Protocol for a mixed method acceptability evaluation of a codesigned bundled COmmunication intervention for use in the adult ICU during the COVID-19 PandEmic: the COPE study.

Introduction: Patients requiring invasive mechanical ventilation via an artificial airway experience sudden voicelessness placing them at risk for adverse outcomes and increasing provider workload. Infection control precautions during the COVID-19 pandemic, including the use of personal protective equipment (eg, gloves, masks, etc), patient isolation, and visitor restrictions may exacerbate communication difficulty. The objective of this study is to evaluate the acceptability of a codesigned communication intervention for use in the adult intensive care unit when infection control precautions such as those used during COVID-19 are required.

Methods And Analysis: This three-phased, prospective study will take place in a medical surgical ICU in a community teaching hospital in Toronto. Participants will include ICU healthcare providers, adult patients and their family members. Qualitative interviews (target n: 20-25) will explore participant perceptions of the barriers to and facilitators for supporting patient communication in the adult ICU in the context of COVID-19 and infection control precautions (phase 1). Using principles of codesign, a stakeholder advisory council of 8-10 participants will iteratively produce an intervention (phase 2). The codesigned intervention will then be implemented and undergo a mixed method acceptability evaluation in the study setting (phase 3). Acceptability, feasibility and appropriateness will be evaluated using validated measures (target n: 60-65). Follow-up semistructured interviews will be analysed using the theoretical framework of acceptability (TFA). The primary outcomes of this study will be acceptability ratings and descriptions of a codesigned COmmunication intervention for use during and beyond the COVID-19 PandEmic.

Ethics And Dissemination: The study protocol has been reviewed, and ethics approval was obtained from the Michael Garron Hospital. Results will be made available to healthcare providers in the study setting throughout the study and through publications and conference presentations.