Implementation of large, multi-site hospital interventions: a realist evaluation of strategies for developing capability.

BACKGROUND: This study presents guidelines for implementation distilled from the findings of a realist evaluation. The setting was local health districts in New South Wales, Australia that implemented three clinical improvement initiatives as part of a state-wide program. We focussed on implementation strategies designed to develop health professionals' capability to deliver value-based care initiatives for multisite programs. Capability, which increases implementers' ability to cope with unexpected scenarios is key to managing change. METHODS: We used a mixed methods realist evaluation which tested and refined program theories elucidating the complex dynamic between context (C), mechanism (M) and outcome (O) to determine what works, for whom, under what circumstances. Data was drawn from program documents, a realist synthesis, informal discussions with implementation designers, and interviews with 10 key informants (out of 37 identified) from seven sites. Data analysis employed a retroductive approach to interrogate the causal factors identified as contributors to outcomes. RESULTS: CMO statements were refined for four initial program theories: Making it Relevant- where participation in activities was increased when targeted to the needs of the staff; Investment in Quality Improvement- where engagement in capability development was enhanced when it was valued by all levels of the organisation; Turnover and Capability Loss- where the effects of staff turnover were mitigated; and Community-Wide Priority- where there was a strategy of spanning sites. From these data five guiding principles for implementers were distilled: (1) Involve all levels of the health system to effectively implement large-scale capability development, (2) Design capability development activities in a way that supports a learning culture, (3) Plan capability development activities with staff turnover in mind, (4) Increased capability should be distributed across teams to avoid bottlenecks in workflows and the risk of losing key staff, (5) Foster cross-site collaboration to focus effort, reduce variation in practice and promote greater cohesion in patient care. CONCLUSIONS: A key implementation strategy for interventions to standardise high quality practice is development of clinical capability. We illustrate how leadership support, attention to staff turnover patterns, and making activities relevant to current issues, can lead to an emergent learning culture.

Perioperative interventions to improve early mobilisation and physical function after hip fracture: a systematic review and meta-analysis.

BACKGROUND: Perioperative interventions could enhance early mobilisation and physical function after hip fracture surgery. OBJECTIVE: Determine the effectiveness of perioperative interventions on early mobilisation and physical function after hip fracture. METHODS: Ovid MEDLINE, CINAHL, Embase, Scopus and Web of Science were searched from January 2000 to March 2022. English language experimental and quasi-experimental studies were included if patients were hospitalised for a fractured proximal femur with a mean age 65 years or older and reported measures of early mobilisation and physical function during the acute hospital admission. Data were pooled using a random effect meta-analysis. RESULTS: Twenty-eight studies were included from 1,327 citations. Studies were conducted in 26 countries on 8,192 participants with a mean age of 80 years. Pathways and models of care may provide a small increase in early mobilisation (standardised mean difference [SMD]: 0.20, 95% confidence interval [CI]: 0.01-0.39, I2 = 73%) and physical function (SMD: 0.07, 95% CI 0.00 to 0.15, I2 = 0%) and transcutaneous electrical nerve stimulation analgesia may provide a moderate improvement in function (SMD: 0.65, 95% CI: 0.24-1.05, I2 = 96%). The benefit of pre-operative mobilisation, multidisciplinary rehabilitation, recumbent cycling and clinical supervision on mobilisation and function remains uncertain. Evidence of no effect on mobilisation or function was identified for pre-emptive analgesia, intraoperative periarticular injections, continuous postoperative epidural infusion analgesia, occupational therapy training or nutritional supplements. CONCLUSIONS: Perioperative interventions may improve early mobilisation and physical function after hip fracture surgery. Future studies are needed to model the causal mechanisms of perioperative interventions on mobilisation and function after hip fracture.

Transition models of care for type 1 diabetes: a systematic review.

BACKGROUND: Managing the care regimen for Type 1 Diabetes is challenging for emerging adults, as they take on greater responsibility for self-management. A diverse range of models of care have been implemented to improve safety and quality of care during transition between paediatric and adult services. However, evidence about acceptability and effectiveness of these is limited. Our aim was to synthesise the evidence for transition models and their components, examine the health related and psychosocial outcomes, and to identify determinants associated with the implementation of person-centred models of transition care. METHOD: We searched Medline, CINAHL, EMBASE and Scopus. Peer reviewed empirical studies that focused on T1D models of care published from 2010 to 2021 in English, reporting experimental, qualitative, mixed methods, and observational studies were included. RESULTS: Fourteen studies reported on health and psychosocial outcomes, and engagement with healthcare. Three key models of care emerged: structured transition education programs (6 studies), multidisciplinary team transition support (5 studies) and telehealth/virtual care (3 studies). Compared with usual practice, three of the six structured transition education programs led to improvements in maintenance of glycaemic control, psychological well-being, and engagement with health services. Four MDT transition care models reported improved health outcomes, and improved engagement with health services, however, three studies reported no benefit. Reduced diabetes related stress and increased patient satisfaction were reported by two studies, but three reported no benefit. Telehealth and virtual group appointments improved adherence to self-management and reduced diabetes distress but did not change health outcomes. CONCLUSIONS: Although some health and psychosocial benefits are reported, the results were mixed. No studies reported on T1D transition model implementation outcomes such as acceptability, adoption, and appropriateness among clinicians or managers implementing these models. This gap needs to be addressed to support future adoption of successful models.

