Mobile health to improve adherence and patient experience in heart transplantation recipients : The mheart trial

Altres ajuts: Amgen SL, General Pharmaceutical Council of Barcelona i Astellas Pharma USBackground:Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients' experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients' experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed

A Mobile App (mHeart) to Detect Medication Nonadherence in the Heart Transplant Population : Validation Study

Medication nonadherence in heart transplant recipients (HTxR) is related to graft loss and death. mHeart is a mobile app that uses electronic patient-reported outcome measures (ePROMs) to identify and manage medication nonadherence in the outpatient heart transplant (HTx) population. The study primarily aimed to validate mHeart to measure medication nonadherence in early stage HTxR by assessing the psychometric properties of ePROMs. The secondary aims were to (1) measure patient satisfaction with the mHeart tool and its usability and (2) explore the impact of a theory-based treatment on medication nonadherence rates to determine its scalability to larger research. A prospective study was conducted in the outpatient clinic of a tertiary hospital. All consecutive early stage HTxR (0.7, P <.001). Reproducibility was moderate (Haynes-Sackett κ=0.6, P <.002) or poor (Morisky-Green-Levine κ=0.3, P =.11) because of unexpected improved medication adherence rates during the test-retest period. According to responsiveness, the theory-based multifaceted intervention program improved medication nonadherence by 16% to 26% (P <.05). A burden analysis showed that ePROMs could potentially overcome traditional on-site limitations (eg, automatic recording of ePROM responses in the hospital information system). The mean score for overall patient satisfaction with the mHeart approach was 9 (SD 2; score range: 0-10). All 100% (29/29) of patients surveyed reported that they would recommend the mHeart platform to other HTxR. ePROMs adhered to the quality standards and successfully identified medication nonadherence in the HTx population, supporting their widespread use. The theory-based intervention program showed a promising improvement in medication adherence rates and produced excellent patient satisfaction and usability scores in HTxR

