Intensive Care Unit Survivors, Informal Caregivers (Family and Friends)
Conditions
Keywords
coping, acute respiratory failure, critical illness, depression, anxiety, post-traumatic stress, intensive care unit
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.
Interventions
6-session coping skills training program delivered by telephone w/ web augmentation
web-based, ICU-specific education program
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale Score | 3 & 6 months post-randomization | Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Events Scale-revised (IES-R) Score | 3 & 6 months post-randomization | The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = not at all, 1 = a little bit, 2 = moderately often, 3 = quite a bit, and 4 = extremely often. The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Weeks at Home Post-randomization | over 6 months follow up | here reported as weeks (instead of days) not at home for simplicity |
Countries
United States
Participant flow
Recruitment details
417 participants were enrolled (277 patients and 140 informal caregivers). 261 participants were randomized (175 patients and 86 caregivers).
Participants by arm
| Arm | Count |
|---|---|
| Coping Skills Training 6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation | 125 |
| Education Program 6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program | 136 |
| Total | 261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 6 |
| Overall Study | Lost to Follow-up | 17 | 16 |
| Overall Study | too ill | 11 | 8 |
Baseline characteristics
| Characteristic | Coping Skills Training | Education Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 26 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 105 Participants | 110 Participants | 215 Participants |
| Age, Continuous Caregivers | 50.0 years STANDARD_DEVIATION 14.9 | 52.9 years STANDARD_DEVIATION 15.2 | 51.4 years STANDARD_DEVIATION 15 |
| Age, Continuous Patients | 49.7 years STANDARD_DEVIATION 13.8 | 53.7 years STANDARD_DEVIATION 13.5 | 51.7 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants | 133 Participants | 258 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 25 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 95 Participants | 102 Participants | 197 Participants |
| Region of Enrollment United States | 125 participants | 136 participants | 261 participants |
| Sex: Female, Male Female | 71 Participants | 73 Participants | 144 Participants |
| Sex: Female, Male Male | 54 Participants | 63 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 125 | 6 / 136 |
| other Total, other adverse events | 0 / 125 | 0 / 136 |
| serious Total, serious adverse events | 0 / 125 | 0 / 136 |
Outcome results
Hospital Anxiety and Depression Scale Score
Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well
Time frame: 3 & 6 months post-randomization
Population: Patients who completed the HADS scale at 3 \& 6 months post-randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coping Skills Training | Hospital Anxiety and Depression Scale Score | 3 months | 16.6 units on a scale (HADS summary score) | Standard Error 0.9 |
| Coping Skills Training | Hospital Anxiety and Depression Scale Score | 6 months | 15.6 units on a scale (HADS summary score) | Standard Error 1 |
| Education Program | Hospital Anxiety and Depression Scale Score | 3 months | 15.3 units on a scale (HADS summary score) | Standard Error 0.9 |
| Education Program | Hospital Anxiety and Depression Scale Score | 6 months | 15.9 units on a scale (HADS summary score) | Standard Error 1 |
Impact of Events Scale-revised (IES-R) Score
The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = not at all, 1 = a little bit, 2 = moderately often, 3 = quite a bit, and 4 = extremely often. The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well.
Time frame: 3 & 6 months post-randomization
Population: Patients who completed the IES-R scale at 3 \& 6 months post-randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coping Skills Training | Impact of Events Scale-revised (IES-R) Score | 3 months | 31.0 units on a scale (IES-R) | Standard Error 2.6 |
| Coping Skills Training | Impact of Events Scale-revised (IES-R) Score | 6 months | 29.4 units on a scale (IES-R) | Standard Error 2.9 |
| Education Program | Impact of Events Scale-revised (IES-R) Score | 3 months | 27.9 units on a scale (IES-R) | Standard Error 2.6 |
| Education Program | Impact of Events Scale-revised (IES-R) Score | 6 months | 25.8 units on a scale (IES-R) | Standard Error 2.9 |
Total Weeks at Home Post-randomization
here reported as weeks (instead of days) not at home for simplicity
Time frame: over 6 months follow up
Population: patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training | Total Weeks at Home Post-randomization | 1.3 weeks not at home during follow up | Standard Deviation 3 |
| Education Program | Total Weeks at Home Post-randomization | 1.6 weeks not at home during follow up | Standard Deviation 3.5 |