Development and validation of a short clinical risk management implementation (Short CRiMI) questionnaire.

Clinical Risk Management (CRM) is an important instrument to continuously improve safety of health care delivery. In Germany, hospitals are required by law to implement CRM and incidence reporting systems. Since 2010, nation-wide surveys have been conducted periodically to evaluate implementation of CRM in hospitals. The instrument used in these surveys is constantly being updated to reflect previous experiences, as well as to adapt to ongoing trends and developments in CRM practices. The survey instrument used in 2022 consisted of up to 200 items and took up to an hour to complete. In this study, we aimed to develop a short instrument to measure the level of CRM implementation in hospitals, evaluate its psychometric properties, and to offer benchmarking data for health care facilities of different sizes. We used data collected in 2022 as part of KHaSiMiR study, employing a cross-sectional self-reported online survey. The hospital administrations were invited to designate one CRM manager to participate in the study. Out of 1,411 general hospitals invited, 401 responses were collected (response rate of 28%). After removing the cases with excessive missings, we imputed remaining missing values using multiple imputation, and split the resulting sample (n=362) in two halves (i.e., exploratory and testing subsamples). A principal component analysis was applied on the first subsample. We validated the resulting model using confirmatory factor analysis in the testing subsample. We evaluated internal consistency, and tested external validity of the established instrument using correlation analysis with two single-item measures: subjective evaluation of CRM implementation compared to similar organizations and compared to own ideal level. The principal component analysis included 45 items from the full instrument. The analysis resulted in a three-factor model with 26 items. In the confirmatory factor analysis, the model demonstrated acceptable fit with the data according to the commonly used fit indices: Chi2/df=1.36, CFI=0.941, TLI=0.930, RMSEA=0.045 (90% CI=0.032-0.056), SRMR=0.049. Cronbach's alpha of all three factors was good (>0.70). All three factors had statistically significant positive correlations with each other (0.359-0.497) and with the two single items (0.282-0.532). None of the correlations were high enough (>0.7) to indicate multicollinearity. The proposed short clinical risk management implementation (Short CRiMI) questionnaire is psychometrically valid and can be used to rapidly evaluate CRM implementation in hospitals. Further research can provide evidence of its external validity and association with quality and safety outcomes. Benchmarking data can be used to compare the results with the data from the most recent Germany-wide survey.

Challenges to implementing planning processes in Brazilian health regions.

OBJECTIVE: To recognize elements that facilitated or hindered the PlanificaSUS implementation stages. METHODS: A multiple case study was carried out in four pre-selected health regions in Brazil-Belo Jardim (PE), Fronteira Oeste (RS), Sul-Mato-Grossense (MT) and Valença (BA) using systemic arterial hypertension and maternal and child care as tracer conditions. Participant observation (in regional interagency commissions) and in-depth interviews with key informants from state and municipal management and primary health care and specialized outpatient care service professionals within the project were carried out in these four regions. Analysis was built according to political, technical-operational, and contextual dimensions. RESULTS: The political dimension evinced that the regions found the project an opportunity to articulate states and municipalities and an important political bet to build networks and lines of care but that there remained much to be faced in the disputes related to building the Unified Health System (SUS). In the technical operational dimension, it is important to consider that primary health care stimulated a culture of local planning and favored traditional tools to organize and improve it, such as organizing registrations, agendas, and demands. However, centralized training and planning-inducing processes fail to always respond to local needs and can produce barriers to implementation. CONCLUSIONS: It is worth considering the central and regional role of state managers in the commitment related to the project and the effect of mobilizing primary health care and expanding its power. There remains much to be faced in the disputes at stake in bullring SUS.

Contextual factors and mechanisms in the implementation of Value Stream Mapping in breast cancer centres - A multiple case study.

