Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study.

The use of allogeneic stem cell transplantation (allo-SCT) for the treatment of hematologic diseases is steadily increasing; however, allo-SCT has the downside of causing considerable treatment-related morbidity and mortality. Mobile technology applied to healthcare (mHealth) has proven to be a cost-effective strategy to improve care and offer new services to people with multimorbidity, but there are little data on its usefulness in allo-SCT recipients. Here we describe a new integrated healthcare model facilitated by an mHealth platform, EMMASalud-MY-Medula, and to report the results of a feasibility and usability pilot study. The MY-Medula platform was developed in 4 phases. First, patient and healthcare professional needs were identified, and technological development and pretesting tests were conducted (phases 1 to 3, January 2016 to March 2021). Then a nonrandomized, prospective, observational, single-center pilot study was conducted (October 2021 to January 2022) at the adult SCT unit of a tertiary university hospital. Twenty-eight volunteer allo-SCT recipients were included in the pilot study, of whom one-half were outpatients in the first-year post-SCT and one-half were affected by steroid-dependent graft-versus-host disease (SR-GVHD). All patients used the MY-Medula app during the 2-month follow-up period, with a median number of visits to the app of 143 (range, 6 to 477). A total of 2067 self-monitoring records were created, and 205 text messages were received, most of them related to symptoms description (47%) and doubts about medication (21%). In 3.4% of the cases, drug dosage was adjusted by the pharmacist because of dosing errors or interactions. At the end of the study, a 6-question Likert-type questionnaire for patients and a 22-question test for healthcare professionals showed a high degree of satisfaction (95% and 100%, respectively) with the new healthcare pathway. Reengineering the follow-up of allo-SCT recipients into an integrated, multidisciplinary model of care facilitated by mHealth tools is feasible and has been associated with high usability and a high degree of satisfaction by patients and healthcare professionals. A randomized trial aiming to determine the cost-effectiveness of MY-Medula-based follow-up post-SCT is currently enrolling participants.

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.

Developing a mHealth intervention to redesign the current journey for people living with HIV: A qualitative study.

OBJECTIVE: People living with human immunodeficiency virus could particularly benefit from mobile health (mHealth). The objective of the study was to  contribute to the design and development of a new standard of care for people  living with human immunodeficiency virus and the mHealth app needed to  support it by 1) exploring the view of people living with human  immunodeficiency virus and healthcare professionals on the possibilities of  mHealth tools on HIV care, and 2) implementing their feedback into the new  app and into the new journey of people living with human immunodeficiency  virus. METHOD: The study was conducted in two different phases: phase one was to  apprise patients' and healthcare professionals' perspectives on mHealth using  the qualitative methodology of the focus groups, whereas phase two aimed to  implement their feedback into the application. RESULTS: A total of five people living with human immunodeficiency virus and  nine healthcare professionals (three clinical pharmacists, three nurses, two  physicians, and one pharmacy technician) participated in the focus groups. The  patients identified the following main aspects to be improved in the  current patients' journey: insufficient information (n = 5), lack of general  population disease awareness (n = 5), and medication dispensation model (n =  3). Moreover, healthcare professionals identified the next health outcomes  to be enhanced with mHealth tools: patients' quality of life (n = 7), control of  the disease (n = 5) and comorbidities (n = 3), and adherence to medication (n = 5). According to these needs, the new healthcare model was designed. The  mHealth was provided with different features, such as information about the  disease, health promotion and prevention, the possibility of two-way patient- healthcare professionals communication, or synchronization with other devices. The new human immunodeficiency virus care journey and the app are currently being tested in a group of people living with human immunodeficiency virus in real-world conditions in our hospital. CONCLUSIONS: Improving patients' quality of life, therapeutic adherence, or  disease control are key objectives for optimizing people living with human  immunodeficiency virus care. Our digital health tool and the new healthcare  model have been implemented based on end-users' feedback to achieve better  patients-healthcare professionals communication and patient engagement with their care.

