Therapies go digital. What drives physicians' acceptance?

National healthcare systems face multiple challenges, including the increasing demand for care and decreasing availability of healthcare professionals. Digital health technologies represent opportunities that offer improved efficiency, accessibility, and patient care. In this scenario, Digital Therapeutics are technological advancements to treat or alleviate a disease and deliver a medical intervention with evidence-based therapeutic impacts and regulatory approval. Digital Therapeutics are a paradigm shift for physicians, who exercise caution in terms of trust and wide usage. Digital Therapeutics represents an opportunity and a challenge in healthcare system integration. The research investigates the factors explaining physicians' acceptance of Digital Therapeutics. A research model that combines organizational mechanisms derived from Institutional Theory and rational factors derived from the Technology Acceptance model was developed. The model was tested through 107 responses from a survey distributed to the members of the leading Italian scientific society in Diabetology. Literature-based hypotheses were empirically tested through Structural Equation Modelling. The analysis confirmed the influence of Perceived Ease of Use on Perceived Usefulness and Perceived Usefulness on the Intention To Use Digital Therapeutics. Rules and norms impact Perceived Usefulness when considering the influence of the scientific society. Culture and mindset towards innovation within the hospital positively affect Perceived Ease of Use. The readiness of hospital facilities enhances the extent to which physicians perceive the ease of employing Digital Therapeutics in their daily practice. Instead, esteemed colleagues' opinions and guidelines from the scientific society reveal to physicians the value of Digital Therapeutics in patients' care pathways. Institutions should prioritize cultural, normative, and regulative aspects to accelerate physicians' endorsement of Digital Therapeutics. Findings advance the theoretical knowledge around clinicians' adoption of innovative digital health technologies, unveiling the interaction between rational and institutional factors. The results highlight practical implications for healthcare institutions and Digital Therapeutics manufacturers willing to promote their adoption.

Online Educational Resources for Youth Living With Type 1 Diabetes Transitioning to Adult Care: An Environmental Scan of Canadian Content.

OBJECTIVES: There are many educational resources for adolescents and young adults living with type 1 diabetes; however, it is unknown whether they address the breadth of topics related to transition to adult care. Our aim in this study was to collect educational resources relevant to Canadian youth and assess their quality and comprehensiveness in addressing the knowledge necessary for youth to prepare for interdependent management of their diabetes. METHODS: We conducted an environmental scan, a systematic assessment and analysis, of online education resources in English and French relevant to Canadian youth living with type 1 diabetes. Resources were screened using an open education resource evaluation grid and relevant resources were mapped to the Readiness for Emerging Adults with Diabetes Diagnosed in Youth, a validated diabetes transition readiness assessment tool. RESULTS: From 44 different sources, 1,245 resources were identified and, of these, 760 were retained for analysis. The majority were webpages (50.1%) and downloadable PDFs (42.4%), and 12.1% were interactive. Most resources covered Diabetes Knowledge (46.0%), Health Behaviour (23.8%), Insulin and Insulin Pump Management (11.8% and 8.6%, respectively), and Health-care System Navigation (9.7%). Topic areas with the fewest resources were disability accommodations (n=5), sexual health/function (n=4), and locating trustworthy diabetes resources (n=3). CONCLUSIONS: There are many resources available for those living with type 1 diabetes preparing to transition to adult care, with the majority pertaining to diabetes knowledge and the least for navigation of the health system. Few resources were available on the topics of substance use, sexual health, and reproductive health. An interactive presentation of these resources, as well as a central repository to house these resources, would improve access for youth and diabetes care providers during transition preparation.

Exploring the use of a digital therapeutic intervention to support the pediatric cardiac care journey: Qualitative study on clinician perspectives.

