BACKGROUND: Artificial intelligence (AI) technologies are expected to \"revolutionise\" healthcare. However, despite their promises, their integration within healthcare organisations and systems remains limited. The objective of this study is to explore and understand the systemic challenges and implications of their integration in a leading Canadian academic hospital.
METHODS: Semi-structured interviews were conducted with 29 stakeholders concerned by the integration of a large set of AI technologies within the organisation (e.g., managers, clinicians, researchers, patients, technology providers). Data were collected and analysed using the Non-Adoption, Abandonment, Scale-up, Spread, Sustainability (NASSS) framework.
RESULTS: Among enabling factors and conditions, our findings highlight: a supportive organisational culture and leadership leading to a coherent organisational innovation narrative; mutual trust and transparent communication between senior management and frontline teams; the presence of champions, translators, and boundary spanners for AI able to build bridges and trust; and the capacity to attract technical and clinical talents and expertise. Constraints and barriers include: contrasting definitions of the value of AI technologies and ways to measure such value; lack of real-life and context-based evidence; varying patients\' digital and health literacy capacities; misalignments between organisational dynamics, clinical and administrative processes, infrastructures, and AI technologies; lack of funding mechanisms covering the implementation, adaptation, and expertise required; challenges arising from practice change, new expertise development, and professional identities; lack of official professional, reimbursement, and insurance guidelines; lack of pre- and post-market approval legal and governance frameworks; diversity of the business and financing models for AI technologies; and misalignments between investors\' priorities and the needs and expectations of healthcare organisations and systems.
CONCLUSIONS: Thanks to the multidimensional NASSS framework, this study provides original insights and a detailed learning base for analysing AI technologies in healthcare from a thorough socio-technical perspective. Our findings highlight the importance of considering the complexity characterising healthcare organisations and systems in current efforts to introduce AI technologies within clinical routines. This study adds to the existing literature and can inform decision-making towards a judicious, responsible, and sustainable integration of these technologies in healthcare organisations and systems.

UNASSIGNED: Eliminating violence against children is a prominent policy goal, codified in the Sustainable Development Goals, and parenting programs are one approach to preventing and reducing violence. However, we know relatively little about dissemination and scale-up of parenting programs, particularly in low- and middle-income countries (LMICs). The scale-up of two parenting programs, Parenting for Lifelong Health (PLH) for Young Children and PLH for Parents and Teens, developed under Creative Commons licensing and tested in randomized trials, provides a unique opportunity to study their dissemination in 25 LMICs.
UNASSIGNED: The Scale-Up of Parenting Evaluation Research (SUPER) study uses a range of methods to study the dissemination of these two programs. The study will examine (1) process and extent of dissemination and scale-up, (2) how the programs are implemented and factors associated with variation in implementation, (3) violence against children and family outcomes before and after program implementation, (4) barriers and facilitators to sustained program delivery, and (5) costs and resources needed for implementation.Primary data collection, focused on three case study projects, will include interviews and focus groups with program facilitators, coordinators, funders, and other stakeholders, and a summary of key organizational characteristics. Program reports and budgets will be reviewed as part of relevant contextual information. Secondary data analysis of routine data collected within ongoing implementation and existing research studies will explore family enrolment and attendance, as well as family reports of parenting practices, violence against children, child behavior, and child and caregiver wellbeing before and after program participation. We will also examine data on staff sociodemographic and professional background, and their competent adherence to the program, collected as part of staff training and certification.
UNASSIGNED: This project will be the first study of its kind to draw on multiple data sources and methods to examine the dissemination and scale-up of a parenting program across multiple LMIC contexts. While this study reports on the implementation of two specific parenting programs, we anticipate that our findings will be of relevance across the field of parenting, as well as other violence prevention and social programs.

