Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation
A Randomized Clinical Trial

Garrouste-Orgeas. JAMA 2019;(3)229-239. doi:10.1001/jama.2019.9058

Clinical Question

• In intensive care patients, does an ICU diary compared to no ICU diary, reduce post-traumatic stress disorder symptoms at 3 months?

Background

• Mental health disorders are common in both patients and their relatives following an ICU stay
• Impaired recall accompanied by delusions may contribute to the post traumatic stress
• Keeping a diary for patients on the ICU may prevent post-traumatic stress disorder symptoms
• The DRIP study found that family authored diaries for patients in intensive care significantly reduced the risk of post-traumatic symptoms in relatives, but made no significant differences to patients

Design

• Randomised controlled trial
  • Web based random number generator, block sizes of 4
  • Stratified by centre
• Outcomes assessed by:
  • Psychologist who was blinded to intervention group
  • Telephone follow up at 3 months
• Monitoring of diaries performed by local leads and co-ordinating centre
• Sample size: 352 patients required at 3 months to detect a reduction from 40% in the control group to 26% difference in the intervention group for the primary outcome with a false positive rate of 5% and a false negative rate of 20%
• Modified intention to treat analysis – for primary outcome, analysis sets included patients with a complete IES-R score at 3 months
• Registered on clinicaltrials.gov

Setting

• 35 Intensive Care Units in France
  • ICUs had to have > 8 beds
  • Physician leaders were members of the French Society of Intensive Care or French Society of Anaesthesiology
  • 3 of the ICUs were routinely using an ICU diary before the beginning of the trial
• Data collected: October 2015 – January 2017

Population

• Inclusion criteria:
  • Age >=18 years
  • Mechanically ventilated for at least 48 hours that was initiated within 48 hours of ICU admission
  • Have a family member available for visiting during ICU stay
• Exclusion criteria:
  • Pre-admission diagnosis of psychosis or dementia
  • Acute neurological diseases, cardiac arrest at admission, mute or deaf, status considered highly likely to lead to death or withdrawal of life support within 48 hours
• 657 patients randomised, 402 patients alive at 3 months, and 339 assessed at 3 months after ICU discharge
• Comparing baseline characteristics of intervention vs. control group
  • Age (median): 62.5 vs. 61years
  • Male: 67% vs. 59%
  • SAPS II (median): 51.5 vs. 53
  • Medical patient: 74% vs. 79%
  • ICU events
    • Physical constraint: 74% vs. 72%
    • Delirium: 34% vs. 33%
    • Weaning failure & re-intubation: 7% vs. 7%
  • Duration of mechanical ventilation (median): 9 vs. 9 days
  • Duration of ICU stay (median): 14 vs. 14 days
• Comparing baseline characteristics of family members included in the study in intervention vs. control group
  • Age: 57 vs. 55
  • Male: 26% vs. 31%
  • Spouse/partner of patient: 56% vs. 55%
  • Child of patient: 30% vs. 31%
  • Educational level – degree: 35% vs. 34%

Intervention

• ICU diary
  • Completed by clinicians & family members
  • 1st page of diary is standardised explanation of the purpose of diary
  • Only instruction to the families & staff members about diary entries is to refrain from writing about confidential matters that could not be shared amongst the patients, staff & relatives
  • As a minimum, ICU staff write a brief entry at each weekly staff meeting. Prior to transfer out of the ICU, a concluding note was written by an ICU clinician
  • Patients discharged to the ward are given their diaries. If the patient dies the diary is given to the family

Control

• No ICU diary completed
  • Patients received usual ICU Care

Outcome

• Primary outcome:
  • Significant post traumatic stress disorder symptoms at 3 months, defined as Impact Event Scale-Revised score >22 (range 0-88; higher scores indicate more severe symptoms)
    • No significant difference
    • 29.9% in intervention group vs. 34.3% in control group
    • Risk difference -4% (95% C.I. -15 to 6%), p=0.39
• Secondary outcomes: Comparing intervention vs. control group
  • No significant difference in
    • Median IES-R score
      • 12 (IQR 5-25) vs. 13 (6-27), p=0.38
    • Symptoms of anxiety in patients: 31% vs. 31%, p=0.91
    • Symptoms of depression in patients: 19% vs 24%, p=0.35
    • Number of family members with IES-R sore >22: 48% vs. 45%, p=0.53
    • Presence of anxiety in family members (HADS-Anxiety score >8): 50% vs. 47%, p=0.56
    • Presence of depression on family members (HADS-Depression score >8): 25% vs. 24%, p=0.77
  • Multivariate analysis found that the occurrence of an unexpected cardiac arrest, emotional memories and delusional memories of the ICU stay were significantly associated with an IES-R score >22 in patients

Authors’ Conclusions

• The use of an ICU diary did not significantly reduce the number of patients that reported significant PTDS symptoms at 3 months

Strengths

• Randomised controlled trial
• Outcomes assessed by psychologists who was blinded to treatment intervention
• Multi-centre
• Registered with clinicaltrials.gov
• Control centre performed content analysis of a random sample of diaries

Weaknesses

• Symptoms of PTSD, anxiety & depression were not assessed at baseline
• Did not meet sample size, and control rate of post-traumatic stress disorder was lower than anticipated
• Study only performed in France limits generalisability. Rate of physical constraint is much higher than in many UK units
• Only studied one type of ICU diary

The Bottom Line

• This randomized controlled trial demonstrated that an ICU diary completed by clinicians & family members did not reduce significant symptoms of post-traumatic stress disorder at 3 months, in patients in France
• Further studies are needed to demonstrate if an ICU diary offers any other benefits, or if a different form of an ICU diary would be of advantage

External Links

• [article] Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial
• [further reading] The effect of family-authored diaries on posttraumatic stress disorder in intensive care unit patients and their relatives: A randomised controlled trial (DRIP-study)
• [further reading] ICU-diary.org

Metadata

Summary author: @davidslessor
Summary date: 3rd October 2019
Peer-review editor: @duncanchambler