Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study) : mixed-methods process evaluation protocol

Medication non-initiation, or primary non-adherence, is a persistent public health problem that increases the risk of adverse clinical outcomes. The initial medication adherence (IMA) intervention is a complex multidisciplinary intervention to improve adherence to cardiovascular and diabetes treatments in primary care by empowering the patient and promoting informed prescriptions based on shared decision-making. This paper presents the development and implementation strategy of the IMA intervention and the process evaluation protocol embedded in a cluster randomised controlled trial (the IMA-cRCT) to understand and interpret the outcomes of the trial and comprehend the extent of implementation and fidelity, the active mechanisms of the IMA intervention and in what context the intervention is implemented and works. We present the protocol for a mixed-methods process evaluation including quantitative and qualitative methods to measure implementation and fidelity and to explore the active mechanisms and the interactions between the intervention, participants and its context. The process evaluation will be conducted in primary care centres and community pharmacies from the IMA-cRCT, and participants include healthcare professionals (general practitioners, nurses and community pharmacists) as well as patients. Quantitative data collection methods include data extraction from the intervention operative records, patient clinical records and participant feedback questionnaires, whereas qualitative data collection involves semistructured interviews, focus groups and field diaries. Quantitative and qualitative data will be analysed separately and triangulated to produce deeper insights and robust results. Ethical approval has been obtained from the Research Ethics Comittee (CEIm) at IDIAP Jordi Gol (codeCEIm 21/051 P). Findings will be disseminated through publications and conferences, as well as presentations to healthcare professionals and stakeholders from healthcare organisations.

Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study)

Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45–75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions’ effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45–75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = −0.09 (95% CI: −0.29–0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: −0.32–0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01–0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64–1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55–1.73), no smoking OR = 0.61 (95% CI: 0.54–1.06), EVA adjusted mean difference = −1.26 (95% CI: −4.98–2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control

Initiation and Single Dispensing in Cardiovascular and Insulin Medications: Prevalence and Explanatory Factors

: Background: Adherence problems have negative effects on health, but there is little information on the magnitude of non-initiation and single dispensing. Objective: The aim of this study was to estimate the prevalence of non-initiation and single dispensation and identify associated predictive factors for the main treatments prescribed in Primary Care (PC) for cardiovascular disease (CVD) and diabetes. Methods: Cohort study with real-world data. Patients who received a first prescription (2013-2014) for insulins, platelet aggregation inhibitors, angiotensin-converting enzyme inhibitors (ACEI) or statins in Catalan PC were included. The prevalence of non-initiation and single dispensation was calculated. Factors that explained these behaviours were explored. Results: At three months, between 5.7% (ACEI) and 9.1% (antiplatelets) of patients did not initiate their treatment and between 10.6% (statins) and 18.4% (ACEI) filled a single prescription. Body mass index, previous CVD, place of origin and having a substitute prescriber, among others, influenced the risk of non-initiation and single dispensation. Conclusions: The prevalence of non-initiation and single dispensation of CVD medications and insulin prescribed in PC in is high. Patient and health-system factors, such as place of origin and type of prescriber, should be taken into consideration when prescribing new medications for CVD and diabetes

Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial

Background: The present study describes the efectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD). Methods: Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45–75 years who presented at least two of the following crite‑ ria were included: smoker, low adherence to the MD or insufcient level of physical activity. The intervention group (IG) had three diferent levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor’s ofce. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors. Results: Three thousand sixty-two participants were included (IG=1,481, CG=1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9–17.5; p<0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the fnal visit. Moreover, the efect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p<0.001) in IG. Conclusions: A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice

Role of personal aptitudes as determinants of incident morbidity, lifestyles, quality of life, use of the health services and mortality (DESVELA cohort): qualitative study protocol for a prospective cohort study in a hybrid analysis

IntroductionMaintaining or acquiring healthier health-oriented behaviours and promoting physical and mental health amongst the Spanish population is a significant challenge for Primary Health Care. Although the role of personal aptitudes (characteristics of each individual) in influencing health behaviours is not yet clear, these factors, in conjunction with social determinants such as gender and social class, can create axes of social inequity that affect individuals’ opportunities to engage in health-oriented behaviours. Additionally, lack of access to health-related resources and opportunities can further exacerbate the issue for individuals with healthy personal aptitudes. Therefore, it is crucial to investigate the relationship between personal aptitudes and health behaviours, as well as their impact on health equity.ObjectivesThis paper outlines the development, design and rationale of a descriptive qualitative study that explores in a novel way the views and experiences on the relationship between personal aptitudes (activation, health literacy and personality traits) and their perception of health, health-oriented behaviours, quality of life and current health status.Method and analysisThis qualitative research is carried out from a phenomenological perspective. Participants will be between 35 and 74 years of age, will be recruited in Primary Health Care Centres throughout Spain from a more extensive study called DESVELA Cohort. Theoretical sampling will be carried out. Data will be collected through video and audio recording of 16 focus groups in total, which are planned to be held in 8 different Autonomous Communities, and finally transcribed for a triangulated thematic analysis supported by the Atlas-ti program.DiscussionWe consider it essential to understand the interaction between health-related behaviours as predictors of lifestyles in the population, so this study will delve into a subset of issues related to personality traits, activation and health literacy.Clinical trial registration: ClinicalTrials.gov, identifier NCT04386135

