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Completed

NCT Number: NCT04921631

Integrated Supportive and Palliative Care for Older Adults in the ICU

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.

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Key information

Conditions

Critical Illness Anxiety Disorders Behavior Behavioral Symptoms Depression Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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
  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Patient and family centeredness of care

    Time frame: 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 outcomes

  1. Composite measure of goal-concordant care

    Time frame: 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.

  2. Unmet palliative care needs

    Time frame: 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.

  3. Surrogates' prognostic awareness

    Time frame: 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.

  4. Surrogates' clarity about patient values and preferences

    Time frame: 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.

  5. Satisfaction with ICU care

    Time frame: 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.

  6. Symptoms of anxiety and depression

    Time frame: 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).

  7. Risk of post-traumatic stress disorder

    Time frame: 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.

  8. Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization

    Time frame: Measured at 6 months

    Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization

  9. Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care during index hospitalization

    Time frame: 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

  10. Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization

    Time frame: Measured at 6 months

    Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization

  11. ICU and hospital length of stay

    Time frame: Measured at 6 months

    Duration of time patient spent in ICU and hospital during index hospitalization

  12. Duration of mechanical ventilation

    Time frame: Measured at 6 months

    Duration of time patient spent on mechanical ventilation during index hospitalization

  13. Cost of index hospitalization

    Time frame: Measured at 6 months

    Assigning costs using validated methods, the cost of index hospitalization will be calculated

  14. Resource utilization over 6-months follow-up

    Time frame: 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.

Other outcomes

  1. Patient hospital survival

    Time frame: Measured at 6 months

    The vital status of the patient will be assessed at the conclusion of index hospitalization.

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

    Time frame: Measured at 6 months

    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.

  3. Days alive outside healthcare facilities

    Time frame: Measured at 6 months

    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.

  4. Patients' functional status

    Time frame: Measured at 6 months

    Assessed using the Katz Index of Independence in Activities of Daily Living, a validated and widely-used scale to quantify patients' functional status.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Massachusetts General Hospital
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: ProPACC

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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