Early Detection of Deterioration in Elderly Residents (EDDIE +) is a multi-modal intervention focused on empowering nursing and personal care workers to identify and proactively manage deterioration of residents living in residential aged care (RAC) homes. Building on successful pilot trials conducted between 2014 and 2017, the intervention was refined for implementation in a stepped-wedge cluster randomised trial in 12 RAC homes from March 2021 to May 2022. We report the process used to transition from a small-scale pilot intervention to a multi-site intervention, detailing the intervention to enable future replication.
The EDDIE + intervention used the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to guide the intervention development and refinement process. We conducted an environmental scan; multi-level context assessments; convened an intervention working group (IWG) to develop the program logic, conducted a sustainability assessment and deconstructed the intervention components into fixed and adaptable elements; and subsequently refined the intervention for trial.
The original EDDIE pilot intervention included four components: nurse and personal care worker education; decision support tools; diagnostic equipment; and facilitation and clinical support. Deconstructing the intervention into core components and what could be flexibly tailored to context was essential for refining the intervention and informing future implementation across multiple sites. Intervention elements considered unsustainable were updated and refined to enable their scalability. Refinements included: an enhanced educational component with a greater focus on personal care workers and interactive learning; decision support tools that were based on updated evidence; equipment that aligned with recipient needs and available organisational support; and updated facilitation model with local and external facilitation.
By using the i-PARIHS framework in the scale-up process, the EDDIE + intervention was tailored to fit the needs of intended recipients and contexts, enabling flexibility for local adaptation. The process of transitioning from a pilot to larger scale implementation in practice is vastly underreported yet vital for better development and implementation of multi-component interventions across multiple sites. We provide an example using an implementation framework and show it can be advantageous to researchers and health practitioners from pilot stage to refinement, through to larger scale implementation.
The trial was prospectively registered with the Australia New Zealand Clinical Trial Registry (ACTRN12620000507987, registered 23/04/2020).

Scale-up and sustainability are often studied separately, with few studies examining the interdependencies between these two processes and the implementation contexts of innovations towards malaria prevention and control. Researchers and implementers offer much more attention to the content of innovations, as they focus on the technological dimensions and the conditions for expansion. Researchers have often considered innovation a linear sequence in which scaling up and sustainability represented the last stages. Using systems thinking in this manuscript, we analyze complex scaling and sustainability processes through adopting and implementing seasonal malaria chemoprevention (SMC) in Burkina Faso from 2014 to 2018.
We conducted a qualitative case study involving 141 retrospective secondary data (administrative, press, scientific, tools and registries, and verbatim) spanning from 2012 to 2018. We complemented these data with primary data collected between February and March 2018 in the form of 15 personal semi-structured interviews with SMC stakeholders and non-participant observations. Processual analysis permitted us to conceptualize scale-up and sustainability processes over time according to different vertical and horizontal levels of analysis and their interconnections.
Our results indicated six internal and external determinants of SMC that may negatively or positively influence its scale-up and sustainability. These determinants are effectiveness, monitoring and evaluation systems, resources (financial, material, and human), leadership and governance, adaptation to the local context, and other external elements. Our results revealed that donors and implementing actors prioritized financial resources over other determinants. In contrast, our study clearly showed that the sustainability of the innovation, as well as its scaling up, depends significantly on the consideration of the interconnectedness of the determinants. Each determinant can concurrently constitute an opportunity and a challenge for the success of the innovation.
Our findings highlight the usefulness of the systemic perspective to consider all contexts (international, national, subnational, and local) to achieve large-scale improvements in the quality, equity, and effectiveness of global health interventions. Thus, complex and systems thinking have made it possible to observe emergent and dynamic innovation behaviors and the dynamics particular to sustainability and scaling up processes.

BACKGROUND: The CRADLE Vital Signs Alert intervention (an accurate easy-to-use device that measures blood pressure and pulse with inbuilt traffic-light early warning system, and focused training package) was associated with reduced rates of eclampsia and maternal death when trialled in urban areas in Sierra Leone. Subsequently, implementation was successfully piloted as evidenced by measures of fidelity, feasibility and adoption. The CRADLE-5 trial will examine whether national scale-up, including in the most rural areas, will reduce a composite outcome of maternal and fetal mortality and maternal morbidity and will evaluate how the CRADLE package can be embedded sustainably into routine clinical pathways.
METHODS: CRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken.
CONCLUSIONS: International guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes.
BACKGROUND: ISRCTN 94429427. Registered on 20 April 2022.