OBJETIVO: Las personas que viven con el virus de la inmunodeficiencia humana podrían beneficiarse de nuevas estrategias de salud móvil (mSalud). El  objetivo del estudio fue contribuir al diseño y desarrollo de un nuevo modelo  asistencial en la población con virus de la inmunodeficiencia humana y de la  aplicación móvil necesaria para apoyarlo mediante: 1) la exploración de la  visión de personas que viven con el virus de la inmunodeficiencia humana y  profesionales sanitarios sobre las herramientas digitales en la atención a este  colectivo, y 2) la implementación de sus perspectivas en la nueva aplicación y  en la nueva ruta asistencial.Método: El estudio se realizó en dos fases: la primera tenía como objetivo conocer las perspectivas de los participantes sobre la salud móvil mediante la metodología cualitativa de los grupos focales, y la segunda implementar estas valoraciones en la aplicación. RESULTADOS: Participaron cinco pacientes y nueve profesionales sanitarios (tres farmacéuticos clínicos, tres enfermeras, dos médicas y una  técnico de farmacia). Los pacientes consideraron que debían mejorarse los siguientes aspectos en su ruta asistencial: información insuficiente (n = 5),  falta de conocimiento de la enfermedad (n = 5) y modelo de dispensación de la medicación (n = 3). Los profesionales identificaron que debían mejorarse: la  calidad de vida de los pacientes (n = 7), el control de su enfermedad (n = 5) y de sus comorbilidades (n = 3), y la adherencia terapéutica (n = 5). De acuerdo con estas necesidades, se diseñó el nuevo modelo asistencial. Las siguientes  características se incorporaron a la mHealth: información sobre la enfermedad,  promoción y prevención de la salud, posibilidad de comunicación  bidireccional profesional-paciente o sincronización con otros dispositivos. La  nueva ruta asistencial y la aplicación están siendo estudiadas en un grupo de  personas que viven con el virus de la inmunodeficiencia humana en  condiciones de vida real y en seguimiento en nuestro hospital. CONCLUSIONES: La mejora de la calidad de vida, la adherencia terapéutica y el  control de la enfermedad son factores clave para la optimización de la atención de las personas que viven con el virus de la inmunodeficiencia humana.  Nuestra herramienta de salud digital y el modelo asistencial han sido diseñados en base a la opinión de pacientes para mejorar la comunicación profesional- paciente sanitario y conseguir un mayor compromiso de los pacientes con su  cuidado.

Implementation of pharmaceutical care through Telepharmacy: A guide for professionals and patients.

OBJECTIVE: To provide a practical guide for the implementation and use of  Pharmaceutical Care through Telepharmacy by healthcare professionals and  patients in its different scopes of application. To establish a definition of  Telepharmacy and describe the technological tools necessary, advantages, and  keys to facilitating its implementation. METHOD: Between December 2020 and January 2021, the Board of Directors of the Spanish Society of Hospital Pharmacy, along with the coordinators of the  project "Outpatient Care Strategies" ("Mapa Estratégico para la Atención al  Paciente Externo") designed a strategy to foster the development and  expansion of Telepharmacy in Spain. This strategy involved four courses of  action. To develop the first course of action, a call was made in March 2021  among the Spanish Society of Hospital Pharmacy members to develop seven  methodological guidelines. The purpose of these documents was to meet the  needs for the implementation of Telepharmacy, the most relevant being the  development of specific guides for professionals and patients. The guides were  developed in four stages between May and October 2021, including a literature review; consensus-based interviews, online workshops, and, finally, the  drafting and validation of the final documents. Once the final draft was  prepared, a public evaluation of suggestions and observations was performed  for a month. The documents were also presented to the Patient Committee of  the Spanish Society of Hospital Pharmacy. RESULTS: The Guide for Professionals provides guidelines for the development and implementation of Telepharmacy in its different scopes of  application. These guides provide a description of specific goals, healthcare benefits, tools required, and keys to the implementation of  Telepharmacy. The Guide for Patients is complementary to face-to-face  pharmaceutical care from the point of view of the patient, with special  emphasis being placed on the most frequently used tools, the potential  benefits, and the keys to facilitating patients' understanding of the purpose  and use of Telepharmacy. CONCLUSIONS: A Practical Guide for Professionals and Patients was developed to ensure the standard development, implementation, and spread of Telepharmacy in all its scopes. This guide is intended to help Hospital Pharmacy professionals benefit from Telepharmacy as a  complementary tool to face-to-face pharmaceutical care.

