This study draws on implementation sciences [7] that are intended to foster the adoption or implementation of an intervention. The selected strategies are presented based on the main corresponding implementation phase: preimplementation, implementation, and postimplementation phase. Central to our implementation strategy is our intention to involve patients and stakeholders through various engagement approaches. Our stakeholder engagement strategy is implemented by an interdisciplinary research team that includes not only researchers (MPP, ELR, CB, TP, CV, CR, and MJE), clinicians (CV, AB, GH, and CG), managers (NN and JP), and decision makers (KM and DO) but also patient coresearchers and former patients (FD, LL, and JTL) [8-11]. Our research and intervention development processes are based on a coconstruction methodology that respects the knowledge and responsibility of the stakeholders based on their values, expertise, and perspectives concerning a health condition and its associated care [12,13]. By involving all stakeholders in this project from the outset, we seek not only to detect and address the challenges associated with recruitment, accessibility, acceptability, and the comprehensibility of procedures and instruments [14] but also to enhance the relevance and meaningfulness of our research results [12].

At the CHUM, certain sectors of activity have been prioritized, including the LT clinic, to improve the patient pathway. The LT clinic constitutes a great target for work on a new model of outpatient care as the medical and nonmedical teams are highly motivated; the number of patients is manageable (60 patients undergoing transplants per year); and the clinic offers a platform where it is possible to integrate and coordinate several medical specialties, such as hepatology, nephrology, cardiology, endocrinology, and even psychiatry.

The proposed intervention is complex; it “comprises multiple interacting components, although additional dimensions of complexity include the difficulty of their implementation and the number of organizational levels they target” [15]. This new health care model is called Transplant’Action Connected in Liver Transplant (TAC) and includes five components implemented before, during, and after LT: (1) clinical team and technical support; (2) a kinesiology-based intervention plan; (3) a nutritional intervention plan; (4) peer support; and (5) the use of a digital platform, including an interface containing the intervention plans with support videos as well as the association of connected objects (COs; ie, a blood pressure monitor, scale, bracelet, and glucometer [if necessary]) to monitor patients’ biological variables and physical activity.

All the HCPs and accompanying patients will be trained in therapeutic education and motivational interviewing to support the patients throughout their treatment, as well as in the use of the digital platform and COs. The team’s role is to provide recommendations on the use of the digital platform, the procedures to follow as part of their intervention plan, the procedures for remote monitoring using the COs, the patient’s daily self-assessment, and information on the educational material to be provided to participants through the patient portal.

When patients receive their COs, they will be supported by the digital platform developers and by the CHUM telehealth coordination center. To centralize technical support, the CHUM telehealth coordinator will communicate with the digital platform development team (ML and ECN) to maintain, configure, and update the patient portal for the duration of the project. Regular meetings will be held to discuss the configuration of the digital platform to ensure that it integrates stakeholder recommendations as obtained from engaged HCPs, accompanying patients, and patients. RdP will also be available to provide technical assistance to patients via email throughout the study.

To ensure that the patients’ needs are met, the accompanying patients and HCPs will be regularly consulted to obtain their feedback on the proposed procedures for remote monitoring and research material (eg, informed consent documents and all the data collection instruments, including the self-assessment). This will help ensure the relevance, comprehensibility, and comprehensiveness of the results.

To effect cyclical change, MPP is planning 4 prototype tests with engaged HCPs (ie, the clinical team), accompanying patients, and a sample of patients. For each test, the members will receive training on the digital platform; use it for 4 days; and then meet to discuss their experiences, report any problems, and make recommendations. Furthermore, a test is planned of the patient app portal involving 5 participants to adjust the intervention as required before the project begins with the patients. During that time, all HCPs, accompanying patients, and researchers will be trained on how to use the platform.

Once the platform is ready, patients will be registered to use it. Participants will be guided by a member of the research staff (CV or ME), who will confirm their identity and explain platform functionalities. The remote registration system will send a unique verification code to the user’s smartphone with a link to the registration page, where the code will be entered. This is to ensure the security and privacy of patient information.