International approaches for implementing accreditation programmes in different healthcare facilities: a comparative case study in Australia, Botswana, Denmark, and Jordan.

Healthcare accreditation programmes have been adopted internationally to maintain the quality and safety of services. Accreditation assesses the compliance of organizations to a series of standards. The evidence base supporting the benefits of accreditation is mixed, potentially influenced by differences in local implementation and operationalization of standards. Successful implementation is associated with optimizing regulation, funding, and government commitment. Implementation of accreditation is a complex intervention that needs to be tailored to meet contextual differences across settings. Comparing why and how accreditation is implemented across countries supports the effective implementation of new programmes and refinements to existing systems. This article presents four case studies from Australia, Botswana, Denmark, and Jordan to consider a geographic spread and mix of high- and upper-middle-income countries. The data were derived from a review of accreditation programme documents and follow-up discussions with directors of the accrediting bodies in the countries of interest. Each case study was summarized according to a standardized framework for comparison: (i) goals (why), (ii) programme implementation (how), (iii) outcomes based on pre-post measures (what), and (iv) lessons learned (enablers and barriers). The accreditation programmes were all introduced in the 2000s to improve quality and safety. Documents from each country outlined motivations for introducing an accreditation programme, which was predominantly initiated by the government. The programmes were adopted in demarcated healthcare sectors (e.g. primary care and hospital settings), with a mix of mandatory and voluntary approaches. Implementation support centred on the interpretation and operationalization of standards and follow-up on variation in compliance with standards, after announced surveys. Most standards focused on patient safety, patient centredness, and governance but differed between using standard sets on quality management or supportive processes for patient care. Methods for evaluation of programme success and outcomes measured varied. Frequently reported enablers of successful implementation included strong leadership and ownership of the process. A lack of awareness of quality and safety, insufficient training in quality improvement methods, and transfer of staff represented the most common challenges. This case analysis of accreditation programmes in a variety of countries highlights consistent strategies utilized, key enabling factors, barriers, and the influence of contextual differences. Our framework for describing why, how, what, and lessons learned demonstrates innovation and experimentation in approaches used across high- and upper-middle-income countries, hospital and primary care, and specialist clinics.

Barriers to and Facilitators of Implementing Guidelines for Detecting Familial Hypercholesterolaemia in Australia.

BACKGROUND: Familial hypercholesterolaemia (FH) is a genetic condition that is a preventable cause of premature cardiovascular morbidity and mortality. High-level evidence and clinical practice guidelines support preventative care for people with FH. However, it is estimated that less than 10% of people at risk of FH have been detected using any approach across Australian health settings. The aim of this study was to identify the implementation barriers to and facilitators of the detection of FH in Australia. METHODS: Four, 2-hour virtual focus groups were facilitated by implementation scientists and a clinicians as part of the 2021 Australasian FH Summit. Template analysis was used to identify themes. RESULTS: There were 28 workshop attendees across four groups (n=6-8 each), yielding 13 barriers and 10 facilitators across three themes: (1) patient related, (2) provider related, and (3) system related. A "lack of care pathways" and "upskilling clinicians in identifying and diagnosing FH" were the most interconnected barriers and facilitators for the detection of FH. CONCLUSIONS: The relationships between barriers and facilitators across the patient, provider, and system themes indicates that a comprehensive implementation strategy is needed to address these different levels. Future research is underway to develop a model for implementing the Australian FH guidelines into practice.

Making implementation science more real.

Implementation science in healthcare aims to understand how to get evidence into practice. Once this is achieved in one setting, it becomes increasingly difficult to replicate elsewhere. The problem is often attributed to differences in context that influence how and whether implementation strategies work. We argue that realist research paradigms provide a useful framework to express the effect of contextual factors within implementation strategy causal processes. Realist studies are theory-driven evaluations that focus on understanding how and why interventions work under different circumstances. They consider the interaction between contextual circumstances, theoretical mechanisms of change and the outcomes they produce, to arrive at explanations of conditional causality (i.e., what tends to work, for whom, under what circumstances). This Commentary provides example applications using preliminary findings from a large realist implementation study of system-wide value-based healthcare initiatives in New South Wales, Australia. If applied judiciously, realist implementation studies may represent a sound approach to help optimise delivery of the right care in the right setting and at the right time.

Effectiveness of knowledge brokering and recommendation dissemination for influencing healthcare resource allocation decisions: A cluster randomised controlled implementation trial.