Pediatric heart disease currently effects over one million infants, children, and adolescents in the United States alone. Unlike the adult population, pediatric patients face a more uncertain path with factors relating to their growth and maturation creating levels of complexity to their care management. With mobile phones increasingly being utilized amongst adolescents, digital therapeutics tools could provide a platform to help patients and families manage their condition. This study explored clinicians' views on the use of a digital therapeutic program to support pediatric heart disease management. Using the principles from user-centered design, semi-structured interviews were conducted with 4 cardiologists, 3 nurse practitioners and 1 cardiology fellow at the Hospital for Sick Children. All interview transcripts underwent inductive thematic analysis using Braun and Clarke's iterative six-phase approach. To further contextualize the analytic interpretation of the study findings, Eakin and Gladstone's value-adding approach was used. Five themes were identified: (i) multidisciplinary model of care; (ii) patient care needs change over time; (iii) treatment burden and difficulties in care management; (iv) transition to adulthood; and (v) filling care gaps with digital health. Clinicians valued the opportunity to monitor a patient's health status in real-time, as it allowed them to modify care regimens on a more preventive basis. However, with adolescent care often varying according to the patient's age and disease severity, a digital therapeutic program would only be valuable if it was customizable to the patients changing care journey. Digital therapeutic programs can ease the process of self-care for adolescents with heart disease throughout the growth and maturation of their care journey. However, to ensure the sustained use of a program, there is a need to work collaboratively with patients, caregivers, and clinicians to ensure their lived experiences guide the design and delivery of the overall program.

A qualitative study on healthcare professional and patient perspectives on nurse-led virtual prostate cancer survivorship care.

BACKGROUND: Virtual nurse-led care models designed with health care professionals (HCPs) and patients may support addressing unmet prostate cancer (PCa) survivor needs. Within this context, we aimed to better understand the optimal design of a service model for a proposed nurse-led PCa follow-up care platform (Ned Nurse). METHODS: A qualitative descriptive study exploring follow-up and virtual care experiences to inform a nurse-led virtual clinic (Ned Nurse) with an a priori convenience sample of 10 HCPs and 10 patients. We provide a health ecosystem readiness checklist mapping facilitators onto CFIR and Proctor's implementation outcomes. RESULTS: We show that barriers within the current standard of care include: fragmented follow-up, patient uncertainty, and long, persisting wait times despite telemedicine modalities. Participants indicate that a nurse-led clinic should be scoped to coordinate care and support patient self-management, with digital literacy considerations. CONCLUSION: A nurse-led follow-up care model for PCa is seen by HCPs as acceptable, feasible, and appropriate for care delivery. Patients value its potential to provide role clarity, reinforce continuity of care, enhance mental health support, and increase access to timely and targeted care. These findings inform design, development, and implementation strategies for digital health interventions within complex settings, revealing opportunities to optimally situate these interventions to improve care.

Prostate cancer (PCa) survivors in Canada receive follow-up care after treatment through a specialist-led model, which is currently straining to meet patient needs. We interviewed healthcare providers (HCPs) and patients to investigate the design and development of a healthcare service that uses technology, also known as virtual care, to provide nurse-led follow-up care. Mixed experiences with virtual care informed participant feedback and concerns, including impacts of the pandemic and digital literacy considerations. We show that HCPs and patients see potential benefit in virtual nurse-led follow-up care if it can increase access to resources, clarify patient and provider care roles, and improve access and continuity of care. This type of approach to follow-up care may help to improve survivor quality of life and PCa follow-up care while extending the reach of healthcare systems with limited resources.

An Actionable Expert-System Algorithm to Support Nurse-Led Cancer Survivorship Care: Algorithm Development Study.

BACKGROUND: Comprehensive models of survivorship care are necessary to improve access to and coordination of care. New models of care provide the opportunity to address the complexity of physical and psychosocial problems and long-term health needs experienced by patients following cancer treatment. OBJECTIVE: This paper presents our expert-informed, rules-based survivorship algorithm to build a nurse-led model of survivorship care to support men living with prostate cancer (PCa). The algorithm is called No Evidence of Disease (Ned) and supports timelier decision-making, enhanced safety, and continuity of care. METHODS: An initial rule set was developed and refined through working groups with clinical experts across Canada (eg, nurse experts, physician experts, and scientists; n=20), and patient partners (n=3). Algorithm priorities were defined through a multidisciplinary consensus meeting with clinical nurse specialists, nurse scientists, nurse practitioners, urologic oncologists, urologists, and radiation oncologists (n=17). The system was refined and validated using the nominal group technique. RESULTS: Four levels of alert classification were established, initiated by responses on the Expanded Prostate Cancer Index Composite for Clinical Practice survey, and mediated by changes in minimal clinically important different alert thresholds, alert history, and clinical urgency with patient autonomy influencing clinical acuity. Patient autonomy was supported through tailored education as a first line of response, and alert escalation depending on a patient-initiated request for a nurse consultation. CONCLUSIONS: The Ned algorithm is positioned to facilitate PCa nurse-led care models with a high nurse-to-patient ratio. This novel expert-informed PCa survivorship care algorithm contains a defined escalation pathway for clinically urgent symptoms while honoring patient preference. Though further validation is required through a pragmatic trial, we anticipate the Ned algorithm will support timelier decision-making and enhance continuity of care through the automation of more frequent automated checkpoints, while empowering patients to self-manage their symptoms more effectively than standard care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2020-045806.

