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Completed

NCT Number: NCT04305353

Intensive Care Unit (ICU) Diary Project

Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress disorder), depression and anxiety.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

About this study

The investigators compared the efficacy of the ICU diary, prospectively written by third-parties during the patient's intensive care course, versus education-alone, on reducing acute PTSD symptoms after discharge. Patients with an ICU stay greater than 72 hours, and who were intubated and mechanically ventilated over 24 hours, were recruited and randomized to either receive a diary at bedside with psychoeducation, or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychometric testing with IES-R, PHQ-8, HADS and GAD-7 was conducted at weeks 4, 12, and 24 after ICU discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • admitted to the intensive care unit for at least 72 hours
  • sedated and mechanically ventilated for at least 24 hours.
  • available over-the-phone, up to 6 months post-ICU discharge

Exclusion criteria

  • any patients who do not voluntarily agree to participate
  • not fluent in the English language
  • patients who have stayed in the ICU for less than 72 hours
  • patients who have been sedated and mechanically ventilated for less than 24 hours
  • patients with pre-existing severe psychotic illness, bipolar disorder, substance use disorder, PTSD, stroke, traumatic brain injury, neurocognitive impairment, or intellectual disability
  • patients with no phone number or reliable contact information for the sake of follow-up
  • prisoners
  • pregnant patients

Treatment and study plan

Diary (blank journal) plus PTSD psycho-education

Other

A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers

PTSD psycho-education alone

Other

We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources.

References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015.

Primary outcomes

  1. Change in PTSD symptoms

    Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

    Revised Impact of Event Scales (IES-R) score, measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. Scores from 1-22 are consistent with mild PTSD, and scores greater than 22 signal clinically significant PTSD symptoms.

Secondary outcomes

  1. Change in Hospital-associated Depression and Anxiety symptoms

    Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

    Hospital Anxiety and Depression Scale (HADS), range of 0-21 for either anxiety or depression subscores, with higher scores corresponding to worse outcomes. Scores of 0-7 are normal, 8-10 are borderline abnormal (mild depression or anxiety), and 11-21 correspond to severe symptoms of anxiety or depression.

  2. Change in Depression symptoms

    Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

    Patient Health Questionnaire (PHQ-8), score ranges 0-24, as higher scores correspond to worse depression symptoms. Scores of 5-10 represent mild symptoms of depression, 10-15 signal moderate symptoms, and 15-24 correspond to severe symptoms.

  3. Change in Anxiety symptoms

    Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

    Generalized Anxiety Disorder 7-item scores (GAD-7) range from 0 to 21, with higher scores corresponding to worse anxiety symptoms. Scores of 0-4 indicate minimal anxiety, 5-9 correspond to mild anxiety, 10-14 signal moderate anxiety, and 15-21 represent severe anxiety.

Sponsors and collaborators

Lead sponsor

Tulane University School of Medicine

Other

Collaborators

  • The Arnold P. Gold Foundation

Registry information

Official study title

Implementing an Intensive Care Unit (ICU) Diary Program at a Large Academic Medical Center: Results From a Randomized Control Trial Evaluating Psychological Morbidity Associated With Critical Illness

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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