BACKGROUND: Implementing evidence into clinical practice is a key focus of healthcare improvements to reduce unwarranted variation. Dissemination of evidence-based recommendations and knowledge brokering have emerged as potential strategies to achieve evidence implementation by influencing resource allocation decisions. The aim of this study was to determine the effectiveness of these two research implementation strategies to facilitate evidence-informed healthcare management decisions for the provision of inpatient weekend allied health services. METHODS AND FINDINGS: This multicentre, single-blinded (data collection and analysis), three-group parallel cluster randomised controlled trial with concealed allocation was conducted in Australian and New Zealand hospitals between February 2018 and January 2020. Clustering and randomisation took place at the organisation level where weekend allied health staffing decisions were made (e.g., network of hospitals or single hospital). Hospital wards were nested within these decision-making structures. Three conditions were compared over a 12-month period: (1) usual practice waitlist control; (2) dissemination of written evidence-based practice recommendations; and (3) access to a webinar-based knowledge broker in addition to the recommendations. The primary outcome was the alignment of weekend allied health provision with practice recommendations at the cluster and ward levels, addressing the adoption, penetration, and fidelity to the recommendations. The secondary outcome was mean hospital length of stay at the ward level. Outcomes were collected at baseline and 12 months later. A total of 45 clusters (n = 833 wards) were randomised to either control (n = 15), recommendation (n = 16), or knowledge broker (n = 14) conditions. Four (9%) did not provide follow-up data, and no adverse events were recorded. No significant effect was found with either implementation strategy for the primary outcome at the cluster level (recommendation versus control ß 18.11 [95% CI -8,721.81 to 8,758.02] p = 0.997; knowledge broker versus control ß 1.24 [95% CI -6,992.60 to 6,995.07] p = 1.000; recommendation versus knowledge broker ß -9.12 [95% CI -3,878.39 to 3,860.16] p = 0.996) or ward level (recommendation versus control ß 0.01 [95% CI 0.74 to 0.75] p = 0.983; knowledge broker versus control ß -0.12 [95% CI -0.54 to 0.30] p = 0.581; recommendation versus knowledge broker ß -0.19 [-1.04 to 0.65] p = 0.651). There was no significant effect between strategies for the secondary outcome at ward level (recommendation versus control ß 2.19 [95% CI -1.36 to 5.74] p = 0.219; knowledge broker versus control ß -0.55 [95% CI -1.16 to 0.06] p = 0.075; recommendation versus knowledge broker ß -3.75 [95% CI -8.33 to 0.82] p = 0.102). None of the control or knowledge broker clusters transitioned to partial or full alignment with the recommendations. Three (20%) of the clusters who only received the written recommendations transitioned from nonalignment to partial alignment. Limitations include underpowering at the cluster level sample due to the grouping of multiple geographically distinct hospitals to avoid contamination. CONCLUSIONS: Owing to a lack of power at the cluster level, this trial was unable to identify a difference between the knowledge broker strategy and dissemination of recommendations compared with usual practice for the promotion of evidence-informed resource allocation to inpatient weekend allied health services. Future research is needed to determine the interactions between different implementation strategies and healthcare contexts when translating evidence into healthcare practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000029291.

Applying a framework to assess the impact of cardiovascular outcomes improvement research.

BACKGROUND: Health and medical research funding agencies are increasingly interested in measuring the impact of funded research. We present a research impact case study for the first four years of an Australian National Health and Medical Research Council funded Centre of Research Excellence in Cardiovascular Outcomes Improvement (2016-2020). The primary aim of this paper was to explore the application of a research impact matrix to assess the impact of cardiovascular outcomes improvement research. METHODS: We applied a research impact matrix developed from a systematic review of existing methodological frameworks used to measure research impact. This impact matrix was used as a bespoke tool to identify and understand various research impacts over different time frames. Data sources included a review of existing internal documentation from the research centre and publicly available information sources, informal iterative discussions with 10 centre investigators, and confirmation of information from centre grant and scholarship recipients. RESULTS: By July 2019, the impact on the short-term research domain category included over 41 direct publications, which were cited over 87 times (median journal impact factor of 2.84). There were over 61 conference presentations, seven PhD candidacies, five new academic collaborations, and six new database linkages conducted. The impact on the mid-term research domain category involved contributions towards the development of a national cardiac registry, cardiovascular guidelines, application for a Medicare Benefits Schedule reimbursement item number, introduction of patient-reported outcome measures into several databases, and the establishment of nine new industry collaborations. Evidence of long-term impacts were described as the development and use of contemporary management for aortic stenosis, a cardiovascular risk prediction model and prevention targets in several data registries, and the establishment of cost-effectiveness for stenting compared to surgery. CONCLUSIONS: We considered the research impact matrix a feasible tool to identify evidence of academic and policy impact in the short- to midterm; however, we experienced challenges in capturing long-term impacts. Cost containment and broader economic impacts represented another difficult area of impact to measure.

