Integrated Supportive and Palliative Care for Older Adults in the ICU

Study Overview
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Brief Summary
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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. The investigators will conduct a randomized trial among 500 patients and 750 surrogates and up to 1250 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.

Official Title
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Randomized Trial of Specialty Palliative Care Integrated With Critical Care for Critically Ill Older Adults

Conditions
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Critical Illness

Intervention / Treatment
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* Behavioral: Early Integration of Specialty Palliative Care with Critical Care


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria Admitted to a participating study ICU Age greater than or equal to 60 years Meets one or more of the following acute or chronic triggers for PC consultation Acute: Cardiac or respiratory arrest with coma1 Ischemic or hemorrhagic stroke requiring mechanical ventilation ICU admission after hospital stay of greater than or equal to 10 days or ICU readmission within 30 days Age greater than or equal to 80 and 1 or more forms of organ support2 Multiorgan system failure3 CCM physician judgment of greater than or equal to 50% risk of in-hospital death or new severe long term functional impairment Chronic: Admission from a SNF or LTACH with progressive functional decline Metastatic (stage IV) cancer or advanced cancer without curative treatment End stage cardiorespiratory disease End stage liver disease4 Advanced dementia or other end-stage neurologic disease Age greater than or equal to 80 with two or more major comorbidities5 Moderate-severe frailty (excluding stable intellectual or physical disability 6 Pittsburgh Cardiac Arrest Category (PCAC) greater than or equal to 2 Organ support: RRT, invasive or non-invasive mechanical ventilation, vasopressors Sequential Organ Failure Assessment (SOFA) score greater than or equal to 10 Model for End-Stage Liver Disease (MELD) greater than or equal to 30 Major comorbidities defined by Charlson Co-morbidity Index (CCI) Clinical Frailty Scale (CFS) score greater than or equal to 6 Patient Exclusion No surrogate decision maker Already received (or refused) a Palliative Care consultation during the same hospitalization Determined to be imminently dying (within hours) by CCM physician Within 1 year of receiving organ transplant, or actively undergoing work-up for organ transplant Non-English speaking Surrogate Inclusion Primary surrogate, as determined by the patient's advance directive or by the hierarchy codified in state law Up to 3 additional surrogates Surrogate Exclusion Age <18 Cannot read or understand English Cannot complete surveys due to physical or cognitive limitations Clinician Inclusion •Patient's primary attending (or their designee)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention arm will receive early specialty palliative care integrated with standard critical care. | Behavioral: Early Integration of Specialty Palliative Care with Critical Care<br>* The PC team will visit the patient within 24 hours of randomization and the consultation will address the following domains of PC: illness understanding and goals of care conversations with patients/surrogates; symptom assessment and management; spiritual needs; patient and family coping and support; and care coordination and transitions. The initial family meeting will be scheduled to occur within two days of randomization. Follow-up visits will be conducted by the PC MD/APP every weekday. During this time, the ICU and PC team will be in daily communication. The PC team will continue to follow the patient in the hospital once discharged from ICU. Prior to discharge, the PC team will document patient goals and preferences for future treatment, coordinate appropriate PC services in the home and/or outpatient clinic settings and contact the patient's primary physician to provide an update on the patient's hospital stay.<br>|
| No Intervention: No intervention<br>Usual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | Measured at 3 months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of goal-concordant care | Assessed by surrogates and patients (if able) at 3-month telephone follow-up using an 8-item composite measure of goal-concordant care. | Measured at 3 months | 
| Unmet palliative care needs | 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. | 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 on study day 5 | 
| Surrogates' clarity about patient values and preferences | 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. | Measured on study day 5 | 
| Satisfaction with ICU care | 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. | Measured at 3 months | 
| Symptoms of anxiety and depression | 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). | Measured at 6 months | 
| Risk of post-traumatic stress disorder | 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. | 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 with new DNR order during index hospitalization and time to first DNR order 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 | 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 enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization | Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization | Measured at 6 months | 
| ICU and hospital length of stay | Duration of time patient spent in ICU and hospital during index hospitalization | Measured at 6 months | 
| Duration of mechanical ventilation | Duration of time patient spent on mechanical ventilation during index hospitalization | Measured at 6 months | 
| Cost of index hospitalization | Assigning costs using validated methods, the cost of index hospitalization will be calculated | Measured at 6 months | 
| Resource utilization over 6-months follow-up | 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. | Measured at 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care, Palliative care, Surrogate decision-making, Quality of communication, Patient-centered care, Anxiety, Depression, Post-traumatic stress disorder