Barriers and Unmet Educational Needs Regarding Implementation of Medication Adherence Management Across Europe: Insights from COST Action ENABLE.

BACKGROUND: Medication adherence is essential for the achievement of therapeutic goals. Yet, the World Health Organization estimates that 50% of patients are nonadherent to medication and this has been associated with 125 billion euros and 200,000 deaths in Europe annually. OBJECTIVE: This study aimed to unravel barriers and unmet training needs regarding medication adherence management across Europe. DESIGN: A cross-sectional study was conducted through an online survey. The final survey contained 19 close-ended questions. PARTICIPANTS: The survey content was informed by 140 global medication adherence experts from clinical, academic, governmental, and patient associations. The final survey targeted healthcare professionals (HCPs) across 39 European countries. MAIN MEASURES: Our measures were barriers and unmet training needs for the management of medication adherence across Europe. KEY RESULTS: In total, 2875 HCPs (pharmacists, 40%; physicians, 37%; nurses, 17%) from 37 countries participated. The largest barriers to adequate medication adherence management were lack of patient awareness (66%), lack of HCP time (44%), lack of electronic solutions (e.g., access to integrated databases and uniformity of data available) (42%), and lack of collaboration and communication between HCPs (41%). Almost all HCPs pointed out the need for educational training on medication adherence management. CONCLUSIONS: These findings highlight the importance of addressing medication adherence barriers at different levels, from patient awareness to health system technology and to fostering collaboration between HCPs. To optimize patient and economic outcomes from prescribed medication, prerequisites include adequate HCP training as well as further development of digital solutions and shared health data infrastructures across Europe.

Validation of an Inhaled Therapy Beliefs Questionnaire in Patients with Chronic Obstructive Pulmonary Disease.

Background: To carry out a validation questionnaire that assesses beliefs about inhaled treatments in patients with chronic obstructive pulmonary disease (COPD), as knowing patients' beliefs could help to improve medication adherence and health outcomes. Methods: We evaluated data from 260 COPD patients from electronic medical record databases from five primary healthcare centers, in a descriptive, cross-sectional study with a sample size calculated for a 10-item questionnaire, with an estimated Cronbach's alpha of 0.70 and a 95% confidence level. Study participants were selected via systematic random sampling. Variables: Ten-item Inhaled Therapy Beliefs Questionnaire, CCTI-Questionnaire v.2.0, time for completion, age, sex, educational level, spirometry severity (GOLD criteria), exacerbations (previous year), characteristics of inhaled treatment, and smoking habit. A two-year follow-up in a subsample of 77 patients from one health center was utilized. The Morisky-Green test, pharmacy dispensing data, test-retest (kappa coefficient), and an exploratory analysis of the adherence-belief relationship (ji-squared) were measured. Results: The 10-item questionnaire showed good viability (3 min completion time) when performed face-to-face or telephonically; its psychometric properties were acceptable, with an internal consistency (Cronbach's alpha) score of 0.613. Three factors explained 47.58% of the total variance (p < 0.0001): use (factor 1), effects (factor 2), and objectives (factor 3) of inhalers. The two-year follow-up ultimately considered 58 out of the 77 patients (10 deceased, 4 unlocated, 2 mistakes, 2 no inhaled treatment, and 1 withdrawal). Non-adherence was 48.3% in terms of the Morisky-Green test; 31% in terms of pharmacy dispensing data; and 40.4% considering both methods. There was low test-retest reliability, indicated by items 4, 8, and 9 of the CCTI-Questionnaire (Kappa = 0.4, 0.26, and 0.34; p-value < 0.0001, 0.008, and 0.001, respectively). There was mild correlation between beliefs and adherence. Conclusions: The ten-item CCTI-Questionnaire v.2.0 demonstrated acceptable psychometric properties regarding feasibility, reliability, and content validity.

Effectiveness of an educational intervention about inhalation technique in healthcare professionals in primary care: a cluster randomized trial.

