flexible and accessible workplace-based intervention for the prevention of non-clinical and clinical symptoms of depression, anxiety and burnout, and the promotion of mental wellbeing. The results of this study will provide a comprehensive overview of the implementation and effectiveness of such an intervention in a variety of contexts, languages and cultures leading to the overall goal of delivering an evidence-based intervention for mental health in the workplace. Trial registration: Please refer to Item 2a and registration ISRCTN14104664. Registered on 12th July 2022. [ABSTRACT FROM AUTHOR]

Background: Sustainable shifts in population behaviours require system-level implementation and embeddedness of large-scale health interventions. This paper aims to understand how different contexts of scaling up interventions affect mechanisms to produce intended and unintended scale up outcomes. Methods: A mixed method study combining a realist perspective and systems analysis (causal loop diagrams) of scaled-up physical activity and/or nutrition interventions implemented at a state/national level in Australia (2010–18). The study involved four distinct phases: Phase 1 expert consultation, database and grey literature searches to identify scaled-up interventions; Phase 2 generating initial Context-Mechanism-Outcome configurations (CMOs) from the WHO ExpandNet framework for scaling up; Phase 3 testing and refining CMOs via online surveys and realist interviews with academics, government and non-government organisations (NGOs) involved in scale up of selected interventions (Phase 1); and Phase 4 generating cross-case mid-range theories represented in systems models of scaling up; validated by member checking. Descriptive statistics were reported for online survey data and realist analysis for interview data. Results: Seven interventions were analysed, targeting nutrition (n = 1), physical activity (n = 1), or a combination (n = 5). Twenty-six participants completed surveys; 19 completed interviews. Sixty-three CMO pathways underpinned successful scale up, reflecting 36 scale up contexts, 8 key outcomes; linked via 53 commonly occurring mechanisms. All five WHO framework domains were represented in the systems models. Most CMO pathways included 'intervention attributes' and led to outcomes 'community sustainability/embeddedness' and 'stakeholder buy-in/perceived value'. Irrespective of interventions being scaled in similar contexts (e.g., having political favourability); mechanisms still led to both intended and unintended scale up outcomes (e.g., increased or reduced sustainability). Conclusion: This paper provides the first evidence for mechanisms underpinning outcomes required for successful scale up of state or nationally delivered interventions. Our findings challenge current prerequisites for effective scaling suggesting other conditions may be necessary. Future scale up approaches that plan for complexity and encourage iterative adaptation throughout, may enhance scale up outcomes. Current linear, context-to-outcome depictions of scale up oversimplify what is a clearly a complex interaction between perceptions, worldviews and goals of those involved. Mechanisms identified in this study could potentially be leveraged during future scale up efforts, to positively influence intervention scalability and sustainability. [ABSTRACT FROM AUTHOR]

Background: Structured risk-stratification to guide clinician assessment and engagement with evidence-based therapies may reduce care variance and improve patient outcomes for Acute Coronary Syndrome (ACS). The Australian Grace Risk score Intervention Study (AGRIS) explored the impact of the GRACE Risk Tool for stratification of ischaemic and bleeding risk in ACS. While hospitals in the active arm had a higher overall rate of invasive ACS management, there was neutral impact on important secondary prevention prescriptions/referrals, hospital performance measures, myocardial infarction and 12-month mortality leading to early trial cessation. Given the Grace Risk Tool is under investigation internationally, this process evaluation study provides important insights into the possible contribution of implementation fidelity on the AGRIS study findings.Methods: Using maximum variation sampling, five hospitals were selected from the 12 centres enrolled in the active arm of AGRIS. From these facilities, 16 local implementation stakeholders (Cardiology advanced practice nurses, junior and senior doctors, study coordinators) consented to a semi-structured interview guided by the Theoretical Domains Framework. Directed Content Analysis of qualitative data was structured using the Capability/Opportunity/Motivation-Behaviour (COM-B) model.Results: Physical capability was enhanced by tool usability. While local stakeholders supported educating frontline clinicians, non-cardiology clinicians struggled with specialist terminology. Physical opportunity was enhanced by the paper-based format but was hampered when busy clinicians viewed risk-stratification as one more thing to do, or when form visibility was neglected. Social opportunity was supported by a culture of research/evidence yet challenged by clinical workflow and rotating medical officers. Automatic motivation was strengthened by positive reinforcement. Reflective motivation revealed the GRACE Risk Tool as supporting but potentially overriding clinical judgment. Divergent professional roles and identity were a major barrier to integration of risk-stratification into routine Emergency Department practice. The cumulative result revealed poor form completion behaviors and a failure to embed risk-stratification into routine patient assessment, communication, documentation, and clinical practice behaviors.Conclusions: Numerous factors negatively influenced AGRIS implementation fidelity. Given the prominence of risk assessment recommendations in United States, European and Australian guidelines, strategies that strengthen collaboration with Emergency Departments and integrate automated processes for risk-stratification may improve future translation internationally. [ABSTRACT FROM AUTHOR]