Scaling-up an experimental intervention is always a challenge. On the border between French Guiana, Brazil and Suriname, an interventional study demonstrated the effectiveness of distributing self-diagnosis and self-treatment kits (Malakits) to control malaria in mobile and hard-to-reach populations. Its integration into the Suriname\'s National Malaria Elimination Plan after a 2-year experiment faced numerous challenges, including human resources to cope with the additional workload of coordinators and to maintain the motivation of community health workers. The economic recession in Suriname, the Covid pandemic, and logistical issues also hampered the scale-up. Finally, thanks to the commitment of stakeholders in Suriname and French Guiana, the integration of Malakit distribution into the Surinamese national programme was proved possible.

To examine the effectiveness, cost-outcome, equity, scalability, and mechanisms of the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) postpartum depression prevention (PPD) program as universal versus selective or indicated prevention.
The United States Preventive Services Task Force (USPSTF) currently recommends PPD prevention for pregnant people at risk of PPD (i.e., selective/indicated prevention). However, universal prevention may be more scalable, equitable, and cost-beneficial.
Effectiveness of ROSE for preventing PPD among people at risk is known. To assess ROSE as universal prevention, we need to determine the effectiveness of ROSE among all pregnant people, including those screening negative for PPD risk. We will enroll 2320 pregnant people, assess them with commonly available PPD risk prediction tools, randomize everyone to ROSE or enhanced care as usual, and assess ROSE as universal, selective, and indicated prevention in terms of: (1) effectiveness (PPD prevention and functioning), (2) cost-benefit, (3) equity (PPD cases prevented by universal prevention that would not be prevented under selective/indicated for minority vs. non-Hispanic white people), (4) quantitative and qualitative measures of scalability (from 98 agencies previously implementing ROSE), (5) ROSE mechanisms across risk levels. We will integrate results to outline pros and cons of the three prevention approaches (i.e., universal, selective, indicated).
This will be the first trial to assess universal vs. selective/indicated PPD prevention. Trial design illustrates a novel, efficient way to make these comparisons. This trial, the largest PPD prevention trial to date, will examine scalability, an understudied area of implementation science.

BACKGROUND: To date, little is known about the sustainability and scalability of MyDiabetesPlan, an eHealth innovation designed to facilitate shared decision-making within diabetes care. To avoid the possibility of its short-lived implementation and promote wider adoption so as to promote patient-centred diabetes care, it is critical to understand MyDiabetesPlan\'s sustainability and scalability in order to ensure its long-term impact at a greater scale. We sought to identify the sustainability and scalability potential of MyDiabetesPlan and its limiting factors.
METHODS: Using a concurrent triangulation mixed-methods approach, data were collected from 20 individuals involved in the development and implementation of MyDiabetesPlan. The National Health Services Sustainability Model (NHSSM) and the Innovation Scalability Self-administered Questionnaire (ISSaQ) were administered using a \'think-aloud\' approach and subsequently, short semi-structured interviews were conducted. Mean aggregate scores and stakeholder-specific scores were generated for the NHSSM and ISSaQ, to quantitatively determine facilitating and limiting factors to sustainability and scalability. Content analysis occurred iteratively with qualitative data, to examine commonalities and differences with the quantitative findings.
RESULTS: The top facilitating factor to sustaining MyDiabetesPlan was \"Staff involvement and training to sustain the process.\", whereas the top limiting factors were: \"Adaptability of Improved Process\", \"Senior Leadership Engagement\" and \"Infrastructure for Sustainability\". The top three facilitating factors for scale-up were \"Acceptability\", \"Development with Theory\" and \"Consistency with Policy Directives.\" Conversely, the top three limiting factors were \"Financial and Human Resources\", \"Achievable Adoption\" and \"Broad Reach\". Qualitative findings corroborated the limiting/facilitating factors identified.
CONCLUSIONS: Addressing staff involvement throughout the dynamic care contexts, and resource constraints impacting scale-up can enhance the sustainability and scalability of MyDiabetesPlan. As such, future plans will focus on garnering organizational leadership buy-in and support, which may address the resource constraints associated with sustainability and scalability and improve the capacity for adequate staff involvement. eHealth researchers will be able to prioritize these limiting factors from the outset of their tool development to purposefully optimize its sustainability and scalability performance.

