Please select the eligibility criteria that correspond to the clinical trial below.
Title: Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries
Brief Summary: The main objective of the study is to test the feasibility of the ICU diaries intervention in the ICU. The investigators do not have sufficient power to detect differences in the hypotheses below, but will use the present pilot study to inform sample size required to adequately power a follow-up randomized control trial.

(1) The investigators hypothesize that subjects exposed to a psychoeducation condition will have reduced rates of post-traumatic stress disorder (PTSD) compared to those experiencing treatment as usual (TAU). (2) The investigators hypothesize that compared to participants in the psychoeducation and TAU groups, those subjects exposed to an ICU diary, and those exposed to both ICU diary + psychoeducation conditions, will have significantly reduced rates of PTSD at follow-up. (3)The investigators hypothesize that participants exposed to the ICU diary + psychoeducation condition will have significantly lower rates of PTSD compared to those in the ICU diary alone condition.


Options:
A: Inclusion Criteria (the investigators will target patients at high risk for psychological distress):

* age ≥18 years
* acute cardiorespiratory failure managed in an intensive care unit
* reside at home before hospital admission (i.e., not in a facility)

  * Respiratory failure, ≥1 of these:
* mechanical ventilation via endotracheal tube for ≥ 12 hours
* non-invasive ventilation (CPAP, BiPAP) for \> 4 hours in a 24 hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)
* high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours

  * Cardiac / circulatory failure, ≥1 of these:
* use of vasopressors for shock of any etiology for \> 1 hour
* use of inotropes for shock of any etiology for \> 1 hour
* use of aortic balloon pump for cardiogenic shock

Exclusion Criteria (present before consent): Patients will be excluded if they have characteristics that would prohibit adequate participation including:

* pre-existing significant cognitive impairment (e.g., dementia)
* treated for severe or unstable mental illness within 6 months preceding current admission (e.g., depression with psychosis, suicidality, schizophrenia as per medical record)
* hospital inpatient within 3 months before current admission
* active substance abuse at the time of admission
* lack of decisional capacity \[\*'Decisional capacity' is defined as the ability to participate in effective decision making and provide informed consent. That is, in the judgment of the examiner, the patient, after reading the IRB approved patient consent document (or having it read to them) can (a) generally understand the terms of participation in the study: the purpose of the study, what will be required of study participants; the potential risks, benefits and alternatives of study participation; pros \& cons of study involvement and (b) can communicate a choice in his/her own words (or write on a communication board)\]
* current significant cognitive impairment (≥3 errors on the Callahan cognitive status screen; see below)
* need for a translator because of poor English fluency \[many study instruments are not validated in other languages\]
* expected survival \<6 months per attending physician
* ICU length of stay \>30 days
* lack of either:
* reliable or sufficient smartphone with cellular data plan or
* reliable computer online access plus telephone access
* unable to complete study procedures as determined by study staff
* discharge to a location other than a home setting
* complex medical care expected soon after discharge (e.g., multiple planned surgeries, transplantation evaluation (including outpatient daily cardiopulmonary rehabilitation), extensive travel needs for hemodialysis, disruptive chemotherapy or XRT regimen, etc)

Other issues relevant to the consent process:

* unable to approach patient for logistical reasons (e.g., off ward in test at time of approach, etc)
* patient discharged before consent could be obtained
* patient dies before consent obtained

Patient exclusion criteria present after consent but before randomization:

After providing informed consent, patients will become ineligible if any of the following are present:

* they become too ill to participate (or die)
* they exhibit significant cognitive disability
* they exhibit suicidality
* patient was unexpectedly discharged to location other than a home setting and then did not arrive home within 1 month from hospital discharge
B: Inclusion Criteria:

* English-speaking
* Admitted to Harborview Medical Center with injuries sufficiently severe to require inpatient admission
* Experienced a traumatic injury
* Exhibits symptoms of PTSD while in the hospital ward

Exclusion Criteria:

* History of head, spinal, or other injury that may prevent participation in the ward interview
* Requires immediate intervention due to conditions such as self-inflicted injury, active psychosis, or active mania
* Currently incarcerated
* Likely to face criminal charges
* Lives more than 50-100 miles from Harborview Medical Center
C: Inclusion Criteria:

* Age ≥ 18 years
* Non-invasive or invasive ventilation ≥ 48 hours (Non-invasive ventilation (NIV) from current guidelines).
* APACHE II score ≥ 12 ≤ 29
* Unrecognized dementia diagnosis

Exclusion Criteria:

* Delirium at randomization (Positive CAM-ICU score)
* Participation in scientific projects which include patient interviews
* Not Speak and understand Danish
D: Inclusion Criteria:

* age greater than 17 years
* enrolment within 72 hours of ICU admission
* time of ICU stay is predicted to be \>72 hours by ICU treatment team
* greater than 24 hours mechanical ventilation required
* understand verbal and written English

Exclusion Criteria:

* no caregiver/family available
* terminal illness with life expectancy of less than 6 months
* pre-existing cognitive impairment
* less than 24 hours of mechanical ventilation
* reason for ICU admission is suicide attempt / overdose

Answer: D