Impact of the Method of Delivering Electronic Health Behavior Change Interventions in Survivors of Cancer on Engagement, Health Behaviors, and Health Outcomes: Systematic Review and Meta-Analysis.

BACKGROUND: Increased accessibility to the internet and mobile devices has seen a rapid expansion in electronic health (eHealth) behavior change interventions delivered to patients with cancer and survivors using synchronous, asynchronous, and combined delivery methods. Characterizing effective delivery methods of eHealth interventions is required to enable improved design and implementation of evidence-based health behavior change interventions. OBJECTIVE: This study aims to systematically review the literature and synthesize evidence on the success of eHealth behavior change interventions in patients with cancer and survivors delivered by synchronous, asynchronous, or combined methods compared with a control group. Engagement with the intervention, behavior change, and health outcomes, including quality of life, fatigue, depression, and anxiety, were examined. METHODS: A search of Scopus, Ovid MEDLINE, Excerpta Medica dataBASE, Cumulative Index to Nursing and Allied Health Literature Plus, PsycINFO, Cochrane CENTRAL, and PubMed was conducted for studies published between March 2007 and March 2019. We looked for randomized controlled trials (RCTs) examining interventions delivered to adult cancer survivors via eHealth methods with a measure of health behavior change. Random-effects meta-analysis was performed to examine whether the method of eHealth delivery impacted the level of engagement, behavior change, and health outcomes. RESULTS: A total of 24 RCTs were included predominantly examining dietary and physical activity behavior change interventions. There were 11 studies that used a synchronous approach and 11 studies that used an asynchronous approach, whereas 2 studies used a combined delivery method. Use of eHealth interventions improved exercise behavior (standardized mean difference [SMD] 0.34, 95% CI 0.21-0.48), diet behavior (SMD 0.44, 95% CI 0.18-0.70), fatigue (SMD 0.21, 95% CI -0.08 to 0.50; SMD change 0.22, 95% CI 0.09-0.35), anxiety (SMD 1.21, 95% CI: 0.36-2.07; SMD change 0.15, 95% CI -0.09 to 0.40), depression (SMD 0.15, 95% CI 0.00-0.30), and quality of life (SMD 0.12, 95% CI -0.10 to 0.34; SMD change 0.14, 95% CI 0.04-0.24). The mode of delivery did not influence the amount of dietary and physical activity behavior change observed. CONCLUSIONS: Physical activity and dietary behavior change eHealth interventions delivered to patients with cancer or survivors have a small to moderate impact on behavior change and a small to very small benefit to quality of life, fatigue, depression, and anxiety. There is insufficient evidence to determine whether asynchronous or synchronous delivery modes yield superior results. Three-arm RCTs comparing delivery modes with a control with robust engagement reporting are required to determine the most successful delivery method for promoting behavior change and ultimately favorable health outcomes.

Impact of disinvestment from weekend allied health services across acute medical and surgical wards: 2 stepped-wedge cluster randomised controlled trials.

