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Clinical Trials/NCT04305353
NCT04305353
Completed
Not Applicable

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

Tulane University School of Medicine1 site in 1 country60 target enrollmentSeptember 26, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
Tulane University School of Medicine
Enrollment
60
Locations
1
Primary Endpoint
Change in PTSD symptoms
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 26, 2017
End Date
September 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Change in Hospital-associated Depression and Anxiety symptoms(at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge)
  • Change in Depression symptoms(at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge)
  • Change in Anxiety symptoms(at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge)

Study Sites (1)

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