Heart Health Begins With Community: Community-Based Research Exploring Innovative Strategies to Support First Nations Heart Health.

Background: Indigenous people have displayed their strength through their holistic practices and spiritual connection to the land. Despite overcoming the impact of discriminatory and disempowering policies within Western institutions, Indigenous people continue to experience a higher risk of cardiovascular disease, compared to the general population. To move toward improving Indigenous health outcomes, researchers need to work in partnership with communities to develop heart health strategies centred on their experienced barriers and sources of healing. We conducted a community-based explorative study in Moosonee, Ontario to explore the local community's needs and priorities regarding heart health and wellness. Methods: A convenience sample of community members and healthcare professionals were invited to participate in a sharing circle. Qualitative data were analyzed using conventional content analysis and the Indigenous method of two-eyed seeing. Results: Eight community members and 5 healthcare professionals participated in the sharing circle. Four dominant themes were identified: (1) heart health is more than metrics; (2) honouring our traumas; (3) destigmatizing care through relationship building; and (4) innovative solutions start with community. With the history of mistreatment among Indigenous people, strength-based solutions involved rebuilding clinical relationships. To bring care closer to home, digital health tools were widely accepted, but the design of these tools needs to integrate both Western and Indigenous approaches to healing. Conclusions: Indigenous health upholds the physical, emotional, psychological, and spiritual needs of an individual as being of equal importance. To improve community heart health, strategies should start by strengthening broken bonds and bridging multiple worldviews of healing.

Contexte: Les peuples autochtones tirent une grande force de leurs pratiques holistiques et de leur lien spirituel avec le territoire, et même s'ils ont surmonté les répercussions des politiques discriminatoires et marginalisantes des institutions occidentales, ils présentent encore un risque de maladies cardiovasculaires supérieur à celui de la population générale. Afin d'aider à améliorer la santé cardiovasculaire des Autochtones, les chercheurs doivent travailler avec les communautés pour mettre en place des stratégies qui tiennent compte des obstacles en matière de soins de santé et des méthodes de guérison traditionnelles. Nous avons réalisé une étude exploratoire en milieu communautaire à Moosonee (Ontario) dans le but d'explorer les besoins et les priorités de la communauté locale en matière de santé cardiovasculaire et de bien-être. Méthodologie: Des membres de la communauté et des professionnels de la santé ont été invités à participer à un cercle de partage. Les données qualitatives ont été analysées au moyen d'une analyse classique et de la méthode autochtone dite à double perspective. Résultats: Huit membres de la communauté et cinq professionnels de la santé ont participé au cercle de partage. Quatre principaux thèmes ont été abordés : 1) la santé cardiovasculaire va au-delà de ce qui se mesure; 2) il faut tenir compte des traumatismes; 3) il faut déstigmatiser les soins en nouant des relations et 4) les solutions novatrices doivent reposer sur la participation de la communauté. En raison du passé de maltraitance envers les peuples autochtones, les solutions axées sur les forces devaient permettre de restaurer la confiance envers les soins cliniques. Les outils de santé numérique, bien adaptés aux besoins de la communauté, ont été largement acceptés, mais ils doivent intégrer les méthodes de soins occidentales et autochtones. Conclusions: Selon la vision autochtone, la santé repose en parts égales sur les aspects physiques, émotionnels, psychologiques et spirituels d'une personne. L'amélioration de la santé cardiovasculaire des membres de la communauté passe donc avant tout par des stratégies qui permettent de recréer les liens qui ont été brisés et qui intèrent plusieurs visions thérapeutiques.

Understanding Whether and How a Digital Health Intervention Improves Transition Care for Emerging Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Realist Evaluation.

