Please select the eligibility criteria that correspond to the clinical trial below.
Title: Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Brief Summary: About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:

1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
3. to explore if the psychosocial intervention results in less need for appropriate ICD therapies.


Options:
A: 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
B: Inclusion Criteria:

* Patients, family members, clinicians attending ICU family conferences, and nurses evaluating the quality of care.
* All ICU patients are eligible if they meet the age criteria, have been in the ICU for at least 12 hours, have acute respiratory failure requiring mechanical ventilation at the time of enrollment, and have an APACHE II score/SOFA score or other diagnosis that predicts a 30-50% or greater risk of mortality.
* Eligible family members and/or friends may include any of the following: legal guardians, durable power of attorney for healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends; if they meet the age criteria, and understand English well enough to complete informed consent and study materials.
* Eligible clinicians include those who are present during a family conference and may include physicians, nurses, nurse practitioners, physician assistants, social workers, respiratory therapists, and clergy.
* All critical care nurses are eligible to participate in the evaluation if they have provided care to a patient on or before the shift in which he or she died or was discharged from the ICU.

Exclusion Criteria:

* Legal or risk management concerns (as determined by the attending physician or via hospital record designation);
* Psychological illness or morbidity; and
* Physical or mental limitations preventing ability to complete questionnaires.
* Patients will be excluded if they do not have at least one family member who is eligible and willing to participate in the study.
* A patient who is readmitted to the ICU, if the patient was enrolled and discharged previously, will not be eligible.
* Post-operative patients who have been admitted to the ICU after a scheduled surgery without complications will be excluded. These patients may meet other eligibility criteria (ventilation, APACHE scores, etc.) within the first 12 to 48 hours of admission, but will usually improve quite rapidly after that period.
C: Inclusion Criteria:

* Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,
* Receiving their first ICD implant for secondary prevention of SCD or for primary prevention of SCD and their underlying heart disease was hypertrophic cardiomyopathy.

Exclusion Criteria:

* Not able to read or understand English;
* Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
* Receiving an ICD for primary prevention of ICD.
D: 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

Answer: C