Background: The World Economic Forum has recently highlighted substantial problems in mental health service provision and called for the rapid deployment of smarter, digitally-enhanced health services as a means to facilitate effective care coordination and address issues of demand. In mental health, the biggest enabler of digital solutions is the implementation of an effective model of care that is facilitated by integrated health information technologies (HITs); the latter ensuring the solution is easily accessible, scalable and sustainable. The University of Sydney's Brain and Mind Centre (BMC) has developed an innovative digital health solution - delivered through the Youth Mental Health and Technology Program - which incorporates two components: 1) a highly personalised and measurement-based (data-driven) model of youth mental health care; and 2) an industrial grade HIT registered on the Australian Register of Therapeutic Goods. This paper describes a research protocol to evaluate the impact of implementing the BMC's digital health solution into youth mental health services (i.e. headspace - a highly accessible, youth-friendly integrated service that responds to the mental health, physical health, alcohol or other substance use, and vocational concerns of young people aged 12 to 25 years) within urban and regional areas of Australia.Methods: The digital health solution will be implemented into participating headspace centres using a naturalistic research design. Quantitative and qualitative data will be collected from headspace health professionals, service managers and administrators, as well as from lead agency and local Primary Health Network (PHN) staff, via service audits, Implementation Officer logs, online surveys, and semi-structured interviews, at baseline and then three-monthly intervals over the course of 12 months.Discussion: At the time of publication, six headspace centres had been recruited to this study and had commenced implementation and impact evaluation. The first results are expected to be submitted for publication in 2021. This study will focus on the impact of implementing a digital health solution at both a service and staff level, and will evaluate digital readiness of service and staff adoption; quality, usability and acceptability of the solution by staff; staff self-reported clinical competency; overall impact on headspace centres as well as their lead agencies and local PHNs; and social return on investment. [ABSTRACT FROM AUTHOR]

Background: The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability.Methods: Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019.Results: Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map.Conclusions: The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.Trial Registration: This review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register. [ABSTRACT FROM AUTHOR]

Background: Evaluation of health technology programmes should be theoretically informed, interdisciplinary, and generate in-depth explanations. The NASSS (non-adoption, abandonment, scale-up, spread, sustainability) framework was developed to study unfolding technology programmes in real time-and in particular to identify and manage their emergent uncertainties and interdependencies. In this paper, we offer a worked example of how NASSS can also inform ex post (i.e. retrospective) evaluation.Methods: We studied the TORPEDO (Treatment of Cardiovascular Risk in Primary Care using Electronic Decision Support) research programme, a multi-faceted computerised quality improvement intervention for cardiovascular disease prevention in Australian general practice. The technology (HealthTracker) had shown promise in a cluster randomised controlled trial (RCT), but its uptake and sustainability in a real-world implementation phase was patchy. To explain this variation, we used NASSS to undertake secondary analysis of the multi-modal TORPEDO dataset (results and process evaluation of the RCT, survey responses, in-depth professional interviews, videotaped consultations) as well as a sample of new, in-depth narrative interviews with TORPEDO researchers.Results: Ex post analysis revealed multiple areas of complexity whose influence and interdependencies helped explain the wide variation in uptake and sustained use of the HealthTracker technology: the nature of cardiovascular risk in different populations, the material properties and functionality of the technology, how value (financial and non-financial) was distributed across stakeholders in the system, clinicians' experiences and concerns, organisational preconditions and challenges, extra-organisational influences (e.g. policy incentives), and how interactions between all these influences unfolded over time.Conclusion: The NASSS framework can be applied retrospectively to generate a rich, contextualised narrative of technology-supported change efforts and the numerous interacting influences that help explain its successes, failures, and unexpected events. A NASSS-informed ex post analysis can supplement earlier, contemporaneous evaluations to uncover factors that were not apparent or predictable at the time but dynamic and emergent. [ABSTRACT FROM AUTHOR]

