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Complex interventions are needed to effectively tackle non-communicable diseases. However, complex interventions can contain a mix of effective and ineffective actions. Process evaluation (PE) in public health research is of great value as it could clarify the mechanisms and contextual factors associ-ated with variation in the outcomes, better identify effective components, and inform adaptation of the intervention. The aim of this paper is to demonstrate the value of PE through five case studies that span the research cycle. The interven-tions include using digital health, salt reduction strategies, use of fixed dose combinations, and task shifting. Insights of the methods used, and the implications of the PE findings to the project, were discussed. PE of complex interventions can refute or confirm the hypothesized mechanisms of action, thereby enabling intervention refinement, and identifying implementation strategies that can address local contextual needs, so as to improve service delivery and public health outcomes.
Assuntos
Doenças não Transmissíveis , Humanos , Doenças não Transmissíveis/prevenção & controle , Saúde Pública , Cloreto de Sódio na DietaRESUMO
Resumen Objetivo: Identificar facilitadores y obstáculos en la implementación del programa Meta Salud Diabetes, una intervención educativa diseñada para disminuir el riesgo de padecer enfermedades cardiovasculares en personas con diabetes, que participan en Grupos de Ayuda Mutua de la Secretaría de Salud, en el norte de México. Materiales y métodos: Estudio de corte cualitativo. A partir de la Teoría del Proceso de Normalización, en particular del constructo de contribución, se analiza la información que da cuenta de la experiencia del personal encargado de la implementación del programa, en cuatro centros de salud seleccionados para este trabajo. Las fuentes constan de bitácoras de contacto con las encargadas de los Grupos de Ayuda Mutua, relatorías de reuniones de retroalimentación con éstas, diarios de campo de la observación no participante de las sesiones de Meta Salud Diabetes y entrevistas semiestructuradas. Resultados: Meta Salud Diabetes pudo ser implementado durante 13 semanas, en los centros de salud que participaron en el estudio. Quienes lo facilitaron, reconocieron su utilidad como un modelo educativo para mejorar las prácticas de autocuidado en las personas con diabetes. Se documentó que el acompañamiento institucional es muy importante para la implementación del programa. Conclusiones: Para la implementación del programa en el futuro, se requiere la asignación sistemática de recursos a los Grupos de Ayuda Mutua, el reconocimiento del trabajo de quienes los coordinan, la mejora en los procesos de supervisión, la contratación de más personal y la colaboración de diferentes profesionales de la salud. El enfoque de la Teoría del Proceso de Normalización para el análisis de la contribución de los agentes, permitió identificar los factores que facilitaron u obstaculizaron la implementación de Meta Salud Diabetes en los casos estudiados. Una limitación de este tipo de investigaciones es la dificultad de aislar el impacto que tienen en los diferentes agentes.
Abstract Objective: Identify facilitators and barriers to implementing Meta Salud Diabetes program, an educational intervention designed to reduce the risk of cardiovascular disease in people with diabetes who participate in Grupos de Ayuda Mutua [Self-help groups] organized by the Ministry of Health in northern Mexico. Materials and methods: This is a qualitative study based on Normalization Process Theory, mainly the "contribution" construct, which analyzes information describing the experience of health personnel in charge of implementing the intervention in four health care centers selected for this article. Data sources include contact logs with Grupos de Ayuda Mutua facilitators and reports from feedback meetings, field notes from non-participant observation of the Meta Salud Diabetes sessions and semi-structured interviews. Results: Meta Salud Diabetes was succesfully implemented for 13 weeks in the health care centers selected for this study. Facilitators recognized its usefulness as an educational model that improves the self-care practices of people with diabetes. The importance of institutional support for the implementation of Meta Salud Diabetes was also documented. Conclusions: Future implementation of the program requires the systematic allocation of resources to the Grupos de Ayuda Mutua, recognition of the work of those who coordinate them, improvement of supervision processes, employing of more staff and collaboration between different health professionals. Using Normalization Process Theory to analyze agentic contribution allowed us to identify the factors that facilitated or hindered the implementation of Meta Salud Diabetes in the studied groups. However, a limitation of this type of study is the difficulty of isolating the specific impact on different agents.
