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BackgroundThe COVID-19 pandemic was an unprecedent challenge to public health systems, with 95% of cases in Quebec sent home for self-isolation. To ensure continuous care, we implemented an intervention supported by a patient portal (Opal) to remotely monitor at-home patients with COVID-19 via daily self-reports of symptoms, vital signs, and mental health that were reviewed by health care professionals. ObjectiveWe describe the intervention’s implementation, focusing on the (1) process; (2) outcomes, including feasibility, fidelity, acceptability, usability, and perceived response burden; and (3) barriers and facilitators encountered by stakeholders. MethodsThe implementation followed a co-design approach operationalized through patient and stakeholder engagement. The intervention included a 14-day follow-up for each patient. In the mixed methods study at the McGill University Health Centre in Montreal, Quebec, participants completed questionnaires on implementation outcomes on days 1, 7, and 14. All scores were examined against predefined success thresholds. Linear mixed models and generalized estimating equations were used to assess changes in scores over time and whether they differed by sex, age, and race. Semistructured interviews were conducted with expert patients, health care professionals, and coordinators for the qualitative analysis and submitted to thematic analysis guided by the Consolidated Framework for Implementation Research. ResultsIn total, 51 participants were enrolled between December 2020 and March 2021; 49 (96%) were included in the quantitative analysis. Observed recruitment and retention rates (51/52, 98% and 49/51, 96%) met the 75% feasibility success threshold. Over 80% of the participants found it “quite easy/very easy” to complete the daily self-report, with a completion rate (fidelity) of >75% and a nonsignificant decreasing trend over time (from 100%, 49/49 to 82%, 40/49; P=.21). Mean acceptability and usability scores at all time points exceeded the threshold of 4 out of 5. Acceptability scores increased significantly between at least 2 time points (days 1, 7, and 14: mean 4.06, SD 0.57; mean 4.26, SD 0.59; and mean 4.25, SD 0.57; P=.04). Participants aged >50 years reported significantly lower mean ease of use (usability) scores than younger participants (days 1, 7, and 14: mean 4.29, SD 0.91 vs mean 4.67, SD 0.45; mean 4.13, SD 0.89 vs mean 4.77, SD 0.35; and mean 4.24, SD 0.71 vs mean 4.72, SD 0.71; P=.004). In total, 28 stakeholders were interviewed between June and September 2021. Facilitators included a structured implementation process, a focus on stakeholders’ recommendations, the adjustability of the intervention, and the team’s emphasis on safety. However, Opal’s thorough privacy protection measures and limited acute follow-up capacities were identified as barriers, along with implementation delays due to data security–related institutional barriers. ConclusionsThe intervention attained targets across all studied implementation outcomes. Qualitative findings highlighted the importance of stakeholder engagement. Telehealth tools have potential for the remote follow-up of acute health conditions. International Registered Report Identifier (IRRID)RR2-10.2196/35760

BackgroundHeart failure (HF) is the primary cause of hospitalization among Canadian patients aged ≥65 years. Care for HF requires regular clinical follow-ups to prevent readmissions and facilitate medical therapy optimization. Multiple barriers lead to therapeutic medical inertia including limited human resources and regional inequities. Remote patient monitoring (RPM) and digital therapeutics (DTx) solutions have been developed to improve HF management, but their adoption remains limited and underexplored. The Continuum project emerged as a collaborative initiative involving a health care center, a software start-up, and an industrial partner. ObjectiveWe aimed to develop and test the feasibility of the Continuum intervention that seamlessly combined an RPM system with a DTx solution for HF within the same software. MethodsA 3-month pre-post pilot study was conducted from October 2020 to June 2021. Patients with HF who owned a smartphone or tablet (having remote patient monitoring [RPM+]), had (1) access to a self-care app where they could enter their vital signs, weight, and HF symptoms and view educational content; (2) daily monitoring of their data by a nurse; and (3) a DTx module with automated HF medication suggestions based on national guidelines, made available to their treating medical team. Bluetooth devices were offered to facilitate data recording. Nurses on RPM monitoring could call patients and arrange appointments with their medical team. Patients without a mobile device or unable to use the app were followed in another group (without remote patient monitoring [RPM–]). ResultsIn total, 52 patients were enrolled in this study (32 RPM+ and 20 RPM–). Among patients owning a mobile device, only 14% (5/37) could not use the app. In the RPM+ group, 47% (15/32) of the patients used the app for more than 80% (67 days) of the 12-week study period. The use of our digital solution was integrated into the regular nursing workday and only 34 calls had to be made by the nurse during the study period. Only 