Implementation Of Complex Interventions Research Articles

Understanding international, practice-based, stakeholder perspectives on implementation of complex suicide prevention interventions: A qualitative exploration.

Complex interventions combining multiple evidence-based strategies have gained substantial traction in suicide prevention across the world. However, implementing these interventions in real-life settings is fraught with several challenges, significant resource demands, and evidence on the merits of implementing complex interventions remains a topic of debate. This study explores the real-world experiences of implementing complex interventions, including challenges, lessons learned, and the way forward. Sixteen participants (nine leaders, five implementors, and two lived experience advocates) from varied professional backgrounds and experiences were purposively recruited from six high-income countries and one low- and middle-income country. Participants were encouraged to reflect on their experiences of implementing complex suicide prevention interventions in their specific country contexts. Thematic analysis was conducted to identify, organize, and offer real-world insights into challenges, lessons learned, and what is needed as the way forward. Important themes related to challenges and lessons learned emerged: (a) stakeholder characteristics, engagement, and dynamics; (b) resources such as funding priorities and capacity; (c) contextual factors including larger sociocultural beliefs, policies, and legislation surrounding suicide and its prevention; (d) nature of lived experience engagement; (e) design and approach to interventions; (f) delivery of interventions; and (g) the scope of evaluation. The study yielded important insights into practice recommendations related to the implementation of complex suicide prevention interventions on the ground. Important pathways for designing interventions, collaboration, and stakeholder engagement for future implementation efforts were discussed. These real-life experiences and lessons learned from international experts are critical in understanding and bridging the know-do gap. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Long-term impact of unhealthy food tax on consumption and the drivers behind: A longitudinal study in Hungary

Several countries have introduced public health product taxes with the objective of reducing the absolute amount of consumption of unhealthy food and tackling obesity. This study aims to estimate the long-term impact of the Hungarian public health product tax introduced in 2011.To achieve this, a unique consumer purchase dataset was analysed to examine daily fast-moving consumer goods purchases from a representative sample of 2,000 households from 2010 to 2018. The results indicate that the tax has been fully reflected in consumer prices. A decline in consumption was observed initially, consistent with previous experiences in Hungary and other countries. However, over time, the data suggests a recovery and even an increase in line with the growth of disposable income. The proportion of taxed products in total fast-moving consumer goods purchases increased from 5.9 % (95 % CI: 5.7 % to 6.0 %) in 2010 to 7.4 % (95 % CI: 7.3 % to 7.6 %) in 2018. Furthermore, the tax has contributed to increased inequality as low-income households spend a higher proportion of their total expenditure on it.Although taxes on unhealthy foods have proven effective in the short-term, they may not be adequate for reducing overall consumption in the long-term, particularly as disposable income increases. In conclusion, implementing complex interventions is necessary to achieve sustainable positive changes in dietary habits.

Commentary: Engagement for Research and Quality Improvement - More Than Just Words.

We reflect on the paper from Hahn-Goldberg et al. (2024) who shared key learnings from a pan-Canadian quality improvement (QI) and patient engagement care transition initiative called Bridge-to-Home. In considering the approach and outcomes presented in their paper, we have generated reflections and practical suggestions on how to amplify engagement work even further: (1) patient engagement and QI are about relationships; (2) seamlessly implementing complex interventions across siloed organizations continues to be a challenge, which engagement alone cannot solve; (3) it is time for a paradigm shift; (4) QI is about human behaviour change and is inherently messy; and (5) embedding fulsome evaluation of engagement is essential.

Views and experiences of healthcare professionals and patients on the implementation of a 23-hour accelerated enhanced recovery programme: a mixed-method study

