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Intensive Care Unit (ICU) Diary Project

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04305353
Enrollment
60
Registered
2020-03-12
Start date
2017-09-26
Completion date
2020-09-01
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post ICU Syndrome, PTSD

Keywords

psychocognitive morbidity, narrative medicine, ICU-related PTSD, Post-ICU Syndrome (PICS), ICU Diary

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.

Interventions

OTHERDiary (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

OTHERPTSD 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.

Sponsors

The Arnold P. Gold Foundation
CollaboratorOTHER
Tulane University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in PTSD symptomsat baseline (within one week of ICU admission) versus twelve-weeks post-ICU dischargeRevised 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

MeasureTime frameDescription
Change in Hospital-associated Depression and Anxiety symptomsat baseline (within one week of ICU admission) versus twelve-weeks post-ICU dischargeHospital 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.
Change in Depression symptomsat baseline (within one week of ICU admission) versus twelve-weeks post-ICU dischargePatient 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.
Change in Anxiety symptomsat baseline (within one week of ICU admission) versus twelve-weeks post-ICU dischargeGeneralized 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026