BACKGROUND: Disinvestment (removal, reduction, or reallocation) of routinely provided health services can be difficult when there is little published evidence examining whether the services are effective or not. Evidence is required to understand if removing these services produces outcomes that are inferior to keeping such services in place. However, organisational imperatives, such as budget cuts, may force healthcare providers to disinvest from these services before the required evidence becomes available. There are presently no experimental studies examining the effectiveness of allied health services (e.g., physical therapy, occupational therapy, and social work) provided on weekends across acute medical and surgical hospital wards, despite these services being routinely provided internationally. The aim of this study was to understand the impact of removing weekend allied health services from acute medical and surgical wards using a disinvestment-specific non-inferiority research design. METHODS AND FINDINGS: We conducted 2 stepped-wedge cluster randomised controlled trials between 1 February 2014 and 30 April 2015 among patients on 12 acute medical or surgical hospital wards spread across 2 hospitals. The hospitals involved were 2 metropolitan teaching hospitals in Melbourne, Australia. Data from n = 14,834 patients were collected for inclusion in Trial 1, and n = 12,674 in Trial 2. Trial 1 was a disinvestment-specific non-inferiority stepped-wedge trial where the 'current' weekend allied health service was incrementally removed from participating wards each calendar month, in a random order, while Trial 2 used a conventional non-inferiority stepped-wedge design, where a 'newly developed' service was incrementally reinstated on the same wards as in Trial 1. Primary outcome measures were patient length of stay (proportion staying longer than expected and mean length of stay), the proportion of patients experiencing any adverse event, and the proportion with an unplanned readmission within 28 days of discharge. The 'no weekend allied health service' condition was considered to be not inferior if the 95% CIs of the differences between this condition and the condition with weekend allied health service delivery were below a 2% increase in the proportion of patients who stayed in hospital longer than expected, a 2% increase in the proportion who had an unplanned readmission within 28 days, a 2% increase in the proportion who had any adverse event, and a 1-day increase in the mean length of stay. The current weekend allied health service included physical therapy, occupational therapy, speech therapy, dietetics, social work, and allied health assistant services in line with usual care at the participating sites. The newly developed weekend allied health service allowed managers at each site to reprioritise tasks being performed and the balance of hours provided by each professional group and on which days they were provided. Analyses conducted on an intention-to-treat basis demonstrated that there was no estimated effect size difference between groups in the proportion of patients staying longer than expected (weekend versus no weekend; estimated effect size difference [95% CI], p-value) in Trial 1 (0.40 versus 0.38; estimated effect size difference 0.01 [-0.01 to 0.04], p = 0.31, CI was both above and below non-inferiority margin), but the proportion staying longer than expected was greater with the newly developed service compared to its no weekend service control condition (0.39 versus 0.40; estimated effect size difference 0.02 [0.01 to 0.04], p = 0.04, CI was completely below non-inferiority margin) in Trial 2. Trial 1 and 2 findings were discordant for the mean length of stay outcome (Trial 1: 5.5 versus 6.3 days; estimated effect size difference 1.3 days [0.9 to 1.8], p < 0.001, CI was both above and below non-inferiority margin; Trial 2: 5.9 versus 5.0 days; estimated effect size difference -1.6 days [-2.0 to -1.1], p < 0.001, CI was completely below non-inferiority margin). There was no difference between conditions for the proportion who had an unplanned readmission within 28 days in either trial (Trial 1: 0.01 [-0.01 to 0.03], p = 0.18, CI was both above and below non-inferiority margin; Trial 2: -0.01 [-0.02 to 0.01], p = 0.62, CI completely below non-inferiority margin). There was no difference between conditions in the proportion of patients who experienced any adverse event in Trial 1 (0.01 [-0.01 to 0.03], p = 0.33, CI was both above and below non-inferiority margin), but a lower proportion of patients had an adverse event in Trial 2 when exposed to the no weekend allied health condition (-0.03 [-0.05 to -0.004], p = 0.02, CI completely below non-inferiority margin). Limitations of this research were that 1 of the trial wards was closed by the healthcare provider after Trial 1 and could not be included in Trial 2, and that both withdrawing the current weekend allied health service model and installing a new one may have led to an accommodation period for staff to adapt to the new service settings. Stepped-wedge trials are potentially susceptible to bias from naturally occurring change over time at the service level; however, this was adjusted for in our analyses. CONCLUSIONS: In Trial 1, criteria to say that the no weekend allied health condition was non-inferior to current weekend allied health condition were not met, while neither the no weekend nor current weekend allied health condition demonstrated superiority. In Trial 2, the no weekend allied health condition was non-inferior to the newly developed weekend allied health condition across all primary outcomes, and superior for the outcomes proportion of patients staying longer than expected, proportion experiencing any adverse event, and mean length of stay. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613001231730 and ACTRN12613001361796.

Application of implementation science for improving the utilization of an international clinical practice guidance on familial hypercholesterolemia.

BACKGROUND: The International Atherosclerosis Society (IAS) published an evidence-informed guidance for familial hypercholesterolemia (FH) that provides both clinical and implementation recommendations. We reference examples of strategies from the literature to explore how these implementation recommendations can be tailored into implementation strategies at the local-level for stakeholders guided by a framework proposed by Sarkies and Jones. METHODS: Four authors of the IAS guidance selected two published exemplar implementation recommendations for detection, management, and general implementation. Each recommendation was described as an implementation strategy using Proctor's guidance for specifying and reporting implementation strategies. It recommends reporting the actor (who), action (what), action-target (who is impacted), temporality (how often), and dose (how much) for each implementation strategy. RESULTS: Detection: A centralized cascade testing model, mobilized nurses (actor) to relative's homes, after the diagnosis of the proband (temporality), once (dose) to consent, obtain a blood sample and health information (action) on relatives (action-target). MANAGEMENT: A primary care initiative to improve FH management included an educational session (action) with clinicians (action-target), computer-based reminder message and message to patients to have their cholesterol screened once (dose) at a visit or outreach (temporality) by researchers (actor). General: A partnership between a statewide public pathology provider, local public hospital network, primary health network, government health ministry, and an academic university (actors) was established to implement a primary-tertiary shared care model (action) to improve the detection of FH (action-target). CONCLUSIONS: We demonstrate that implementation recommendations can be specified and reported for different local contexts with examples on monitoring, evaluation, and sustainability in practice.

International Atherosclerosis Society Roadmap for Familial Hypercholesterolaemia.

