Integrated Supportive and Palliative Care for Older Adults in the ICU

NCT ID: NCT04921631

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2026-05-31

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention

The intervention arm will receive early specialty palliative care integrated with standard critical care.

Group Type: EXPERIMENTAL

Early Integration of Specialty Palliative Care with Critical Care

Intervention Type: BEHAVIORAL

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.

No intervention

Usual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Douglas White

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas B White, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Yael Schenker, MD, MAS, FAAHPM

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11532588 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33822069 (View on PubMed)

Andersen SK, Vincent G, Butler RA, Brown EHP, Maloney D, Khalid S, Oanesa R, Yun J, Pidro C, Davis VN, Resick J, Richardson A, Rak K, Barnes J, Bezak KB, Thurston A, Reitschuler-Cross E, King LA, Barbash I, Al-Khafaji A, Brant E, Bishop J, McComb J, Chang CH, Seaman J, Temel JS, Angus DC, Arnold R, Schenker Y, White DB. ProPACC: Protocol for a Trial of Integrated Specialty Palliative Care for Critically Ill Older Adults. J Pain Symptom Manage. 2022 Jun;63(6):e601-e610. doi: 10.1016/j.jpainsymman.2022.02.344.

Reference Type: DERIVED

PMID: 35595373 (View on PubMed)

Other Identifiers

R01AG068567-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY20030163

Identifier Type: -

Identifier Source: org_study_id