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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG066731-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Baystate Medical Center | OTHER |
| Oregon Health and Science University | OTHER |
| National Institute on Aging (NIA) |
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The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision-makers often experience lasting psychological distress from the ICU experience. We will conduct a multicenter randomized trial among 370 incapacitated, critically ill older adult patients at high risk of death or severe functional impairment, their surrogate decision-makers, and their ICU clinicians to determine whether a multi-component family support intervention can improve the patient- and family-centeredness of care (primary outcome), as well as positively impact a variety of other patient, family, and healthcare delivery outcomes. The multicomponent intervention involves: Proactive family meetings scheduled within 48 hours of ICU admission and approximately every 5-7 days after that.
Surrogates will have access (computer, tablet, or mobile phone) to the interactive web-based Family Support Tool. The tool will familiarize families with the ICU and prepare them for their interactions with the clinical team by completing specific sections of the Family Support Tool upon study enrollment, before family meetings, and any other time they wish. The ICU team will receive a tool-generated summary of information about the family before each family meeting, including their main questions and concerns, information about the patient's values and preferences, prognostic expectations, and unmet psychological needs.
The Family Support Tool intervention is designed to help families navigate the emotional, psychological, and cognitive complexities of being a surrogate for an incapacitated critically ill patient and also to enhance the timeliness and quality of clinician-family communication. The intervention consists of three components:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Multi-component Family Support Intervention |
|
| Control | No Intervention | Usual ICU care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-component Family Support Intervention | Other | The multi-component intervention is designed to enhance the quality of clinician-family communication and help families manage the emotional and cognitive complexities of surrogate decision-making. It involves: 1) proactive clinician-family meetings; 2) use by surrogates of an interactive web-based tool throughout the ICU stay which is narrated by family members of ICU patients and includes stories and experiences from other families, self-care strategies, brief videos explaining what to expect during family meetings, a question prompt list, an interactive values clarification exercise, and an explanation of different treatment pathways for critically ill patients. 3. Prior to the proactive family meetings, the ICU team is provided with a summary of the family's main questions/concerns, their prognostic expectations, a summary of the patient's values and preferences, and surrogates' current ratings of the extent to which their psychosocial needs are being addressed in the ICU. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and family centeredness of care | 12-item Patient Perceived Patient-Centeredness of Care Scale (PPPC), previously modified for use by surrogates, completed at 3-month telephone follow-up of surrogates. | 3 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Composite measure of goal-concordant care | Assessed by surrogates at 3-month telephone follow-up using an 8-item composite measure of goal-concordant care. | 3 months after hospital discharge |
| Satisfaction with ICU care |
| Measure | Description | Time Frame |
|---|---|---|
| Patient hospital survival | The vital status of the patient will be assessed at the conclusion of index hospitalization | 6 months after hospital discharge |
| Duration of survival from hospital discharge through 6-month follow-up |
INCLUSION
Patient
Surrogate
Clinician
1. Patient's primary attending (or their designee)
EXCLUSION
Patient
Surrogate
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| Name | Affiliation | Role |
|---|---|---|
| Douglas B White, MD, MAS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States | ||
| NYC Health + Hospitals/Lincoln Hospital |
Raw data and derived datasets will be made available to external investigators and the public on a case-by-case basis, to be approved by the PI and in accordance with institutional, HIPAA, state and federal regulations. A data-sharing agreement may be instituted, depending upon the data to be shared. All data that is shared will be de-identified to protect participant privacy and confidentiality. Data and datasets will be retained and available to share for at least three years following completion of the project, in accordance with NIH regulations.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| NIH |
| New York City Health and Hospitals Corporation | OTHER |
| VA Pittsburgh Healthcare System | FED |
| University of North Carolina, Chapel Hill | OTHER |
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Assessed using the Family Satisfaction in the ICU (FS-ICU) instrument at 3-month telephone follow-up of surrogates. The FS-ICU is a 24-item scale concerning satisfaction with care, communication, and decision-making in the ICU.