Familial hypercholesterolaemia (FH), a common monogenic disorder, is a preventable cause of premature coronary artery disease and death. Up to 35 million people worldwide have FH, but most remain undetected and undertreated. Several clinical guidelines have addressed the gaps in care of FH, but little focus has been given to implementation science and practice. The International Atherosclerosis Society (IAS) has developed an evidence-informed guidance for the detection and management of patients with FH, supplemented with implementation strategies to optimize contextual models of care. The guidance is partitioned into detection, management and implementation sections. Detection deals with screening, diagnosis, genetic testing and counselling. Management includes risk stratification, treatment of adults and children with heterozygous and homozygous FH, management of FH during pregnancy, and use of lipoprotein apheresis. Specific and general implementation strategies, guided by processes specified by the Expert Recommendations for Implementing Change taxonomy, are provided. Core generic implementation strategies are given for improving care. Nation-specific cholesterol awareness campaigns should be utilized to promote better detection of FH. Integrated models of care should be underpinned by health policy and adapted to meet local, regional and national needs. Clinical centres of excellence are important for taking referrals from the community. General practitioners should work seamlessly with multidisciplinary teams. All health-care providers must receive training in essential skills for caring for patients and families with FH. Management should be supported by shared decision-making and service improvement driven by patient-reported outcomes. Improvements in services require sharing of existing resources that can support care. Advocacy should be utilized to ensure sustainable funding. Digital health technologies and clinical quality registries have special value. Finally, academic-service partnerships need to be developed to identify gaps in care and set priorities for research. This new IAS guidance on FH complements the recent World Heart Federation Cholesterol Roadmap.

Implementation of a primary-tertiary shared care model to improve the detection of familial hypercholesterolaemia (FH): a mixed methods pre-post implementation study protocol.

INTRODUCTION: Familial hypercholesterolaemia (FH) is an autosomal dominant inherited disorder of lipid metabolism and a preventable cause of premature cardiovascular disease. Current detection rates for this highly treatable condition are low. Early detection and management of FH can significantly reduce cardiac morbidity and mortality. This study aims to implement a primary-tertiary shared care model to improve detection rates for FH. The primary objective is to evaluate the implementation of a shared care model and support package for genetic testing of FH. This protocol describes the design and methods used to evaluate the implementation of the shared care model and support package to improve the detection of FH. METHODS AND ANALYSIS: This mixed methods pre-post implementation study design will be used to evaluate increased detection rates for FH in the tertiary and primary care setting. The primary-tertiary shared care model will be implemented at NSW Health Pathology and Sydney Local Health District in NSW, Australia, over a 12-month period. Implementation of the shared care model will be evaluated using a modification of the implementation outcome taxonomy and will focus on the acceptability, evidence of delivery, appropriateness, feasibility, fidelity, implementation cost and timely initiation of the intervention. Quantitative pre-post and qualitative semistructured interview data will be collected. It is anticipated that data relating to at least 62 index patients will be collected over this period and a similar number obtained for the historical group for the quantitative data. We anticipate conducting approximately 20 interviews for the qualitative data. ETHICS AND DISSEMINATION: Ethical approval has been granted by the ethics review committee (Royal Prince Alfred Hospital Zone) of the Sydney Local Health District (Protocol ID: X23-0239). Findings will be disseminated through peer-reviewed publications, conference presentations and an end-of-study research report to stakeholders.

Guiding principles for effective collaborative implementation strategies for multisite hospital improvement initiatives: a mixed-method realist evaluation of collaborative strategies used in four multisite initiatives at public hospitals in New South Wales, Australia.

OBJECTIVE: Large-scale, multisite hospital improvement initiatives can advance high-quality care for patients. Implementation support is key to adoption of change in this context. Strategies that foster collaboration within local teams, across sites and between initiative developers and users are important. However not all implementation strategies are successful in all settings, sometimes realising poor or unintended outcomes. Our objective here is to develop guiding principles for effective collaborative implementation strategies for multi-site hospital initiatives. DESIGN: Mixed-method realist evaluation. Realist studies aim to examine the underlying theories that explain differing outcomes, identifying mechanisms and contextual factors that may trigger them. SETTING: We report on collaborative strategies used in four multi-site initiatives conducted in all public hospitals in New South Wales, Australia (n>100). PARTICIPANTS: Using an iterative process, information was gathered on collaborative implementation strategies used, then initial programme theories hypothesised to underlie the strategies' outcomes were surfaced using a realist dialogic approach. A realist interview schedule was developed to elicit evidence for the posited initial programme theories. Fourteen participants from 20 key informants invited participated. Interviews were conducted via Zoom, transcribed and analysed. From these data, guiding principles of fostering collaboration were developed. RESULTS: Six guiding principles were distilled: (1) structure opportunities for collaboration across sites; (2) facilitate meetings to foster learning and problem-solving across sites; (3) broker useful long-term relationships; (4) enable support agencies to assist implementers by giving legitimacy to their efforts in the eyes of senior management; (5) consider investment in collaboration as effective well beyond the current projects; (6) promote a shared vision and build momentum for change by ensuring inclusive networks where everyone has a voice. CONCLUSION: Structuring and supporting collaboration in large-scale initiatives is a powerful implementation strategy if contexts described in the guiding principles are present.