Resumo Objetivo: Identificar facilitadores e obstáculos na implementação do programa Meta Salud Diabetes, uma intervenção educacional destinada a reduzir o risco de doença cardiovascular em pessoas com diabetes que participam de Grupos de Ajuda Mútua do Ministério da Saúde no norte do México. Materiais e métodos: Estudo qualitativo baseado na Teoria do Processo de Normalização, particularmente no construto "contribuição", são analisadas informações que explicam a experiência do equipe na implementação e coordenação do programa em quatro centros de saúde selecionados para este trabalho. As fontes de informação incluem registros de contatos com os funcionarios dos Grupos de Ajuda Mútua, relatórios sobre reuniões de feedback com eles, jornais de observação de campo não participante das sessões de Meta Salud Diabetes e entrevistas semiestruturadas. Resultados: Meta Salud Diabetes pôde ser implementado por 13 semanas nos centros de saúde que participaram do estudo. Os facilitadores reconheceram sua utilidade como um modelo educacional que aprimora as práticas de autocuidado para pessoas com diabetes. A importância do apoio institucional para a implementação da Meta Salud Diabetes foi documentada. Conclusões: Para a implementação do programa no futuro, é necessária a alocação sistemática de recursos aos Grupos de Ajuda Mútua, o reconhecimento do trabalho daqueles que os coordenam, a melhoria dos processos de supervisão, a contratação de mais pessoal e a colaboração de diferentes profissionais de saúde. A abordagem da Teoria do Processo de Normalização para analisar a contribuição dos agentes, permitiu identificar os fatores que facilitaram ou dificultaram a implementação do Meta Salud Diabetes nos casos estudados. Uma limitação desse tipo de pesquisa é a dificuldade de isolar o impacto que eles têm sobre diferentes agentes.
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Background: Within health promotion research, there is a need to assess strategies for integration and scale up in primary care settings. Hybrid interventions that combine clinical effectiveness trials with implementation studies can elicit important contextual information on facilitators and barriers to integration within a health care system. This article describes lessons learned in developing and implementing a qualitative study of a cluster-randomized controlled trial (RCT) to reduce cardiovascular disease (CVD) among people with diabetes in Sonora, Mexico, 2015-2019. Methods:The research team worked cooperatively with health center personnel from 12 Centers that implemented the intervention. The study used observations, stakeholder meetings, case studies, staff interviews and decision maker interviews to explore issues such as staff capacity, authority, workflow, space, and conflicting priorities, as well as patients' response to the program within the clinical context and their immediate social environments. Applying a multi-layered contextual framework, two members of the research team coded an initial sample of the data to establish inclusion criteria for each contextual factor. The full team finalized definitions and identified sub nodes for the final codebook. Results: Characteristics of management, staffing, and the local environment were identified as essential to integration and eventual adoption and scale up across the health system. Issues included absence of standardized training and capacity building in chronic disease and health promotion, inadequate medical supplies, a need for program monitoring and feedback, and lack of interdisciplinary support for center staff. Lack of institutional support stemming from a curative vs. preventive approach to care was a barrier for health promotion efforts. Evolving analysis, interpretation, and discussion resulted in modifications of flexible aspects of the intervention to realities of the health center environment. Conclusion: This study illustrates that a robust and comprehensive qualitative study of contextual factors across a social ecological spectrum is critical to elucidating factors that will promote future adoption and scale up of health promotion programs in primary care. Application of conceptual frameworks and health behavior theory facilitates identification of facilitators and barriers across contexts. Trial registration: www.ClinicalTrials.gov, identifier: NCT02804698 Registered on June 17, 2016.
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INTRODUCTION: Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. METHODS AND ANALYSIS: The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico's national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. ETHICS AND DISSEMINATION: This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials. TRIAL REGISTRATION NUMBER: NCT0280469; Pre-results.