BACKGROUND: Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to an increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from pediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which groups of individuals. OBJECTIVE: This study aims to evaluate the design and implementation of a multicomponent SMS text message-based digital health intervention to support emerging adults living with T1D in real-world settings. The objectives are to identify the intervention components and associated mechanisms that support user engagement and T1D health care transition experiences and determine the individual characteristics that influence the implementation process. METHODS: We used a realist evaluation embedded alongside a randomized controlled trial, which uses a sequential mixed methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and realist interviews. In step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships among "individual-level contextual factors, intervention components and features, mechanisms, and outcomes," with special attention paid to user engagement. Among them, intervention components and features depict 10 core characteristics such as transition support information, problem-solving information, and real-time interactivity. The proximal outcomes of interest include user engagement, self-efficacy, and negative emotions, whereas the distal outcomes of interest include transition readiness, self-blood glucose monitoring behaviors, and blood glucose. In step 2, we plan to conduct semistructured realist interviews with the randomized controlled trial's intervention-arm participants to test the hypothesized "context-intervention-mechanism-outcome" configurations. In step 3, we plan to triangulate all sources of data using a coincidence analysis to identify the necessary combinations of factors that determine whether and how the desired outcomes are achieved and use these insights to consolidate the program theory. RESULTS: For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for this realist evaluation was anticipated to start in July 2023 and continue until we reached thematic saturation or achieved informational power. CONCLUSIONS: Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46115.

The Complexity of Transferring Remote Monitoring and Virtual Care Technology Between Countries: Lessons From an International Workshop.

International deployment of remote monitoring and virtual care (RMVC) technologies would efficiently harness their positive impact on outcomes. Since Canada and the United Kingdom have similar populations, health care systems, and digital health landscapes, transferring digital health innovations between them should be relatively straightforward. Yet examples of successful attempts are scarce. In a workshop, we identified 6 differences that may complicate RMVC transfer between Canada and the United Kingdom and provided recommendations for addressing them. These key differences include (1) minority groups, (2) physical geography, (3) clinical pathways, (4) value propositions, (5) governmental priorities and support for digital innovation, and (6) regulatory pathways. We detail 4 broad recommendations to plan for sustainability, including the need to formally consider how highlighted country-specific recommendations may impact RMVC and contingency planning to overcome challenges; the need to map which pathways are available as an innovator to support cross-country transfer; the need to report on and apply learnings from regulatory barriers and facilitators so that everyone may benefit; and the need to explore existing guidance to successfully transfer digital health solutions while developing further guidance (eg, extending the nonadoption, abandonment, scale-up, spread, sustainability framework for cross-country transfer). Finally, we present an ecosystem readiness checklist. Considering these recommendations will contribute to successful international deployment and an increased positive impact of RMVC technologies. Future directions should consider characterizing additional complexities associated with global transfer.

Technology-Supported Integrated Care Innovations to Support Diabetes and Mental Health Care: Scoping Review.

BACKGROUND: For individuals living with diabetes and its psychosocial comorbidities (eg, depression, anxiety, and distress), there remains limited access to interprofessional, integrated care that includes mental health support, education, and follow-up. Health technology, broadly defined as the application of organized knowledge or skill as software, devices, and systems to solve health problems and improve quality of life, is emerging as a means of addressing these gaps. There is thus a need to understand how such technologies are being used to support, educate, and help individuals living with co-occurring diabetes and mental health distress or disorder. OBJECTIVE: The purpose of this scoping review was to (1) describe the literature on technology-enabled integrated interventions for diabetes and mental health; (2) apply frameworks from the Mental Health Commission of Canada and World Health Organization to elucidate the components, type, processes, and users of technology-enabled integrated interventions for diabetes and mental health; and (3) map the level of integration of interventions for diabetes and mental health. METHODS: We searched 6 databases from inception to February 2022 for English-language, peer-reviewed studies of any design or type that used technology to actively support both diabetes and any mental health distress or disorder in succession or concurrently among people with diabetes (type 1 diabetes, type 2 diabetes, and gestational diabetes). Reviewers screened citations and extracted data including study characteristics and details about the technology and integration used. RESULTS: We included 24 studies described in 38 publications. These studies were conducted in a range of settings and sites of care including both web-based and in-person settings. Studies were mostly website-based (n=13) and used technology for wellness and prevention (n=16) and intervention and treatment (n=15). The primary users of these technologies were clients and health care providers. All the included intervention studies (n=20) used technology for clinical integration, but only 7 studies also used the technology for professional integration. CONCLUSIONS: The findings of this scoping review suggest that there is a growing body of literature on integrated care for diabetes and mental health enabled by technology. However, gaps still exist with how to best equip health care professionals with the knowledge and skills to offer integrated care. Future research is needed to continue to explore the purpose, level, and breadth of technology-enabled integration to facilitate an approach to overcome or address care fragmentation for diabetes and mental health and to understand how health technology can further drive the scale-up of innovative integrated interventions.