Background: Incorrect inhalation technique (IT) is an important issue for chronic obstructive pulmonary disease (COPD) patients and healthcare professionals. Studies in which counseling is carried out with healthcare professionals beforehand so that they can properly educate their patients are required. The objective of the present trial is to assess the improvement in the performance of the IT in subjects with COPD and prescribed inhaled therapy after the implementation of an educational intervention conducted by their general practitioners. Methods: A cluster randomized clinical trial was conducted. A total of 286 COPD patients received scheduled inhalation therapy from 27 general practices in seven primary care centers. A teach-back educational intervention was implemented for both healthcare professionals and patients. The primary outcome of this study was the performance of the correct inhalation technique. It is considered a good technique if all steps in the inhalation data sheet are correctly performed. The secondary outcomes were assessed using forced spirometry, the basal dyspnea index, the Medical Research Council dyspnea scale, St George's Respiratory Questionnaire (SGRQ), and EuroQoL5D-5L for health-related quality of life. A one-year follow-up was conducted using an intention-to-treat analysis. Results: After the intervention, incorrect IT was observed in 92% of professionals and patients, with rates reaching 50% and 69.2%, respectively. The effectiveness in patients was significant, with a number needed to treat of 2.14 (95% CI 1.79-2.66). Factors related to correct IT in patients included the type of intervention, length of intervention (>25 min), good pulmonary function, age (youngest <=65, oldest >83), and less limitation of activity due to dyspnea. There was no relation with the cluster. Conclusion: This study shows the effectiveness of direct inhaler technique training provided by a trained professional on an appropriate timescale (for example, a specific consultation for medication reviews), aiming to help subjects improve their performance using the teach-back method. This could be an encouraging intervention to improve medication adherence and health promotion in people with COPD. Clinical Trial Registration: clinicaltrials.gov, identifier ISRCTN93725230.

Reimbursed medication adherence enhancing interventions in 12 european countries: Current state of the art and future challenges.

Background: Medication non-adherence jeopardises the effectiveness of chronic therapies and negatively affects financial sustainability of healthcare systems. Available medication adherence-enhancing interventions (MAEIs) are utilised infrequently, and even more rarely reimbursed. The aim of this paper was to review reimbursed MAEIs across selected European countries. Methods: Data on reimbursed MAEIs were collected from European countries at the ENABLE Cost Action expert meeting in September 2021. The identified MAEIs were analysed and clustered according to their characteristics, direct vs. indirect relation to adherence, and the targeted adherence phase. Results: Out of 12 contributing countries, 10 reported reimbursed MAEIs, 28 in total, of which 20 were identified as MAEIs targeting adherence directly. Reimbursed MAEIs were most often performed by either doctors (n = 6), nurses (n = 6), or pharmacists (n = 3). The most common types of MAEIs were education (n = 6), medication regimen management (n = 5), and adherence monitoring feedback (n = 4). Only seven reimbursed MAEIs were technology-mediated, whereas 11 addressed two interlinked phases of medication adherence, i.e., implementation and persistence. Conclusion: Our review highlights the scarcity of reimbursed MAEIs across the selected European countries, and calls for their more frequent use and reimbursement.

Sex differences in social support perceived by polymedicated older adults with multimorbidity. MULTIPAP study.

The beneficial effects of social support on morbidity, mortality, and quality of life are well known. Using the baseline data of the MULTIPAP study (n = 593), an observational, descriptive, cross-sectional study was carried out that analyzed the sex differences in the social support perceived by polymedicated adults aged 65 to 74 years with multimorbidity. The main outcome variable was social support measured through the Duke-UNC-11 Functional Social Support (DUFSS) questionnaire in its two dimensions (confident support and affective support). For both sexes, the perception of functional social support was correlated with being married or partnered and having a higher health-related quality of life utility index. In women, it was correlated with a higher level of education, living alone, and treatment adherence, and in men with higher monthly income, prescribed drugs and fewer diagnosed diseases.

Effectiveness of the MULTIPAP Plus intervention in youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care: study protocol of a cluster randomized trial.

BACKGROUND: The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process. OBJECTIVE: To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care. METHODS/DESIGN: This is a pragmatic cluster-randomized clinical trial with a follow-up of 18 months in health centres of the Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient. POPULATION: Patients aged 65-74 years with multimorbidity (≥ 3 chronic diseases) and polypharmacy (≥ 5 drugs) during the previous 3 months were included. SAMPLE SIZE: n = 1148 patients (574 per study arm). INTERVENTION: Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system. OUTCOMES: The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables. STATISTICAL ANALYSIS: The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle. DISCUSSION: It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT-enhanced routine clinical practice could improve the prescription process in patient care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04147130 . Registered on 22 October 2019.