6% (2/32) of the patients in the RPM+ group experienced at least 1 all-cause hospitalization versus 35% (7/20) of the RPM– ones during the follow-up (6%, 2/32 vs 25%, 5/20 for HF hospitalization) and patients were more likely to have their HF therapy optimized if the DTx solution was available. Quality of life improved in patients compliant with the use of the mobile app (mean score variation +10.6, SD 14.7). ConclusionsThis pilot study demonstrated the feasibility of implementing our digital solution, within the specific context of HF. The seamless integration of Continuum into nursing workflow, mobile app accessibility, and adoption by patients, were the 3 main key learning points of this study. Further investigation is required to assess the potential impacts on hospitalizations, drug optimization, and quality of life. Trial RegistrationClinicalTrials.gov NCT05377190; https://clinicaltrials.gov/study/NCT05377190 (pilot study #21.403)

BackgroundLiver transplantation (LT) is indicated in patients with severe acute or chronic liver failure for which no other therapy is available. With the increasing number of LTs in recent years, liver centers worldwide must manage their patients according to their clinical situation and the expected waiting time for transplantation. The LT clinic at the Centre hospitalier de l’Université de Montréal (CHUM) is developing a new health care model across the entire continuum of pre-, peri-, and posttransplant care that features patient monitoring by an interdisciplinary team, including an accompanying patient; a digital platform to host a clinical plan; a learning program; and data collection from connected objects. ObjectiveThis study aims to (1) evaluate the outcomes following the implementation of a patient platform with connected devices and an accompanying patient, (2) identify implementation barriers and facilitators, (3) describe service outcomes in terms of health outcomes and the rates and nature of contact with the accompanying patient, (4) describe patient outcomes, and (5) assess the intervention’s cost-effectiveness. MethodsSix types of participants will be included in the study: (1) patients who received transplants and reached 1 year after transplantation before September 2023 (historical cohort or control group), (2) patients who will receive an LT between December 2023 and November 2024 (prospective cohort/intervention group), (3) relatives of those patients, (4) accompanying patients who have received an LT and are interested in supporting patients who will receive an LT, (5) health care professionals, and (6) decision makers. To describe the study sample and collect data to achieve all the objectives, a series of validated questionnaires, accompanying patient logbooks, transcripts of interviews and focus groups, and clinical indicators will be collected throughout the study. ResultsIn total, 5 (steering, education, clinical-technological, nurse prescription, and accompanying patient) working committees have been established for the study. Recruitment of patients is expected to start in November 2023. All questionnaires and technological platforms have been prepared, and the clinicians, stakeholders, and accompanying patient personnel have been recruited. ConclusionsThe implementation of this model in the trajectory of LT recipients at the CHUM may allow for better monitoring and health of patients undergoing transplantation, ultimately reducing the average length of hospital stay and promoting better use of medical resources. In the event of positive results, this model could be transposed to all transplant units at the CHUM and across Quebec (potentially affecting 888 patients per year) but could also be applied more widely to the monitoring of patients with other chronic diseases. The lessons learned from this project will be shared with decision makers and will serve as a model for other initiatives involving accompanying patients, connected objects, or digital platforms. International Registered Report Identifier (IRRID)PRR1-10.2196/54440

BackgroundArtificial intelligence (AI)–based chatbots could help address some of the challenges patients face in acquiring information essential to their self-health management, including unreliable sources and overburdened health care professionals. Research to ensure the proper design, implementation, and uptake of chatbots is imperative. Inclusive digital health research and responsible AI integration into health care require active and sustained patient and stakeholder engagement, yet corresponding activities and guidance are limited for this purpose. ObjectiveIn response, this manuscript presents a master protocol for the development, testing, and implementation of a chatbot family in partnership with stakeholders. This protocol aims to help efficiently translate an initial chatbot intervention (MARVIN) to multiple health domains and populations. MethodsThe MARVIN chatbots study has an adaptive platform trial design consisting of multiple parallel individual chatbot substudies with four common objectives: (1) co-construct a tailored AI chatbot for a specific health care setting, (2) assess its usability with a small sample of participants, (3) measure implementation outcomes (usability, acceptability, appropriateness, adoption, and fidelity) within a large sample, and (4) evaluate