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

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, 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

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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://ichgcp.net/clinical-trials-registry/NCT04978233.

International registered report identifier (irrid): DERR1-10.2196/35760.

Keywords: Canada; SARS-CoV-2; app; coronavirus; health information technology; implementation science; infectious disease; mobile phone; patient portal; remote monitoring; telehealth; telemedicine.

Conflict of interest statement

Conflicts of Interest: BL has received research support and consulting fees from ViiV Healthcare, Merck, and Gilead. NK reports research funding from Gilead Sciences, advisory fees from Gilead Sciences, ViiV Healthcare, Merck, and AbbVie, and speaker fees from Gilead Sciences and Merck, all outside of the submitted work.

©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.

Figures

Figure 1
Figure 1
Opal-COVID Study patient participant path.

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