INTRODUCTION: Lean, especially Value Stream Mapping is increasingly used in hospitals to optimize processes. This method, which originated in the automotive industry, enables all staff involved in the process to make it more customer-friendly. Despite the widely reported success of Lean projects, they have failed in some cases. This study investigated the contextual factors and mechanisms that contribute to a successful implementation of Value Stream Mapping. METHODS: Value Stream Mapping was applied to the discharge process in four breast cancer centers. A mixed-method approach was used in two steps. First, to verify the successful implementation, defined as time optimization, time measurement was conducted at three points in time and analyzed using an ANOVA. Second, an analysis of contextual factors was combined with a qualitative content analysis of mechanisms based on normalization process theory, using routine data, meeting protocols, field notes, and interview transcripts as data source. RESULTS: At one of the four breast cancer centers, lead- and waiting time were significantly reduced; at the others, these reductions did not occur. Failure/success cannot be explained by the size of the hospital, the number of cases or staffing levels. The variable project team composition is evident, especially leadership involvement. DISCUSSION: A comparative analysis was conducted to identify the factors that led to success. These factors were: participation of all leaders relevant to the process, in the case of the discharge process including medical and nursing leaders; dissemination of the changes from the project team to colleagues including its sense and possibility to discuss it; joint reflection of the implementation process in regular work team meetings. CONCLUSIONS: These results confirm the important role of leadership in implementation projects. Leadership support enabled the mechanisms found. The used combination of theoretical approaches from management research and implementation science determined the interpretation and should be applied more often in implementation science.

An implementation strategy postmortem method developed in the VA rural Transitions Nurse Program to inform spread and scale-up.

BACKGROUND: High-quality implementation evaluations report on intervention fidelity and adaptations made, but a practical process for evaluating implementation strategies is needed. A retrospective method for evaluating implementation strategies is also required as prospective methods can be resource intensive. This study aimed to establish an implementation strategy postmortem method to identify the implementation strategies used, when, and their perceived importance. We used the rural Transitions Nurse Program (TNP) as a case study, a national care coordination intervention implemented at 11 hospitals over three years. METHODS: The postmortem used a retrospective, mixed method, phased approach. Implementation team and front-line staff characterized the implementation strategies used, their timing, frequency, ease of use, and their importance to implementation success. The Expert Recommendations for Implementing Change (ERIC) compilation, the Quality Enhancement Research Initiative phases, and Proctor and colleagues' guidance were used to operationalize the strategies. Survey data were analyzed descriptively, and qualitative data were analyzed using matrix content analysis. RESULTS: The postmortem method identified 45 of 73 ERIC strategies introduced, including 41 during pre-implementation, 37 during implementation, and 27 during sustainment. External facilitation, centralized technical assistance, and clinical supervision were ranked as the most important and frequently used strategies. Implementation strategies were more intensively applied in the beginning of the study and tapered over time. CONCLUSIONS: The postmortem method identified that more strategies were used in TNP than planned and identified the most important strategies from the perspective of the implementation team and front-line staff. The findings can inform other implementation studies as well as dissemination of the TNP intervention.

Retrospective genetic testing (Traceback) in women with early-onset breast cancer after revised national guidelines: a clinical implementation study.

PURPOSE: This study focused on identifying a hereditary predisposition in women previously diagnosed with early-onset breast cancer through a retrospective outreach activity (Traceback). The objectives were to evaluate the possible clinical implementation of a simplified Traceback strategy and to identify carriers of pathogenic variants among previously untested women. METHODS: Three hundred and fifteen Traceback-eligible women diagnosed with breast cancer at 36-40 years in Southern Sweden between 2000 and 2019 were identified and offered an analysis of the genes ATM, BARD1, BRCA1, BRCA2, CHEK2, PALB2, RAD51C, and RAD51D through a standardized letter. Women who chose to participate were asked about their experiences through a questionnaire. The workload for the study personnel was measured and recorded. RESULTS: One hundred and seventy-six women underwent genetic testing and pathogenic variants were identified in 9.7%: ATM (n = 6), BARD1 (n = 1), BRCA1 (n = 3), CHEK2 (n = 5), and PALB2 (n = 2). Women with normal test results were informed through a standardized letter. Carriers of pathogenic variants were contacted by telephone and offered in-person genetic counseling. One hundred and thirty-four women returned the subsequent questionnaire. Most study participants were satisfied with both written pre- and post-test information and many expressed their gratitude. The extra workload as compared to routine clinical genetic counseling was modest (8 min per patient). CONCLUSION: The insights from the participants' perspectives and sentiments throughout the process support the notion that the Traceback procedure is a safe and an appreciated complement to routine genetic counseling. The genetic yield of almost 10% also suggests that the associated extra workload for genetic counselors could be viewed as acceptable in clinical implementation scenarios.

