Pilot RCT assessing the impact of the family support tool on family members' ratings of the quality of communication in ICUS

Rationale: Family members of incapacitated, critically ill patients often struggle in the role of surrogate decision maker and experience breakdowns in communication with clinicians. We assessed in a pilot RCT the impact of an interactive, web‐based tool designed to support surrogates and improve surrogate‐clinician communication on ratings of the quality of communication and shared decision‐making in ICUs. Methods: We conducted a two‐arm, single blind, patient‐level randomized pilot trial comparing the Family Support Tool (FST) to augmented usual care. Eligible subjects included surrogates of incapacitated patients judged by their physicians to have ≥40% risk of death or severe long‐term functional impairment. The control arm involved usual care augmented to receive family meetings within 2 days and 5‐9 days of study enrollment. The intervention group received unlimited access to the FST tool, with prompts to complete specific content upon enrollment and before two family meetings. The first section of the FST, viewed upon enrollment, contains brief videos and graphics to orient surrogates to the ICU, convey support, and provide self‐care tips. Subsequent sections, viewed prior to the first and second family meetings, contain content to help surrogates prepare for family meetings, elicited surrogates' questions, prognostic expectations, and patients' values and preferences‐ and described treatment pathways (full life support, time‐limited trial, comfortfocused care). Research staff shared with clinicians a one‐page summary of the surrogates' main responses to questions on the FST before family meetings. Blinded research staff collected surrogates' responses to the Quality of Communication (QOC) questionnaire by telephone three months after discharge. We analyzed the QOC overall rating and 6 items which correspond to core aspects of the shared decision‐making process: giving information, listening to questions, discussing prognosis, eliciting patient preferences, including and assisting surrogate in decision‐making. We used t‐tests to compare scores between groups. Results: Of 52 enrolled patients, 47 completed the QOC scale. As summarized in the Table, surrogates in the FST arm reported higher QOC overall ratings than the control group, a difference that did not reach statistical significance due to small sample size. Similar trends were observed in all questions pertaining to shared decision‐making (Table 1). Conclusions: Although underpowered to achieve statistical significance, this pilot trial suggests that the FST may improve families' overall rating of the quality of communication and shared decision‐making. These results support proceeding with an appropriately powered trial to assess the efficacy of the tool on patient‐ and family‐level outcomes. (Table Presented) .