Our strategy is to re-examine the implementation phase by analyzing the participants’ and stakeholders’ views on implementation barriers and facilitators after implementation (based on qualitative interviews).

To assess the implementation outcomes (for objective 1), a series of interviews will be conducted 1 and 6 months before the transplant and 6 and 12 months after the transplant. These interviews will include questions on acceptability, response burden, and usability.

To evaluate the effort required to complete the questionnaires and further evaluate acceptability, the perceived response burden measure [22] will be used. It consists of a single question on a 5-point response scale adapted from a survey question from the UK Office for National Statistics.

Usability (the extent to which users can achieve the specific goal of a product) and acceptability (how agreeable, pleasant, or satisfactory the intervention is to the stakeholders [6]) are considered important aspects of implementation outcomes [23]. Both aspects will be assessed using the System Usability Scale questionnaire [24], which consists of 10 items rated on a 5-point Likert scale that are then averaged to produce a total score from 1 to 5. The participants’ scores for each question are converted to a new number, added together, and then multiplied by 2.5 to convert the original scores from a scale from 0 to 40 to a scale from 0 to 100. A System Usability Scale score of >68 will indicate that the technology is considered to have an important impact and be useful and easy to use.

Satisfaction with teleconsultations (for objective 4) will be evaluated using the Telemedicine Satisfaction Questionnaire [25], which will be sent to patients after each teleconsultation.

To describe the study sample and collect the data needed to achieve the study objectives, a series of validated questionnaires will be completed by all patients. The questionnaires will cover patient characteristics, the assessment of the partnership relationship between patients and professionals (CADICEE) [26], quality of life (SF-6Dv2) [27], the ability to engage in one’s own care (PAM) [28], the perception of one’s ability to change one’s lifestyle habits [29], monitoring of compliance with medication treatments [30], internet-based 24-hour recall (dietary assessment) [31], the Subjective Global Assessment [32], out-of-pocket costs by patients for health care (CoPaQ) [33], and medical visits and consultations. Table 3 presents a summary of the timing and frequency of data collection. The secure internet-based platform REDCap (Research Electronic Data Capture; Vanderbilt University), an application for building and managing web-based surveys and databases, will be used to administer the questionnaires, organize the data collection, and analyze the data.

Clinical indicators will be determined by the physician in charge of the patient or the team’s kinesiologist. Among the clinical tests specific to this study, the physician will explore signs of hepatic encephalopathy (ie, deterioration of brain function that occurs in people with severe liver failure) using the Stroop test [34] to assess psychomotor speed and cognitive flexibility by recording the response time to interference between recognizing color fields and writing color names performed at different time points during the study (Table 3). Other clinical tests include the Liver Frailty Index [35], which consists of 3 tests representing 3 major components of the multidimensional construct of frailty in patients with cirrhosis: grip strength, chair stands (muscle weakness), and balance (altered neuromotor coordination). Moreover, the 6-Minute Walk Test (6MWT) [36], which assesses aerobic capacity and endurance, will be performed by the team’s kinesiologist during the initial patient assessment (baseline) and every 3 months after the LT. The 6MWT measures the distance covered in 6 minutes (outcome) and will be used to identify changes in performance capacity. In conjunction with the 6MWT, the kinesiologist will also measure calf circumference [37], a representative anthropometric index used to screen for sarcopenia and in patient follow-up to adapt nutritional and exercise plans to meet each patient’s needs throughout the posttransplant period. Other clinical indicators will be collected using COs: blood pressure, weight, pulse, number of steps/type of exercise, and capillary glucose (if needed).

In addition, to monitor the platform’s reliability, we will look at the number of false alerts, the number of interventions required to solve problems related to COs, and the replacement of COs because of technological problems.

Output indicators will also be collected: number of medical visits (hepatologist, nephrologist, cardiologist, endocrinologist, psychiatrist, medical specialist in addiction, and dentist; via telephone, on the platform, or in person), number of nonmedical visits (via telephone, on the platform, or in person), number of emergency room visits, number of hospitalization days while waiting for the transplant and the reasons for these hospitalizations, number of days between registration on the transplant list and the transplant, number of hospitalization days during the transplant, surgical revisions, and number of hospitalization days after the transplant and the reasons for these hospitalizations.

