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Original Investigation
Caring for the Critically Ill Patient
February 18, 2019

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

Author Affiliations
  • 1Critical Care Department, University College London Hospitals NHS Foundation Trust, London, United Kingdom
  • 2Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom
  • 3London School of Hygiene & Tropical Medicine, London, United Kingdom
  • 4Centre for Experimental Medicine, Queen’s University Belfast, Belfast, Northern Ireland, United Kingdom
  • 5Patient representative, United Kingdom
  • 6Research Department of Clinical, Educational & Health Psychology, University College London, London, United Kingdom
  • 7University College London Hospitals National Institute for Health Research Biomedical Research Centre, London, United Kingdom
  • 8Institute of Pharmaceutical Science, King’s College London, London, United Kingdom
JAMA. 2019;321(7):665-675. doi:10.1001/jama.2019.0073
Visual Abstract.
Visual Abstract.
Nurse-Led Preventive Psychological Intervention and Symptoms of PTSD in Critically Ill Patients
Nurse-Led Preventive Psychological Intervention and Symptoms of PTSD in Critically Ill Patients
Key Points

Question  What is the effect of a nurse-led preventive, complex psychological intervention delivered to critically ill patients and initiated in the intensive care unit on posttraumatic stress disorder (PTSD) symptom severity?

Findings  In this cluster-randomized clinical trial, involving 1458 patients, there was no significant difference in patient-reported PTSD symptom severity at 6 months (adjusted difference of −0.03 on the PTSD Symptom Scale; score range, 0-51, with higher scores indicating greater symptom severity; the minimal clinically important difference was considered to be 4.2 points).

Meaning  A nurse-led preventive, complex psychological intervention delivered to critically ill patients and initiated in the intensive care unit did not significantly reduce patient-reported PTSD symptom severity at 6 months.

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

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