| 3 months after hospital discharge |
| Unmet palliative care needs | Measured using the adapted Needs of Social Nature, Existential Concerns, Symptoms, and Therapeutic Interaction (NEST) scale administered to surrogates on day 5 post-randomization. The adapted NEST scale is designed for ICU use; it is a 13-item instrument developed to identify unmet social, emotional, physical, and care-system needs in serious illness. | Measured at day 5 post-randomization |
| Surrogates' prognostic awareness | Assessed on study day 5 using the validated Clinician-Surrogate Concordance Scale (CSCS), which our research team developed. The single item CSCS has excellent test-retest reliability (r =0.91). It has established criterion validity and responsiveness to change. | Measured at day 5 post-randomization |
| Surrogates' clarity about patient values and preferences | Assessed by surrogates after family meetings on study day 5 using the "informed" and "values clarity" subscales, 6 items out of the 16-item Decisional Conflict Scale (DCS). The scale has established responsiveness to change, test-retest reliability (r=0.81), internal consistency (α=0.92), and discriminant validity. | Measured at day 5 post-randomization |
| Clinician-family conflict | A brief survey (measured by both surrogates and ICU clinicians) to determine the level of family-clinician conflict during index hospitalization | Measured at day 5 post-randomization |
| Perceived effectiveness of Family Support Tool | A brief survey asking (intervention only) surrogate participants perceived effectiveness of the FST intervention | Measured at day 5 post-randomization |
| Risk of post-traumatic stress disorder | Assessed using the Impact of Events Scale-revised (IES-R) at 6 months. The IES-R is a valid, reliable, and responsive 22 -item instrument measuring symptoms of avoidance and intrusive thoughts. A score 33 indicates a high risk of PTSD. It has been used successfully among ICU surrogates. | 6 months after hospital discharge |
| Surrogates' symptoms of anxiety and depression | The HADS is a 14-item, two-domain (anxiety, depression) instrument with established reliability and validity among ICU surrogates that is recommended by consensus guidelines for use among ICU surrogates. Assessed at 6-month telephone follow-up. | 6 months after hospital discharge |
| Resource utilization | Among hospital survivors we will perform interviews with surrogates at 3-months and 6-months to identify patient's post-discharge healthcare utilization (e.g. hospital admissions, ED visits, skilled-nursing facility use, hospice use, etc.), assigning costs using validated methods. | 3 months and 6 months after hospital discharge |
| Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization | 6 months after hospital discharge |
| Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care | 6 months after hospital discharge |
| Proportion of patients enrolled in hospice during index hospitalization | 6 months after hospital discharge |
| ICU and hospital length of stay | Duration of time patient spent in ICU and hospital | 6 months after hospital discharge |
| Duration of mechanical ventilation | Duration of time patient spent on mechanical ventilation during index hospitalization | 6 months after hospital discharge |
| Cost of index hospitalization | Assigning costs using validated methods, the cost of index hospitalization will be calculated | 6 months after hospital discharge |
| Time to hospice | time in days from enrollment to hospice | 6 months after hospital discharge |
This will be measured as a time-to-event variable, with time 0 being the date of hospital discharge. All death dates will be confirmed by querying the SSDMF or institutional death indices at the completion of the trial.
| 6 months after hospital discharge |
| Days alive outside healthcare facilities | We will calculate the number of days a patient was alive from discharge to 6 months, then subtract that from the number of days the patient was in a hospital, LTAC, SNF, rehab facility, or hospice. | 6 months after hospital discharge |
| Patients' functional status | Assessed using the Katz Index of Independence in Activities of Daily Living, a validated and widely-used scale to quantify patients' functional status. Katz is a 6-item (1 or 0 point) scale measuring independency in older adults. Lower scores indicate a greater level of dependence for measured skills. | 6 months after hospital discharge |
| New York |
| New York |
| 10451 |
| United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Pittsburgh VA Medical Center | Pittsburgh | Pennsylvania | 15240 | United States |