Background: This is the seventh in a series of papers reporting Sustainability in Health care by Allocating Resources Effectively (SHARE) in a local healthcare setting. The SHARE Program was a systematic, integrated, evidence-based program for resource allocation within a large Australian health service. It aimed to facilitate proactive use of evidence from research and local data; evidence-based decision-making for resource allocation including disinvestment; and development, implementation and evaluation of disinvestment projects. From the literature and responses of local stakeholders it was clear that provision of expertise and education, training and support of health service staff would be required to achieve these aims. Four support services were proposed. This paper is a detailed case report of the development, implementation and evaluation of a Data Service, Capacity Building Service and Project Support Service. An Evidence Service is reported separately.Methods: Literature reviews, surveys, interviews, consultation and workshops were used to capture and process the relevant information. Existing theoretical frameworks were adapted for evaluation and explication of processes and outcomes.Results: Surveys and interviews identified current practice in use of evidence in decision-making, implementation and evaluation; staff needs for evidence-based practice; nature, type and availability of local health service data; and preferred formats for education and training. The Capacity Building and Project Support Services were successful in achieving short term objectives; but long term outcomes were not evaluated due to reduced funding. The Data Service was not implemented at all. Factors influencing the processes and outcomes are discussed.Conclusion: Health service staff need access to education, training, expertise and support to enable evidence-based decision-making and to implement and evaluate the changes arising from those decisions. Three support services were proposed based on research evidence and local findings. Local factors, some unanticipated and some unavoidable, were the main barriers to successful implementation. All three proposed support services hold promise as facilitators of EBP in the local healthcare setting. The findings from this study will inform further exploration. [ABSTRACT FROM AUTHOR]

Background: This is the fifth in a series of papers reporting Sustainability in Health care by Allocating Resources Effectively (SHARE) in a local healthcare setting. This paper synthesises the findings from Phase One of the SHARE Program and presents a model to be implemented and evaluated in Phase Two. Monash Health, a large healthcare network in Melbourne Australia, sought to establish an organisation-wide systematic evidence-based program for disinvestment. In the absence of guidance from the literature, the Centre for Clinical Effectiveness, an in-house 'Evidence Based Practice Support Unit', was asked to explore concepts and practices related to disinvestment, consider the implications for a local health service and identify potential settings and methods for decision-making.Methods: Mixed methods were used to capture the relevant information. These included literature reviews; online questionnaire, interviews and structured workshops with a range of stakeholders; and consultation with experts in disinvestment, health economics and health program evaluation. Using the principles of evidence-based change, the project team worked with health service staff, consumers and external experts to synthesise the findings from published literature and local research and develop proposals, frameworks and plans.Results: Multiple influencing factors were extracted from these findings. The implications were both positive and negative and addressed aspects of the internal and external environments, human factors, empirical decision-making, and practical applications. These factors were considered in establishment of the new program; decisions reached through consultation with stakeholders were used to define four program components, their aims and objectives, relationships between components, principles that underpin the program, implementation and evaluation plans, and preconditions for success and sustainability. The components were Systems and processes, Disinvestment projects, Support services, and Program evaluation and research. A model for a systematic approach to evidence-based resource allocation in a local health service was developed.Conclusion: A robust evidence-based investigation of the research literature and local knowledge with a range of stakeholders resulted in rich information with strong consistent messages. At the completion of Phase One, synthesis of the findings enabled development of frameworks and plans and all preconditions for exploration of the four main aims in Phase Two were met. [ABSTRACT FROM AUTHOR]