How to Improve Healthcare for Patients with Multimorbidity and Polypharmacy in Primary Care: A Pragmatic Cluster-Randomized Clinical Trial of the MULTIPAP Intervention.

(1) Purpose: To investigate a complex MULTIPAP intervention that implements the Ariadne principles in a primary care population of young-elderly patients with multimorbidity and polypharmacy and to evaluate its effectiveness for improving the appropriateness of prescriptions. (2) Methods: A pragmatic cluster-randomized clinical trial was conducted involving 38 family practices in Spain. Patients aged 65-74 years with multimorbidity and polypharmacy were recruited. Family physicians (FPs) were randomly allocated to continue usual care or to provide the MULTIPAP intervention based on the Ariadne principles with two components: FP training (eMULTIPAP) and FP patient interviews. The primary outcome was the appropriateness of prescribing, measured as the between-group difference in the mean Medication Appropriateness Index (MAI) score change from the baseline to the 6-month follow-up. The secondary outcomes were quality of life (EQ-5D-5 L), patient perceptions of shared decision making (collaboRATE), use of health services, treatment adherence, and incidence of drug adverse events (all at 1 year), using multi-level regression models, with FP as a random effect. (3) Results: We recruited 117 FPs and 593 of their patients. In the intention-to-treat analysis, the between-group difference for the mean MAI score change after a 6-month follow-up was -2.42 (95% CI from -4.27 to -0.59) and, between baseline and a 12-month follow-up was -3.40 (95% CI from -5.45 to -1.34). There were no significant differences in any other secondary outcomes. (4) Conclusions: The MULTIPAP intervention improved medication appropriateness sustainably over the follow-up time. The small magnitude of the effect, however, advises caution in the interpretation of the results given the paucity of evidence for the clinical benefit of the observed change in the MAI. Trial registration: Clinicaltrials.gov NCT02866799.

Relevancia clínica de la técnica de utilización de inhaladores en pacientes con enfermedad pulmonar obstructiva crónica / The clinical relevance of inhalation technique in chronic obstructive pulmonary disease patients

Introducción:Numerosos estudios muestran que los pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC) realizan una técnica de inhalación (TI) incorrecta. Nuestra investigación pretende describir los errores cometidos y la Importancia Clínica de dichos Fallos (ICF), e identificar los factores relacionados con ello.Pacientes y métodos:Estudio descriptivo transversal de 995 pacientes seguidos en 20 Centros de Salud de Andalucía. Se recogieron variables sociodemográficas, calidad de vida, estado mental-cognitivo, espirometría, gravedad, número de dispositivos, realización correcta de la TI, instrucción previa e ICF.Resultados:906 pacientes (91,1%) realizaban una TI incorrecta. Los errores más frecuentes presentaban ICF2-moderada y se relacionaron con nivel cognitivo bajo, pico flujo inhalatorio bajo y menos visitas al neumólogo. Los errores críticos-ICF3 mostraron relación con mayor gravedad, uso de Turbuhaler® y peor calidad de vida.Discusión:Altísima tasa de técnica incorrecta cuyos errores más frecuentes comprometen de forma moderada la eficacia del fármaco, se relacionan con el modo de realizar la TI y no con la dificultad en el manejo del dispositivo. Esto muestra la importancia de entrenar correctamente a nuestros pacientes. (AU)

Introduction:Numerous studies show that patients with chronic obstructive pulmonary disease (COPD) perform an incorrect inhalation technique (IT). This research aims to describe inhalation errors committed and their clinical importance, and to identify factors related to them.Patients and methods:A total of 995 patients were recruited in this cross-sectional, descriptive study that was conducted across 20 Andalusian Health Care Centres. The following variables were collected: socio-demographic data, quality of life, mental and cognitive status, spirometry tests, severity, number of IT devices, IT correct performance, previous instruction and clinical importance of errors.Results:Of the 995 patients, 906 (91,1%) performed an incorrect IT. The most common errors showed moderate errors, which were related to low-cognitive level, low-peak expiratory flow and fewer medical consultations with the pulmonologist. Critical errors were correlated with greater severity, usage of Turbuhaler® and worse quality of life.Discussion:Soaring incorrect technique rate, whose most common errors sparingly compromise the drug effectiveness. These errors are related to the way the patients perform the IT, and not to the difficulty in handling the device. This information demonstrates the relevance of training patients in a proper way. (AU)

[The clinical relevance of inhalation technique in chronic obstructive pulmonary disease patients]. / Relevancia clínica de la técnica de utilización de inhaladores en pacientes con enfermedad pulmonar obstructiva crónica.