Findings from an Organizational Context Survey to Inform the Implementation of a Collaborative Care Study for Co-occurring Disorders.

Primary care is an opportune setting to deliver treatments for co-occurring substance use and mental health disorders; however, treatment delivery can be challenging due multi-level implementation barriers. Documenting organizational context can provide insight into implementation barriers and the adaptation of new processes into usual care workflows. This study surveyed primary care and behavioral health staff from 13 clinics implementing a collaborative care intervention for opioid use disorders co-occurring with PTSD and/or depression as part of a multisite randomized controlled trial. A total of 323 completed an online survey for a 60% response rate. The Consolidated Framework for Implementation Research guided this assessment of multi-level factors that influence implementation. Most areas for improvement focused on inner setting (organizational level) constructs whereas individual-level constructs tended to be strengths. This work addresses a research gap regarding how organizational analyses can be used prior to implementation and provides practical implications for researchers and clinic leaders.

The Collaborative Service Design Playbook to plan, design, and implement sustainable health services for impact.

This paper sets out the Collaborative Service Design Playbook, to guide planning, design, and implementation of co-created health services. Successful health service development and implementation is best guided by theoretically informed approaches; however, organisations often lack design and implementation know-how and have difficulty applying it. This study seeks to improve health service design and potential for scale-up by proposing a tool to guide an end-to-end process, drawing together service design, co-design, and implementation science; and exploring the tool's feasibility to establish a sustainable service solution developed with participants and experts that is scalable and sustainable. The Collaborative Service Design Playbook phases include, (1) Define the opportunity and initiatives, (2) Design the concept and prototype, (3) Deliver to scale and evaluate; and (4) Optimise to transform and sustain. This paper has implications for health marketing through providing an end-to-end approach with phased guidance for health service development, implementation, and scale up.

Guia de políticas de saúde: implementando sistemas de melhoria da qualidade na atenção primária em saúde / Health policy guide: implementing quality improvement systems in primary health care

O Guia de Políticas de Saúde - Implementando Sistemas de Melhoria da Qualidade na Atenção Primária em Saúde oferece orientações abrangentes para gestores que desejem criar e implementar Sistemas de Qualidade na Atenção Primária à Saúde (APS) e para sanitaristas, acadêmicos e organizações da área da saúde interessadas no tema. Neste guia, você vai encontrar: O DESAFIO: Promover o acesso e a qualidade da APS é fundamental para garantir um SUS mais igualitário, mas essa não é uma tarefa simples. Fatores como a diversidade do território brasileiro e questões de governança dos dados em Saúde são desafios que precisam ser considerados para garantir um melhor funcionamento da APS. Nesta seção, apresentamos esses e outros desafios e motivos que fazem da APS um modelo eficaz e custo-efetivo. O IEPS TESTOU: A 1ª edição do Guia de Políticas de Saúde foi elaborado a partir da experiência de construção do programa Recife Monitora, que integra o projeto Qualifica Atenção Básica, uma parceria do IEPS com a Prefeitura do Recife e que conta com o apoio da Umane. O programa foi iniciado em 2022 e apresentou resultados expressivos em seu primeiro ano de implementação. Nesta seção, apresentamos um relato de experiência com as lições aprendidas no primeiro ano do projeto e os referenciais teóricos que embasaram a construção dos sistemas avaliativos da qualidade da APS, informações que podem ser valiosas para a implementação de sistemas de qualidade em todo o país. CODIFICANDO A ESTRATÉGIA: Nesta seção, apresentamos elementos-chaves e um passo a passo detalhado para que as gestões municipais de todo o país possam implementar sistemas de melhoria da qualidade da APS. Também apresentamos alguns desafios que podem ser enfrentados, considerando as singularidades de cada território.

