Many survivors of critical illness and their family members experience significant psychological distress after hospital discharge.
To determine if assigning participants to a postdischarge coping-skills training (CST) program reduces patient and family psychological distress compared with assigning participants to an educational program.
A multicenter randomized clinical trial conducted between December 2013 and February 2016.
Five academic and community hospitals.
Adult patients (≥18 years) who received mechanical ventilation >48 hours were randomized individually after discharge; 1 family member per patient was also offered a chance to participate. Ten patient and family member stakeholders participated as advisors in the planning and conduct of this study.
Participants assigned to CST were offered six 30-minute weekly telephone calls with a psychologist. CST was designed to teach coping strategies for managing distress related to critical illness. CST participants also received access to a complementary study website. An education program comparator included 2 telephone calls to review printed and web-based information about critical illness.
The primary outcome was the Hospital Anxiety and Depression Scale (HADS) summary score assessed among patients 3 months postrandomization. Secondary outcomes included HADS depression and anxiety subscale scores and posttraumatic stress disorder symptoms measured using the Impact of Events Scale-Revised scale assessed at 3 and 6 months.
Among 175 patients randomized to CST (n = 86) or education (n = 89), 131 (75%) completed the 6-month follow-up. Of the patients, 44 (25%) did not complete the study, generally because of death or medical illness. At 3 months, there were no significant differences between the CST and education groups in HADS summary score improvement (difference 1.3 [95% CI, −0.9 to 3.4], = .24). Secondary outcomes for patients and family members were similar by treatment group at 3 and 6 months. A priori exploratory secondary analyses revealed that among patients with high baseline distress (HADS summary score >14), those randomized to CST had improved HADS summary scores (difference −4.6, [95% CI, −8.6 to −0.6], = .02) compared with education participants at 6 months.
Nearly 40% more participants than planned to offset higher-than-expected attrition observed after consent but before randomization. Additionally, the generalizability of our results may be limited because the cohort was drawn largely from academic institutions.
Among critical illness survivors, CST did not reduce symptoms of psychological distress compared with an education program. However, among patients with high baseline distress, CST may have improved symptoms of distress at 6 months. Future efforts to reduce psychological distress among critical illness survivors will require greater patient engagement and should specifically target high-risk populations.
QUESTION: Does a postdischarge coping-skills training (CST) intervention delivered by telephone and online reduce symptoms of depression, anxiety, and posttraumatic stress disorder compared with a similarly delivered critical illness education program? FINDINGS: In this randomized clinical trial that included 175 patients and 86 family members, CST did not reduce psychological distress compared with education overall. Exploratory analyses suggest that symptoms of psychological distress may have been reduced among patients with high levels of baseline distress in the CST group, but not the education group. MEANING: CST did not reduce symptoms of psychological distress among a general population of intensive care unit survivors. The CST intervention requires further study among patients with high baseline distress and should include features that enhance participant engagement to aid in adherence.
