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Article History

Received: 3 June 2025

Accepted: 21 November 2025

First Online: 16 December 2025

Declarations

:

: The study received ethics approval by the Royal Victoria Regional Health Centre Research Ethics Board (September 2, 2022; REB Study No. R22-003). For patients randomized to the f-GOCD group, study ICU nurses will obtain verbal consent from competent patients or, otherwise, their substitute decision-makers. A waiver of the requirements for signed informed consent is requested for the f-GOCD intervention arm of the study. This approach is justified in comparative effectiveness trials involving the randomization of patients to one or more standard of care interventions [ ] because the trial poses no more than minimal risk, the alteration from written to verbal consent does not materially affect the rights or welfare of the patient, and verbal consent would be the usual approach used to initiate any GOCD with any patient and/or their substitute decision-maker during routine clinical care. In our pilot study, we used verbal consent from patients or their substitute decision-makers without any adverse consequences documented. Using this approach, 90.2% (95% CI 76.9, 97.3) of patients or their substitute decision-makers consented to receiving the f-GOCD intervention (42). In that study, 100% of patients or their substitute decision-makers completed the intervention. In addition, these patients will be approached for written verbal consent, documented by electronic e-signatures via REDCap by the Clinical Research Associate (CRA) after completion of the GOCD intervention and asked to complete the 7-item SDM GOCD tool evaluation questionnaire. For those participants who consent, the CRA may help them complete the survey during the index hospitalization. These surveys will only be completed during the index hospitalization. Only completed surveys will be compared between groups. For all participants in both the control and intervention arms, the CRA will seek verbal consent to complete the Quality of Communications and 4-item SURE questionnaires. These questionnaires will only be available for completion during the index hospitalization. The CRA will approach these patients for verbal consent after their CODE STATUS has been completed and documented in the EMR. The rationale for not requiring written consent in this part of the study is a quality improvement initiative as the results of the two questionnaires will be fed back to the physicians who signed the patient’s CODE STATUS and the organization so that subsequent improvements can be made in how we approach patients and their substitute decision-makers for end-of-life care decisions. Patients or their substitute decision-makers will be told that they may refuse to participate or withdraw their participation after consent at any time without fear of their ongoing care being compromised. Patients or their substitute decision-makers will be informed that any preferences documented in the CODE STATUS can be changed at any time during their hospitalization, and the trial personnel or principal investigators will be available to answer any questions they may have after the f-GOCD intervention has been completed. Trial personnel will be available to review any questions related to a previously completed CODE STATUS and will also be available to assist patients or their substitute decision-makers in revising these at any time during their index hospitalization.

: Not applicable.

: The authors declare that they have no competing interests.