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      Remote Follow-up of Self-isolating Patients With COVID-19 Using a Patient Portal: Protocol for a Mixed Methods Pilot Study (Opal-COVID Study)

      , PhD 1 , 2 , 3 , , PhD 1 , 2 , , MSc 1 , 2 , 3 , 4 , , PhD 1 , 2 , 3 , 5 , , PhD 2 , 6 , Opal-COVID-19 Patient Expert Committee 2 , , MD 1 , 3 , , MD 3 , , MD 3 , 7 , , MD 3 , , PhD 8 , , MD 9 , , MD 10 , , PhD 11 , , MD 12 , , MD, PhD 1 , 2 , 3 , 5 ,
      (Reviewer), (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      SARS-CoV-2, coronavirus, infectious disease, implementation science, Canada, patient portal, telehealth, telemedicine, app, health information technology, remote monitoring, mobile phone

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          People 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.


          This 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.


          This 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.


          Between 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.


          This 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 Registration

          ClinicalTrials.gov NCT04978233; https://clinicaltrials.gov/ct2/show/NCT04978233

          International Registered Report Identifier (IRRID)


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          Most cited references61

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          The psychological impact of quarantine and how to reduce it: rapid review of the evidence

          Summary The December, 2019 coronavirus disease outbreak has seen many countries ask people who have potentially come into contact with the infection to isolate themselves at home or in a dedicated quarantine facility. Decisions on how to apply quarantine should be based on the best available evidence. We did a Review of the psychological impact of quarantine using three electronic databases. Of 3166 papers found, 24 are included in this Review. Most reviewed studies reported negative psychological effects including post-traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma. Some researchers have suggested long-lasting effects. In situations where quarantine is deemed necessary, officials should quarantine individuals for no longer than required, provide clear rationale for quarantine and information about protocols, and ensure sufficient supplies are provided. Appeals to altruism by reminding the public about the benefits of quarantine to wider society can be favourable.
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            Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

            Background Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. Methods We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. Results The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. Conclusion The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.
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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.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                August 2022
                18 August 2022
                18 August 2022
                : 11
                : 8
                : e35760
                [1 ] Research Institute of the McGill University Health Centre Centre for Outcomes Research & Evaluation Montreal, QC Canada
                [2 ] See Acknowledgments
                [3 ] Department of Medicine Division of Infectious Diseases and Chronic Viral Illness Service McGill University Health Centre Montreal, QC Canada
                [4 ] Department of Mechanical Engineering École Polytechnique de Montréal Montreal, QC Canada
                [5 ] Department of Family Medicine Faculty of Medicine McGill University Montreal, QC Canada
                [6 ] Department of Mathematics and Statistics Université de Montréal Montreal, QC Canada
                [7 ] Department of Psychiatry Faculty of Medicine McGill University Montreal, QC Canada
                [8 ] Medical Physics Unit McGill University Montreal, QC Canada
                [9 ] Department of Radiation Oncology McGill University Health Centre Montreal, QC Canada
                [10 ] Centre hospitalier de l’Université de Montréal Montreal, QC Canada
                [11 ] Department of Medicine Divisions of Experimental Medicine, Clinical Epidemiology, Respiratory Medicine, and Rheumatology McGill University Montreal, QC Canada
                [12 ] Department of Medicine Division of Medical Oncology McGill University Health Centre Montreal, QC Canada
                Author notes
                Corresponding Author: Bertrand Lebouché bertrand.lebouche@ 123456mcgill.ca
                Author information
                ©David Lessard, Kim Engler, Yuanchao Ma, Adriana Rodriguez Cruz, Serge Vicente, Opal-COVID-19 Patient Expert Committee, Nadine Kronfli, Sapha Barkati, Marie-Josée Brouillette, Joseph Cox, John Kildea, Tarek Hijal, Marie-Pascale Pomey, Susan J Bartlett, Jamil Asselah, Bertrand Lebouché. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 18.08.2022.

                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.

                : 16 December 2021
                : 12 May 2022
                : 28 June 2022
                : 11 July 2022

                sars-cov-2,coronavirus,infectious disease,implementation science,canada,patient portal,telehealth,telemedicine,app,health information technology,remote monitoring,mobile phone


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