Background: This is the third in a series of papers reporting a program of Sustainability in Health care by Allocating Resources Effectively (SHARE) in a local healthcare setting. Leaders in a large Australian health service planned to establish an organisation-wide, systematic, integrated, evidence-based approach to disinvestment. In order to introduce new systems and processes for disinvestment into existing decision-making infrastructure, we aimed to understand where, how and by whom resource allocation decisions were made, implemented and evaluated. We also sought the knowledge and experience of staff regarding previous disinvestment activities.Methods: Structured interviews, workshops and document analysis were used to collect information from multiple sources in an environmental scan of decision-making systems and processes. Findings were synthesised using a theoretical framework.Results: Sixty-eight respondents participated in interviews and workshops. Eight components in the process of resource allocation were identified: Governance, Administration, Stakeholder engagement, Resources, Decision-making, Implementation, Evaluation and, where appropriate, Reinvestment of savings. Elements of structure and practice for each component are described and a new framework was developed to capture the relationships between them. A range of decision-makers, decision-making settings, type and scope of decisions, criteria used, and strengths, weaknesses, barriers and enablers are outlined. The term 'disinvestment' was not used in health service decision-making. Previous projects that involved removal, reduction or restriction of current practices were driven by quality and safety issues, evidence-based practice or a need to find resource savings and not by initiatives where the primary aim was to disinvest. Measuring resource savings is difficult, in some situations impossible. Savings are often only theoretical as resources released may be utilised immediately by patients waiting for beds, clinic appointments or surgery. Decision-making systems and processes for resource allocation are more complex than assumed in previous studies.Conclusion: There is a wide range of decision-makers, settings, scope and type of decisions, and criteria used for allocating resources within a single institution. To our knowledge, this is the first paper to report this level of detail and to introduce eight components of the resource allocation process identified within a local health service. [ABSTRACT FROM AUTHOR]

Background: Since the early 90s, patient navigation programs were introduced in the United States to address inequitable access to cancer care. Programs have since expanded internationally and in scope. The goals of patient navigation programs are to: a) link patients and families to primary care services, specialist care, and community-based health and social services (CBHSS); b) provide more holistic patient-centred care; and, c) identify and resolve patient barriers to care. This paper fills a gap in knowledge to reveal what is known about motivators and factors influencing implementation and maintenance of patient navigation programs in primary care that link patients to CBHSS. It also reports on outcomes from these studies to help identify gaps in research that can inform future studies.Methods: This scoping literature review involved: i) electronic database searches; ii) a web site search; iii) a search of reference lists from literature reviews; and, iv) author follow up. It included papers from Canada, the United States, the United Kingdom, Australia, New Zealand, and/or Western Europe published between January 1990 and June 2013 if they discussed navigators or navigation programs in primary care settings that linked patients to CBHSS.Results: Of 34 papers, most originated in the United States (n = 29) while the remainder were from the United Kingdom, Canada and Australia. Motivators for initiating navigation programs were to: a) improve delivery of health and social care services; b) support and manage specific health needs or specific population needs, and; c) improve quality of life and wellbeing of patients. Eleven factors were found to influence implementation and maintenance of these patient navigation programs. These factors closely aligned with the Diffusion of Innovation in Service Organizations model, thus providing a theoretical foundation to support them. Various positive outcomes were reported for patients, providers and navigators, as well as the health and social care system, although they need to be considered with caution since the majority of studies were descriptive.Conclusions: This study contributes new knowledge that can inform the initiation and maintenance of primary care patient navigation programs that link patients with CBHSS. It also provides directions for future research. [ABSTRACT FROM AUTHOR]

