JMIR Res Protoc. 2022 Jul 11. doi: 10.2196/35760. Online ahead of print.
ABSTRACT
BACKGROUND: Individuals diagnosed with COVID-19 are instructed to self-isolate at home. However, during self-isolation, they may experience anxiety and insufficient care. Patient portals can allow patients to self-monitor and share their health status with healthcare professionals for remote follow-up, but little data is available on the feasibility of their use.
OBJECTIVE: This manuscript presents the protocol of the Opal-COVID Study which has four objectives: 1) assess the implementation of using the Opal patient portal for distance monitoring of COVID-19 patients self-isolating at home; 2) identify influences on the intervention’s implementation; and describe 3) service and 4) patient outcomes of this intervention.
METHODS: This mixed-method pilot study aims to recruit 50 COVID-19 patient participants tested at the McGill University Health Centre (Montreal, Canada) for 14 days of remote follow-up. With access through a smartphone app to an existing patient portal configured for this study, 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, recruitment/retention rates and fidelity, as well as on the frequency and nature of contacts with healthcare professionals via Opal. 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 to the qualitative analyses, for Objective 2 (influences on implementation), semi-structured qualitative interviews will be conducted with four groups of stakeholders (i.e., patient participants, healthcare professionals, technology developers and study administrators) and submitted to content analysis, guided by the Consolidated Framework for Implementation Research to help identify barriers and facilitators of implementation. For Objective 3 (service outcomes), reasons for contacting healthcare professionals through Opal will also be submitted to content analysis.
RESULTS: Between December 2020 and March 2021, 51 patient-participants were recruited. Qualitative interviews were conducted with 39 involved stakeholders, from April to September 2021. Delays were experienced due to measures taken at the MUHC to address COVID-19. The quantitative and qualitative analyses began in May 2022. As of June 2022, two manuscripts (respectively on the implementation and the patient outcomes) were being prepared and three 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.
CLINICALTRIAL: ClinicalTrials.gov identifier NCT04978233.
INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/35760.
PMID:35820054 | DOI:10.2196/35760
