Clinical trial NCT01983254: Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
Official title: Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Survivors
Informal Caregivers (Family and Friends)
Keywords: coping
acute respiratory failure
critical illness
depression
anxiety
post-traumatic stress
intensive care unit
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: University of Pittsburgh
name: University of Washington
name: Patient-Centered Outcomes Research Institute
First posted: 2013-11-13
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who receive life support in intensive care units commonly suffer from persistent depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We are trying to learn which is a better way to manage this distress: a telephone-based adaptive coping skills training program or an educational program.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale Score
timeFrame: 3 & 6 months post-randomization
Secondary outcomes:
measure: Impact of Events Scale-revised (IES-R) Score
timeFrame: 3 & 6 months post-randomization
Other outcomes:
measure: Total Weeks at Home Post-randomization
timeFrame: over 6 months follow up
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Duke University
name: Christopher E Cox, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox CE, Porter LS, Hough CL, White DB, Kahn JM, Carson SS, Tulsky JA, Keefe FJ. Development and preliminary evaluation of a telephone-based coping skills training intervention for survivors of acute lung injury and their informal caregivers. Intensive Care Med. 2012 Aug;38(8):1289-97. doi: 10.1007/s00134-012-2567-3. Epub 2012 Apr 18.
citation: Cox CE, Hough CL, Carson SS, White DB, Kahn JM, Olsen MK, Jones DM, Somers TJ, Kelleher SA, Porter LS. Effects of a Telephone- and Web-based Coping Skills Training Program Compared with an Education Program for Survivors of Critical Illness and Their Family Members. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jan 1;197(1):66-78. doi: 10.1164/rccm.201704-0720OC.