Background: Deadly Liver Mob (DLM) is a peer-driven, incentivised health promotion program aimed at increasing understanding of hepatitis C, promoting harm reduction in relation to injecting drug use, and linking participants to screening for hepatitis C, other blood borne viruses and sexually transmissible infections among Aboriginal people in Western Sydney, NSW. This paper presents the evaluation of a pilot study examining the acceptability of the program as a first step of a scalability assessment. Methods: Deadly Liver Mob operated in co-located needle and syringe programs and sexual health clinics in two sites: (Site 1: two and a half years for 2 days/week; Site 2: 1 year for 1 day per week). Comparisons were made of the proportion of Aboriginal clients (Site 1) and occasions of service provided to Aboriginal clients (Site 2) in the 12 months prior and post-introduction of DLM. Interviews were conducted with 13 staff involved in delivery of DLM and with 19 clients. Results: A total of 655 and 55 Aboriginal clients, respectively, attended Site 1 and Site 2 for health education. The proportion of Aboriginal clients attending both sites was significantly higher during the DLM compared with prior to its implementation. Of those attending for health education, 79 and 73%, respectively, attended screening following education. DLM clients strongly endorsed the program. Some staff were concerned about workforce capacity to effectively engage Aboriginal clients with multiple and complex needs, managing the differing aims of the participating services involved, and about offering of incentives for attendance at health services. Conclusion: While acceptability was high among staff and clients and preliminary results show high engagement with Aboriginal communities, this evaluation of a pilot program raises some issues to consider in scale up of DLM to other sites. The initiation of additional DLM sites should address issues of alignment with governing strategies and workforce capacity. [ABSTRACT FROM AUTHOR]

Background: The Localities Embracing and Accepting Diversity (LEAD) programme was established to improve the health of ethnic minority communities through the reduction of racial discrimination. Local governments in the state of Victoria, Australia, were at the forefront of LEAD implementation in collaboration with leading state and national organisations. Key aims included expanding the available evidence regarding effective anti-racism interventions and facilitating the uptake of this evidence in organisational policies and practices.Methods: One rural and one metropolitan local government areas were selected to participate in LEAD. Key informant interviews and discussions were conducted with individuals who had participated in LEAD implementation and members of LEAD governance structures. Data were also collected on programme processes and implementation, partnership formation and organisational assessments.Results: The LEAD model demonstrated both strengths and weaknesses in terms of facilitating the use of evidence in a complex, community-based health promotion initiative. Representation of implementing, funding and advisory bodies at different levels of governance enabled the input of technical advice and guidance alongside design and implementation. The representation structure assisted in ensuring the development of a programme that was acceptable to all partners and informed by the best available evidence. Simultaneous evaluation also enhanced perceived validity of the intervention, allowed for strategy correction when necessary and supported the process of double-loop organisational learning. However, due to the model's demand for simultaneous and intensive effort by various organisations, when particular elements of the intervention were not functional, there was a considerable loss of time and resources across the partner organisations. The complexity of the model also presented a challenge in ensuring clarity regarding roles, functions and the direction of the programme.Conclusions: The example of LEAD provides guidance on mechanisms to strengthen the entry of evidence into complex community-based health promotion programmes. The paper highlights some of the strengths and weaknesses of the LEAD model and implications for practical collaboration between policymakers, implementers and researchers. [ABSTRACT FROM AUTHOR]

Background: While there is a growing interest in the field of research translation, there are few published examples of public health interventions that have been effectively scaled up and implemented in the community. This paper provides a case study of the community-wide implementation of the Melbourne Infant, Feeding, Activity and Nutrition Trial (InFANT), an obesity prevention program for parents with infants aged 3-18 months. The study explored key factors influencing the translation of the Program into routine practice and the respective role of policy makers, researchers and implementers.Methods: Case studies were conducted of five of the eight prevention areas in Victoria, Australia who implemented the Program. Cases were selected on the basis of having implemented the Program for 6 months or more. Data were collected from January to June 2015 and included 18 individual interviews, one focus group and observation of two meetings. A total of 28 individuals, including research staff (n = 4), policy makers (n = 2) and implementers (n = 22), contributed to the data collected. Thematic analysis was conducted using cross case comparisons and key themes were verified through member checking.Results: Key facilitators of implementation included availability of a pre-packaged evidence based program addressing a community need, along with support and training provided by research staff to local implementers. Partnerships between researchers and policy makers facilitated initial program adoption, while local partnerships supported community implementation. Community partnerships were facilitated by local coordinators through alignment of program goals with existing policies and services. Workforce capacity for program delivery and administration was a challenge, largely overcome by embedding the Program into existing roles. Adapting the Program to fit local circumstance was critical for feasible and sustainable delivery, however balancing this with program fidelity was a critical issue. The lack of ongoing funding to support translation activities was a barrier for researchers continued involvement in community implementation.Conclusion: Policy makers, researchers and practitioners have important and complementary roles to play in supporting the translation of effective research interventions into practice. New avenues need to be explored to strengthen partnerships between researchers and end users to support the integration of effective public health research interventions into practice. [ABSTRACT FROM AUTHOR]