Improvement in clinical practice using mHealth technology

La multimorbiditat i complexitat terapèutica poden comprometre els resultats en salut en poblacions cròniques d'elevada complexitat. Baixes xifres d'adherència terapèutica podrien estar relacionades amb aquesta complexitat, i resulten ser una causa directa de pèrdua de l'empelt i mort després d'un trasplantament cardíac. Les creences negatives del pacient versus la seva pauta terapèutica poden estar al seu torn afectant l'experiència del pacient i a l'adherència a les recomanacions. Molt poc es sap sobre la magnitud real en el nostre entorn d'aquest problema, quins són els instruments per a mesurar-lo, així com quines són les estratègies més eficients per a reduir el seu impacte. Tenint en compte aquesta problemàtica, es van implementar 4 fases abreujades com l'estudi mHeart (The mHeart Study). Els objectius de cadascuna de les fases van donar lloc a aquesta tesi doctoral dividida en 4 sub-estudis consecutius. La primera de les fases va ser dirigida a mesurar quantitativament la complexitat terapèutica mitjançant un índex àmpliament validat en patologia crònica i descrit en la literatura, així com la mesura de la càrrega de morbiditat que suporten les persones trasplantades cardíaques en estadi crònic (>1.5 anys des del trasplantament). El nivell de complexitat mitjançant el total pMRCI-S va obtenir una mitjana de 42 (SD 11), molt superior al nivell publicat per a altres patologies cròniques. Els tractaments per a les comorbiditats van ser els principals causants de l&#8217;elevada complexitat terapèutica [OR=3.1 (2.8;3.4), P-valor<.001]. L'objectiu de la segona fase va ser implementar un innovador model amb l'objectiu de millorar la pràctica clínica dels pacients trasplantats cardíacs ambulatoris. Aquest nou model dibuixa una innovadora ruta assistencial, dissenyada amb un caràcter holístic i basada en teories per a promoure el canvi conductual. L'estudi descriu quins van ser els factors facilitadors per a implementar-lo i avalua les principals barreres, beneficis i predisposició dels usuaris de la tecnologia. La combinació de diferents habilitats dels farmacèutics clínics involucrats, van ser essencials. El programari mHeart es va desenvolupar com a suport a aquesta pràctica, consistint en una aplicació per al mòbil i una pàgina web. El 98% dels pacients entrevistats estaven disposats a usar mHeart. El tercer estudi va ser un estudi pilot per a validar l'estratègia mHeart (the mHeart strategy). Dissenyada com una intervenció clínica multinivell duta a terme per una farmacèutica clínica en el si d'un equip interdisciplinari amb el suport de la salut digital i mitjançant l'ús de tècniques del canvi conductual. L'estratègia mHeart va millorar significativament les xifres d'adherència terapèutica entre un 16% i 26% [P-valor0.7, P-valor<.001], i van superar les principals limitacions del mètode tradicional presencial. Sobre la base dels resultats obtinguts en les fases anteriors, es va dur a terme un assaig clínic aleatoritzat que va incloure a 180 pacients. L'estratègia mHeart va obtenir un impacte positiu en els resultats de salut preestablerts. La xifra de pacients adherents al tractament immunosupressor va millorar un 65% en el grup intervenció segons el qüestionari SMAQ [OR=2.3 (0.3;19.7), P-valor=.000]. A més, es va obtenir una millora en l'experiència del pacient amb la seva pauta terapèutica [P-valor<.05] i una reducció de la necessitat de seguiment presencial [OR=3.4 (1.7;6.9), P-valor=.001]. El programa assistencial mHeart és una alternativa viable per a proporcionar un seguiment individualitzat i anticipat a llarg termini dels pacients trasplantats cardíacs. Les implicacions futures d'aquesta tesi són un prometedor punt de partida per a l'establiment d'innovadores rutes assistencials per a poblacions d'elevada complexitat en el nostre entorn amb el suport de la Salut Digital.La multimorbilidad y complejidad terapéutica pueden comprometer los resultados en salud en poblaciones crónicas de elevada complejidad. Bajas cifras de adherencia terapéutica podrían estar relacionadas con dicha complejidad, y resultan ser una causa directa de pérdida del injerto y muerte tras un trasplante cardíaco. Las creencias negativas del paciente versus su pauta terapéutica pueden estar a su vez afectando a la experiencia del paciente y a la adherencia a las recomendaciones. Muy poco se sabe sobre la magnitud real en nuestro entorno de este problema, cuáles son los instrumentos para medirlo, así como cuáles son las estrategias más eficientes para reducir su impacto. En base a la problemática, se implementaron 4 fases abreviadas como el estudio mHeart (The mHeart Study). Los objetivos de cada una de las fases dieron lugar a esta tesis doctoral dividida en 4 sub-estudios consecutivos. La primera de las fases fue dirigida a medir cuantitativamente la complejidad terapéutica mediante un índice ampliamente validado en patología crónica y descrito en la literatura, así como la medida de la carga de morbilidad que soportan las personas trasplantadas cardíacas en estadio crónico (>1.5 años desde el trasplante). El nivel de complejidad mediante el total pMRCI-S obtuvo una media de 42 (SD 11), muy superior al nivel publicado para otras patologías crónicas. Los tratamientos para las comorbilidades se asociaron con una elevada complejidad terapéutica [OR=3.1 (2.8;3.4), P-valor<.001]. El objetivo de la segunda fase fue implementar un innovador modelo con el objetivo de mejorar la práctica clínica de los pacientes trasplantados cardíacos ambulatorios. Este nuevo modelo dibuja una innovadora ruta asistencial, diseñada con un carácter holístico y basada en teorías para promover el cambio conductual. El estudio describe cuáles fueron los factores facilitadores para implementarlo y evalúa las principales barreras, beneficios y predisposición de los usuarios de la