the impact of patient and stakeholder partnerships on chatbot development. For objective 1, a needs assessment will be conducted within the setting, involving four 2-hour focus groups with 5 participants each. Then, a co-construction design committee will be formed with patient partners, health care professionals, and researchers who will participate in 6 workshops for chatbot development, testing, and improvement. For objective 2, a total of 30 participants will interact with the prototype for 3 weeks and assess its usability through a survey and 3 focus groups. Positive usability outcomes will lead to the initiation of objective 3, whereby the public will be able to access the chatbot for a 12-month real-world implementation study using web-based questionnaires to measure usability, acceptability, and appropriateness for 150 participants and meta-use data to inform adoption and fidelity. After each objective, for objective 4, focus groups will be conducted with the design committee to better understand their perspectives on the engagement process. ResultsFrom July 2022 to October 2023, this master protocol led to four substudies conducted at the McGill University Health Centre or the Centre hospitalier de l’Université de Montréal (both in Montreal, Quebec, Canada): (1) MARVIN for HIV (large-scale implementation expected in mid-2024), (2) MARVIN-Pharma for community pharmacists providing HIV care (usability study planned for mid-2024), (3) MARVINA for breast cancer, and (4) MARVIN-CHAMP for pediatric infectious conditions (both in preparation, with development to begin in early 2024). ConclusionsThis master protocol offers an approach to chatbot development in partnership with patients and health care professionals that includes a comprehensive assessment of implementation outcomes. It also contributes to best practice recommendations for patient and stakeholder engagement in digital health research. Trial RegistrationClinicalTrials.gov NCT05789901; https://classic.clinicaltrials.gov/ct2/show/NCT05789901 International Registered Report Identifier (IRRID)PRR1-10.2196/54668

BackgroundThe number of elective outpatient surgeries in Canada has increased markedly in the last 10 years. However, unanticipated cancellations on the day of surgery and adverse postoperative events are frequent. Modern technologies have been shown to be of great help in the medical field in improving patient care. Thus, it is likely that dedicated technologies could also significantly improve surgical outpatients’ pathways. Therefore, the department of anesthesiology at the University of Montreal Medical Center, in collaboration with LeoMed, a telemedicine platform, has developed a telehealth solution to offer more efficient perioperative support and follow-up for patients undergoing ambulatory surgery. ObjectiveThe objective is to evaluate the medicoeconomic benefit of a dedicated perioperative telehealth platform for patients undergoing day surgery. Our hypothesis is that this dedicated telecare solution will allow more efficient patient care, which will reduce all types of medical costs related to day surgery pathways. MethodsThis study is a single-center, single-blinded, 2-group randomized controlled trial. One thousand patients aged over 18 years with internet access who are scheduled to undergo ambulatory surgery will be enrolled and randomized either to follow a perioperative path that includes a patient-tailored perioperative digital app via the LeoMed telecare platform for 1 month or to follow the standard of care, which does not offer personalized digital support. The primary outcome will be to evaluate the cost-effectiveness of the telecare platform, assessing direct costs from factors such as unanticipated cancellations on the day of surgery due to preoperative instructions not being followed, calls to the local health information line, calls to the provincial health information line, emergency department consultations, unplanned readmissions, or medical visits for problems related to the surgical procedure within the first 30 days after the intervention. The secondary outcome will be to evaluate cost utility using a questionnaire assessing quality-adjusted life years. A blinded independent research team will analyze outcomes. All data will be analyzed according to the intention-to-treat principle. A sample size of 500 subjects in each group was calculated to detect a 21% reduction in postoperative complications with a power of 90%. This study has been approved by the ethics board of Centre hospitalier de l’Université de Montréal (University of Montreal Health Centre). No employee of LeoMed was involved in the study conception, and none will be involved in either data collection or analysis. ResultsResults of this trial will be useful to determine the economic benefit of a telecare platform specifically developed for surgical outpatient pathways. ConclusionsWe believe that the deployment of a dedicated perioperative telehealth app will lead to better patient care and fewer postoperative complications, which will lower all types of costs related to surgical outpatient care. Trial RegistrationClinicalTrials.gov NCT04948632; https://ClinicalTrials.gov/ct2/show/NCT04948632 International Registered Report Identifier (IRRID)DERR1-10.2196/44006