BACKGROUND: Refugees are at an increased risk of developing symptoms of mental disorders but face various structural and socio-cultural barriers to accessing mental health care. The SPIRIT project (Scaling-up Psychological Interventions in Refugees In SwiTzerland) seeks to promote the resilience of refugees and improve their access to mental health care. For this purpose, Problem Management Plus (PM+), an evidence-based low-intensity psychological intervention delivered by trained non-specialist \"helpers\", is being scaled-up in Switzerland.
OBJECTIVE: To identify factors influencing the process of the large-scale implementation of PM + for refugees in Switzerland and to develop recommendations to guide the implementation process.
METHODS: 22 semi-structured interviews were conducted with key informants (Syrian refugees who previously participated in PM+, PM + helpers, health professionals working with refugees and decision-makers from the migration, integration, social, and health sectors). The data were analyzed using thematic analysis, combining an inductive and deductive approach.
RESULTS: The data revealed three major themes, which might have an impact for the longer-term implementation of PM + in Switzerland. First, preconditions for successful integration in the health system prior to scaling-up such as sustainable funding or the introduction of a stepped care approach. Second, the requirements for the PM + intervention supporting scale-up such as quality control during PM + delivery, PM + modality, time and setting when PM + is offered or the views on task sharing. Third, the perceived benefits of scaling-up PM + in Switzerland.
CONCLUSIONS: Our results have shown that PM + must be scaled-up within a stepped care approach, including a functioning triage system and sustainable funding. Rather than selecting one modality or setting, it seemed preferable to offer a variety of formats and settings to achieve maximum reach and benefits. A successful scale-up of PM + in Switzerland might have various benefits. Communicating them to policy-makers and health providers, might enhance their acceptability of the intervention and their willingness to adopt PM + in regulatory structure and promote it.

Engaging communities is an important component of multisectoral action to address the growing burden of non-communicable diseases (NCDs) in low- and middle-income countries. We conducted research with non-communicable disease stakeholders in Bangladesh to understand how a community-led intervention which was shown to reduce the incidence of type 2 diabetes in rural Bangladesh could be scaled-up.
We purposively sampled any actor who could have an interest in the intervention, or that could affect or be affected by the intervention. We interviewed central level stakeholders from donor agencies, national health policy levels, public, non-governmental, and research sectors to identify scale-up mechanisms. We interviewed community health workers, policy makers, and non-governmental stakeholders, to explore the feasibility and acceptability of implementing the suggested mechanisms. We discussed scale-up options in focus groups with community members who had attended a community-led intervention. We iteratively developed our data collection tools based on our analysis and re-interviewed some participants. We analysed the data deductively using a stakeholder analysis framework, and inductively from codes identified in the data.
Despite interest in addressing NCDs, there was a lack of a clear community engagement strategy at the government level, and most interventions have been implemented by non-governmental organisations. Many felt the Ministry of Health and Family Welfare should lead on community engagement, and NCD screening and referral has been added to the responsibilities of community health workers and health volunteers. Yet there remains a focus on reproductive health and NCD diagnosis and referral instead of prevention at the community level. There is potential to engage health volunteers in community-led interventions, but their present focus on engaging women for reproductive health does not fit with community needs for NCD prevention.
Research highlighted the need for a preventative community engagement strategy to address NCDs, and the potential to utilise existing cadres to scale-up community-led interventions. It will be important to work with key stakeholders to address gender issues and ensure flexibility and responsiveness to community concerns. We indicate areas for further implementation research to develop scaled-up models of community-led interventions to address NCDs.