The Family Communication Study: A randomized trial of prospective pediatric palliative care consultation, study methodology and perceptions of participation burden.
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 ≥8days was the trigger for early palliative care involvement.



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 3months 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.



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.



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.
Dept. of Bioethics and Humanities, School of Medicine, University of Washington, Seattle, WA, United States; Dept. of Pediatrics, School of Medicine, University of Washington, Seattle, WA, United States; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, WA, United States. Electronic address: tigiba@uw.edu.
Helene
H
Starks
Cambia Palliative Care Center of Excellence, University of Washington, Seattle, WA, United States; Dept. of Biobehavioral Nursing & Health Systems, School of Nursing, University of Washington, Seattle, WA, United States; Department of Anesthesiology and Pain Medicine, School of Medicine, University of Washington, Seattle, WA, United States.
Ardith
A
Doorenbos
Cambia Palliative Care Center of Excellence, University of Washington, Seattle, WA, United States; School of Social Work, University of Washington, Seattle, WA, United States.
Taryn
T
Lindhorst
Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States.
Erica
E
Bourget
Department of Anesthesiology and Pain Medicine, School of Medicine, University of Washington, Seattle, WA, United States; School of Social Work, University of Washington, Seattle, WA, United States.
Eugene
E
Aisenberg
Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States.
Natalie
N
Oman
Department of Biostatistics, University of Washington, Seattle, WA, United States.
Tessa
T
Rue
Dept. of Bioethics and Humanities, School of Medicine, University of Washington, Seattle, WA, United States; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, WA, United States; Dept. of Medicine, Division of Pulmonary and Critical Care Medicine, School of Medicine, University of Washington, Seattle, WA, United States.
J Randall
JR
Curtis
Dept. of Bioethics and Humanities, School of Medicine, University of Washington, Seattle, WA, United States; Dept. of Pediatrics, School of Medicine, University of Washington, Seattle, WA, United States; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, WA, United States; Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States; Dept. of Rehabilitative Medicine, School of Medicine, University of Washington, Seattle, WA, United States.
Ross
R
Hays
D000328:Adult; D001294:Attitude to Health; D002648:Child; D002675:Child, Preschool; D005190:Family / Q000523:psychology*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D065126:Palliative Medicine; D010290:Parents / Q000523:psychology; D010372:Pediatrics; D010465:Perception; D012017:Referral and Consultation; D013315:Stress, Psychological / Q000523:psychology*; D011795:Surveys and Questionnaires; D055815:Young Adult
Family/caregivers psychology; Intensive care unit; Pediatrics; Psychological adaptation; Randomized trial; Stress disorders