BackgroundAn accumulating body of research suggests that an accelerating enhanced recovery after colon surgery protocol is beneficial for patients, however, to obtain these effects, adherence to all elements of the protocol is important. The implementation of complex interventions, such as the Enhanced Recovery After Surgery protocol (ERAS), and their strict adherence have proven to be difficult. The same challenges can be expected in the implementation of the accelerated Enhanced Recovery Pathways (ERPs). This study aimed to understand the perspectives of both healthcare professionals (HCPs) and patients on the locally studied acCelerated enHanced recovery After SurgEry (CHASE) protocol.MethodsFor this mixed-method study, HCPs who provided CHASE care and patients who received CHASE care were recruited using purposive sampling. Ethical approval was obtained by the Medical Ethical Committee of the Zuyderland Medical Centre (NL71804.096.19, METCZ20190130, October 2022). Semi-structured, in-depth, one-on-one interviews were conducted with HCPs (n = 13) and patients (n = 11). The interviews consisted of a qualitative and quantitative part, the protocol evaluation and the Measurement Instrument or Determinant of Innovations-structured questionnaire. We explored the perspectives, barriers, and facilitators of the CHASE protocol implementation. The interviews were audiotaped, transcribed verbatim and analysed independently by two researchers using direct content analysis.ResultsThe results showed that overall, HCPs support the implementation of the CHASE protocol. The enablers were easy access to the protocol, the relevance of the intervention, and thorough patient education. Some of the reported barriers included the difficulty of recognizing CHASE patients, the need for regular feedback, and the updates on the implementation progress. Most patients were enthusiastic about early discharge after surgery and expressed satisfaction with the care they received. On the other hand, the patients sometimes received different information from different HCPs, considered the information to be too extensive and few experienced some discomfort with CHASE care.ConclusionBringing CHASE care into practice was challenging and required adaptation from HCPs. The experiences of HCPs showed that the protocol can be improved further, and the mostly positive experiences of patients are a motivation for this improvement. These results yielded practical implications to improve the implementation of accelerated ERPs.

The effect of contextual factors on a health intervention against podoconiosis in Ethiopia

IntroductionUnderstanding contextual factors that influence the implementation and outcome of interventions is crucial to improving them. Outcome and process evaluation studies have to date focused on the successes and limitations of interventions with little consideration of external factors that could either facilitate or impede them. Guided by the Context and Implementation of Complex Intervention (CICI) framework, we evaluated the effect of contextual factors on a health intervention implemented against the neglected tropical disease (NTD) podoconiosis in Ethiopia.MethodWe purposefully selected a health intervention jointly implemented by two NGOs in podoconiosis-endemic districts in Northwestern Ethiopia. We employed an exploratory mixed methods approach, and data were collected between April and July 2022. We first conducted document analysis, observations, 4 focus group discussions, 32 in-depth interviews and 19 key informant interviews. Subsequently, we administered a survey to 369 rural residents, of whom 42 were affected by podoconiosis. The qualitative data were managed with NVivo version 12 software. The quantitative data were analyzed using Stata version 15 software.ResultsMost project activities were implemented as per the initial plan and the intervention reached patients that never had access to treatment services before. Contextual factors (geographical, epidemiological, socio-economic, socio-cultural, ethical, legal and political) and lived experience of patients influenced the implementation and outcome of the intervention. Most of the contextual factors pose constraints on implementation and affected the acceptability and sustainability of project activities. On the other hand, political context such the commitment of the government to rollout national programs and set up NTD structures at district level positively influenced the implementation of the intervention.ConclusionHealth intervention implementors should be aware of the interactive effects of contextual factors wherein interventions are put into practice. Minimizing the constraining effects of these contextual factors while utilizing opportunities presented by them might help implement optimal strategies to improve the lives of individuals affected by podoconiosis and similar NTDs.

Barcelona Aging coLLaboratory (BALL): an open-innovation ecosystem to co-create and test innovative solutions for older people in real-life settings.

