Facilitating communication for critically ill patients and their family members: Study protocol for two randomized trials implemented in the U.S. and France.

Abstract Background Critically-ill patients and their families suffer a high burden of psychological symptoms due, in part, to many transitions among clinicians and settings during and after critical illness, resulting in fragmented care. Communication facilitators may help. Design and intervention We are conducting two cluster-randomized trials, one in the U.S. and one in France, with the goal of evaluating a nurse facilitator trained to support, model, and teach communication strategies enabling patients and families to secure care consistent with patients' goals, beginning in ICU and continuing for 3 months. Participants We will randomize 376 critically-ill patients in the US and 400 in France to intervention or usual care. Eligible patients have a risk of hospital mortality of greater than15% or a chronic illness with a median survival of approximately 2 years or less. Outcomes We assess effectiveness with patient- and family-centered outcomes, including symptoms of depression, anxiety, and post-traumatic stress, as well as assessments of goal-concordant care, at 1-, 3-, and 6-months post-randomization. The primary outcome is family symptoms of depression over 6 months. We also evaluate whether the intervention improves value by reducing utilization while improving outcomes. Finally, we use mixed methods to explore implementation factors associated with implementation outcomes (acceptability, fidelity, acceptability, penetration) to inform dissemination. Conducting the trial in U.S. and France will provide insights into differences and similarities between countries. Conclusions We describe the design of two randomized trials of a communication facilitator for improving outcomes for critically ill patients and their families in two countries.