Integrated Supportive and Palliative Care for Older Adults in the ICU

NCT04921631 | Completed DMC

• 2 other identifiers: STUDY20030163R01AG068567-01
• Study Type: interventional
• Target: 1,091
• Locations: 1 country
• Sites: 1

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

Keywords

Intensive care; Palliative care; Surrogate decision-making; Quality of communication; Patient-centered care; Anxiety; Depression; Post-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Composite measure of goal-concordant care

  Measured at 3 months

• Unmet palliative care needs

  Measured at day 5 post-randomization

• Surrogates' prognostic awareness

  Measured on study day 5

• Surrogates' clarity about patient values and preferences

  Measured on study day 5

• Satisfaction with ICU care

  Measured at 3 months

Other Outcomes (4)

• Patient hospital survival

  Measured at 6 months

• Duration of survival from hospital discharge through 6-month follow-up

  Measured at 6 months

• Days alive outside healthcare facilities

  Measured at 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Early Integration of Specialty Palliative Care with Critical Care

No intervention

NO INTERVENTION

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

Interventions

Early Integration of Specialty Palliative Care with Critical Care 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.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Massachusetts General Hospital: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 11532588 BACKGROUND

• 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.

  PMID: 33822069 BACKGROUND

• 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.

  PMID: 35595373 DERIVED

MeSH Terms

Conditions

Critical Illness; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic

Interventions

Critical Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Douglas B White, MD, MAS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Yael Schenker, MD, MAS, FAAHPM

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 10, 2021
• Study Start: June 28, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)