Currently, more than 700 million people worldwide are, at least, 65 years old, with this number expected to surpass 1 billion by 2050. Multi-morbidity and complex health and social care needs will increase in turn, exacerbating the demands for policies and services aimed at older adults, which the COVID-19 pandemic has highlighted as lacking. Furthermore, the increased life expectancy and a more participatory society underline a change in roles, with seniors becoming not just consumers but also producers, constituting a vital part of the economy. 
 With other nine institutions from Catalonia, Spain, the PSPV recently launched the Barcelona Aging coLLaboratory (BALL), an open-innovation, person-centered ecosystem, based on the systemic co-creation of services and products with older people. BALL aims to integrate research and innovation processes in the real-life settings of our communities, as well as to act as an intermediary between citizens, research institutions, universities, private companies and public administrations, thereby adopting a quadruple-helix innovation framework, to co-create value and to prototype, validate and scale-up innovation. The ten participating organizations represent older adults and their caregivers, health and social care providers, research centers and universities, and small- and medium-sized enterprises. Aligned with UN Sustainable Development Goals, BALL seeks to: establish communities of practice aimed at carrying out systemic diagnoses in our communities to identify real needs and challenges related to aging, and propose strategic and operational plans; co-create and implement complex interventions and new services that respond to those real needs; co-create innovative products and test them with end-users in real-life settings. BALL is creating an ethics framework to guarantee the protection, safety and reward of participants in the co-creation process. 
 Since its conception in 2021, BALL has incorporated several innovative projects in its catalogue: ADMIT, focused on transforming the health and social care model in order to ensure integrated care; MoviMent, which alters the physical environment and employs gamification techniques to improve physical activity and cognitive function in older adults admitted to hospitals or long-term care facilities; UDhA-AGIL-App, aimed at guiding healthcare professionals in the prescription of physical activity for older adults according to their needs (physical and cognitive function and technological knowledge) and preferences through a decision support algorithm; AI-EAT, a care robot that seeks to assist disabled older adults with feeding; A-MIDA, a person-centered approach for optimizing pharmacological interventions according to life expectancy and frailty instead of age; and QCOA, a toolkit for evaluating long-term care facilities based on PROMs and PREMs. 
 The impact of BALL will be evaluated yearly in terms of: number of projects, number of pilots tested, number of solutions introduced into the marketplace, number of co-creation sessions and personal interviews performed, different user profiles, number of grant applications and their characteristics (national or European), visibility in media and congresses, number of new sponsorships and market impact/value, among others. We expect to influence the health and social care system and society as a whole by increasing awareness on aging challenges, influencing polices for healthy aging and enhancing local economic activities related to aging." Results: The core components of PN programmes for cancer prevention among PEH agreed cross-nationally with all the relevant key participants are (1) Promote cancer awareness and self-management (Facilitate the delivery of cancer education; Promote healthy behaviours and preventative measures; Encourage user involvement in health-related decisions), (2) Identify health needs and barriers (Develop a personalised approach to assessing user need; Seek solutions regarding barriers to care), (3) Co-ordinate access to care (Develop trusting relationships with and facilitate communication between local health and social care providers; Enhance understanding of the needs of PEH among local health and social care providers; Arrange referrals to healthcare services and cancer screening; Co-ordinate and support attendance of appointments), (4) Offer practical assistance (Arrange transportation, mobile phones, clothing, access to hygiene facilities, and storage of medication; Assist with completion of paperwork).
 Lessons learned: Results from the discussions indicate a high level of consistency and cross-national agreement about what the core components of the intervention should be, and how this should be designed and implemented.
 Next Steps: This intervention will be adapted to reflect the country-specifics, to ensure that the PN is appropriate to the four local contexts in which it is piloted. 
 Bibliography
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 Seiler-Ramadas, R. & Grabovac, I. (2022) Exploring the application of the navigation model with
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Implementing the QUALI-DEC project in Argentina, Burkina Faso, Thailand and Viet Nam: a process delineation and theory-driven process evaluation protocol

ABSTRACT The project ‘Quality Decision-making by women and providers’ (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women’s birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing. Trial registration: ISRCTN67214403.

An iterative approach to developing a multifaceted implementation strategy for a complex eHealth intervention within clinical practice

BackgroundThe number of complex eHealth interventions has increased considerably. Despite available implementation theory outlining well-designed strategies, implementing complex interventions within practice proves challenging and often does not lead to sustainable use. To improve sustainability, theory and practice should be addressed during the development of an implementation strategy. By subsequently transparently reporting the executed theory-based steps and their corresponding practice findings, others can learn from these valuable lessons learned. This study outlines the iterative approach by which a multifaceted implementation strategy for a complex eHealth intervention in clinical practice was developed, tested and refined.MethodsWe implemented the BENEFIT program, an advanced eHealth platform with Personal Health Portal facilitating healthy living in cardiac patients. In six iterative phases alternating between theory and practice, the implementation strategy was developed, tested and refined. The initial implementation strategy (phase 1) was drawn up using the Implementation model and RE-AIM. Subsequently, this strategy was further updated in brainstorming sessions and group discussions with twenty key stakeholders from three cardiac care centres and then evaluated in a pilot (phases 2 and 3).ResultsThe pilot of the program led to the identification of (context-specific) key challenges in practice (phase 4), which were subsequently connected back to broader theory (phase 5) using the Consolidated Framework of Implementation Research (CFIR). In the final phase, practice recommendations tackling the key challenges were formulated (phase 6) based on CFIR theory, the CFIR-ERIC Matching Tool, and stakeholders’ input and feedback. These recommendations were then added to the refined strategy. Thus, executing this approach led to the realisation and use of a multifaceted theory-informed practice-based implementation strategy.ConclusionThis case study gives an in-depth description of an iterative approach to developing an evidence-based, practice-tailored strategy for implementing a complex eHealth intervention in cardiac care. As such, this study may serve as a blueprint for other researchers aspiring to implement complex eHealth interventions within clinical practice sustainably.