INTRODUCTION: Numerous studies show that patients with chronic obstructive pulmonary disease (COPD) perform an incorrect inhalation technique (IT). This research aims to describe inhalation errors committed and their clinical importance, and to identify factors related to them. PATIENTS AND METHODS: A total of 995 patients were recruited in this cross-sectional, descriptive study that was conducted across 20 Andalusian Health Care Centres. The following variables were collected: socio-demographic data, quality of life, mental and cognitive status, spirometry tests, severity, number of IT devices, IT correct performance, previous instruction and clinical importance of errors. RESULTS: Of the 995 patients, 906 (91,1%) performed an incorrect IT. The most common errors showed moderate errors, which were related to low-cognitive level, low-peak expiratory flow and fewer medical consultations with the pulmonologist. Critical errors were correlated with greater severity, usage of Turbuhaler® and worse quality of life. DISCUSSION: Soaring incorrect technique rate, whose most common errors sparingly compromise the drug effectiveness. These errors are related to the way the patients perform the IT, and not to the difficulty in handling the device. This information demonstrates the relevance of training patients in a proper way.

Identification of the multimorbidity training needs of primary care professionals: Protocol of a survey.

Current epidemiological situation has prompted the consideration of multimorbility (MM) as a prevalent condition, influenced by age, educational level and social support, related to unfavorable social and health determinants. Primary Care (PC) has a key role in its approach but further training of professionals in MM is required. The evidence on the effectiveness of training interventions in MM is still limited. Knowing the experiences, opinions and training needs of professionals is essential to enhance training interventions. OBJECTIVES: Identify perceived training needs by PC health professionals (doctors and nurses) in MM and polypharmacy. METHODS: Design: Cross-sectional study based on an online survey (anonymous-ad hoc questionnaire). Participants and recruitment: 384 doctors and nurses working in healthcare centers and out-of-hospital emergencies of the Spanish National Health System. Non-probabilistic convenience sampling via email addressed to Health Institutions, and social networks. DATA: Demographic characteristics and professional profile data (close-ended and multiple-choice questions) will be collected. Open-ended questions will be used to identify training needs, difficulties and resources about MM; required skills to care patients with MM will be assessed using a 4-item ordinal scale. ANALYSIS: Coding of data prior to analysis. Descriptive statistical analysis, participation and completion rates of the questionnaire and estimation of absolute and relative frequencies and 95% confidence intervals in close-ended questions. Content analysis with inductive methodology in open-ended questions. Ethics: Ethical approval, Online informed consent. CONCLUSIONS: The identification of training needs of health professionals who care for patients with MM will be necessary data for developing highly effective training activities.

[Validation into Spanish of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire to assess patients' attitudes towards deprescribing. Research protocol]. / Validación al castellano del cuestionario revised Patients' Attitudes Towards Deprescribing (rPATD) para evaluar las actitudes de los pacientes hacia la deprescripción. Protocolo de investigación.

INTRODUCTION AND OBJECTIVE: Polypharmacy has become a priority public health problem in developed countries. In response to its approach, deprescription stands out. Its success will depend largely on the attitudes and beliefs of patients towards the number of drugs they are taking and their willingness to initiate a process of deprescription. To explore these factors, researchers have developed the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire, originally in English. The objective of this study is the validation into Spanish of rPATD questionnaire, both older adults and caregivers versions. MATERIAL AND METHODS: A first qualitative validation phase and a second phase of analysis of its psychometric characteristics will be carried out through an observational descriptive study of validation of a measurement instrument. One hundred and twenty subjects (polymedicated older adults and caregivers) from three health centers will be selected by consecutive sampling. The questionnaire will be provided and clinical and sociodemographic data will be collected. Feasibility, reliability (through internal consistency and intraobserver reliability) and validity (apparent, construct and criterion) of the questionnaire will be evaluated. EXPECTED RESULTS: It is expected to obtain a questionnaire that will serve as a tool for the clinician to identify patients with a favorable predisposition to deprescription and that will allow to contribute the patient's perspective to this process. CONCLUSION: The use of the rPATD questionnaire, alone or integrated into other more complex interventions, may lead to an improvement in the quality of care for the polymedicated patients.

Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course.

Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.

Potentially inappropriate prescriptions according to explicit and implicit criteria in patients with multimorbidity and polypharmacy. MULTIPAP: A cross-sectional study.

BACKGROUND: Multimorbidity is a global health challenge that is associated with polypharmacy, increasing the risk of potentially inappropriate prescribing (PIP). There are tools to improve prescription, such as implicit and explicit criteria. OBJECTIVE: To estimate the prevalence of PIP in a population aged 65 to 74 years with multimorbidity and polypharmacy, according to American Geriatrics Society Beers Criteria® (2015, 2019), the Screening Tool of Older Person's Prescription -STOPP- criteria (2008, 2014), and the Medication Appropriateness Index -MAI- criteria in primary care. METHODS: This was an observational, descriptive, cross-sectional study. The sample included 593 community-dwelling elderly aged 65 to 74 years, with multimorbidity and polypharmacy, who participated in the MULTIPAP trial. Socio-demographic, clinical, professional, and pharmacological-treatment variables were recorded. Potentially inappropriate prescribing was detected by computerized prescription assistance system, and family doctors evaluated the MAI. The MAI-associated factors were analysed using a logistic regression model. RESULTS: A total of 4,386 prescriptions were evaluated. The mean number of drugs was 7.4 (2.4 SD). A total of 94.1% of the patients in the study had at least one criterion for drug inappropriateness according to the MAI. Potentially inappropriate prescribing was detected in 57.7%, 43.6%, 68.8% and 71% of 50 patients according to the explicit criteria STOPP 2014, STOPP 2008, Beers 2019 and Beers 2015 respectively. For every new drug taken by a patient, the MAI score increased by 2.41 (95% CI 1.46; 3.35) points. Diabetes, ischaemic heart disease and asthma were independently associated with lower summated MAI scores. CONCLUSIONS: The prevalence of potentially inappropriate prescribing detected in the sample was high and in agreement with previous literature for populations with multimorbidity and polypharmacy. The MAI criteria detected greater inappropriateness than did the explicit criteria, but their application was more complex and difficult to automate.

Social support, social context and nonadherence to treatment in young senior patients with multimorbidity and polypharmacy followed-up in primary care. MULTIPAP Study.

OBJECTIVE: To estimate the prevalence of nonadherence to treatment and its relationship with social support and social context in patients with multimorbidity and polypharmacy followed-up in primary care. METHODS: This was an observational, descriptive, cross-sectional, multicenter study with an analytical approach. A total of 593 patients between 65-74 years of age with multimorbidity (≥3 diseases) and polypharmacy (≥5 drugs) during the last three months and agreed to participate in the MULTIPAP Study. The main variable was adherence (Morisky-Green). The predictors were social support (structural support and functional support (DUFSS)); sociodemographic variables; indicators of urban objective vulnerability; health-related quality of life (EQ-5D-5L-VAS & QALY); and clinical variables. Descriptive, bivariate and multivariate analyses with logistic regression models and robust estimators were performed. RESULTS: Four out of ten patients were nonadherent, 47% had not completed primary education, 28.7% had an income ≤1050 €/month, 35% reported four or more IUVs, and the average perceived health-related quality of life (HRQOL) EQ-5D-5L-VAS was 65.5. The items that measure functional support, with significantly different means between nonadherent and adherent patients were receiving love and affection (-0.23; 95%CI: -0.40;-0.06), help when ill (-0.25; 95%CI: -0.42;-0.08), useful advice (-0.20; 95%CI: -0.37;-0.02), social invitations (-0.22; 95%CI:-0.44;-0.01), and recognition (-0.29; 95%CI:-0.50;-0.08). Factors associated with nonadherence were belonging to the medium vs. low tertile of functional support (0.62; 95%CI: 0.42;0.94), reporting less than four IUVs (0.69; 95%CI: 0.46;1.02) and higher HRQOL perception (0.98; 95%CI: 0.98;0.99). CONCLUSIONS: Among patients 65-74 years of age with multimorbidity and polypharmacy, lower functional support was related to nonadherence to treatment. The nonadherence decreased in those patients with higher functional support, lower urban vulnerability and higher perceived health status according to the visual analog scale of health-related quality of life.