Reflection on the application of the Consolidated Framework for Implementation Research to a national policy to improve inclusion of people with disabilities.

People with disabilities face many barriers in the built environment impacting their mobility, health, and social participation. In the US, under the Americans with Disabilities Act (ADA), municipalities were required to develop and implement barrier-removal plans for pedestrian infrastructure, called ADA transition plans, but very few have done so. Many communities know they need a plan but do not know how to get it done because of a lack of understanding of the many different implementation considerations. Implementation science offers a useful approach for understanding complex policy implementation such as ADA plans. This paper provides a reflection on the adaptation of the Consolidated Framework for Implementation Research (CFIR) to evaluate the implementation of ADA transition planning. To apply the CFIR, we tailored the construct definitions and modified them to fit the specific context of the ADA transition planning process. We documented the constructs that were more challenging to apply, those that were not relevant, and those that were particularly useful. This paper can serve as a valuable example that other researchers can use when considering adapting the CFIR or other implementation frameworks for the evaluation of complex social policy beyond the ADA.

Healthy eating and active living policy, systems, and environmental changes in rural Louisiana: a contextual inquiry to inform implementation strategies.

BACKGROUND: Healthy eating and active living policy, systems, and environmental (PSE) changes are implemented across the United States through Cooperative Extension. However, translating multisector PSE changes to practice in community settings is challenging and there is a lack of knowledge about barriers and facilitators to PSE changes among state Extension systems using standardized frameworks. Therefore, a research-to-practice partnership effort aimed to identify Louisiana Cooperative Extension Service Family and Consumer Science (LFCS) practitioners' barriers and facilitators to implementing PSE changes in rural Louisiana communities. METHODS: A qualitative approach using the 2022 Consolidated Framework for Implementation Research (2022 CFIR) was used. Focus group discussions were conducted at five LFCS regional trainings between February and May 2022. All LFCS practitioners with any level of experience implementing healthy eating and active living PSE changes were eligible to participate, with emphasis on understanding efforts within more rural communities. Focus group discussions were audio-recorded and transcribed verbatim. Researchers analyzed qualitative data using the constant comparison method and 2022 CFIR domains and constructs including Inner Setting (LFCS organization), Outer Setting (rural Louisiana communities), Innovation (PSE changes), and Individuals (PSE change implementation actors/partners). RESULTS: Across the five regions, LFCS practitioners (n = 40) described more barriers (n = 210) than facilitators (n = 100); findings were often coded with multiple 2022 CFIR domains. Reported Inner Setting barriers were lack of formal or informal information sharing and lack of access to knowledge and information. Outer Setting barriers included sustaining and initiating community partnerships and local environmental or political conditions. Individual barriers included a lack of time and expertise, and Innovation barriers included the complex nature of rural PSE changes. Facilitators were mentioned at multiple levels and included community partner buy-in and practitioners' motivation to implement PSE changes. CONCLUSIONS: Implementation strategies are needed to build on organizational strengths and to overcome multi-level barriers to PSE change implementation among LFCS practitioners. The results from the in-depth contextual inquiry used could serve as a guide for future pragmatic assessment efforts among other state Extension systems or as a model for identifying barriers and facilitators and associated implementation strategies among other public health systems in the U.S. and abroad.

Application of the Expert Recommendations for Implementing Change (ERIC) compilation of strategies to health intervention implementation in low- and middle-income countries: a systematic review.