Text message-based intervention, Keeping in Touch (KiT), to support youth as they transition to adult type 1 diabetes care: a protocol for a multisite randomised controlled superiority trial.

INTRODUCTION: Transition from paediatric to adult care can be challenging for youth living with type 1 diabetes (T1D), as many youth feel unprepared to transfer to adult care and are at high risk for deterioration of glycaemic management and acute complications. Existing strategies to improve transition experience and outcomes are limited by cost, scalability, generalisability and youth engagement. Text messaging is an acceptable, accessible and cost-effective way of engaging youth. Together with adolescents and emerging adults and paediatric and adult T1D providers, we co-designed a text message-based intervention, Keeping in Touch (KiT), to deliver tailored transition support. Our primary objective is to test the effectiveness of KiT on diabetes self-efficacy in a randomised controlled trial. METHODS AND ANALYSIS: We will randomise 183 adolescents with T1D aged 17-18 years within 4 months of their final paediatric diabetes visit to the intervention or usual care. KiT will deliver tailored T1D transition support via text messages over 12 months based on a transition readiness assessment. The primary outcome, self-efficacy for diabetes self-management, will be measured 12 months after enrolment. Secondary outcomes, measured at 6 and 12 months, include transition readiness, perceived T1D-related stigma, time between final paediatric and first adult diabetes visits, haemoglobin A1c, and other glycaemia measures (for continuous glucose monitor users), diabetes-related hospitalisations and emergency department visits and the cost of implementing the intervention. The analysis will be intention-to-treat comparing diabetes self-efficacy at 12 months between groups. A process evaluation will be conducted to identify elements of the intervention and individual-level factors influencing implementation and outcomes. ETHICS AND DISSEMINATION: The study protocol version 7 July 2022 and accompanying documents were approved by Clinical Trials Ontario (Project ID: 3986) and the McGill University Health Centre (MP-37-2023-8823). Study findings will be presented at scientific conferences and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05434754.

A Qualitative Study of the Perspectives of Healthcare Professionals on Features of Digital Health Interventions to Support Physical Activity in Solid Organ Transplant Recipients.

Introduction: Digital health interventions may support physical activity among solid organ transplant recipients. These interventions should be designed with users in mind, including healthcare professionals who counsel transplant recipients on physical activity to ensure acceptance and to promote an optimal user experience. The purpose of this study was to explore the perspectives of health care providers on the features of digital health interventions that would be useful in the promotion, implementation, and maintenance of physical activity among solid organ transplant recipients. Methods: This qualitative, cross-sectional study used semistructured interviews that were conducted remotely, via videoconferencing software, with providers who worked with transplant recipients. Interviews were transcribed, and an iterative-inductive, thematic analysis was used to identify common themes. Data were coded using NVivo software. Findings: Thirteen providers participated in this study. Four main themes were identified: (a) physical activity and exercise features (eg, physical activity guidelines, and exercise instructions); (b) credibility; (c) self-management; and (d) user engagement. Potential barriers to using digital health interventions included staffing requirements, professional regulatory issues, cost, perceived low patient motivation to use, and lack of technological literacy or access. Discussion: Digital health interventions were perceived to be a potential adjunct to current physical activity counseling practices, and part of an innovative strategy to address identified barriers to physical activity participation in solid organ transplant recipients.

Defending Against Medical Error: Personal Reflections on the Legacy of John Senders.

OBJECTIVE: To honor the legacy of John Senders, a distinguished member of the Human Factors and Ergonomics Society, by a short, personal history of him, but then to honor his legacy by extending it through our own professional opinions, with an emphasis on the study of human error and its implications for healthcare systems-two topics in which he excelled. BACKGROUND: The authors are familiar with the topic and subject matter. One was a friend of Senders for over 50 years. Another was a collaborator and joint author with Senders (as well as his stepdaughter). All three authors have extensive publications in the topic areas. METHOD, RESULTS, AND CONCLUSION: The authors used personal accounts of interactions with Senders at conferences, experiences living and working with him, and a brief review of his most personal, notable publications in healthcare. The reflections indicate a strong resonance on Senders' contributions to system design that are relevant today in healthcare's most challenging period in its history.

