Intensive Care Unit (ICU) Diary Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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PTSD, Post ICU Syndrome

Intervention / Treatment
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* Other: Diary (blank journal) plus PTSD psycho-education
* Other: PTSD psycho-education alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD symptoms | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychocognitive morbidity, narrative medicine, ICU-related PTSD, Post-ICU Syndrome (PICS), ICU Diary