P93: Characteristics of complex, non-pharmacological cognitive stimulation interventions for people with dementia in nursing homes: systematic review

Objective:Several guidelines propose the use of cognitive stimulation (CS) in people with dementia. Multi-component CS interventions seem most effective in improving cognitive function, quality of life, and behavioral and psychological symptoms of dementia. For successful implementation, it is important to analyze CS interventions in detail in order to identify frequently used and potentially effective components. The aim of this systematic review is to identify, describe and summarise multicomponent CS interventions conducted in nursing homes aiming to improve cognitive function, quality of life, mood, and behavior of people with dementia in nursing homes.Methods:This review is based on established methodological frameworks for systematic evidence syntheses. We conducted a database search in February 2021, using PubMed, CENTRAL, PsycINFO, ALOIS and CINAHL. Two independent reviewers assessed all search results for eligible studies and assessed studies’ methodological quality using the Cochrane Risk of Bias tool for RCTs and the Joanna Briggs Institute checklist for quasi-experimental studies. Evaluation and intervention development studies of any design examining multicomponent interventions CS were included. Components of included intervention programs were analyzed using the TIDieR and CReDECI 2 criteria following a narrative analysis.Results:We identified 19,992 references and included 45 publications. We observed large heterogeneity regarding intervention components, delivery, materials, mode of delivery, intervention provider, and intervention duration. Intervention components included for example reminiscence therapy, activities of daily living, cognitive exercises or reality orientation. Risk of bias was generally low. Reporting of complex interventions was frequently insufficient. No study reported patient and public involvement (PPI) at any stage of the research process.Conclusion:This systematic review is the first to describe complex CS interventions conducted in nursing homes in detail. Results indicate the need for more detailed intervention description for future studies based on TIDieR and CReDECI2 guidelines to allow reliable replication of these interventions. Despite enormous research activities, many questions regarding the implementation and efficacy are still unanswered as process evaluations are lacking. In addition, reproducibility of interventions is hardly possible due to limited reporting. Future studies should use established frameworks for the development, evaluation and implementation of complex interventions and apply PPI concepts.

Training nurses to facilitate and implement CURA in palliative care institutions: development and evaluation of a blended learning program

BackgroundHealthcare professionals in palliative care are found to be confronted with moral challenges on a frequent basis. CURA is a low-threshold instrument for dialogical ethical reflection that was developed to deal with these challenges. A previous study identified the need of healthcare professionals to be trained to introduce CURA in their organization, initiate and facilitate reflections with CURA, and contribute to the implementation of CURA. The aim of this study was to develop and evaluate a training for professionals to become ‘CURA-ambassadors’.MethodsThe training was developed in a participatory way in two cycles. We trained 72 healthcare professionals. The training was evaluated by means of a questionnaire and six semi-structured interviews.ResultsThe study resulted in a blended learning training combining training sessions with an e-module and with practicing with organizing and facilitating CURA in daily healthcare practice. The main objectives of the training are to enable CURA-ambassadors to introduce CURA within their organization, initiate and facilitate ethical reflections using CURA, and contribute to the implementation of CURA. Participants were generally positive about the training program and the trainers. Technical difficulties related to the e-module were mentioned as main point of improvement.DiscussionThe training program can generate ownership, responsibility, and competency among CURA-ambassadors, which are essential foundations for implementing complex interventions in healthcare practice. The training program received positive evaluations shortly after completing the program. This study adds to our understanding of what is needed for healthcare professionals to use CURA, in order to support them in dealing with moral challenges and to foster their moral resilience. Further research is needed to assess whether participants experience the training as sufficient and effective when using and implementing CURA structurally in their organizations over a longer period of time.

Impact of a quality improvement intervention on the incidence of surgical site infection in patients undergoing colorectal surgery: Pre-test-post-test design.