BACKGROUND: The Expert Recommendations for Implementing Change (ERIC) project developed a compilation of implementation strategies that are intended to standardize reporting and evaluation. Little is known about the application of ERIC in low- and middle-income countries (LMICs). We systematically reviewed the literature on the use and specification of ERIC strategies for health intervention implementation in LMICs to identify gaps and inform future research. METHODS: We searched peer-reviewed articles published through March 2023 in any language that (1) were conducted in an LMIC and (2) cited seminal ERIC articles or (3) mentioned ERIC in the title or abstract. Two co-authors independently screened all titles, abstracts, and full-text articles, then abstracted study, intervention, and implementation strategy characteristics of included studies. RESULTS: The final sample included 60 studies describing research from all world regions, with over 30% published in the final year of our review period. Most studies took place in healthcare settings (n = 52, 86.7%), while 11 (18.2%) took place in community settings and four (6.7%) at the policy level. Across studies, 548 distinct implementation strategies were identified with a median of six strategies (range 1-46 strategies) included in each study. Most studies (n = 32, 53.3%) explicitly matched implementation strategies used for the ERIC compilation. Among those that did, 64 (87.3%) of the 73 ERIC strategies were represented. Many of the strategies not cited included those that target systems- or policy-level barriers. Nearly 85% of strategies included some component of strategy specification, though most only included specification of their action (75.2%), actor (57.3%), and action target (60.8%). A minority of studies employed randomized trials or high-quality quasi-experimental designs; only one study evaluated implementation strategy effectiveness. CONCLUSIONS: While ERIC use in LMICs is rapidly growing, its application has not been consistent nor commonly used to test strategy effectiveness. Research in LMICs must better specify strategies and evaluate their impact on outcomes. Moreover, strategies that are tested need to be better specified, so they may be compared across contexts. Finally, strategies targeting policy-, systems-, and community-level determinants should be further explored. TRIAL REGISTRATION: PROSPERO, CRD42021268374.

Designing an Efficient Implementation Process for Large Scale Adoption of Telehealth.

Telehealth may be one of the solutions to the increasing demand of healthcare. However, implementation of such systems is a considerable effort, and requires an efficient and systemized process for large scale adoption. This study provides a process for telehealth implementation. Although quantitative studies of implementation processes introduce significant challenges, the study provide initial indications of increasing effectiveness, specifically in time to deployment.

Encontro com Especialistas - PNAISC: Diretrizes para implementação

Encontro com Especialistas da Equipe da Coordenação de Saúde da Criança e Aleitamento Materno (COCAM), do Departamento de Ações Programáticas Estratégicas (DAPES), da Secretaria de Atenção Primária à Saúde (SAPS), Ministério da Saúde (MS).

iCHECK-DH: Guidelines and Checklist for the Reporting on Digital Health Implementations.

BACKGROUND: Implementation of digital health technologies has grown rapidly, but many remain limited to pilot studies due to challenges, such as a lack of evidence or barriers to implementation. Overcoming these challenges requires learning from previous implementations and systematically documenting implementation processes to better understand the real-world impact of a technology and identify effective strategies for future implementation. OBJECTIVE: A group of global experts, facilitated by the Geneva Digital Health Hub, developed the Guidelines and Checklist for the Reporting on Digital Health Implementations (iCHECK-DH, pronounced "I checked") to improve the completeness of reporting on digital health implementations. METHODS: A guideline development group was convened to define key considerations and criteria for reporting on digital health implementations. To ensure the practicality and effectiveness of the checklist, it was pilot-tested by applying it to several real-world digital health implementations, and adjustments were made based on the feedback received. The guiding principle for the development of iCHECK-DH was to identify the minimum set of information needed to comprehensively define a digital health implementation, to support the identification of key factors for success and failure, and to enable others to replicate it in different settings. RESULTS: The result was a 20-item checklist with detailed explanations and examples in this paper. The authors anticipate that widespread adoption will standardize the quality of reporting and, indirectly, improve implementation standards and best practices. CONCLUSIONS: Guidelines for reporting on digital health implementations are important to ensure the accuracy, completeness, and consistency of reported information. This allows for meaningful comparison and evaluation of results, transparency, and accountability and informs stakeholder decision-making. i-CHECK-DH facilitates standardization of the way information is collected and reported, improving systematic documentation and knowledge transfer that can lead to the development of more effective digital health interventions and better health outcomes.