OBJETIVO: Desarrollar una guía práctica sobre atención farmacéutica mediante  Telefarmacia para profesionales y pacientes, en cada uno de sus ámbitos de  aplicación. Definir en qué consiste, las herramientas utilizadas, los potenciales  beneficios y las claves para facilitar su comprensión.Método: Entre diciembre de 2020 y enero de 2021, la Junta directiva de la  Sociedad Española de Farmacia Hospitalaria, junto con coordinadores del  proyecto "Mapa Estratégico para la Atención al Paciente Externo", diseñaron  una estrategia para favorecer el desarrollo y expansión de la Telefarmacia en  España. Esta estrategia incluyó cuatro líneas de actuación. Para el desarrollo  de la primera, en marzo de 2021 se llevó a cabo una convocatoria dirigida a los socios de la Sociedad Española de Farmacia Hospitalaria con objeto de  desarrollar siete documentos de apoyo metodológico destinados a cubrir las  necesidades para la implantación de la Telefarmacia, entre las cuales se  consideraron como claves el desarrollo de una guía específica para  profesionales y otra para pacientes. Las guías se desarrollaron en cuatro fases  entre mayo y octubre de 2021: revisión de literatura, entrevistas de consenso,  desarrollo de improtalleres de trabajo online y debate y, por último,  laboración y validación de los documentos finales. Una vez elaborado el borrador  definitivo se llevó a cabo una valoración pública de sugerencias y alegaciones durante un mes, así como una presentación al comité de pacientes de la Sociedad Española de Farmacia Hospitalaria. RESULTADOS: La guía para profesionales se ha orientado para dar las pautas  para el desarrollo e implementación de programas de Telefarmacia en cada uno de sus ámbitos de aplicación. Está estructurada de forma que resalte los  objetivos concretos, los beneficios asistenciales, las herramientas necesarias,  así como las claves para implantarla. La guía para pacientes se ha desarrollado como herramienta complementaria a la atención farmacéutica presencial desde la visión del paciente, destacando las herramientas más comúnmente  utilizadas, los potenciales beneficios y las claves para facilitar la comprensión  sobre la finalidad y uso de estas intervenciones. CONCLUSIONES: Se ha desarrollado una guía práctica de apoyo, tanto a profesionales como a pacientes, para estandarizar el desarrollo, implantación  y expansión de la Telefarmacia en todos sus ámbitos de  actuación. La guía pretende ayudar al colectivo de farmacia hospitalaria a  alcanzar los potenciales beneficios de una herramienta que se presenta como  complementaria a la atención farmacéutica presencial.

Desarrollo de una intervención mHealth para rediseñar la ruta asistencial de las personas que viven con VIH: Estudio cualitativo / Developing a mHealth intervention to redesign the current journey for people living with HIV: A qualitative study

