Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers

Public Summary of Research Project Why is this important? Nearly 800,000 Americans receive
mechanical ventilation for acute respiratory failure in the ICU each year. Afterward, over
half of both patients and their family caregivers suffer from psychological distress
(depression, anxiety, and post-traumatic stress ["PTSD"]) for over 1 year after discharge.
Patients and families told us that they need help with their distress because it worsens
their quality of life. More specifically, patients said that learning how to adapt (that is,
how to cope) with the physical and emotional changes of critical illness would be helpful.
In fact, most ICU survivors use coping skills infrequently, which worsens psychological
distress. But patients also told us that they wanted more information about critical
illness, recovery, and what to expect. A lack of information increases PTSD symptoms.
However, there are few treatments for this distress that can overcome ICU survivors'
physical disability, great distance from expert medical centers, and concerns about how much
treatments would cost. Therefore, we developed two treatments to address coping and lack of
information.

What is the main goal? We aim to compare which of two treatments are more effective in
reducing psychological distress and improving quality of life. One is a coping skills
training (CST) program provided by telephone. The other is an education program about
critical illness that is accessed primarily online. Also, we will determine if unique groups
of people with special characteristics have especially good improvement—and if so, what
personal factors explain this response.

How will we know which treatment is better? We will determine which treatment is most
helpful by comparing participants' levels of psychological distress and quality of life with
surveys taken over 6 months. We'll also record patients' own descriptions of how the
treatments impacted their daily lives. The study will take 3 years and would be performed at
5 medical centers across the US that treat patients with diverse backgrounds and illnesses.
200 ICU survivor-family member pairs will be randomly assigned (like a coin flip) to receive
either the CST program or the education program. Treatments consist of 6 weekly telephone
calls with a trained staff member, web-based modules, and handouts.

How will this help others in the future? This research is important because it aims to
improve long-term recovery for entire families by focusing on a devastating, common, yet
inadequately addressed problem. These treatments were developed with the direct input of
patients and families. These treatments represent a new direction in treating critical
illness because they can be delivered inexpensively by phone, easily adapted to future
technologies, overcome barriers to care common to ICU survivors, and shared easily by phone
or computer with others in need across the world.

Patient inclusion criteria:

- age >=18 and

- mechanical ventilation for more than 48 consecutive hours

Patient exclusions (pre-consent):

- current significant cognitive impairment (>=3 errors on the Callahan scale) or lacks
decisional capacity

- pre-existing significant cognitive impairment

- residence at location other than home before hospital admission

- need for a translator because of poor English fluency [many study instruments are not
validated in other languages]

- expected survival <3 months

- discharged to hospice (outpatient or inpatient)

- not liberated from mechanical ventilation at discharge

Additional patient exclusion criteria (present post-consent but pre-randomization):

- Patients will become ineligible if they become too ill to participate

- they develop significant cognitive disability, exhibit suicidality, they do not
return home within 2 months after hospital discharge, or die.

Informal caregiver inclusion criteria:

- age >=18 years

- person most likely to provide the most post-discharge care.

Exclusions for caregivers are:

- history of significant cognitive impairment

- English fluency poor enough to require a medical translator

Informal caregiver exclusion criteria present after consent but before randomization:

- no longer available

- become too ill to participate

- exhibit suicidality

A total of 200 patient-caregiver dyads (total cohort = 400) are targeted