Measurement Characteristics of the Wraparound Fidelity Index Short Form: Results from a Statewide Implementation.

Implementation fidelity has been an important issue in the service provision and associated outcomes of Wraparound, an intensive, individualized care planning process that uses a team-based approach to integrate youth into the community to minimize the need for intensive, institutional services. In response to the growing need to monitor fidelity to the Wraparound process, a variety of instruments have been created and tested. In this study, the authors present the results of several analyses designed to better understand the measurement characteristics of the Wraparound Fidelity Index Short Form (WFI-EZ), a multi-informant fidelity instrument. The results from our analysis of 1027 WFI-EZ responses indicate that the internal consistency of the instrument is very good, although the negatively worded items did not appear to function as well as positively worded items. Results from two confirmatory factor analyses were unable to validate the original domains identified by the instrument developers, but for certain outcomes the WFI-EZ demonstrated deseriable predictive validity. Preliminary evidence is also provided that WFI-EZ responses likely differ by respondent type. We conclude by discussing the implications of using the WFI-EZ in programming, policy, and practice considering the findings of our study.

Plan interinstitucional para la atención en salud en el marco de los XXIV Juegos Centroamericanos y del Caribe, San Salvador 2023 / Inter-institutional plan for health care in the framework of the XXIV Central American and Caribbean Games, San Salvador 2023

Los Juegos Centroamericanos y del Caribe son un evento multideportivo, que se realizan cada 4 años desde 1926 en diferentes países de la región que comprenden América Central y la cuenca del Mar Caribe. Es el evento multidisciplinario regional más antiguo del mundo, son coordinados por la Organización Centro Caribe Sports. Para el año 2023 se estima que la fecha de realización de estos juegos será del 23 de junio al 8 de julio, esperando una afluencia masiva de atletas y delegaciones extrajeras. El Ministerio de Salud, como ente rector del Sistema Nacional Integrado de Salud, emite el presente Plan interinstitucional para la atención en salud en el marco de los XXIV Juegos Centroamericanos y del Caribe, San Salvador 2023, en la vigilancia epidemiológica, prevención y atención de la salud en casos de emergencias. El plan contiene estrategias de atención en casos de emergencias médicas (traumas, fracturas, intoxicaciones alimentarias, reacciones alérgicas, atenciones de primeros auxilios, atenciones masivas de víctimas en casos de desastres naturales y accidentes de tránsito), entre otros. Además, incluye una breve descripción del acceso a los puntos de atención médica y zonas de evacuación asignadas en los diferentes escenarios deportivos

The Central American and Caribbean Games are a multi-sport event, held every 4 years since 1926 in different countries of the region comprising Central America and the Caribbean Sea basin. It is the oldest regional multidisciplinary event in the world, coordinated by the Centro Caribe Sports Organization. For 2023 it is estimated that the date of these games will be from 23 June to 8 July, expecting a massive influx of athletes and foreign delegations. The Ministry of Health, as the governing body of the Integrated National Health System, issues this inter-institutional plan for health care within the framework of the twenty-third Central American and Caribbean Games, San Salvador 2023, in epidemiological surveillance, prevention and health care in emergencies The plan contains strategies for dealing with medical emergencies (traumas, fractures, food poisoning, allergic reactions, first-aid care, mass care of victims in cases of natural disasters and traffic accidents), among others. In addition, it includes a brief description of access to health care points and designated evacuation areas in different sports arenas

On-the-Go Adaptation of Implementation Approaches and Strategies in Health: Emerging Perspectives and Research Opportunities.