Objetivo: Las personas que viven con el virus de la inmunodeficienciahumana podrían beneficiarse de nuevas estrategias de salud móvil (mSalud). El objetivo del estudio fue contribuir al diseño y desarrollo de unnuevo modelo asistencial en la población con virus de la inmunodeficiencia humana y de la aplicación móvil necesaria para apoyarlo mediante:1) la exploración de la visión de personas que viven con el virus de lainmunodeficiencia humana y profesionales sanitarios sobre las herramientas digitales en la atención a este colectivo, y 2) la implementación desus perspectivas en la nueva aplicación y en la nueva ruta asistencial.Método: El estudio se realizó en dos fases: la primera tenía como objetivo conocer las perspectivas de los participantes sobre la salud móvilmediante la metodología cualitativa de los grupos focales, y la segundaimplementar estas valoraciones en la aplicación.Resultados: Participaron cinco pacientes y nueve profesionales sanitarios (tres farmacéuticos clínicos, tres enfermeras, dos médicas y una técnico de farmacia). Los pacientes consideraron que debían mejorarse lossiguientes aspectos en su ruta asistencial: información insuficiente (n = 5), falta de conocimiento de la enfermedad (n = 5) y modelo de dispensación de la medicación (n = 3). Los profesionales identificaron que debíanmejorarse: la calidad de vida de los pacientes (n = 7), el control de suenfermedad (n = 5) y de sus comorbilidades (n = 3), y la adherencia terapéutica (n = 5). De acuerdo con estas necesidades, se diseñó el nuevomodelo asistencial. (AU)

Objective: People living with human immunodeficiency virus couldparticularly benefit from mobile health (mHealth). The objective of thestudy was to contribute to the design and development of a new standard of care for people living with human immunodeficiency virus andthe mHealth app needed to support it by 1) exploring the view of peopleliving with human immunodeficiency virus and healthcare professionals onthe possibilities of mHealth tools on HIV care, and 2) implementing theirfeedback into the new app and into the new journey of people living withhuman immunodeficiency virus.Method: The study was conducted in two different phases: phase onewas to apprise patients’ and healthcare professionals’ perspectives onmHealth using the qualitative methodology of the focus groups, whereasphase two aimed to implement their feedback into the application.Results: A total of five people living with human immunodeficiency virusand nine healthcare professionals (three clinical pharmacists, three nurses, two physicians, and one pharmacy technician) participated in thefocus groups. The patients identified the following main aspects to be improved in the current patients’ journey: insufficient information (n = 5),lack of general population disease awareness (n = 5), and medicationdispensation model (n = 3). Moreover, healthcare professionals identifiedthe next health outcomes to be enhanced with mHealth tools: patients’quality of life (n = 7), control of the disease (n = 5) and comorbidities(n = 3), and adherence to medication (n = 5). According to these needs,the new healthcare model was designed. (AU)

Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial.

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.

Interdisciplinary Mobile Health Model to Improve Clinical Care After Heart Transplantation: Implementation Strategy Study.

BACKGROUND: Solid organ transplantation could be the only life-saving treatment for end-stage heart failure. Nevertheless, multimorbidity and polypharmacy remain major problems after heart transplant. A technology-based behavioral intervention model was established to improve clinical practice in a heart transplant outpatient setting. To support the new strategy, the mHeart app, a mobile health (mHealth) tool, was developed for use by patients and providers. OBJECTIVE: The primary objective of this study was to describe the implementation of the mHeart model and to outline the main facilitators identified when conceiving an mHealth approach. The secondary objectives were to evaluate the barriers, benefits, and willingness to use mHealth services reported by heart transplant recipients and cardiology providers. METHODS: This was an implementation strategy study directed by a multidisciplinary cardiology team conducted in four stages: design of the model and the software, development of the mHeart tool, interoperability among systems, and quality and security requirements. A mixed methods study design was applied combining a literature review, several surveys, interviews, and focus groups. The approach involved merging engineering and behavioral theory science. Participants were chronic-stage heart transplant recipients, patient associations, health providers, stakeholders, and diverse experts from the legal, data protection, and interoperability fields. RESULTS: An interdisciplinary and patient-centered process was applied to obtain a comprehensive care model. The heart transplant recipients (N=135) included in the study confirmed they had access to smartphones (132/135, 97.7%) and were willing to use the mHeart system (132/135, 97.7%). Based on stakeholder agreement (>75%, N=26), the major priorities identified of the mHealth approach were to improve therapy management, patient empowerment, and patient-provider interactions. Stakeholder agreement on the barriers to implementing the system was weak (<75%). Establishing the new model posed several challenges to the multidisciplinary team in charge. The main factors that needed to be overcome were ensuring data confidentiality, reducing workload, minimizing the digital divide, and increasing interoperability. Experts from various fields, scientific societies, and patient associations were essential to meet the quality requirements and the model scalability. CONCLUSIONS: The mHeart model will be applicable in distinct clinical and research contexts, and may inspire other cardiology health providers to create innovative ways to deal with therapeutic complexity and multimorbidity through health care systems. Professionals and patients are willing to use such innovative mHealth programs. The facilitators and key strategies described were needed for success in the implementation of the new holistic theory-based mHealth strategy.