The aim of this study was to measure the impact of a complex quality improvement intervention on the incidence of SSI in patients undergoing elective colorectal surgery. Surgical site infections are a major postoperative complication for patients undergoing colorectal surgery. Prevention of SSIs necessitates a complex intervention requiring many elements to be in place to ensure the successful implementation of prevention measures. This study was a non-equivalent pre-test post-test design where consecutive patients undergoing colorectal surgery were surveyed for surgical site infections for 30 days postoperatively and is reported using the SQUIRE 2.0. A baseline cohort of patients was retrospectively reviewed in a single centre to ascertain the surgical site infection incidence rate in the first 6 months of 2018 (T0) and prospectively at two 6-month time periods in 2019 (T1, T2) following the introduction of a complex intervention. There were 311 patients included across three time periods. There was a notable decrease in surgical site infection incidence rates from baseline over the course of the study. Univariate analysis identified Body Mass Index, a wound contamination classification of dirty or contaminated, duration of surgery >75th percentile and a National Healthcare Safety Network risk index score of 3 as factors that significantly increase the probability of developing a surgical site infection. Multivariate analysis identified duration of surgery and body mass index increased the probability of an SSI. The results of the logistical regression model found that there was a significant reduction in the probability of an SSI between T0 and T2. The implementation of a complex intervention led to a reduction in the incidence of surgical site infections and improved implementation of evidence-based practices as part of a care bundle in relation to the prevention of surgical site infections in patients undergoing elective colorectal surgery. A multicomponent multidisciplinary complex intervention as part of a quality improvement project can successfully reduce the incidence rates of surgical site infections in patients who require elective colorectal surgery. Normalisation Process Theory provides guidance and support in implementing complex interventions for the prevention of surgical site infection. Patients provided post-discharge information on their wound healing as part of the surveillance component of the intervention. Five patients reviewed and provided feedback on a patient information booklet which was developed from this quality improvement intervention. A multidisciplinary steering group guided all stages of the project.

Protocol for intervention development to improve adolescent perinatal mental health in Kenya and Mozambique: The INSPIRE project

IntroductionMental health interventions have traditionally been developed by clinicians and researchers without the meaningful engagement and partnership with those who would receive, deliver, and fund them. Recent progress has highlighted the importance of the co-design of interventions, through stakeholder participation, as a means of increasing the integration of mental health interventions into existing health, education, and social care systems. This protocol describes the pre-implementation phase of the INSPIRE (Innovative approaches to adolescent perinatal wellbeing) project which aims to identify challenges, and design and test interventions to promote mental wellbeing and good mental health of adolescent girls during pregnancy and the year after birth with local stakeholders in Kenya and Mozambique. MethodsA participatory approach that blends human-centred design, systems thinking, and implementation science methods will be used to engage adolescents (aged 15–19 years), their families, and other stakeholders who can influence implementation efforts, in planning and preparing interventions. First, an understanding of context, barriers, and opportunities related to adolescent perinatal mental health will be elicited through individual interviews, focus group discussions, and observations. This will be complemented by a scoping review of relevant interventions. The research team will identify contextual insights relating to adolescent and system characteristics, strengths, and challenges. These will be shared with and refined by stakeholders. Thematic analysis will be conducted to describe the experiences of adolescent girls, and barriers and enablers to maintaining good mental health. The former will be triangulated with the Context and Implementation of Complex Intervention (CICI) framework. Causal loop diagrams will be developed to illustrate the individual and system-level variables which influence adolescent perinatal mental health.Stakeholder workshops will be used to identify priorities, brainstorm potential interventions, develop a program theory, and prototype an intervention and implementation strategies. Intervention acceptability, appropriateness, and feasibility will be assessed, and a theory of change map finalized. ResultsTo date the study has recruited 169 participants to complete individual interviews, focus group discussions and observation activities. ConclusionsIt is anticipated that the use of a participatory and systematic approach to the development of an intervention to improve mental health, will improve its perceived appropriateness, acceptability, and feasibility among key stakeholders. This may, in turn, significantly improve its availability, uptake, and sustainability.

Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial—using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME)

BackgroundThe OPTIMIZE trial is a multi-site, comparative effectiveness research (CER) study that uses a Sequential Multiple Assessment Randomized Trial (SMART) designed to examine the effectiveness of complex health interventions (cognitive behavioral therapy, physical therapy, and mindfulness) for adults with chronic low back pain. Modifications are anticipated when implementing complex interventions in CER. Disruptions due to COVID have created unanticipated challenges also requiring modifications. Recent methodologic standards for CER studies emphasize that fully characterizing modifications made is necessary to interpret and implement trial results. The purpose of this paper is to outline the modifications made to the OPTIMIZE trial using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) to characterize modifications to the OPTIMIZE trial in response to the COVID pandemic and other challenges encountered.MethodsThe FRAME outlines a strategy to identify and report modifications to evidence-based interventions or implementation strategies, whether planned or unplanned. We use the FRAME to characterize the process used to modify the aspects of the OPTIMIZE trial. Modifications were made to improve lower-than-anticipated rates of treatment initiation and COVID-related restrictions. Contextual modifications were made to permit telehealth delivery of treatments originally designed for in-person delivery. Training modifications were made with study personnel to provide more detailed information to potential participants, use motivational interviewing communication techniques to clarify potential participants’ motivation and possible barriers to initiating treatment, and provide greater assistance with scheduling of assigned treatments.ResultsModifications were developed with input from the trial’s patient and stakeholder advisory panels. The goals of the modifications were to improve trial feasibility without compromising the interventions’ core functions. Modifications were approved by the study funder and the trial steering committee.ConclusionsFull and transparent reporting of modifications to clinical trials, whether planned or unplanned, is critical for interpreting the trial’s eventual results and considering future implementation efforts.Trial registrationClinicalTrials.gov NCT03859713. Registered on March 1, 2019

Methodological approaches to study context in intervention implementation studies: an evidence gap map

BackgroundWithin implementation science studies, contextual analysis is increasingly recognized as foundational to interventions' successful and sustainable implementation. However, inconsistencies between methodological approaches currently limit progress in studying context and guidance to standardize the use of those approaches is scant. Therefore, this study's objective was to systematically review and map current methodological approaches to contextual analysis in intervention implementation studies. The results would help us both to systematize the process of contextual analysis and identify gaps in the current evidence.MethodsWe conducted an evidence gap map (EGM) based on literature data via a stepwise approach. First, using an empirically developed search string, we randomly sampled 20% of all intervention implementation studies available from PubMed per year (2015–2020). Second, we assessed included studies that conducted a contextual analysis. Data extraction and evaluation followed the Basel Approach for CoNtextual ANAlysis (BANANA), using a color-coded rating scheme. Also based on BANANA and on the Context and Implementation of Complex Interventions (CICI) framework–an implementation framework that pays ample attention to context– we created visual maps of various approaches to contextual analysis.ResultsOf 15, 286 identified intervention implementation studies and study protocols, 3017 were screened for inclusion. Of those, 110 warranted close examination, revealing 22% that reported on contextual analysis.Only one study explicitly applied a framework for contextual analysis. Data were most commonly collected via surveys (n = 15) and individual interviews (n = 13). Ten studies reported mixed-methods analyses. Twenty-two assessed meso-level contextual and setting factors, with socio-cultural aspects most commonly studied. Eighteen described the use of contextual information for subsequent project phases (e.g., intervention development/adaption, selecting implementation strategies). Nine reported contextual factors' influences on implementation and/or effectiveness outcomes.ConclusionsThis study describes current approaches to contextual analysis in implementation science and provides a novel framework for evaluating and mapping it. By synthesizing our findings graphically in figures, we provide an initial evidence base framework that can incorporate new findings as necessary. We strongly recommend further development of methodological approaches both to conduct contextual analysis and to systematize the reporting of it. These actions will increase the quality and consistency of implementation science research.

Unraveling implementation context: the Basel Approach for coNtextual ANAlysis (BANANA) in implementation science and its application in the SMILe project