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial

Methods: A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. Results: 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. Conclusions: Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness

El problema de la no iniciación del tratamiento farmacológico: evaluación con métodos cualitativos

[spa] La no iniciación ocurre cuando se le prescribe un nuevo tratamiento farmacológico a un paciente y este, toma la decisión de no empezarlo. La prevalencia de no iniciación oscila entre el 6% y el 28% en atención primaria y se asocia con peores resultados clínicos, más días de baja por enfermedad y costos más altos. Las patologías cardiovasculares y la diabetes tienen altas tasas de prevalencia, morbilidad y falta de adherencia secundaria. En España, la prevalencia de no iniciación en atención primaria de tratamientos farmacológicos para estas enfermedades se sitúa entre el 6% y el 13%. OBJETIVOS: 1. Conocer y entender las motivaciones que llevan a una persona a no iniciar un tratamiento prescrito en atención primaria desde la perspectiva del paciente, teniendo en cuenta distintos perfiles de tratamiento (agudo, crónico asintomático, crónico sintomático y mental). 2. Conocer y entender las motivaciones que llevan a una persona a no iniciar un tratamiento prescrito en atención primaria desde la perspectiva del profesional sanitario, teniendo en cuenta distintos perfiles de tratamiento. 3. Comprender a qué modelos teóricos se ajusta la práctica actual de la prevención primaria y promoción de la salud en atención primaria en España desde la perspectiva de los profesionales sanitarios de distintas disciplinas de este ámbito asistencial. 4. Diseñar una intervención de mejora de la no iniciación que sea factible y aplicable en atención primaria y comunitaria. MÉTODOS: Para dar respuesta a los objetivos se desarrollaron cuatro estudios que se describen a continuación. Estudio 1: Estudio cualitativo exploratorio explicativo basado en la Teoría Fundamentada. A través de un muestreo teórico de conveniencia, entre marzo del 2015 y diciembre del 2016, se realizaron 30 entrevistas individuales semi-estructuradas a pacientes no iniciadores de centros de atención primaria de Barcelona, Girona y Málaga siguiendo un diseño circular de inclusión, análisis y reflexión. El análisis de datos se realizó siguiendo procedimientos del análisis de contenido temático de comparación constante. El análisis fue triangulado para asegurar los criterios de credibilidad, consistencia y reflexividad. Se realizaron entrevistas hasta saturar la información. Estudio 2: Estudio cualitativo interpretativo-explicativo basado en la Teoría Fundamentada. A través de un muestreo teórico de conveniencia, entre abril y julio del 2018, se realizaron 6 entrevistas grupales semi-estructuradas con profesionales del primer nivel asistencial (médicos, personal de enfermería y trabajadores sociales de los centros de atención primaria y farmacéuticos comunitarios) de la provincia de Barcelona siguiendo un diseño circular de inclusión, análisis y reflexión. El análisis de datos se realizó siguiendo procedimientos de análisis de contenido temático de comparación constante. El análisis fue triangulado para asegurar los criterios de credibilidad, consistencia y reflexividad. Estudio 3: Se realizó un análisis secundario de un estudio cualitativo descriptivo interpretativo que se realizó en el marco del diseño, implementación y evaluación de una intervención compleja multirriesgo para mejorar los estilos de vida de la población española (Proyecto EIRA). Entre noviembre de 2013 y mayo de 2014 se realizaron 14 entrevistas grupales en centros de salud de 7 comunidades autónomas de España (Andalucía, Aragón, Baleares, Castilla-la Mancha, Castilla-León, Cataluña y País Vasco). En 2018, se realizó una revisión bibliográfica consensuando siete modelos de cambio de conducta que frecuentemente se utilizan para diseñar intervenciones de prevención y promoción de la salud y posteriormente se realizó el análisis secundario de datos siguiendo procedimientos de análisis de contenido temático y de acuerdo con 7 modelos teóricos de promoción de la salud a nivel micro, meso y macro. El análisis fue triangulado para asegurar los criterios de credibilidad, consistencia y reflexividad. Estudio 4: En base a la evidencia encontrada, los resultados obtenidos de los anteriores estudios y siguiendo los criterios para el diseño de intervenciones complejas, se elaboró una primera versión de la intervención. Con la finalidad de aumentar la aceptabilidad y transferibilidad de la intervención, entre abril y julio del 2018, se realizaron 8 grupos de discusión con profesionales del primer nivel asistencial y especialistas. Los resultados de los grupos de discusión se utilizaron para optimizar la intervención IMA. RESULTADOS: Estudio 1: Los resultados fueron similares para todos los grupos terapéuticos. Ante una nueva prescripción farmacológica, los pacientes realizan una evaluación de riesgo- beneficio basada en múltiples factores. La evaluación está influida por las percepciones de los pacientes sobre la patología y la medicación, la reacción emocional, la alfabetización en salud y factores culturales. La toma decisiones, además, puede estar condicionada por el contexto del