tecnología. La combinación de diferentes habilidades de los farmacéuticos clínicos involucrados, fueron esenciales. El software mHeart se desarrolló como soporte a esta práctica, consistiendo en una aplicación para el móvil y una página web. El 98% de los pacientes entrevistados estaban dispuestos a usar mHeart. El tercer estudio fue un estudio piloto para validar la estrategia mHeart (the mHeart strategy). Diseñada como una intervención clínica multinivel llevada a cabo por una farmacéutica clínica en el seno de un equipo interdisciplinar con el soporte de la salud digital y mediante el empleo de técnicas del cambio conductual. La estrategia mHeart mejoró significativamente las cifras de adherencia terapéutica entre un 16% y 26% [P-valor0.7, P-valor<.001], y sobrellevaron las principales limitaciones del método tradicional presencial. En base a los resultados obtenidos, se llevó a cabo un ensayo clínico aleatorizado que incluyó a 180 pacientes. La estrategia mHeart obtuvo un impacto positivo en los resultados de salud preestablecidos. La cifra de pacientes adherentes al tratamiento inmunosupresor mejoró un 65% en el grupo intervención según el cuestionario SMAQ [OR=2.3 (0.3;19.7), P-valor=.000]. Además, se obtuvo una mejora en la experiencia del paciente con su pauta terapéutica [P-valor<.05] y una reducción de la necesidad de seguimiento presencial [OR=3.4 (1.7;6.9), P-valor=.001]. El programa asistencial mHeart es una alternativa viable para proporcionar un seguimiento individualizado y anticipado a largo plazo de los pacientes trasplantados cardíacos desde su domicilio. Las implicaciones futuras de la presente tesis son un prometedor punto de partida para el establecimiento de una innovadora vía para proveer asistencia de calidad a poblaciones de elevada complejidad en nuestro entorno con el soporte de la salud digital.Multimorbidity and therapeutic complexity are undermining health outcomes in chronic populations such as the outpatient heart transplant (HTx) recipients. Medication nonadherence may be a consequence of this complexity and is a direct cause of graft loss and death after HTx. Nevertheless, even these are recognized problems, little is known about how best to quantify this complexity or the strategies that could reduce its burden. Based on this background, four sequential phases were implemented and abbreviated as The mHeart Study. This thesis is the result of the specific goals of these phases, presented as consecutive studies. All of them were conducted in the outpatient setting of the Heart Transplant Unit of a tertiary university hospital. The first phase aimed to quantitatively measure therapeutic complexity by using a validated quantitative index in chronic-stage HTx recipients. Therapeutic complexity observed was the highest compared with those previously published in chronic diseases and was mainly influenced by a higher count of drugs to treat comorbidities. Based on the results obtained in the first study, strategies were urgently needed to reduce post-HTx complexity. Therefore, the second phase aimed to develop the mHeart software and to implement an eHealth behavioral-based intervention model to provide healthcare to complex populations in the outpatient setting. The study the model implemented, outlines the facilitators and barriers, and the willingness to use the model reported by potential users. The tool was seek to improve medication safety and efficacy, to enhance patient-providers interactions and to provide comprehensive clinical care. Clinical pharmacists&#8217; skills on patient engagement, motivational interviewing and managerial experience were essential to lead the implementation. The patients confirmed that 98% of them were willing to use the mHeart system. The third study came to validate the main clinical aim of the mHeart tool, which is to improve medication nonadherence in HTx recipients. With this aim in mind, the mHeart strategy designed consisted of an intensive follow-up program based on multilevel individually-tailored digital interventions aiming to change behavior by a pharmacist using the mHeart technology in an interdisciplinary environment. The mHeart electronic patient-reported outcome measures (ePROMs) met the existing quality standards, and the exploratory clinical intervention established showed a promising improvement of 30% in medication adherence rates. These results supported the mHeart mobile application widespread use in larger research and usual clinical practice. Based on above-mentioned stages, this thesis work went further including a randomized clinical trial. An alarming 36% of the recipients were non-adherent to immunosuppressive treatment at baseline according to the SMAQ test, and 41% of patients were unaware of the consequences of forgetting to take their antirejection medicines. Therefore, the main objective of this long-term study was to improve recipients&#8217; adherence to immunosuppressive medication, their experience of therapeutic regimens, and to optimize in-clinic healthcare delivery. The intervention consisted of a long-term mHeart strategy versus a traditional in-clinic follow-up by a multidisciplinary team. The mHeart strategy positively impacted on the health outcomes preestablished. At the end of the study, medication adherence rates were statistically significantly improved in the intervention group (85%) versus the control group (46%). Furthermore, the strategy had a positive impact on patients&#8217; experience of therapeutic regimens and showed statistically significant reductions in the number of patients needing to travel to the clinic for follow-up appointments. The implications of the thesis will be a promising starting point for an emerging way of providing further assistance to the most complex populations based on eHealth.Universitat Autònoma de Barcelona. Programa de Doctorat en Medicin

