Integrated Supportive and Palliative Care for Older Adults in the ICU

Critical Illness Clinical Trial

— ProPACC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921631
• Other study ID #: STUDY20030163
• Secondary ID: R01AG068567-01
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Douglas B White, MD, MAS
• Phone: 412-864-3757
• Email: douglas.white[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: May 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Patient Inclusion Criteria

1. Admitted to a participating study ICU

2. Age greater than or equal to 60 years

3. Meets one or more of the following acute or chronic triggers for PC consultation

Acute:

• Cardiac or respiratory arrest with coma

• 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 support

• Multiorgan system failure

• 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 disease

• Advanced dementia or other end-stage neurologic disease

• Age greater than or equal to 80 with two or more major comorbidities

• Moderate-severe frailty (excluding stable intellectual or physical disability

1. Pittsburgh Cardiac Arrest Category (PCAC) greater than or equal to 2

2. Organ support: RRT, invasive or non-invasive mechanical ventilation, vasopressors

3. Sequential Organ Failure Assessment (SOFA) score greater than or equal to 10

4. Model for End-Stage Liver Disease (MELD) greater than or equal to 30

5. Major comorbidities defined by Charlson Co-morbidity Index (CCI)

6. 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)

Related Conditions & MeSH terms

• Critical Illness

Intervention

Behavioral:
• Early Integration of Specialty Palliative Care with Critical Care
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Massachusetts General Hospital, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Glass DP, Wang SE, Minardi PM, Kanter MH. Concordance of End-of-Life Care With End-of-Life Wishes in an Integrated Health Care System. JAMA Netw Open. 2021 Apr 1;4(4):e213053. doi: 10.1001/jamanetworkopen.2021.3053. — View Citation

Teno JM, Clarridge B, Casey V, Edgman-Levitan S, Fowler J. Validation of Toolkit After-Death Bereaved Family Member Interview. J Pain Symptom Manage. 2001 Sep;22(3):752-8. doi: 10.1016/s0885-3924(01)00331-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient hospital survival	The vital status of the patient will be assessed at the conclusion of index hospitalization.	Measured at 6 months
Other	Duration of survival from hospital discharge through 6-month follow-up	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 at the completion of the trial.	Measured at 6 months
Other	Days alive outside healthcare facilities	Investigators 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.	Measured at 6 months
Other	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.	Measured at 6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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 (a=0.92), and discriminant validity.	Measured on study day 5
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ICU and hospital length of stay	Duration of time patient spent in ICU and hospital during index hospitalization	Measured at 6 months
Secondary	Duration of mechanical ventilation	Duration of time patient spent on mechanical ventilation during index hospitalization	Measured at 6 months
Secondary	Cost of index hospitalization	Assigning costs using validated methods, the cost of index hospitalization will be calculated	Measured at 6 months
Secondary	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