MULTIPAP Study: Improving healthcare for patients with multimorbidity.

BACKGROUND: The steady rise in multimorbidity entails serious consequences for our populations, challenges healthcare systems, and calls for specific clinical approaches of proven effectiveness. The MULTIPAP Study comprises three sequential projects (MULTIPAP and MULTIPAP Plus RCTs, and the MULTIPAP Cohort). Results of MULTIPAP RCT are presented. AIM: To evaluate the effectiveness of a complex, patient-centred intervention in young-old patients with multimorbidity and polypharmacy. METHOD: Pragmatic cluster-randomised clinical trial in a primary healthcare setting. GPs were randomly allocated to either conventional care or the MULTIPAP intervention based on the Ariadne Principles with two components: GPs e-training (that is, eMULTIPAP addresses specific, key concepts on multimorbidity, polypharmacy and shared decision-making) and GP-patient-centred interview. Young-old patients aged 65-74 years with multimorbidity and polypharmacy were included. MAIN OUTCOME: difference in the Medication Appropriateness Index (MAI) after 6-month follow-up between groups. SECONDARY OUTCOMES: MAI, quality of life, patient perception, health services use, treatment adherence and cost-effectiveness after 12-month follow-up. RESULTS: 117 GPs from 38 Spanish primary health care recruited 593 patients randomly assigned to the intervention/control groups. Difference in MAI scores between groups in the intention-to-treat analysis after 6 months' follow-up: -2.42 (-4.27 to -0.59), P = 0.009 (adjusted difference in mean MAI score -1.81(-3.35 to -0.27), P = 0.021). SECONDARY OUTCOMES: not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (-1.39 to 7.28), P = 0.183, EQ-5D-5L (index) -0.006(-0.034 to 0.022), P = 0.689). CONCLUSION: The intervention significantly improved medication appropriateness. The observed quality of life improvement was not significant. GPs e-training in multimorbidity has shown to be feasible and well accepted by the professionals. Future studies may test whether this format facilitates implementation.

A Methodological Approach for Implementing an Integrated Multimorbidity Care Model: Results from the Pre-Implementation Stage of Joint Action CHRODIS-PLUS.

Patients with multimorbidity (defined as the co-occurrence of multiple chronic diseases) frequently experience fragmented care, which increases the risk of negative outcomes. A recently proposed Integrated Multimorbidity Care Model aims to overcome many issues related to fragmented care. In the context of Joint Action CHRODIS-PLUS, an implementation methodology was developed for the care model, which is being piloted in five sites. We aim to (1) explain the methodology used to implement the care model and (2) describe how the pilot sites have adapted and applied the proposed methodology. The model is being implemented in Spain (Andalusia and Aragon), Lithuania (Vilnius and Kaunas), and Italy (Rome). Local implementation working groups at each site adapted the model to local needs, goals, and resources using the same methodological steps: (1) Scope analysis; (2) situation analysis-"strengths, weaknesses, opportunities, threats" (SWOT) analysis; (3) development and improvement of implementation methodology; and (4) final development of an action plan. This common implementation strategy shows how care models can be adapted according to local and regional specificities. Analysis of the common key outcome indicators at the post-implementation phase will help to demonstrate the clinical effectiveness, as well as highlight any difficulties in adapting a common Integrated Multimorbidity Care Model in different countries and clinical settings.