Bridging community and clinic through digital health: Community-based adaptation of a mobile phone-based heart failure program for remote communities in Uganda.

Background: In Uganda, limited healthcare access has created a significant burden for patients living with heart failure. With the increasing use of mobile phones, digital health tools could offer an accessible platform for individualized care support. In 2016, our multi-national team adapted a mobile phone-based program for heart failure self-care to the Ugandan context and found that patients using the system showed improvements in their symptoms and quality of life. With approximately 84% of Ugandans residing in rural communities, the Medly Uganda program can provide greater benefit for communities in rural areas with limited access to care. To support the implementation of this program within rural communities, this study worked in partnership with two remote clinics in Northern Uganda to identify the cultural and service level requirements for the program. Methods: Using the principles from community-based research and user-centered design, we conducted a mixed-methods study composed of 4 participatory consensus cycles, 60 semi-structured interviews (SSI) and 8 iterative co-design meetings at two remote cardiac clinics. Patient surveys were also completed during each SSI to collect data related to cell phone access, community support, and geographic barriers. Qualitative data was analyzed using inductive thematic analysis. The Indigenous method of two-eyed seeing was also embedded within the analysis to help promote local perspectives regarding community care. Results: Five themes were identified. The burden of travel was recognized as the largest barrier for care, as patients were travelling up to 19 km by motorbike for clinic visits. Despite mixed views on traditional medicine, patients often turned to healers due to the cost of medication and transport. With most patients owning a non-smartphone (n = 29), all participants valued the use of a digital tool to improve equitable access to care. However, to sustain program usage, integrating the role of village health teams (VHTs) to support in-community follow-ups and medication delivery was recognized as pivotal. Conclusion: The use of a mobile phone-based digital health program can help to reduce the barrier of geography, while empowering remote HF self-care. By leveraging the trusted role of VHTs within the delivery of the program, this will help enable more culturally informed care closer to home. Supplementary Information: The online version contains supplementary material available at 10.1186/s44247-023-00020-5.

A Voice App Design for Heart Failure Self-management: Proof-of-Concept Implementation Study.

BACKGROUND: Voice user interfaces are becoming more prevalent in health care and are commonly being used for patient engagement. There is a growing interest in identifying the potential this form of interface has on patient engagement with digital therapeutics (DTx) in chronic disease management. Making DTx accessible through an alternative interaction model also has the potential to better meet the needs of some patients, such as older adults and those with physical and cognitive impairments, based on existing research. OBJECTIVE: This study aimed to evaluate how participants with heart failure interacted with a voice app version of a DTx, Medly, through a proof-of-concept implementation study design. The objective was to understand whether the voice app would enable the participants to successfully interact with the DTx, with a focus on acceptability and feasibility. METHODS: A mixed methods concurrent triangulation design was used to better understand the acceptability and feasibility of the use of the Medly voice app with the study participants (N=20) over a 4-week period. Quantitative data included engagement levels, accuracy rates, and questionnaires, which were analyzed using descriptive statistics. Qualitative data included semistructured interviews and were analyzed using a qualitative descriptive approach. RESULTS: The overall average engagement level was 73% (SD 9.5%), with a 14% decline between results of weeks 1 and 4. The biggest difference was between the average engagement levels of the oldest and youngest demographics, 84% and 43%, respectively, but these results were not significant-Kruskal-Wallis test, H(2)=3.8 (P=.14). The Medly voice app had an overall accuracy rate of 97.8% and was successful in sending data to the clinic. From an acceptability perspective, the voice app was ranked in the 80th percentile, and overall, the users felt that the voice app was not a lot of work (average of 2.1 on a 7-point Likert scale). However, the overall average score for whether users would use it in the future declined by 13%. Thematic analysis revealed the following: the theme feasibility of clinical integration had 2 subthemes, namely users adapted to the voice app's conversational style and device unreliability, and the theme voice app acceptability had 3 subthemes, namely the device integrated well within household and users' lives, users blamed themselves when problems arose with the voice app, and voice app was missing specific, desirable user features. CONCLUSIONS: In conclusion, participants were largely successful in using the Medly voice app despite some of the barriers faced, proving that an app such as this could be feasible to be deployed in the clinic. Our data begin to piece together the patient profile this technology may be most suitable for, namely those who are older, have flexible schedules, are confident in using technology, and are experiencing other medical conditions.

