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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI PFA 195 | Other Grant/Funding Number | PCORI PFA 195 |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| University of Pittsburgh | OTHER |
| University of Washington | OTHER |
| Patient-Centered Outcomes Research Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coping skills training | Experimental | 6 sessions of weekly telephone-based coping skills training delivered by trained interventionist |
|
| education program | Active Comparator | 6 week access to a web-based, critical illness-specific education program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coping skills training | Behavioral | 6-session coping skills training program delivered by telephone w/ web augmentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 & 6 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Weeks at Home Post-randomization | here reported as weeks (instead of days) not at home for simplicity | over 6 months follow up |
Patient inclusion criteria:
Patient exclusions (pre-consent):
Additional patient exclusion criteria (present post-consent but pre-randomization):
Informal caregiver inclusion criteria:
Exclusions for caregivers are:
Informal caregiver exclusion criteria present after consent but before randomization:
A total of 200 patient-caregiver dyads (total cohort = 400) are targeted
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| Name | Affiliation | Role |
|---|---|---|
| Christopher E Cox, MD MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22527082 | Background | 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. | |
| 28872898 |
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417 participants were enrolled (277 patients and 140 informal caregivers). 261 participants were randomized (175 patients and 86 caregivers).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Education Program | 6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This includes 86 patients and 39 caregivers (coping skills training group) plus 89 patients and 47 caregivers (education program group).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Education Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients who completed the HADS scale at 3 & 6 months post-randomization. | Posted | Mean | Standard Error | units on a scale (HADS summary score) | 3 & 6 months post-randomization |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Cox, PI | Duke University | 9196817232 | christopher.cox@duke.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| OTHER |
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| education program | Other | web-based, ICU-specific education program |
|
| 3 & 6 months post-randomization |
| Durham |
| North Carolina |
| 27710 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| 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. |
| too ill |
|
6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Separate tables are shown for patients (n=175) and family members (n=86). | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Education Program | 6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program |
|
|
| Secondary | 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. | Patients who completed the IES-R scale at 3 & 6 months post-randomization. | Posted | Mean | Standard Error | units on a scale (IES-R) | 3 & 6 months post-randomization |
|
|
|
| Other Pre-specified | Total Weeks at Home Post-randomization | here reported as weeks (instead of days) not at home for simplicity | patients | Posted | Mean | Standard Deviation | weeks not at home during follow up | over 6 months follow up | weeks | weeks |
|
|
|
| 6 |
| 125 |
| 0 |
| 125 |
| 0 |
| 125 |
| EG001 | Education Program | 6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program | 6 | 136 | 0 | 136 | 0 | 136 |
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| D001519 | Behavior |
| D001523 | Mental Disorders |
| D011314 | Preventive Health Services |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 6 months |
|
|