BackgroundPeople with COVID-19 are instructed to self-isolate at home. During self-isolation, they may experience anxiety and insufficient care. Patient portals can allow patients to self-monitor and remotely share their health status with health care professionals, but little data are available on their feasibility. ObjectiveThis paper presents the protocol of the Opal-COVID Study. Its objectives are to assess the implementation of the Opal patient portal for distance monitoring of self-isolating patients with COVID-19, identify influences on the intervention’s implementation, and describe service and patient outcomes of this intervention. MethodsThis mixed methods pilot study aims to recruit 50 patient participants with COVID-19 tested at the McGill University Health Centre (Montreal, Canada) for 14 days of follow-up. With access to an existing patient portal through a smartphone app, patients will complete a daily self-assessment of symptoms, vital signs, and mental health monitored by a nurse, and receive teleconsultations as needed. Study questionnaires will be administered to collect data on sociodemographic characteristics, medical background, implementation outcomes (acceptability, usability, and respondent burden), and patient satisfaction. Coordinator logbook entries will inform on feasibility outcomes, namely, on recruitment, retention, and fidelity, as well as on the frequency and nature of contacts with health care professionals. The statistical analyses for objectives 1 (implementation outcomes), 3 (service outcomes), and 4 (patient outcomes) will evaluate the effects of time and sociodemographic characteristics on the outcomes. For objectives 1 (implementation outcomes) and 4 (patient outcomes), the statistical analyses will also examine the attainment of predefined success thresholds. As for the qualitative analyses, for objective 2 (influences on implementation), semistructured qualitative interviews will be conducted with 4 groups of stakeholders (ie, patient participants, health care professionals, technology developers, and study administrators) and submitted for content analysis, guided by the Consolidated Framework for Implementation Research to help identify barriers to and facilitators of implementation. For objective 3 (service outcomes), reasons for contacting health care professionals through Opal will also be submitted for content analysis. ResultsBetween December 2020 and March 2021, a total of 51 patient participants were recruited. Qualitative interviews were conducted with 39 stakeholders from April to September 2021. Delays were experienced owing to measures taken at the McGill University Health Centre to address COVID-19. The quantitative and qualitative analyses began in May 2022. As of June 2022, a total of 2 manuscripts (on the implementation and the patient outcomes) were being prepared, and 3 conference presentations had been given on the study’s methods. ConclusionsThis protocol is designed to generate multidisciplinary knowledge on the implementation of a patient portal–based COVID-19 care intervention and will lead to a comprehensive understanding of feasibility, stakeholder experience, and influences on implementation that may prove useful for scaling up similar interventions. Trial RegistrationClinicalTrials.gov NCT04978233; https://clinicaltrials.gov/ct2/show/NCT04978233 International Registered Report Identifier (IRRID)DERR1-10.2196/35760

BackgroundThe use of social robots as innovative therapeutic tools has been increasingly explored in recent years in an effort to address the growing need for alternative intervention modalities in mental health care. ObjectiveThe aim of this scoping review was to identify and describe social robot interventions in mental health facilities and to highlight their outcomes as well as the barriers and facilitators to their implementation. MethodsA scoping review of the literature published since 2015 was conducted using the Arksey and O’Malley’s framework. The MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and PsycINFO databases were searched, and 2239 papers were retrieved. The papers included were primary empirical studies published in peer-reviewed literature. Eligible studies were set in mental health facilities and they included participants with a known mental health disorder. The methodological quality of the included papers was also assessed using the Mixed Methods Appraisal Tool. ResultsA total of 30 papers met the eligibility criteria for this review. Studies involved participants with dementia, cognitive impairment, schizophrenia, depression, autism spectrum disorder, attention-deficit hyperactivity disorder, and an intellectual disability. The outcomes studied included engagement, social interaction, emotional state, agitation, behavior, and quality of life. ConclusionsThe methodological weaknesses of the studies conducted this far and the lack of diversity in the conditions studied limit the generalizability of the results. However, despite the presence of certain barriers to their implementation (eg, technical problems, unsuitable environment, staff resistance), social robot interventions generally show positive effects on patients with mental health disorders. Studies of stronger methodological quality are needed to further understand the benefits and the place of social robots in mental health care.