Background: Effective implementation can maximise the beneficial impacts of health services. It is therefore important to review implementation in the context of Indigenous populations, who suffer some of the greatest disadvantage within developed countries. This paper analyses Aboriginal and Torres Strait Islander (hereafter Indigenous) Australian health implementation reviews to examine the research question: What is the effectiveness of implementation, as reported in the Indigenous Australian health implementation literature? Methods: Eight databases were systematically searched to find reviews of Indigenous Australian health services and/or programs where implementation was the focus. Search terms included Aborigin* OR Indigen* OR Torres AND health AND service OR program* OR intervention AND implementation (or like terms) AND Australia AND review. Review findings were analysed through the lens of the PARiHS framework which theorises that successful implementation occurs through the interplay of evidence, context and facilitation. The review followed Cochrane methods but was not registered. Results: Six reviews were found; these encompassed 107 studies that considered health service/program implementation. Included studies described many health services implemented across Australia as not underpinned by rigorous impact evaluation; nevertheless implementers tended to prefer evidence-based interventions. Effective implementation was supported by clearly defined management systems, employment of Indigenous health workers as leaders, community control, partnerships, tailoring for diverse places and settings; and active facilitation methods. Short-term funding meant most studies focused on implementation in one site through pilot initiatives. Only two mentioned cost effectiveness. Indigenous Australian studies incorporated two elements not included in the PARiHS reference guide: the value of community control and equity of service provision across sites. Conclusions: Comparison of the Indigenous Australian review findings against the PARiHS reference guide elements suggested a fledgling but growing state of Indigenous implementation research, and considerable scope to improve the effectiveness of implementation. Further research is required to explore Indigenous people's understandings of what is important in healthcare implementation; particularly in relation to the value of community control and equity issues. [ABSTRACT FROM AUTHOR]

Background: Pragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for 'real life' implementation challenges in routine practice. The methodological challenges of PRCT implementation, particularly in primary care, are not well understood. The Kanyini Guidelines Adherence to Polypill study (Kanyini GAP) was a recent primary care PRCT involving multiple private general practices, Indigenous community controlled health services and private community pharmacies. Through the experiences of Kanyini GAP participants, and using data from study materials, this paper identifies the critical enablers and barriers to implementing a PRCT across diverse practice settings and makes recommendations for future PRCT implementation.Methods: Qualitative data from 94 semi-structured interviews (47 healthcare providers (pharmacists, general practitioners, Aboriginal health workers; 47 patients) conducted for the process evaluation of Kanyini GAP was used. Data coded to 'trial impact', 'research motivation' and 'real world' were explored and triangulated with data extracted from study materials (e.g. Emails, memoranda of understanding and financial statements).Results: PRCT implementation was facilitated by an extensive process of relationship building at the trial outset including building on existing relationships between core investigators and service providers. Health providers' and participants' altruism, increased professional satisfaction, collaboration, research capacity and opportunities for improved patient care enabled implementation. Inadequate research infrastructure, excessive administrative demands, insufficient numbers of adequately trained staff and the potential financial impact on private practice were considered implementation barriers. These were largely related to this being the first experience of trial involvement for many sites. The significant costs of addressing these barriers drew study resources from the task of achieving recruitment targets.Conclusions: Conducting PRCTs is crucial to generating credible evidence of intervention effectiveness in routine practice. PRCT implementation needs to account for the particular challenges of implementing collaborative research across diverse stakeholder organisations. Reliance on goodwill to participate is crucial at the outset. However, participation costs, particularly for organisations with little or no research experience, can be substantial and should be factored into PRCT funding models. Investment in a pool to fund infrastructure in the form of primary health research networks will offset some of these costs, enabling future studies to be implemented more cost-effectively.Trial Registration: ACTRN126080005833347. [ABSTRACT FROM AUTHOR]