AzTrials
AzTrials

Critical IllnessProPACCNCT04921631

Integrated Supportive and Palliative Care for Older Adults in the ICU

A study testing Early Integration of Specialty Palliative Care with Critical Care in people with Critical Illness, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Critical Illness
What is being tested?
Early Integration of Specialty Palliative Care with Critical Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,091 participants
Where
1 siteUnited States
Study dates
28 Jun 2021to 28 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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.

Being tested
Early Integration of Specialty Palliative Care with Critical Care
Keywords
Intensive care, Palliative care, Surrogate decision-making, Quality of communication, Patient-centered care, Anxiety, Depression, Post-traumatic stress disorder
Medical subject headings
Critical Illness, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Integration of Specialty Palliative Care with Critical CareBehavioural

    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.

Study groups in NCT04921631
Study groupRoleWhat they receive
InterventionExperimentalThe intervention arm will receive early specialty palliative care integrated with standard critical care.
Receives: Behavioral: Early Integration of Specialty Palliative Care with Critical Care
No interventionNo interventionUsual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured at 3 months after hospital discharge

Secondary outcomes (14)

  1. 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: Measured at 3 months

  2. 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: Measured at day 5 post-randomization

  3. 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: Measured on study day 5

  4. 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: Measured on study day 5

  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: Measured at 3 months

  6. 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: Measured at 6 months

  7. 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: Measured at 6 months

  8. 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: Measured at 6 months

  9. 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: Measured at 6 months

  10. 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: Measured at 6 months

  11. ICU and hospital length of stay

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

    Measured: Measured at 6 months

  12. Duration of mechanical ventilation

    Duration of time patient spent on mechanical ventilation during index hospitalization

    Measured: Measured at 6 months

  13. Cost of index hospitalization

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

    Measured: Measured at 6 months

  14. 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: Measured at 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start28 Jun 2021
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,091 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04921631
Sponsor's protocol ID
STUDY20030163
Other IDs
R01AG068567-01
Acronym
ProPACC
Status last verified
Apr 2026
First submitted
28 May 2021
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Raw data and derived datasets will be made available to external investigators and the public on a case-by-case basis, to be approved by the PI and in accordance with institutional, HIPAA, state and federal regulations. A data-sharing agreement may be instituted, depending upon the data to be shared. All data that is shared will be de-identified to protect participant privacy and confidentiality. Data and datasets will be retained and available to share for at least three years following completion of the project, in accordance with NIH regulations.

Publications

  • 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.

    PubMed 11532588

  • 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.

    PubMed 33822069

  • 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.

    PubMed 35595373

Questions about this trial

What is this clinical trial studying?

A study testing Early Integration of Specialty Palliative Care with Critical Care in people with Critical Illness, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient and family centeredness of care (time frame: Measured at 3 months after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04921631, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in