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      Telehealth-Delivered Program and Accompanying Patients to Enhance the Clinical Condition of Patients Throughout a Liver Transplant: Protocol for a Mixed Methods Study

      research-article
      , MD, PhD 1 , 2 , 3 , , , PhD 1 , 4 , 5 , , MSc 1 , , MSc 1 , 6 , , MSc 1 , 7 , 8 , , PhD 9 , , PhD 2 , 10 , 11 , 11 , , MSc 11 , , MSc 1 , , PhD 1 , , PhD 1 , , MD 7 , 11 , , MD 7 , 11 , , PhD 9 , , MSc 1 , , MSc 12 , , MD 7 , 11
      (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      liver transplantation, accompanying patients, connected objects, health care model, digital platform

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          Abstract

          Background

          Liver 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.

          Objective

          This 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.

          Methods

          Six 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.

          Results

          In 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.

          Conclusions

          The 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

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          Most cited references48

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          The qualitative content analysis process.

          This paper is a description of inductive and deductive content analysis. Content analysis is a method that may be used with either qualitative or quantitative data and in an inductive or deductive way. Qualitative content analysis is commonly used in nursing studies but little has been published on the analysis process and many research books generally only provide a short description of this method. When using content analysis, the aim was to build a model to describe the phenomenon in a conceptual form. Both inductive and deductive analysis processes are represented as three main phases: preparation, organizing and reporting. The preparation phase is similar in both approaches. The concepts are derived from the data in inductive content analysis. Deductive content analysis is used when the structure of analysis is operationalized on the basis of previous knowledge. Inductive content analysis is used in cases where there are no previous studies dealing with the phenomenon or when it is fragmented. A deductive approach is useful if the general aim was to test a previous theory in a different situation or to compare categories at different time periods.
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            Developing and evaluating complex interventions: the new Medical Research Council guidance

            Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
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              Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda

              An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of “implementation outcomes” distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                2024
                22 March 2024
                : 13
                : e54440
                Affiliations
                [1 ] Carrefour de l’Innovation Centre de recherche du Centre hospitalier de l'Université de Montréal Montréal, QC Canada
                [2 ] Département de gestion évaluation et politique de santé, école de santé publique Université de Montréal Montreal, QC Canada
                [3 ] Centre d’excellence sur le partenariat avec les patients et le public Montreal, QC Canada
                [4 ] Université Paris Cité ECEVE UMR 1123, Inserm, Faculté de Médecine Paris France
                [5 ] AP-HP.Nord-Université Paris Cité Hôpital Universitaire Robert Debré Unité d'épidémiologie clinique, Inserm, CIC 1426 Paris France
                [6 ] Regroupement cardio-vasculaire, hépatologie et transplantation Centre hospitalier de l'Université de Montréal Montreal, QC Canada
                [7 ] Axe immunopathologie Centre de recherche du Centre hospitalier de l'Université de Montréal Montreal, QC Canada
                [8 ] Réseau transplantation et cliniques externes de transplantation et d’hépatologie Centre hospitalier de l'Université de Montréal Montreal, QC Canada
                [9 ] Axe Cardiométabolique Centre de recherche du Centre hospitalier de l'Université de Montréal Montreal, QC Canada
                [10 ] Centre de recherche de l’IUSMM CIUSSS de l’Est de l’Île de Montréal Montreal, QC Canada
                [11 ] Département d’hépatologie Centre hospitalier universitaire de Montréal (CHUM) Montreal, QC Canada
                [12 ] Direction de la biovigilance et de la biologie médicale Ministère de la Santé et des Services sociaux du Québec Montreal, QC Canada
                Author notes
                Corresponding Author: Marie-Pascale Pomey marie-pascale.pomey@ 123456umontreal.ca
                Author information
                https://orcid.org/0000-0001-5180-8139
                https://orcid.org/0000-0002-2238-7133
                https://orcid.org/0009-0006-1176-9124
                https://orcid.org/0009-0002-7678-9696
                https://orcid.org/0000-0003-3680-9437
                https://orcid.org/0000-0003-2757-5958
                https://orcid.org/0000-0001-7017-096X
                https://orcid.org/0009-0006-3604-9457
                https://orcid.org/0009-0002-8573-3029
                https://orcid.org/0009-0000-8361-9463
                https://orcid.org/0009-0004-2736-9323
                https://orcid.org/0000-0003-2354-9541
                https://orcid.org/0000-0002-8166-8090
                https://orcid.org/0009-0000-2591-1351
                https://orcid.org/0009-0006-3738-2083
                https://orcid.org/0000-0001-9854-6834
                https://orcid.org/0000-0001-8419-0507
                https://orcid.org/0009-0004-1270-2437
                https://orcid.org/0000-0001-9711-8010
                Article
                v13i1e54440
                10.2196/54440
                10998179
                38517464
                43135138-f6c8-4ca4-9ae3-e247ca6ddd4f
                ©Marie-Pascale Pomey, Enora Le Roux, Nathalie Nadon, Jessie Perron, Angèle Barry, Chantal Bémeur, Thomas G Poder, Fernand Duford, Louise Laviolette, Johanne Tétrault-Lassonde, Cécile Vialaron, Manuel J Escalona, Louise Normandin, Geneviève Huard, Catherine Girardin, Christopher Rose, Kathy Malas, Denis Ouellet, Catherine Vincent. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.03.2024.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 16 November 2023
                : 28 January 2024
                : 2 February 2024
                : 5 February 2024
                Categories
                Protocol
                Protocol

                liver transplantation,accompanying patients,connected objects,health care model,digital platform

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