Integrated Supportive and Palliative Care for Older Adults in the ICU
- Conditions
- Critical Illness
- Interventions
- Behavioral: Early Integration of Specialty Palliative Care with Critical Care
- Registration Number
- NCT04921631
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
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. The investigators will conduct a randomized trial among 500 patients and 750 surrogates and up to 150 clinicians to determine whether early integration of specialty palliative care with standard critical care can improve outcomes for critically ill older patients at high risk of death or severe functional impairments and their family members.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Early Integration of Specialty Palliative Care with Critical Care The intervention arm will receive early specialty palliative care integrated with standard critical care.
- Primary Outcome Measures
Name Time Method Patient and family centeredness of care Measured at 3 months after hospital discharge 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.
- Secondary Outcome Measures
Name Time Method Unmet palliative care needs Measured at day 5 post-randomization Measured using the adapted Needs of Social Nature, Existential Concerns, Symptoms, and Therapeutic Interaction (NEST) scale administered to surrogates and patients (if able) 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.
Surrogates' clarity about patient values and preferences Measured on study day 5 Assessed by surrogates/patients 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.
Duration of mechanical ventilation Measured at 6 months Duration of time patient spent on mechanical ventilation during index hospitalization
Composite measure of goal-concordant care Measured at 3 months Assessed by surrogates and patients (if able) at 3-month telephone follow-up using an 8-item composite measure of goal-concordant care.
Satisfaction with ICU care Measured at 3 months Assessed using the Family Satisfaction in the ICU (FS-ICU) instrument at 3-month telephone follow-up of surrogates and patients (if able). The FS-ICU is a 24-item scale concerning satisfaction with care, communication, and decision-making in the ICU.
Risk of post-traumatic stress disorder Measured at 6 months Assessed using the Impact of Events Scale-revised (IES-R) at 6-month telephone follow-up of surrogates and patients (if able). 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.
Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care during index hospitalization Measured at 6 months Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care during index hospitalization
Surrogates' prognostic awareness Measured on study day 5 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.
Symptoms of anxiety and depression Measured at 6 months The Hospital Anxiety and Depression Scale (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 of surrogates and patients (if able).
Cost of index hospitalization Measured at 6 months Assigning costs using validated methods, the cost of index hospitalization will be calculated
Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization Measured at 6 months Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization
Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization Measured at 6 months Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization
ICU and hospital length of stay Measured at 6 months Duration of time patient spent in ICU and hospital during index hospitalization
Resource utilization over 6-months follow-up Measured at 3 months and 6 months Among hospital survivors investigators 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.
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States