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

BACKGROUND: 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. OBJECTIVE: 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. METHODS: A prospective study was conducted in the outpatient clinic of a tertiary hospital. All consecutive early stage HTxR (<1.5 years from HTx) were included. The ePROM psychometric properties assessed were validity, reliability, responsiveness, interpretability, and burden. ePROMs comprised the 4-item Morisky-Green-Levine questionnaire and an adapted version of the Haynes-Sackett questionnaire. The Simplified Medication Adherence Questionnaire (SMAQ) was also applied on-site. Three consecutive medication nonadherence assessments were performed by a transplant pharmacist. To improve medication nonadherence, theory-based interventions were delivered in a 1-month period. Patient satisfaction was assessed by a semiquantitative Web-based survey at the end of the study. RESULTS: We included 31 early stage HTxR (age: mean 54 years, SD 12 years), and 71% (22/31) of them were men. The HTxR were taking a mean 13 (SD 4; range 7-18) drugs per day. A total of 42% (13/31) of patients were unaware of the consequences of medication nonadherence, and 39% (12/31) of patients were nonadherent to immunosuppressive treatment. The content validity measure showed excellent levels of expert panel agreement for the Haynes-Sacket (14/14, 100%) and Morisky-Green-Levine (13/14, 93%) questionnaires. SMAQ and Morisky-Green-Levine ePROMs showed similar measurement domains (convergent validity, phi=0.6, P<.001), which, as expected, differed from Haynes-Sackett ePROMs (divergent validity, phi=0.3, P=.12). Reliability assessment revealed a very strong association between ePROM and on-site PROMs (phi>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. CONCLUSIONS: 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.

Multimorbidity and medication complexity: New challenges in heart transplantation.

INTRODUCTION: Multimorbidity and therapeutic complexity are a recognized problem in the heart transplant (HTx) population. However, little is known about how best to quantify this complexity or the strategies that could reduce its burden. METHODS: This single-center, observational study included adult heart transplant recipients (HTxR) >1.5 years from transplant. We assessed multimorbidity (>2 comorbidities) and the patient-level Medication Regimen Complexity Index Spanish version (pMRCI-S) score. We also analyzed the independent predictors of pMRCI-S and the impact of the index score on specific clinical variables. RESULTS: We included 135 chronic-stage HTxR. Comorbidities significantly increased after HTx (6 ± 3 vs 2 ± 2, P-value < .001). Patients took 12 ± 3 chronic drugs/d, 58% of them to treat comorbidities. The mean total pMRCI-S score was 42 ± 11, higher than in several other chronic diseases. The medication category drugs to treat comorbidities predicted a higher total pMRCI-S score (OR = 3.12, 95% CI 2.8-3.43, P-value < .001). Therapeutic complexity after HTx had an impact on solid malignancies (OR = 1.1, 95% CI 1.02-1.18, P-value = .02) and renal function (OR=-0.81, 95% CI -1.21-(-0.42), P-value < .001). CONCLUSIONS: The multimorbidity and pMRCI-S scores obtained in HTx population were worrisomely high. The pMRCI score is a sensitive method that allows identification of the factors determining therapeutic complexity after HTx and selection of strategies to reduce pMRCI-S values.