paciente y su relación con el sistema de salud. A raíz de los resultados obtenidos se genera el Modelo Teórico de Iniciación a la Medicación. Estudio 2: El discurso generado por los profesionales de atención primaria coincide casi al completo con el de los pacientes y confirma el Modelo Teórico de Iniciación. Se completó el modelo añadiendo algunos factores que influyen en la iniciación a la medicación como el nivel educativo del paciente, el apoyo social y familiar y el papel del personal de enfermería y de los auxiliares de farmacia. Estudio 3: Las actividades de prevención primaria y promoción de la salud que los profesionales de los centros participantes aplican más en su práctica diaria coinciden mayoritariamente con modelos intrapersonales, en menor grado con modelos interpersonales y raramente con modelos comunitarios. Los profesionales se centran en empoderar al paciente aumentando la percepción de riesgo y de los beneficios del cambio en los comportamientos y guiándoles en la implementación de hábitos y actitudes saludables. Estudio 4: La intervención compleja IMA es multicomponente y multidisciplinaria. Está basada en la toma de decisiones compartidas e informadas y centrada en tratamientos farmacológicos relacionados con la patología cardiovascular y la diabetes en atención primaria. Los elementos fijos están formados por la intervención del médico de atención primaria y un soporte informativo relacionado con la enfermedad y la medicación prescrita. Los elementos flexibles son el apoyo del personal de enfermería de atención primaria y del farmacéutico comunitario. Además, cuenta con un soporte web que aporta información contrastada en todas las fases de la intervención. CONCLUSIONES: El Modelo Teórico de Iniciación a la Medicación explica que la decisión de no iniciar un fármaco está influida por múltiples factores. Ante una nueva prescripción el paciente realiza una valoración beneficio-riesgo afectada por la percepción que tiene sobre la patología y la medicación. A su vez, esta percepción viene condicionada por factores intrapersonales e interpersonales y por factores externos. Los profesionales de la salud deben explorar las creencias de los pacientes sobre los beneficios y los riesgos para ayudarlos a tomar decisiones informadas y promover la toma de decisiones compartidas. Los médicos generales deben asegurarse de que los pacientes comprendan los beneficios y los riesgos de la enfermedad y el tratamiento, a la vez que explican todos los tratamientos alternativos, animando a los pacientes a que hagan preguntas y apoyen las decisiones de su tratamiento. Se ha diseñado una intervención compleja específica de IMA para patología cardiovascular y la diabetes para minimizar el impacto negativo que produce la no iniciación de estos fármacos en la salud de las personas a largo plazo.[eng] Non-initiation occurs when a new pharmacological treatment is prescribed to a patient who decides not to start it. The prevalence of non-initiation ranges from 6% to 28% in primary care and it is associated with worse clinical outcomes, more days on sick leave and higher costs. Cardiovascular disease and diabetes have high rates of prevalence, morbidity and lack of secondary adherence. In Spain, the prevalence of non-initiation in primary care of pharmacological treatments for these diseases is between 6% and 13%. OBJECTIVES: 1. To explore and understand the motivations that lead a person not to initiate a prescribed treatment in primary care from the patient's perspective, taking into account different treatment profiles (acute, chronic asymptomatic, chronic symptomatic and mental). 2. To explore and understand the motivations that lead a person not to initiate a prescribed treatment in primary care from the perspective of the healthcare professional, taking into account different treatment profiles. 3. To explore the theoretical models that fit the current practice of primary prevention and health promotion in primary care in Spain from the perspective of health professionals from different disciplines. 4. To design a non-initiation improvement intervention that would be feasible and applicable in primary and community care. METHODS: To respond to the objectives, four studies were developed and described below. Study 1: Exploratory explanatory qualitative study based on Grounded Theory. Through a theoretical sampling of convenience, between March 2015 and December 2016, 30 semi- structured individual interviews were conducted with non-initiating patients in primary care centers in Barcelona, Girona and Malaga following a circular design of inclusion, analysis and reflexivity. Data analysis was performed following thematic content analysis procedures with constant comparison. The analysis was triangulated to ensure credibility, consistency and reflexivity. Interviews were conducted until the information was saturated. Study 2: Exploratory interpretive qualitative study based on Grounded Theory. Through a theoretical sampling of convenience, between April and July 2018, 6 semi-structured group interviews were carried out with professionals of the first level of care (doctors, nurses and social workers of primary care centres and community pharmacists) of the province of Barcelona following a circular design of inclusion, analysis and reflexivity. The