The Family Communication Study: A randomized trial of prospective pediatric palliative care consultation, study methodology and perceptions of participation burden☆

Abstract Background To describe the study methods, baseline characteristics and burden of study procedures of an intervention designed to reduce family stress symptoms through early support from the palliative care team. Length of stay of ≥ 8 days was the trigger for early palliative care involvement. Methods Cluster-randomized trial with children as the unit of randomization. Up to 3 family members per child were recruited. Family stress symptoms were recorded at baseline, discharge from the ICU, and 3 months post-enrollment. Questionnaire burden was assessed on a 1–10 point scale at each time point and open-ended comments were analyzed to describe the participants' experience in the study. Results 380 family members of 220 children (control = 115 children and 204 family members; intervention = 105 children and 176 family members) were recruited, which represented 50% of all eligible families. Most family participants were parents (86% control; 92% intervention) and female (66% both groups). Retention rates were high through the 3-month follow-up: 93% and 90% for the control and intervention groups respectively. Questionnaire burden was very low: mean (sd) scores were 1.1 (1.6), 0.7 (1.5), and 0.9 (1.6) for the baseline, discharge and follow-up questionnaires, respectively. Comments suggest that participation was beneficial by promoting reflection and self-awareness about stress, coping and resilience, and feeling cared for because the intervention and questionnaires focused on their own well-being. Conclusions The participants' comments regarding the focus on them as the point of intervention reflects the value of conducting research with family members of seriously ill children during ICU stays.