Mobile Mindfulness to Improve Psychological Distress After Critical Illness

This is an interventional treatment trial for Psychological Distress focused on measuring mindfulness, critical illness, intensive care unit, mindfulness-based stress reduction Read More

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