Multimorbilidad en medicina de familia y los principios Ariadne. Un enfoque centrado en la persona / Multimorbidity in general practice and the Ariadne principles. A person-centred approach

La multimorbilidad, definida como la presencia de dos o más enfermedades crónicas en un mismo individuo, conlleva consecuencias negativas para la persona e importantes retos para los sistemas sanitarios. En atención primaria, donde recae esencialmente la atención de este grupo de pacientes, la consulta es más compleja que la de un paciente con una única enfermedad debido, entre otros, al hecho de tener que manejar mayor cantidad de información clínica, disponer de poca evidencia científica para abordar la multimorbilidad, y tener que coordinar la labor de múltiples profesionales para garantizar la continuidad asistencial. Además, para poder implementar correctamente los planes de tratamiento en estos pacientes es necesario un proceso de toma de decisiones compartida médico-paciente. Entre las distintas herramientas disponibles para apoyar dicho proceso, recientemente se ha desarrollado una dirigida específicamente a pacientes con multimorbilidad en atención primaria y que se describe en el presente artículo: los principios Ariadne

Multimorbidity, defined as the coexistence of two or more chronic conditions in one same individual, has negative consequences for people suffering from it and it poses a real challenge for health systems. In primary care, where most of these patients are attended, the clinical management of multimorbidity can be a complex task due, among others, to the high volume of clinical information that needs to be handled, the scarce scientific evidence available to approach multimorbidity, and the need for coordination among multiple health providers to guarantee continuity of care. Moreover, the adequate implementation of the care plan in these patients requires a process of shared decision making between patient and physician. One of the available tools to support this process, which is specifically directed to patients with multimorbidity in primary care, is described in the present article: the Ariadne principles

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

BACKGROUND: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care. METHODS/DESIGN: Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. SCOPE: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). POPULATION: patients aged 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months). SAMPLE SIZE: n = 400 (200 per study arm). INTERVENTION: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. OUTCOMES: MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables. STATISTICAL ANALYSIS: primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle. DISCUSSION: It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02866799.

[Multimorbidity in general practice and the Ariadne principles. A person-centred approach]. / Multimorbilidad en medicina de familia y los principios Ariadne. Un enfoque centrado en la persona.

Multimorbidity, defined as the coexistence of two or more chronic conditions in one same individual, has negative consequences for people suffering from it and it poses a real challenge for health systems. In primary care, where most of these patients are attended, the clinical management of multimorbidity can be a complex task due, among others, to the high volume of clinical information that needs to be handled, the scarce scientific evidence available to approach multimorbidity, and the need for coordination among multiple health providers to guarantee continuity of care. Moreover, the adequate implementation of the care plan in these patients requires a process of shared decision making between patient and physician. One of the available tools to support this process, which is specifically directed to patients with multimorbidity in primary care, is described in the present article: the Ariadne principles.

Efficacy of an educational intervention in primary health care in inhalation techniques: study protocol for a pragmatic cluster randomised controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) accounts for 10-12 % of primary care consultations, 7 % of hospital admissions and 35 % of chronic incapacity related to productivity. The misuse of inhalers is a significant problem in COPD because it is associated with reduced therapeutic drug effects leading to lack of control of both symptoms and disease. Despite all advice, health care professionals' practice management of inhalation treatments is usually deficient. Interventions to improve inhaler technique by health care professionals are limited, especially among primary care professionals, who provide the most care to patients with COPD. The aim of this study is to evaluate the efficacy of an educational intervention to train general practitioners (GPs) in the right inhalation technique for the most commonly used inhalers. METHODS/DESIGN: We are conducting a pragmatic cluster randomised controlled trial. The sample population is composed of 267 patients diagnosed with COPD using inhalation therapy selected from among those in 20 general practices, divided into two groups (control and intervention) by block randomisation at 8 primary care centres. The sample has two levels. The first level is patients with COPD who agree to participate in the trial and receive the educational intervention from their GPs. The second level is GPs who are primary health care professionals and receive the educational intervention. The intervention is one session of the educational intervention with a monitor given to GPs for training in the right inhalation technique. The primary outcome is correct inhalation technique in patients. Secondary outcomes are functional status (spirometry) and quality of life. The follow-up period will be 1 year. GPs will have two visits (baseline and at the 1-year follow-up visit. Patients will have four visits (at baseline and 3, 6 and 12 months). Analysis will be done on an intention-to-treat basis. DISCUSSION: We carried out three previous clinical trials in patients with COPD, which showed the efficacy of an educational intervention based on monitor training to improve the inhalation technique in patients. This intervention is suitable and feasible in the context of clinical practice. Now we are seeking to know if we can improve it when the monitor is the GP (the real care provider in daily practise). TRIAL REGISTRATION: ISRCTN Registry identifier ISRCTN93725230 . Registered on 18 August 2014.