In many cases, implementation approaches (composed of one or more strategies) may need to change over time to work optimally. We use a literature review to inform a mechanistic analysis of such on-the-go adaptations. We suggest that such adaptations of implementation strategies consist of three necessary steps. The first component is the initial effect of the implementation approach on intended implementation, service delivery, or clinical outcomes. Second, these initial effects must in turn be used to modify, alter, intensify, or otherwise change the implementation approach. Third, the modified approach itself has effects. Conceiving of adaptation as all three steps implies that a full understanding of adaptation involves (a) a sense of initial effects, (b) conceptualizing and documenting content and rationale for changes in approach (e.g., alteration, intensification), and (c) the effects of the changed approach (including how the latter effects depend on initial effects). Conceptualizing these steps can help researchers ask questions about adaptation (e.g., thresholds for change, dosing, potentiation, sequencing) to advance our understanding of implementation strategies.

Local public health projectification in practice: a qualitative study of facilitators and barriers to a public health plan implementation.

AIMS: To identify factors perceived by local government employees to affect the implementation of a municipal public health plan. METHODS: Qualitative individual interviews (n=13) were carried out. Participants were sampled from three districts in Oslo municipality, Norway, and asked about their experiences with an ongoing implementation of the Oslo Public Health Plan (2017-2020). The conceptual framework of public sector projectification - a growing reliance on project organisation of policies - informed the study. The consolidated framework for implementation research was used to aid data coding and subsequent thematic analysis. RESULTS: Implementation facilitators included factors perceived to support flexibility, including plan adaptability to the local setting, and factors perceived to enable structure and control during the implementation process, such as the articulation of specific goals and a shared understanding of public health work. Barriers were mainly related to complex aspects of the plan, such as the need to involve multiple stakeholders and levels of governance, and to tensions between the time-limited implementation process and the permanent organisational structures. CONCLUSIONS: This study has demonstrated how research-based methods can be used for the evaluation of a local community implementation process. It has identified implementation determinants using a predetermined taxonomy of operationally defined factors that are likely to influence implementation. However, while implementing a time-limited public health plan can be seen as 'taking action' in relation to multidimensional and complex problems, further research is needed to investigate whether plan implementation has a long-term impact on the surrounding organisation and, eventually, on public health outcomes.

Can systematic implementation support improve programme fidelity by improving care providers' perceptions of implementation factors? A cluster randomized trial.

BACKGROUND: Investigations of implementation factors (e.g., collegial support and sense of coherence) are recommended to better understand and address inadequate implementation outcomes. Little is known about the relationship between implementation factors and outcomes, especially in later phases of an implementation effort. The aims of this study were to assess the association between implementation success (measured by programme fidelity) and care providers' perceptions of implementation factors during an implementation process and to investigate whether these perceptions are affected by systematic implementation support. METHODS: Using a cluster-randomized design, mental health clinics were drawn to receive implementation support for one (intervention) and not for another (control) of four evidence-based practices. Programme fidelity and care providers' perceptions (Implementation Process Assessment Tool questionnaire) were scored for both intervention and control groups at baseline, 6-, 12- and 18-months. Associations and group differences were tested by means of descriptive statistics (mean, standard deviation and confidence interval) and linear mixed effect analysis. RESULTS: Including 33 mental health centres or wards, we found care providers' perceptions of a set of implementation factors to be associated with fidelity but not at baseline. After 18 months of implementation effort, fidelity and care providers' perceptions were strongly correlated (B (95% CI) = .7 (.2, 1.1), p = .004). Care providers perceived implementation factors more positively when implementation support was provided than when it was not (t (140) = 2.22, p = .028). CONCLUSIONS: Implementation support can facilitate positive perceptions among care providers, which is associated with higher programme fidelity. To improve implementation success, we should pay more attention to how care providers constantly perceive implementation factors during all phases of the implementation effort. Further research is needed to investigate the validity of our findings in other settings and to improve our understanding of ongoing decision-making among care providers, i.e., the mechanisms of sustaining the high fidelity of recommended practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03271242 (registration date: 05.09.2017).