Effect of a Standardized Family Participation Program in the ICU: A Multicenter Stepped-Wedge Cluster Randomized Controlled Trial*

Abstract

Objectives: To determine the effect of a standardized program for family participation in essential care activities in the ICU on symptoms of anxiety, depression, posttraumatic stress and satisfaction among relatives, and perceptions and experiences of ICU healthcare providers (HCPs). Design: Multicenter stepped-wedge cluster randomized controlled trial. Setting: Seven adult ICUs, one university, and six general teaching hospitals. Participants: Three hundred six relatives and 235 ICU HCPs. Interventions: A standardized program to facilitate family participation inpatient communication, amusement/distraction, comfort, personal care, breathing, mobilization, and nutrition. Measurements and Main Results: Data were collected through surveys among relatives and ICU HCPs. There were no significant differences in symptoms of anxiety in relatives in the intervention period compared with the control period (median Hospital Anxiety and Depression Scale [HADS] 5 [interquartile range (IQR) 2–10] vs 6 [IQR 3–9]; median ratio [MR] 0.72; 95% CI, 0.46–1.13; p = 0.15), depression (median HADS 4 [IQR 2–6] vs 3 [IQR 1–6]; MR 0.85; 95% CI, 0.55–1.32; p = 0.47) or posttraumatic stress (median Impact of Event Scale-Revised score 0.45 [IQR 0.27–0.82] vs 0.41 [IQR 0.14–1]; MR 0.94; 95% CI, 0.78–1.14; p = 0.54). Reported satisfaction was slightly lower in the intervention period (mean 8.90 [sd 1.10] vs mean 9.06 [sd 1.10], difference –0.60; 95% CI, –1.07 to –0.12; p = 0.01). ICU HCPs perceived that more relatives knew how to participate: 47% in the intervention period versus 22% in the control period (odds ratio [OR] 3.15; 95% CI, 1.64–6.05; p < 0.01). They also reported relatives having sufficient knowledge (41% vs 16%; OR 3.56; 95% CI, 1.75–7.25; p < 0.01) and skills (44% vs 25%; OR 2.38; 95% CI, 1.22–4.63; p = 0.01) to apply family participation. Conclusions: Application of a standardized program to facilitate family participation did not change mental health symptoms in relatives of ICU patients 3 months after discharge. ICU HCPs reported increased clarity, knowledge, and skills among relatives and ICU HCPs.

Family Members' Engagement in Symptom Communication, Assessment, and Management in the Intensive Care Unit

“…A review of family members' role in pain management in the ICU concluded that family members were willing and capable of contributing in pain assessment and management, but research on this topic was scarce 26 . In existing literature, family members' contribution in the ICU is commonly described as either family participation, 27 family involvement, 2,12 or family engagement 28 . For this study, family engagement is considered the proper term to use, as the researchers understand “engagement” as more proactive than “participation” or “involvement.” There is a gap in knowledge about family members' engagement in symptom communication, assessment, and management.…”