Does an eHealth Intervention Reduce Complications and Healthcare Resources? A mHeart Single-Center Randomized-Controlled Trial

(1) Background: In the mHeart trial, we showed that an eHealth intervention, mHeart, improved heart transplant (HTx) recipients&rsquo; adherence to immunosuppressive therapy compared with the standard of care. Herein, we present the analysis assessing whether mHeart reduces complication frequency and healthcare resource use, and whether this reduction depends on patients&rsquo; adherence. (2) Methods: The mHeart was a single-center randomized-controlled trial (IIBSP-MHE-2014-55) in 134 adult HTx recipients (n = 71 intervention; n = 63 controls). The endpoints were mortality, complications, and resource use during follow-up (mean 1.6 &plusmn; 0.6 years). (3) Results: A significantly lower proportion of HTx recipients in mHeart had echocardiographic alteration (2.8% vs. 13.8%; p = 0.02), cardiovascular events (0.35% vs. 2.4%; p = 0.006), infections (17.2% vs. 56%; p = 0.03), and uncontrolled Hba1c (40.8% vs. 59.6%; p = 0.03) than controls. In addition, a significantly lower proportion of patients in the intervention needed hospital (32.4% vs. 56.9%; p = 0.004) or urgent admissions (16.9% vs. 41.4%; p = 0.002) and emergency room visits (50.7% vs. 69.0%; p = 0.03). Adherence status (measured by the self-reported SMAQ) influenced only controls regarding hospitalizations and emergency room visits. Differences were not significant on deaths (intervention 4.2% vs. control 9.5%; p = 0.4) (4) Conclusions: the mHeart strategy significantly reduced the occurrence of the studied post-transplant complications and the need for medical attention in HTx recipients. Adherence status influenced controls in their need for medical care

Does an eHealth Intervention Reduce Complications and Healthcare Resources? A mHeart Single-Center Randomized-Controlled Trial

(1) Background: In the mHeart trial, we showed that an eHealth intervention, mHeart, improved heart transplant (HTx) recipients’ adherence to immunosuppressive therapy compared with the standard of care. Herein, we present the analysis assessing whether mHeart reduces complication frequency and healthcare resource use, and whether this reduction depends on patients’ adherence. (2) Methods: The mHeart was a single-center randomized-controlled trial (IIBSP-MHE-2014-55) in 134 adult HTx recipients (n = 71 intervention; n = 63 controls). The endpoints were mortality, complications, and resource use during follow-up (mean 1.6 ± 0.6 years). (3) Results: A significantly lower proportion of HTx recipients in mHeart had echocardiographic alteration (2.8% vs. 13.8%; p = 0.02), cardiovascular events (0.35% vs. 2.4%; p = 0.006), infections (17.2% vs. 56%; p = 0.03), and uncontrolled Hba1c (40.8% vs. 59.6%; p = 0.03) than controls. In addition, a significantly lower proportion of patients in the intervention needed hospital (32.4% vs. 56.9%; p = 0.004) or urgent admissions (16.9% vs. 41.4%; p = 0.002) and emergency room visits (50.7% vs. 69.0%; p = 0.03). Adherence status (measured by the self-reported SMAQ) influenced only controls regarding hospitalizations and emergency room visits. Differences were not significant on deaths (intervention 4.2% vs. control 9.5%; p = 0.4) (4) Conclusions: the mHeart strategy significantly reduced the occurrence of the studied post-transplant complications and the need for medical attention in HTx recipients. Adherence status influenced controls in their need for medical care