All accompanying patients participating in the study will document each of the meetings carried out with the patient in a logbook that will be available to all researchers and medical personnel in the project as well as in the REDCap application. In the logbook, the accompanying patient will provide information about the patient (last name and first name), the context of the meeting (health care facility, date of the meeting, start and end time of the meeting, person who requested the meeting, meeting number, and people present during the meeting), the stage of the patient’s trajectory (pre-, peri-, or posttransplant stage), meeting method (in person or remotely and location of the meeting), the themes addressed (general aspects, organizational aspects, consequences on daily and family life, and clinical aspects), the accompanying patient’s perceptions of the contribution to the patient and of the relationship with the patient, the difficulties encountered by the accompanying patient, unanswered questions, feedback to the clinical team and planned follow-ups, and any other comments deemed relevant by the accompanying patient. The accompanying patient’s logbook can be found in Multimedia Appendix 1.

The coordinator logbook will capture qualitative and feasibility data that include entries on the following: (1) questions or challenges reported by the participants during consent and baseline educational meetings; (2) details about participant recruitment and fidelity throughout the intervention; (3) the recruitment rate (ie, the proportion of contacted eligible individuals who are included in the study); and (4) the retention rate, defined as the proportion of included participants who are retained over the full follow-up period. Fidelity, or the degree to which the intervention was implemented as intended, will be measured as the proportion of included patients who complete their daily self-assessments over the full follow-up period. The reasons for each of these activities will also be categorized and described based on the detailed information recorded in the coordinator logbook.

All qualitative interviews and focus groups will be conducted individually, preferably in person and, if not, via videoconference or phone. Each interview and focus group will be recorded and follow a semistructured guide with open-ended questions and specific prompts. Although adapted to each stakeholder group, the interview guide includes broad questions on the individual’s experience of and thoughts on using the digital platform follow-up, with prompts on challenges and facilitators [38] as well as open questions to identify information and education needs during the study. The interview guides for each stakeholder group can be found in Multimedia Appendix 2.

With the agreement of patients, accompanying patients, HCPs, managers, and decision makers, all interviews and focus groups will be recorded and transcribed to ensure the reliability of the information collected. The recordings will be transcribed and uploaded into the QDA Miner software (Provalis Research) for further analysis and to identify expected and emerging themes.

Implementation outcomes will be summarized using descriptive statistics. Acceptability and usability will be evaluated using a linear mixed model for each corresponding outcome. The evaluation of perceived response burden and fidelity will be conducted using a generalized linear mixed model for each corresponding outcome, which is appropriate when the dependent variable is not continuous. For all these calculations, the dependent variable of each model will be the outcome, and the independent variables will be the different time points of data collection (Table 3), 3 sociodemographic variables that are reported to influence patient portal use (gender [man or woman], age [≤50 or ≥50 years], and ethnicity), clinical data from the Stroop test, and the presence or absence of relatives during the transplantation process. The goals of testing each model are to determine whether the outcome’s mean score changes significantly over time and whether it differs significantly between the groups represented by the sociodemographic variables over time.

Thus, for acceptability and usability, if at each time point the outcome’s mean score is greater than or equal to the predefined success threshold, then the target will be considered met. If it is below the threshold, we will use a unilateral t test to test the null hypothesis of threshold attainment as being slightly below this mark does not imply failure given the sample mean’s variability. To evaluate threshold attainment during the evaluation of perceived response burden and fidelity, if the observed proportion is under the predefined success threshold, a unilateral z test will be conducted as it is appropriate for hypothesis testing with proportions. Finally, an evaluation of feasibility will be conducted by comparing the observed recruitment and retention rates with the predefined success thresholds at the end of the recruitment period and at the 1-year patient follow-up, respectively. If the observed rates are greater than or equal to the success threshold, the target will be considered met. If they are under the success threshold, we will use a unilateral z test to test the null hypothesis of threshold attainment.