Design of a Patient Voice App Experience for Heart Failure Management: Usability Study.

BACKGROUND: The use of digital therapeutics (DTx) in the prevention and management of medical conditions has increased through the years, with an estimated 44 million people using one as part of their treatment plan in 2021, nearly double the number from the previous year. DTx are commonly accessed through smartphone apps, but offering these treatments through additional platforms can improve the accessibility of these interventions. Voice apps are an emerging technology in the digital health field; not only do they have the potential to improve DTx adherence, but they can also create a better user experience for some user groups. OBJECTIVE: This research aimed to identify the acceptability and feasibility of offering a voice app for a chronic disease self-management program. The objective of this project was to design, develop, and evaluate a voice app of an already-existing smartphone-based heart failure self-management program, Medly, to be used as a case study. METHODS: A voice app version of Medly was designed and developed through a user-centered design process. We conducted a usability study and semistructured interviews with patients with heart failure (N=8) at the Peter Munk Cardiac Clinic in Toronto General Hospital to better understand the user experience. A Medly voice app prototype was built using a software development kit in tandem with a cloud computing platform and was verified and validated before the usability study. Data collection and analysis were guided by a mixed methods triangulation convergence design. RESULTS: Common themes were identified in the results of the usability study, which involved 8 participants with heart failure. Almost all participants (7/8, 88%) were satisfied with the voice app and felt confident using it, although half of the participants (4/8, 50%) were unsure about using it in the future. Six main themes were identified: changes in physical behavior, preference between voice app and smartphone, importance of music during voice app interaction, lack of privacy concerns, desired reassurances during voice app interaction, and helpful aids during voice app interaction. These findings were triangulated with the quantitative data, and it concluded that the main area for improvement was related to the ease of use; design changes were then implemented to better improve the user experience. CONCLUSIONS: This work offered preliminary insight into the acceptability and feasibility of a Medly voice app. Given the recent emergence of voice apps in health care, we believe that this research offered invaluable insight into successfully deploying DTx for chronic disease self-management using this technology.

A digital self-care intervention for Ugandan patients with heart failure and their clinicians: User-centred design and usability study.

Background: The prevalence of heart failure (HF) is increasing in Uganda. Ugandan patients with HF report receiving limited information about their illness and associated self-care behaviours. Interventions targeted at improving HF self-care have been shown to improve patient quality of life and reduce hospitalizations in high-income countries. However, such interventions remain underutilized in resource-limited settings like Uganda. This study aimed to develop a digital health intervention that enables improved self-care amongst HF patients in Uganda. Methods: We implemented a user-centred design (UCD) process to develop a self-care intervention entitled Medly Uganda. The ideation phase comprised a scoping review and preliminary data collection amongst HF patients and clinicians in Uganda. An iterative design process was then used to advance an initial prototype into a functional digital health intervention. The evaluation phase involved usability testing of the intervention amongst Ugandan patients with HF and their clinicians. Results: Medly Uganda is a digital health intervention that allows patients to report daily HF symptoms, receive tailored treatment advice and connect with a clinician when showing signs of decompensation. The system harnesses Unstructured Supplementary Service Data (USSD) technology that is already widely used in Uganda for mobile phone-based financial transactions. Usability testing showed Medly Uganda to be both acceptable and feasible amongst clinicians, patients and caregivers. Conclusions: Medly Uganda is a functional digital health intervention with demonstrated acceptability and feasibility in enabling Ugandan HF patients to better care for themselves. We are hopeful that the system will improve self-care efficacy amongst HF patients in Uganda.

Assessment of a Decision Support System for Adults with Type 1 Diabetes on Multiple Daily Insulin Injections.

