Intensive Care Unit (ICU) Diary Project

Tulane University School of Medicine

Status: Completed

Conditions: PTSD; Post ICU Syndrome

Treatments: Other: Diary (blank journal) plus PTSD psycho-education; Other: PTSD psycho-education alone

Study type: Interventional

Funder types: Other

Identifiers

NCT04305353

ICU Diary RCT NOLA

GH-17-022 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

ICU Diary Group

Experimental group

Description:

Patients randomized to this group receive the ICU diary, along with PTSD education

Treatment:

Other: Diary (blank journal) plus PTSD psycho-education

Other: PTSD psycho-education alone

PTSD Education-only Group

Other group

Description:

Control Group: patients randomized to this group only receive PTSD education

Treatment:

Other: PTSD psycho-education alone