data analysis was performed following procedures of thematic content analysis with constant comparison. The analysis was triangulated to ensure credibility, consistency and reflexivity. Study 3: Secondary analysis of a qualitative descriptive study that was carried out in the framework of the design, implementation and evaluation of a complex multi-risk intervention to improve the lifestyles of the Spanish population (EIRA Project). Between November 2013 and May 2014, 14 group interviews were conducted in health centres from 7 autonomous communities in Spain (Andalusia, Aragon, Balearic Islands, Castilla-La Mancha, Castilla-León, Catalonia and the Basque Country). A bibliographic review was carried out and seven models of behaviour change that are frequently used to design health prevention and promotion interventions were selected. Subsequently, the secondary data analysis was carried out following procedures of thematic content analysis and in accordance with 7 theoretical models of health promotion at micro, meso and macro level. The analysis was triangulated to ensure the criteria of credibility, consistency and reflexivity. Study 4: Based on the evidence founded, the results obtained from previous studies and following the criteria for the design of complex interventions, a first version of the intervention was developed. In order to increase the acceptability and transferability of the intervention, between April and July 2018, 8 discussion groups with professionals of the first level of care and specialists were conducted. The results of the discussion groups were used to optimize the intervention of Adherence to the Initiation to Medication (IMA). RESULTS: Study 1: The results were similar for all therapeutic groups. Facing a new pharmacological prescription, patients perform a risk-benefit evaluation based on multiple factors. The evaluation is influenced by the patient’s perceptions of the pathology and medication, the emotional reaction, health literacy and cultural factors. In addition, decision making may be conditioned by the context of the patient and their relationship with the health system. Following the results obtained, the Theoretical Model of Medication Initiation was generated. Study 2: The discourse generated by primary care professionals and by patients coincides almost completely, confirming the Theoretical Model of Initiation. The model was completed by adding some factors that influence the initiation of medication such as the educational level of the patient, social and family support and the role of nursing staff and pharmacy assistants. Study 3: The activities of primary prevention and health promotion that the professionals of the participating centres mainly apply in their daily practice coincide mostly with intrapersonal models, to a lesser extent with interpersonal models and rarely with community models. Professionals focus on empowering the patient by increasing the perception of risk and the benefits of changing behaviours and guiding them in the implementation of healthy habits and attitudes. Study 4: The complex IMA intervention is multicomponent and multidisciplinary. It is based on shared and informed decisions making and focused on pharmacological treatments related to cardiovascular disease and diabetes in primary care. The fixed elements include the intervention of the primary care physician and an informative support related to the disease and the prescribed medication. The flexible elements are the support of the primary care nursing staff and the community pharmacist. In addition, it has a web support that provides proven information in all phases of the IMA intervention. CONCLUSIONS: The Theoretical Model of Medication Initiation explains that the decision not to start a pharmacological treatment is influenced by multiple factors. Facing a new prescription, the patient makes a benefit-risk assessment affected by the perception he has about the pathology and medication. In turn, this perception is conditioned by intrapersonal and interpersonal factors and external factors. Health professionals should explore patients' beliefs about the benefits and risks to help them make informed decisions and promote shared decision making. General practitioners should ensure that patients understand the benefits and risks of disease and treatment, while explaining all alternative treatments, encouraging patients to ask questions and support their treatment decisions. A specific complex IMA intervention for cardiovascular pathology and diabetes has been designed to minimize the negative impact of non-initiation of these drugs on people's long-term health

El problema de la no-iniciació de tractament farmacològic prescrit a l'atenció primària

Tractament farmacològic prescrit; Prescripció de medicaments; Atenció primària;Prescribed pharmacological treatment; Prescription drugs; Primary care;Tratamiento farmacológico prescrito; Prescripción de medicamentos; Atención primaria;La no iniciació es defineix com el rebuig a començar un tractament farmacològic prescrit per primera vegada a un pacient. La no iniciació podria empitjorar el quadre clínic i afectar la qualitat de vida dels pacients, i també augmentar la despesa sanitària, donat que augmenta la probabilitat de fer una baixa laboral i la durada de la mateixa