Assessment of shared decision-making tool for eliciting informed goals of care in the hospitalized elderly (ASKmeGOC): protocol for a randomized clinical trial.

backgroundGoals of care discussions (GOCDs) occur between patients, substitute decision-makers, and healthcare providers to ensure shared decision-making about treatment preferences that are aligned with both patients' values and goals and healthcare provider recommendations. GOCDs promote patient autonomy and high-value care. This study will examine the real-world effectiveness of using a novel ASKmeGOC e-tool (ASKmeGOC e-tool) to support nursing-facilitated GOCDs with patients and their substitute decision-makers. We hypothesize that these GOCDs will be acceptable to patients and attending physicians, promote more informed decisions about life-sustaining treatment preferences, and result in fewer undocumented CODE STATUS preferences that will result in both reduced rates of intensive care utilization and direct patient hospitalization costs compared to usual GOCDs conducted by physicians.

methodsThe ASKmeGOC trial is designed as a prospective, single-center, stratified, parallel group, allocation concealed, assessor masked, randomized, pragmatic, mixed-method, and comparative effectiveness trial. This study will enrol all consecutive hospitalized patients ≥ 80 years old. Patients will be randomized 1:1 to either the ASKmeGOC intervention or usual GOCD control group. The primary outcomes include total days of intensive care, ventilator and dialysis utilization during both the index hospitalization, and at 12 months post-admission. The hypothesized sample size is 950 participants per group to demonstrate a reduction in utilization of ≥ 20%. Count regression models will be used to analyze the primary outcomes using an intention-to-treat approach. DISCUSSION: Ensuring patient autonomy in medical decision-making is an essential human right, and GOCDs are critical to ensure patient-centered medical care. This study will evaluate the real-world effectiveness of a novel tool to facilitate GOCDs by non-physician healthcare providers. If shown to be effective, the plan is to spread and scale the tool to other acute care hospitals, primary care practices, and assisted living facilities to evaluate the implementation effectiveness of its use in different healthcare environments by different healthcare providers with the goal of ensuring equitable access to standardized GOCDs to all eligible patients.

trial registrationClinicalTrials.gov NCT06002113. Registered on July 27, 2023.