BackgroundDesigning intervention and implementation strategies with careful consideration of context is essential for successful implementation science projects. Although the importance of context has been emphasized and methodology for its analysis is emerging, researchers have little guidance on how to plan, perform, and report contextual analysis. Therefore, our aim was to describe the Basel Approach for coNtextual ANAlysis (BANANA) and to demonstrate its application on an ongoing multi-site, multiphase implementation science project to develop/adapt, implement, and evaluate an integrated care model in allogeneic SteM cell transplantatIon facILitated by eHealth (the SMILe project).MethodsBANANA builds on guidance for assessing context by Stange and Glasgow (Contextual factors: the importance of considering and reporting on context in research on the patient-centered medical home, 2013). Based on a literature review, BANANA was developed in ten discussion sessions with implementation science experts and a medical anthropologist to guide the SMILe project’s contextual analysis. BANANA’s theoretical basis is the Context and Implementation of Complex Interventions (CICI) framework. Working from an ecological perspective, CICI acknowledges contextual dynamics and distinguishes between context and setting (the implementation’s physical location).ResultsBANANA entails six components: (1) choose a theory, model, or framework (TMF) to guide the contextual analysis; (2) use empirical evidence derived from primary and/or secondary data to identify relevant contextual factors; (3) involve stakeholders throughout contextual analysis; (4) choose a study design to assess context; (5) determine contextual factors’ relevance to implementation strategies/outcomes and intervention co-design; and (6) report findings of contextual analysis following appropriate reporting guidelines. Partly run simultaneously, the first three components form a basis both for the identification of relevant contextual factors and for the next components of the BANANA approach.DiscussionUnderstanding of context is indispensable for a successful implementation science project. BANANA provides much-needed methodological guidance for contextual analysis. In subsequent phases, it helps researchers apply the results to intervention development/adaption and choices of contextually tailored implementation strategies. For future implementation science projects, BANANA’s principles will guide researchers first to gather relevant information on their target context, then to inform all subsequent phases of their implementation science project to strengthen every part of their work and fulfill their implementation goals.

Implementation lessons learnt when trialling palliative care interventions in the intensive care unit: relationships between determinants, implementation strategies, and models of delivery—a systematic review protocol

BackgroundHeterogeneity amongst palliative care interventions in the intensive care unit (ICU) and their outcomes has meant that, even when found to be effective, translation of evidence into practice is hindered. Previous evidence reviews have suggested that the field of ICU-based palliative care would benefit from well-designed, targeted interventions, with explicit knowledge translation research demonstrating valid implementation strategies. Reviewing effectiveness studies alongside process evaluations for these interventions will give insight into the implementation barriers or constraints identified, and the implementation strategies adopted.MethodsA systematic review to identify and synthesise knowledge on how models of integrating palliative care into the ICU have been implemented and provide critical recommendations for successful future development and implementation of complex interventions in the field. The search will be carried out using MEDLINE, Embase, Cochrane, CINAHL, and PsycINFO. The search strategy will combine terms related to palliative care, intensive care, and implementation. Only full-text articles will be considered and conference abstracts excluded. There will be no date or language restrictions. The Implementation Research Logic Model will be used as a framework for synthesis. Findings will be reported following the Preferred Reporting Items of Systematic Reviews and Meta-Analyses (PRISMA) guidelines.DiscussionThis review will provide understanding of implementation facilitators, barriers, and strategies, when employing palliative care interventions within the ICU. This will provide valuable recommendations for successful future development of complex interventions using implementation frameworks or theories. This can increase the potential for sustained change in practice, reduce heterogeneity in interventions, and therefore help produce measurable and comparable outcomes.Systematic review registrationInternational Prospective Register of Systematic reviews PROSPERO (CRD42022311052)

Process evaluation of complex interventions in non-communicable and neglected tropical diseases in low- and middle-income countries: a scoping review

ObjectivesThe aim of this review is to map out the use of process evaluation (PE) in complex interventions that address non-communicable diseases (NCDs) and neglected tropical diseases (NTDs) to identify...

Understanding dynamic complexity in context-Enriching contextual analysis in implementation science from a constructivist perspective.

Context in implementation science includes not only characteristics of a setting in which an intervention will be delivered, but also social systems (e.g., interrelationships). Context is dynamic and interacts with both, the intervention and its implementation. Therefore, contextual analysis is recognized as an indispensable part of implementation science methodology: it provides the foundation for successful and sustainable implementation projects. Yet, driven by the prevailing post-positivist understanding of context, contextual analysis typically focuses on individual characteristics of context i.e., contextual dynamics and interactions go unnoticed. Conducting contextual analysis from a constructivist perspective promotes a multilayered approach, building a more comprehensive understanding of context, and thus facilitating successful implementation. In this article, we highlight the limitations of prevailing perspectives on context and approaches to contextual analysis. We then describe how contextual analysis can be enriched by working from a constructivist perspective. We finish with a discussion of the methodological and practical implications the proposed changes would entail. Emerging literature attempts to address both the concept of context and methods for contextual analysis. Various theories, models and frameworks consider context, however, many of these are reductionistic and do not acknowledge the dynamic nature of context or interactions within it. To complement recent conceptualizations of context, we suggest consider the following five constructivist concepts: 1) social space; 2) social place; 3) agency; 4) sensation; and 5) embodiment. We demonstrate the value of these concepts using COVID-19 vaccination uptake as an example and integrate the concepts in the Context and Implementation of Complex Interventions (CICI) framework-an implementation science framework that pays ample attention to context. To study context from a constructivist perspective, we also suggest additional considerations in view of methodologies for data collection and analysis, e.g., rapid ethnographic methods. A constructivist perspective contributes to a stronger conceptualization of contextual analysis. Considering the five constructivist concepts helps to overcome contextual analysis' current shortcomings, while revealing complex dynamics that usually go unnoticed. Thus, more comprehensive understanding of context can be developed to inform subsequent phases of an implementation project, thereby maximizing an intervention's uptake and sustainability.

