Effect of a Nurse-Led Preventive Psychological Intervention on Symptoms of Posttraumatic Stress Disorder Among Critically Ill Patients: A Randomized Clinical Trial

Abstract

Importance: A meta-analysis of outcomes during the 6 months after intensive care unit (ICU) discharge indicate a prevalence for clinically important posttraumatic stress disorder (PTSD) symptoms of 25%.

Objective: To determine whether a nurse-led preventive, complex psychological intervention, initiated in the ICU, reduces patient-reported PTSD symptom severity at 6 months.

Design, setting, and participants: A multicenter, parallel-group, cluster-randomized clinical trial with integrated economic and process evaluations conducted in 24 ICUs in the United Kingdom. Participants were critically ill patients who regained mental capacity following receipt of level 3 (intensive) care. A total of 2961 eligible patients were identified from September 2015 to January 2017. A total of 2048 were approached for participation in the ICU, of which 1458 provided informed consent. Follow-up was completed December 2017.

Interventions: Twenty four ICUs were randomized 1:1 to the intervention or control group. Intervention ICUs (n = 12; 669 participants) delivered usual care during a baseline period followed by an intervention period. The preventive, complex psychological intervention comprised promotion of a therapeutic ICU environment plus 3 stress support sessions and a relaxation and recovery program delivered by trained ICU nurses to high-risk (acutely stressed) patients. Control ICUs (n = 12; 789 participants) delivered usual care in both baseline and intervention periods.

Main outcomes and measures: The primary clinical outcome was PTSD symptom severity among survivors at 6 months measured using the PTSD Symptom Scale-Self-Report questionnaire (score range, 0-51, with higher scores indicating greater symptom severity; the minimal clinically important difference was considered to be 4.2 points).

Results: Among 1458 enrolled patients (mean [SD] age, 58 [16] years; 599 women [41%]), 1353 (93%) completed the study and were included in the final analysis. At 6 months, the mean PTSD Symptom Scale-Self-Report questionnaire score in intervention ICUs was 11.8 (baseline period) compared with 11.5 (intervention period) (difference, -0.40 [95% CI, -2.46 to 1.67]) and in control ICUs, 10.1 (baseline period) compared with 10.2 (intervention period) (difference, 0.06 [95% CI, -1.74 to 1.85]) between periods. There was no significant difference in PTSD symptom severity at 6 months (treatment effect estimate [difference in differences] of -0.03 [95% CI, -2.58 to 2.52]; P = .98).

Conclusions and relevance: Among critically ill patients in the ICU, a nurse-led preventive, complex psychological intervention did not significantly reduce patient-reported PTSD symptom severity at 6 months. These findings do not support the use of this psychological intervention.

Trial registration: ISRCTN53448131.

Figure 1.. Recruitment, Randomization, and Assessment of Intensive Care Units (ICUs) and Patients

^aOther reasons included poor performance in previous multicenter randomized clinical trials, low evidence of ICU-wide enthusiasm and engagement, already delivering early psychological support, and had planned to increase psychological support during the trial period. ^bMedian number (interquartile range) [range] of patients per ICU are shown.

Figure 2.. Subgroup Analyses of the Primary Clinical Effectiveness Outcome

ICU indicates intensive care unit; PSS-SR, PTSD Symptom Scale–Self-Report, and STAI-6, State Trait Anxiety Inventory. ^aMean (95% CI) of the difference between baseline and intervention periods in mean PSS-SR score. The PSS-SR scale is from 0 to 51 (higher scores indicate greater posttraumatic stress symptoms). A value of 18 points is considered the threshold for prediction of likely current or future PTSD. The minimal clinically important difference was considered to be 4.2 points based on observing an improvement equal to the reliable change index among patients receiving stress support sessions. ^bAdjusted for age, sex, race/ethnicity, deprivation, preexisting anxiety/depression, planned admission following elective surgery, and Intensive Care National Audit & Research Centre Physiology Score. ^cThe Index of Multiple Deprivation 2015 is reported by quintiles (higher values indicate greater deprivation). ^dDuration of delirium is reported as the number of days on which patients were assessed as positive for delirium on the Confusion Assessment Method for the ICU. ^eScores on the STAI-6 range from 20 to 80 (higher scores indicate greater anxiety). STAI-6 was self-reported by participants at the time of consent. ^fPredicted PSS-SR (heterogeneity of treatment effect) is reported by quintiles from a prediction model for the primary outcome derived using data from patients receiving usual care and adjusted for a priori important covariates (age, sex, socioeconomic status, duration of delirium, STAI-6, and surgical status). ^gSite implementation score encompasses dose, fidelity, and reach and is derived from data collected as part of the independent process evaluation (see eMethods and eTable 6 in Supplement 2 for more information). In the intervention ICUs, there were 170, 174, and 215 patients in low, medium, and high score categories, respectively. In the control ICUs, there were 674 patients receiving usual care.