Intensive Care Unit (ICU) Diary Project

April 12, 2021 updated by: Tulane University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ICU Diary Group
Patients randomized to this group receive the ICU diary, along with PTSD education
Other: Diary (blank journal) plus PTSD psycho-education
A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers
Other: PTSD psycho-education alone

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.
OTHER: PTSD Education-only Group
Control Group: patients randomized to this group only receive PTSD education
Other: PTSD psycho-education alone

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
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.
at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
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.
at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University School of Medicine

Collaborators

The Arnold P. Gold Foundation

Investigators

  • Principal Investigator: Rachel Hammer, MD, MFA, Tulane University School of Medicine
  • Principal Investigator: George Sayde, MD, MPH, Tulane University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 26, 2017

Primary Completion (ACTUAL)

September 25, 2018

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (ACTUAL)

March 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICU Diary RCT NOLA
  • GH-17-022 (OTHER_GRANT: The Arnold P. Gold Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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