Curtis 2016.

Methods	Design: RCT
Participants	Setting: 5 ICUs in 2 hospitals Type of trauma exposure: family members of patients in ICU with high risk of mortality. Inclusion criteria: predicted mortality ≥ 30% and a surrogate decision maker. Eligibility criteria for patients included: in ICU for > 24 hours; aged > 18 years; mechanically ventilated at enrolment; SOFA score ≥ 6 or diagnostic criteria predicting a ≥ 30% risk of hospital mortality; legal surrogate decision maker to consent for patient participation; and a family member able to come to the hospital. Eligibility criteria for family members included aged > 18 years and able to complete consent process and questionnaires in English. Exclusion criteria: none. Sample size: 2209 ICU patients screened for eligibility. Family members for 488 patients approached for participation and 170 enrolled; 2 family members withdrew before randomisation. The 168 randomised patients had 268 family members who participated. Mean age of family member participants where available: 50.85 (SD 13.12) years Gender (family members): 79 (29.5%) men; 189 (70.5%) women. Ethnicity where available: 4.8% African‐American; 84.8% white; 2.2% Asian; 3.9% Native American; 0.4% Native Hawaiian; 3.9% other or mixed Country: USA
Interventions	Group 1: communication facilitator: n = 137 Communication facilitators assisted families of patients by providing communication support during the ICU stay with the aim to increase families' and clinicians' self‐efficacy expectations about communication in the ICU. Intervention included: interviews by facilitators with family to understand the family's concerns, needs and communication characteristics; meetings by facilitators with physicians, nurses or other clinicians offering brief summary of family concerns, needs and communication characteristics; provision of communication and emotional support adapted to the family member's attachment style; facilitator participation in family conferences and 24‐hour follow‐up with the family after discharge to acute care. Group 2: usual care: n = 131
Outcomes	PTSD: PCL Other: PHQ‐9; GAD‐7; length of stay in ICU; cost of care Follow‐up: symptoms were assessed 3 and 6 months after the patient died in, or was discharged from, the ICU.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was stratified by hospital in block sizes of six, with results provided to study staff in sealed, opaque, consecutively numbered envelopes". Comment: information in the study paper implied computer‐based randomisation.
Allocation concealment (selection bias)	Low risk	As above
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Follow‐up surveys assessing depression, anxiety and PTSD were mailed to family members' homes at follow‐up points.
Incomplete outcome data (attrition bias) All outcomes	High risk	Loss to follow‐up was high. Analysis was based on 133 (49.6%) of those randomised at 3 months and 122 (45.5%) at 6 months.
Selective reporting (reporting bias)	Low risk	Results reported as described in preregistered protocol.
Other bias	Unclear risk	Eligibility criteria were changed during the trial to improve recruitment: the required SOFA score was lowered from ≥ 10 to ≥ 6.