To identify implementation facilitators and barriers and their proposed solutions, 2 analysts will conduct an analysis of the content extracted during the study. The source materials will include semistructured interview and focus group transcripts with the HCPs and the accompanying patients’ logbook entries. The analysis will be conducted in three phases [40]: (1) the preparation phase, or the period during which the analysts become familiarized with the data set; (2) the organization phase, when the analysts systematically code the data using the QDA Miner software to identify implementation facilitators and barriers while remaining open to any possible emerging categories; and (3) the reporting phase, which consists of presenting and discussing the identified categories during monthly team meetings with the clinical and research teams to identify discrepancies either in coding or interpretation, ensuring data reliability.

A qualitative analysis will be conducted of the patients’ health status, including visits to emergency rooms and continuous clinical monitoring as well as the reasons underlying participant contact with the team of HCPs (Table 1). This information will be monitored continuously and extracted from the medical records. Moreover, a content analysis will be conducted to assess the nature of contact with the accompanying patient based on the data collected in the accompanying patient logbooks. In addition, a content analysis will be conducted to assess expectations and experience with the health care model as well as the user experience with the digital platform and COs using data collected during interviews and from discussion groups (Multimedia Appendix 1).

Descriptive statistics will be used to report patient outcomes collected from medical records (Table 1), daily health data self-reported through the use of COs, self-reported questionnaires completed throughout the study (Table 3), and patient satisfaction with teleconsultations and tools. For the analysis, each patient constitutes their own reference and comparison. Thus, δ calculations will be conducted, derived by comparing individual questionnaire results with outcomes from the same questionnaires at other time points throughout the study (ie, baseline vs time points before and after transplantation). For continuous outcomes, the mean, SD, minimum, and maximum values will be reported. For ordinal and nominal qualitative outcomes, absolute and relative frequencies (proportions) will be reported. Descriptive statistics will also be presented by gender and age group.

A cost minimization analysis will be used to meet this objective. The out-of-pocket costs for the patient and the caregiver will be measured using the cost for patient questionnaire, which was developed and validated in Quebec [41,42]. The costs for the health care institution will be measured using the PowerHealth software (PowerHealth Solutions) used at the CHUM, which combines financial data with data in patient clinical files. The costs for the health care system will include the costs borne by the institution, including physician remuneration. To identify these costs, a questionnaire on medical visits and consultations will be sent to the patient every 3 months so that the patient can indicate the number and nature of these events. The Régie de l’assurance maladie du Québec pricing manual will then be used to identify these costs.

Ethics approval was obtained from the research ethics board at the Centre hospitalier de l’Université de Montréal (CHUM), Quebec, Canada (study ID: 20-5185). The research team and principal investigators at the hospital are responsible for recruitment and monitoring of participants. Any major modifications or protocol deviations are discussed with the other principal investigators during monthly meetings, and any major protocol modifications are reported and submitted to the ethics board for approval. Participants will be approached by the project medical team and then by the research team to inform them about the objectives, benefits, and risks of the research. If the participant is accepted for LT, the research team will meet with the patient and have them sign the consent form.

There are no direct risks to participants in this study. Data security risks will be addressed through numerous measures, such as copying data to the CHUM Research Centre (CRCHUM) server and protecting them with a user code and password. Moreover, the study questionnaires, semistructured interviews, and accompanying patient logbook sessions may lead to distress related to the transplant procedure or follow-up, the economic details collected, or depression and anxiety explorations. Therefore, these research tasks carry a risk of emotional vulnerability. Individuals who experience psychological distress because of their involvement in the study will be instructed to inform a member of the study staff. Regular psychological assessments or support services will be provided by the team’s psychologist throughout the study.

All collected data and personal information will be deidentified (coded) and kept in computer format at the CRCHUM. No identification of individual participants in any images of the manuscripts or supplementary materials will be possible. When the study results are released, participants will not be identifiable. The project’s principal investigator (MPP) and coinvestigators will have access to the data and study results. All computer data will be copied to the CRCHUM server and protected by a user code and password. Research data will be retained for 10 years after project closure. The person in charge will be the principal investigator of the study, MPP. To join the scientific community, peer-reviewed scientific publications will be recommended.

No financial compensation is offered for participating in this study. However, patients will have access at no cost to all COs and follow-up consultations.