Dislipidemias y prevención del ictus: recomendaciones del Grupo de Estudio de Enfermedades Cerebrovasculares de la Sociedad Española de Neurología

Objective: We present an update of the Spanish Society of Neurology's recommendations for prevention of both primary and secondary stroke in patients with dyslipidaemia. Development: We performed a systematic review to evaluate the main aspects of the management of dyslipidaemias in primary and secondary stroke prevention and establish a series of recommendations. Conclusions: In primary prevention, the patient's vascular risk should be determined in order to define target values for low-density lipoprotein cholesterol. In secondary prevention after an atherothrombotic stroke, a target value <55 mg/dL is recommended; in non-atherothombotic ischaemic strokes, given the unclear relationship with dyslipidaemia, target value should be established according to the vascular risk group of each patient. In both primary and secondary prevention, statins are the drugs of first choice, and ezetimibe and/or PCSK9 inhibitors may be added in patients not achieving the target value.Objetivo: Actualizar las recomendaciones de la Sociedad Española de Neurología para la prevención del ictus, tanto primaria como secundaria en pacientes con dislipidemia. Desarrollo: Se ha realizado una revisión sistemática en Pubmed evaluando los principales aspectos relacionados con el manejo de las dislipidemias en la prevención primaria y secundaria del ictus, elaborándose una serie de recomendaciones relacionadas con los mismos. Conclusiones: En prevención primaria se recomienda determinar el riesgo vascular del paciente con el fin de definir los objetivos de LDLc. En prevención secundaria tras un ictus de origen aterotrombótico se recomienda un objetivo de LDLc < 55 mg/dl, mientras que en ictus isquémicos de origen no aterotrombótico dado que su relación con dislipidemias es incierta se establecerán los objetivos en base al grupo de riesgo vascular de cada paciente. Tanto en prevención primaria como secundaria las estatinas son los fármacos de primera elección, pudiendo asociarse ezetimiba y/o inhibidores de PCSK9 en aquellos casos que no alcancen los objetivos terapéuticos

Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial

Background: Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from previous studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesised that anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, would reduce the risk of recurrent ischaemic stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE ESUS trial. Methods: NAVIGATE ESUS was a double-blinded, randomised, phase 3 trial done at 459 centres in 31 countries that assessed the efficacy and safety of rivaroxaban versus aspirin for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined on the basis of transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE). The primary efficacy outcome was time to recurrent ischaemic stroke between treatment groups. The primary safety outcome was major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis. The primary analyses were based on the intention-to-treat population. Additionally, we did a systematic review and random-effects meta-analysis of studies in which patients with cryptogenic stroke and PFO were randomly assigned to receive anticoagulant or antiplatelet therapy. Findings: Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive rivaroxaban (n=3609) or aspirin (n=3604). Patients were followed up for a mean of 11 months because of early trial termination. PFO was reported as present in 534 (7·4%) patients on the basis of either TTE or TOE. Patients with PFO assigned to receive aspirin had a recurrent ischaemic stroke rate of 4·8 events per 100 person-years compared with 2·6 events per 100 person-years in those treated with rivaroxaban. Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22–1·36), and the risk was similar for those without known PFO (1·06; 0·84–1·33; pinteraction=0·18). The risks of major bleeding with rivaroxaban versus aspirin were similar in patients with PFO detected (HR 2·05; 95% CI 0·51–8·18) and in those without PFO detected (HR 2·82; 95% CI 1·69–4·70; pinteraction=0·68). The random-effects meta-analysis combined data from NAVIGATE ESUS with data from two previous trials (PICSS and CLOSE) and yielded a summary odds ratio of 0·48 (95% CI 0·24–0·96; p=0·04) for ischaemic stroke in favour of anticoagulation, without evidence of heterogeneity. Interpretation: Among patients with ESUS who have PFO, anticoagulation might reduce the risk of recurrent stroke by about half, although substantial imprecision remains. Dedicated trials of anticoagulation versus antiplatelet therapy or PFO closure, or both, are warranted. Funding: Bayer and Janssen