Implementation of consensus-based perioperative care pathways to reduce clinical variation for elective surgery in an Australian private hospital: a mixed-methods pre-post study protocol.

INTRODUCTION: Addressing clinical variation in elective surgery is challenging. A key issue is how to gain consensus between largely autonomous clinicians. Understanding how the consensus process works to develop and implement perioperative pathways and the impact of these pathways on reducing clinical variation can provide important insights into the effectiveness of the consensus process. The primary objective of this study is to understand the implementation of an organisationally supported, consensus approach to implement perioperative care pathways in a private healthcare facility and to determine its impact. METHODS: A mixed-methods Effectiveness-Implementation Hybrid (type III) pre-post study will be conducted in one Australian private hospital. Five new consensus-based perioperative care pathways will be developed and implemented for specific patient cohorts: spinal surgery, radical prostatectomy, cardiac surgery, bariatric surgery and total hip and knee replacement. The individual components of these pathways will be confirmed as part of a consensus-building approach and will follow a four-stage implementation process using the Exploration, Preparation, Implementation and Sustainment framework. The process of implementation, as well as barriers and facilitators, will be evaluated through semistructured interviews and focus groups with key clinical and non-clinical staff, and participant observation. We anticipate completing 30 interviews and 15-20 meeting observations. Administrative and clinical end-points for at least 152 participants will be analysed to assess the effectiveness of the pathways. ETHICS AND DISSEMINATION: This study received ethical approval from Macquarie University Human Research Ethics Medical Sciences Committee (Reference No: 520221219542374). The findings of this study will be disseminated through peer-reviewed publications, conference presentations and reports for key stakeholders.

International Atherosclerosis Society guidance for implementing best practice in the care of familial hypercholesterolaemia.

This contemporary, international, evidence-informed guidance aims to achieve the greatest good for the greatest number of people with familial hypercholesterolaemia (FH) across different countries. FH, a family of monogenic defects in the hepatic LDL clearance pathway, is a preventable cause of premature coronary artery disease and death. Worldwide, 35 million people have FH, but most remain undiagnosed or undertreated. Current FH care is guided by a useful and diverse group of evidence-based guidelines, with some primarily directed at cholesterol management and some that are country-specific. However, none of these guidelines provides a comprehensive overview of FH care that includes both the lifelong components of clinical practice and strategies for implementation. Therefore, a group of international experts systematically developed this guidance to compile clinical strategies from existing evidence-based guidelines for the detection (screening, diagnosis, genetic testing and counselling) and management (risk stratification, treatment of adults or children with heterozygous or homozygous FH, therapy during pregnancy and use of apheresis) of patients with FH, update evidence-informed clinical recommendations, and develop and integrate consensus-based implementation strategies at the patient, provider and health-care system levels, with the aim of maximizing the potential benefit for at-risk patients and their families worldwide.

Innovative models of healthcare delivery: an umbrella review of reviews.

OBJECTIVE: To undertake a synthesis of evidence-based research for seven innovative models of care to inform the development of new hospitals. DESIGN: Umbrella review. SETTING: Interventions delivered inside and outside of acute care settings. PARTICIPANTS: Children and adults with one or more identified acute or chronic health conditions. DATA SOURCES: PsycINFO, Ovid MEDLINE and CINAHL. PRIMARY AND SECONDARY OUTCOME MEASURES: Clinical indicators and mortality, healthcare utilisation, quality of life, self-management and self-care and patient knowledge. RESULTS: A total of 66 reviews were included, synthesising evidence from 1272 primary studies across the 7 models of care. Virtual care was the most common model studied, addressed by 47 (73%) of the reviews. Common outcomes evaluated across reviews were clinical indicators and mortality, healthcare utilisation, self-care and self-management, patient knowledge, quality of life and cost-effectiveness. The findings indicate that the innovative models of healthcare we identified in this review may be effective in managing patients with a range of acute and chronic conditions. Most of the included reviews reported evidence of comparable or improved care. CONCLUSIONS: A consideration of local infrastructure and individual patient characteristics, such as health literacy, may be critical in determining the suitability of models of care for patients and their implementation in local health systems. TRIAL REGISTRATION NUMBER: 10.17605/OSF.IO/PS6ZU.

Socio-environmental models of allied health disability support: an exploration of narrative experiences in the Australian National Disability and Insurance Scheme.

