Garrouste-Orgeas

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

Metadata

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

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