The Effects of Expectation Setting and Bundle Consent on Acute Caregiver Stress in the PICU: A Randomized Controlled Trial

OBJECTIVES:Having a child admitted to the PICU is a stressful experience for parents and can have long-term negative mental health consequences. The objective was to determine if formalized expectation setting and bundled consent for invasive procedures upon admission impacts the acute stress burden on parents. DESIGN:Prospective cluster randomized controlled trial. SETTING:Single-center, tertiary PICU. SUBJECTS:Parents/guardians of patients, 0-18 years old, admitted to PICU. INTERVENTIONS:During experimental weeks, all patients admitted to PICU were bundled-consented for common procedures and given a novel unit introductory letter and "Common Procedures Explained" document. During control weeks, all patients were consented for invasive procedures with separate consents for each procedure. Parents then completed a demographic survey and Stress Overload Scale-Short (SOS-S) 48-72 hours after their child's admission. For each participant, the SOS-S generates a Personal Vulnerability (PV) score and an Event Load (EL) score. Parents' perception of the life-threatening nature of their child's condition was also evaluated. MEASUREMENTS AND MAIN RESULTS:Over 73 weeks, 1,882 patients were screened and 261 consented to the SOS-S. Median PV score was 10.4 in the control group and 9.1 in the experimental group (p = 0.15). Median EL score was 11.3 for the control group and 10.5 in the experimental group (p = 0.42). Adjusting for demographic variables and severity of illness, there was no independent association between either PV or EL and bundled consent. However, a parent's perception of threat-to-life was significantly related to the allocated group (p = 0.036), which resulted in a decreased percentage of parents who rated their child's illness as "Extremely" life-threatening (experimental group, 17% vs control group, 26%). CONCLUSIONS:This study did not demonstrate a decrease in stress when bundled consent was obtained. However, this intervention decreased the parents' perceived severity of illness. Further multicenter studies are needed to evaluate the effects of bundled consent on parents.