Effect, economic and process-evaluation of a generic function focused care program for long-term care; study protocol of a multicenter cluster–randomized trial

BackgroundNurses are in a key position to stimulate older people to maximize their functional activity and independence. However, nurses still often work in a task-oriented manner and tend to take over tasks unnecessarily. It is evident to support nurses to focus on the capabilities of older people and provide care assistance only when required. Function-Focused Care (FFC) is a holistic care-philosophy aiming to support nurses to deliver care in which functioning and independence of older people is optimized. Dutch and internationally developed FFC-based interventions often lack effectiveness in changing nurses’ and client’s behavior. Process-evaluations have yielded lessons and implications resulting in the development of an advanced generic FFC-program: the ‘SELF-program’. The SELF-program aims to improve activity stimulation behavior of nurses in long-term care services, and with that optimize levels of self-reliance in activities of daily living (ADL) in geriatric clients. The innovative character of the SELF-program lies for example in the application of extended behavior change theory, its interactive nature, and tailoring its components to setting-specific elements and needs of its participants. This paper describes the outline, content and theoretical background of the SELF-program. Subsequently, this paper describes a protocol for the assessment of the program’s effect, economic and process-evaluation in a two-arm (SELF-program vs care as usual) multicenter cluster-randomized trial (CRT).MethodThe proposed CRT has three objectives, including getting insight into the program’s: (1) effectiveness regarding activity stimulation behavior of nurses and self-reliance in ADL of geriatric clients, and (2) cost-effectiveness from a societal perspective including assessments of quality of life and health-care use. Measurements will take place prior to program implementation (baseline), directly after (T1), and in long-term (T2). Parallel to the CRT, a process evaluation will be conducted to provide insight into the program’s: (3) feasibility regarding implementation, mechanisms of impact and contextual factors.DiscussionThe SELF-program was developed following the Medical Research Council framework, which addresses the systematic development, feasibility testing, evaluation and implementation of complex interventions. The program has been subjected to a feasibility study before and results of studies described in this protocol are expected to be available from end 2022 onwards.Trial-registrationThe study is registered in the Dutch Trial Register (NL9189), as of December 22 2020.

Multilevel, risk group-oriented strategies to decrease sickness absence in the public sector: evaluation of interventions in two regions in Sweden

PurposeSickness absence has been identified as needing to be addressed through multilevel interventions, but knowledge regarding optimal design and implementation of such interventions is scarce. The aim of this study was to evaluate the implementation and effects of a large-scale multilevel intervention in the public sector in Sweden.MethodsThe overall effect of the intervention was assessed using mixed-effect models. Sickness absence data (before, and 6 or 12 months after the intervention) for 90 intervention groups and 378 reference groups was retrieved from administrative personnel systems from the two participating regional councils. The implementation processes were evaluated using qualitative content analysis of qualitative interviews conducted at two timepoints.ResultsThe results show that the vast majority of implemented measures were on an individual level and the integration of the intervention differed between the two regions. The reception and perception of the intervention activities seem to have been influenced by the implementation process, and how well the interventions were communicated and integrated, both regarding the integration of the different interventions and their integration into the discrete context and existing routines. No short-term overall effects on sickness absence were found.ConclusionsThe results point to the many challenges in implementing complex interventions, especially where organizational measures are involved—including adequate participation by, and communication between, the involved actors, as well as sufficient resources. The results indicate potential learning effects regarding the awareness of organizational factors in sick leave, after implementing and integrating multilevel strategies.