Introduction: DailyDose is a decision support system designed to provide real-time dosing advice and weekly insulin dose adjustments for adults living with type 1 diabetes using multiple daily insulin injections. Materials and Methods: Twenty-five adults were enrolled in this single-arm study. All participants used Dexcom G6 for continuous glucose monitoring, InPen for short-acting insulin doses, and Clipsulin to track long-acting insulin doses. Participants used DailyDose on an iPhone for 8 weeks. The primary endpoint was % time in range (TIR) comparing the 2-week baseline to the final 2-week period of DailyDose use. Results: There were no significant differences between TIR or other glycemic metrics between the baseline period compared to final 2-week period of DailyDose use. TIR significantly improved by 6.3% when more than half of recommendations were accepted and followed compared with 50% or fewer recommendations (95% CI 2.5%-10.1%, P = 0.001). Conclusions: Use of DailyDose did not improve glycemic outcomes compared to the baseline period. In a post hoc analysis, accepting and following recommendations from DailyDose was associated with improved TIR. Clinical Trial Registration Number: NCT04428645.

Exploring the value of using patient-oriented MRI reports in clinical practice - a pilot study.

PURPOSE: Standard radiology reports (SRR) are designed to communicate information between doctors. With many patients having instantaneous access to SRRs on patient portals, interpretation without guidance from doctors can cause anxiety and panic. In this pilot study, we designed a patient-centred prostate MRI template report (PACERR) to address some of these challenges and tested whether PACERRs improve patient knowledge and experience. MATERIALS AND METHODS: Patients booked for clinical prostate MRI were randomly assigned to SRR or SRR + PACERR. Questionnaires included multiple-choice that targeted 4 domains (understanding, usefulness, next steps, emotional experience) hypothesized to improve with patient-centred reports and short answer questions, testing knowledge regarding MRI results. Clinical encounters were observed and recorded to explore whether adding PACERR improved communication. Likert scaled-responses and short-answer questions were compared using Mann-Whitney U test and Kruskal-Wallis test. RESULTS: Of the 40 participants, the majority were MRI naïve (70%). Patients receiving a PACERR had higher scores in the categories of patient understanding (mean: 4.17 vs. 3.39, p=0.006), usefulness (mean: 4.58 vs. 3.07, p<0.001), and identifying next steps (mean: 1.89 vs. 3.03, p=0.003) but not emotional experience (mean: 4.18 vs. 3.79, p=0.22). PACERR participants found the layout and design more patient friendly (mean: 4.47 vs. 2.61, p<0.001) and easier to understand (mean: 4.37 vs. 2.38, p<0.001). In the knowledge section, overall, the PACERR arm scored better (87% vs. 56%, p=0.004). CONCLUSION: With the addition of prostate MRI PACERR, participants had better understanding of their results and felt more prepared to involve themselves in discussions with their doctor.

Designing a Framework for Remote Cancer Care Through Community Co-design: Participatory Development Study.

BACKGROUND: Recent shifts to telemedicine and remote patient monitoring demonstrate the potential for new technology to transform health systems; yet, methods to design for inclusion and resilience are lacking. OBJECTIVE: The aim of this study is to design and implement a participatory framework to produce effective health care solutions through co-design with diverse stakeholders. METHODS: We developed a design framework to cocreate solutions to locally prioritized health and communication problems focused on cancer care. The framework is premised on the framing and discovery of problems through community engagement and lead-user innovation with the hypothesis that diversity and inclusion in the co-design process generate more innovative and resilient solutions. Discovery, design, and development were implemented through structured phases with design studios at various locations in urban and rural Kentucky, including Appalachia, each building from prior work. In the final design studio, working prototypes were developed and tested. Outputs were assessed using the System Usability Scale as well as semistructured user feedback. RESULTS: We co-designed, developed, and tested a mobile app (myPath) and service model for distress surveillance and cancer care coordination following the LAUNCH (Linking and Amplifying User-Centered Networks through Connected Health) framework. The problem of awareness, navigation, and communication through cancer care was selected by the community after framing areas for opportunity based on significant geographic disparities in cancer and health burden resource and broadband access. The codeveloped digital myPath app showed the highest perceived combined usability (mean 81.9, SD 15.2) compared with the current gold standard of distress management for patients with cancer, the paper-based National Comprehensive Cancer Network Distress Thermometer (mean 74.2, SD 15.8). Testing of the System Usability Scale subscales showed that the myPath app had significantly better usability than the paper Distress Thermometer (t63=2.611; P=.01), whereas learnability did not differ between the instruments (t63=-0.311; P=.76). Notable differences by patient and provider scoring and feedback were found. CONCLUSIONS: Participatory problem definition and community-based co-design, design-with methods, may produce more acceptable and effective solutions than traditional design-for approaches.