Objective The primary aims of this study were to explore: (1) manifestations of socio-environmental models of allied health support provision in the disability sector; and (2) narrative experiences of individual allied health professionals in the disability sector. Methods A narrative qualitative study using interviews from a purposive sample of two allied health professionals working in the disability sector explored manifestations of socio-environmental models of allied health support provision and their experiences from case examples. The key informants had more than 10 years of experience in the disability support services setting. Results Seven key themes exploring manifestations of socio-environmental models of allied health professional practice in the disability sector emerged: (1) dignity of risk; (2) models of care; (3) considerations when working in the supported person's environment; (4) goal-oriented work; (5) informed choice and informed consent; (6) reactive and flexible plans; and (7) training and education role. Conclusions Socio-environmental models of allied health support provision in the disability sector focus on empowering people with disability to achieve their goals. This may require displacement of cultural norms within the allied health professions. What is known about the topic? Socio-environmental models of allied health support provision in the disability sector focus on empowering people with disability to achieve their goals. What does this paper add? Displacement of cultural norms within the allied health professions may be needed to promote positive risk taking. Challenges for allied health professionals remain in navigating conflicting goals between clients and family members, empowering informed choice and consent, and working in uncontrolled environments. What are the implications for practitioners? Adopting training and education roles for clients, family members and carers when implementing National Disability and Insurance Scheme plans may represent one of the many pragmatic and flexible approaches to achieve people's goals.

Conceptualising contexts, mechanisms and outcomes for implementing large-scale, multisite hospital improvement initiatives: a realist synthesis.

DESIGN: Realist synthesis. STUDY BACKGROUND: Large-scale hospital improvement initiatives can standardise healthcare across multiple sites but results are contingent on the implementation strategies that complement them. The benefits of these implemented interventions are rarely able to be replicated in different contexts. Realist studies explore this phenomenon in depth by identifying underlying context-mechanism-outcome interactions. OBJECTIVES: To review implementation strategies used in large-scale hospital initiatives and hypothesise initial programme theories for how they worked across different contexts. METHODS: An iterative, four-step process was applied. Step 1 explored the concepts inherent in large-scale interventions using database searches and snowballing. Step 2 identified strategies used in their implementation. Step 3 identified potential initial programme theories that may explain strategies' mechanisms. Step 4 focused on one strategy-theory pairing to develop and test context-mechanism-outcome hypotheses. Data was drawn from searches (March-May 2020) of MEDLINE, Embase, PubMed and CINAHL, snowballed from key papers, implementation support websites and the expertise of the research team and experts. INCLUSION CRITERIA: reported implementation of a large-scale, multisite hospital intervention. RAMESES reporting standards were followed. RESULTS: Concepts were identified from 51 of 381 articles. Large-scale hospital interventions were characterised by a top-down approach, external and internal support and use of evidence-based interventions. We found 302 reports of 28 different implementation strategies from 31 reviews (from a total of 585). Formal theories proposed for the implementation strategies included Diffusion of Innovation, and Organisational Readiness Theory. Twenty-three context-mechanism-outcome statements for implementation strategies associated with planning and assessment activities were proposed. Evidence from the published literature supported the hypothesised programme theories and were consistent with Organisational Readiness Theory's tenets. CONCLUSION: This paper adds to the literature exploring why large-scale hospital interventions are not always successfully implemented and suggests 24 causative mechanisms and contextual factors that may drive outcomes in the planning and assessment stage.

The human impact of commercial delivery cycling injuries: a pilot retrospective cohort study.

BACKGROUND: Commercial delivery cyclists represent a uniquely vulnerable and poorly understood road user. The primary aim of this study was to pilot whether cycling injuries could be categorised as either commercial or non-commercial using documentation entered into routine hospital medical records, in order to determine the feasibility of conducting a large cohort study of commercial cycling injuries in the future. A secondary aim was to determine which key demographic, incident and injury characteristics were associated with commercial versus non-commercial cycling injuries in emergency. METHODS: Pilot retrospective cohort study of adults presenting to an acute public hospital emergency department between May 2019 and April 2020 after sustaining a cycling-related injury. Multinomial logistic regression was used to examine the demographic, incident and injury characteristics associated with commercial compared to non-commercial cycling. RESULTS: Of the 368 people presenting to the emergency department with a cycling-related injury, we were able to categorise 43 (11.7%) as commercial delivery cyclists, 153 (41.6%) as non-commercial cyclists and the working status of 172 (46.7%) was unable to be confirmed. Both commercial and unconfirmed cyclists were more likely to be younger than non-commercial cyclists. Compared to non-commercial cyclists, commercial cyclists were 11 times more likely to speak a language other than English (AOR 11.3; 95% CI 4.07-31.30; p<0.001), less likely to be injured from non-collision incidents than vehicle collisions (AOR 0.36; 95% CI 0.15-0.91; p=0.030) and were over 13 times more likely to present to the emergency department between 8.00pm and 12.00am compared to the early morning hours (12.00 to 8.00am) (AOR 13.43; 95% CI 2.20-82.10; p=0.005). CONCLUSIONS: The growth of commercial cycling, particularly through online food delivery services, has raised concern regarding commercial cyclist safety. Improvements in the recording of cycling injury commercial status is required to enable ongoing surveillance of commercial cyclist injuries and establish the extent and risk factors associated with commercial cycling.