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Randomized Controlled Trial
. 2016 Jul:49:15-20.
doi: 10.1016/j.cct.2016.05.004. Epub 2016 Jun 1.

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

Helene Starks  1 , Ardith Doorenbos  2 , Taryn Lindhorst  3 , Erica Bourget  4 , Eugene Aisenberg  5 , Natalie Oman  4 , Tessa Rue  6 , J Randall Curtis  7 , Ross Hays  8
Affiliations
Randomized Controlled Trial

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

Helene Starks et al. Contemp Clin Trials. 2016 Jul.

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 ≥8days 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 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.

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.

Trial registration: ClinicalTrials.gov NCT02144779.

Keywords: Family/caregivers psychology; Intensive care unit; Pediatrics; Psychological adaptation; Randomized trial; Stress disorders.

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Figures

Figure 1
Figure 1
Family Adjustment and Adaptation Response Framework (FAAR) Informing Intervention Design
Figure 2
Figure 2
Example of Consult Note Template
See this image and copyright information in PMC

References

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