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Integrated Supportive and Palliative Care for Older Adults in the ICU (ProPACC)

Primary Purpose

Critical Illness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Integration of Specialty Palliative Care with Critical Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Intensive care, Palliative care, Surrogate decision-making, Quality of communication, Patient-centered care, Anxiety, Depression, Post-traumatic stress disorder

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 coma1
  • 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 support2
  • Multiorgan system failure3
  • 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 disease4
  • Advanced dementia or other end-stage neurologic disease
  • Age greater than or equal to 80 with two or more major comorbidities5

  • Moderate-severe frailty (excluding stable intellectual or physical disability 6

    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)

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

No intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).
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.
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
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
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
ICU and hospital length of stay
Duration of time patient spent in ICU and hospital during index hospitalization
Duration of mechanical ventilation
Duration of time patient spent on mechanical ventilation during index hospitalization
Cost of index hospitalization
Assigning costs using validated methods, the cost of index hospitalization will be calculated
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.

Full Information

First Posted
May 28, 2021
Last Updated
October 10, 2023
Sponsor
University of Pittsburgh
Collaborators
Massachusetts General Hospital, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04921631
Brief Title
Integrated Supportive and Palliative Care for Older Adults in the ICU
Acronym
ProPACC
Official Title
Randomized Trial of Specialty Palliative Care Integrated With Critical Care for Critically Ill Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Massachusetts General Hospital, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Intensive care, Palliative care, Surrogate decision-making, Quality of communication, Patient-centered care, Anxiety, Depression, Post-traumatic stress disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention arm will receive early specialty palliative care integrated with standard critical care.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Usual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter.
Intervention Type
Behavioral
Intervention Name(s)
Early Integration of Specialty Palliative Care with Critical Care
Intervention Description
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 Outcome Measure Information:
Title
Patient and family centeredness of care
Description
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.
Time Frame
Measured at 3 months after hospital discharge
Secondary Outcome Measure Information:
Title
Composite measure of goal-concordant care
Description
Assessed by surrogates and patients (if able) at 3-month telephone follow-up using an 8-item composite measure of goal-concordant care.
Time Frame
Measured at 3 months
Title
Unmet palliative care needs
Description
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.
Time Frame
Measured at day 5 post-randomization
Title
Surrogates' prognostic awareness
Description
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.
Time Frame
Measured on study day 5
Title
Surrogates' clarity about patient values and preferences
Description
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.
Time Frame
Measured on study day 5
Title
Satisfaction with ICU care
Description
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.
Time Frame
Measured at 3 months
Title
Symptoms of anxiety and depression
Description
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).
Time Frame
Measured at 6 months
Title
Risk of post-traumatic stress disorder
Description
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.
Time Frame
Measured at 6 months
Title
Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization
Description
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
Title
Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care during index hospitalization
Description
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
Title
Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization
Description
Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization
Time Frame
Measured at 6 months
Title
ICU and hospital length of stay
Description
Duration of time patient spent in ICU and hospital during index hospitalization
Time Frame
Measured at 6 months
Title
Duration of mechanical ventilation
Description
Duration of time patient spent on mechanical ventilation during index hospitalization
Time Frame
Measured at 6 months
Title
Cost of index hospitalization
Description
Assigning costs using validated methods, the cost of index hospitalization will be calculated
Time Frame
Measured at 6 months
Title
Resource utilization over 6-months follow-up
Description
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.
Time Frame
Measured at 3 months and 6 months
Other Pre-specified Outcome Measures:
Title
Patient hospital survival
Description
The vital status of the patient will be assessed at the conclusion of index hospitalization.
Time Frame
Measured at 6 months
Title
Duration of survival from hospital discharge through 6-month follow-up
Description
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.
Time Frame
Measured at 6 months
Title
Days alive outside healthcare facilities
Description
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.
Time Frame
Measured at 6 months
Title
Patients' functional status
Description
Assessed using the Katz Index of Independence in Activities of Daily Living, a validated and widely-used scale to quantify patients' functional status.
Time Frame
Measured at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 coma1 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 support2 Multiorgan system failure3 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 disease4 Advanced dementia or other end-stage neurologic disease Age greater than or equal to 80 with two or more major comorbidities5 Moderate-severe frailty (excluding stable intellectual or physical disability 6 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas B White, MD, MAS
Phone
412-864-3757
Email
douglas.white@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Grace M Vincent, BA
Phone
412-383-3239
Email
grv7@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas B White, MD, MAS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yael Schenker, MD, MAS, FAAHPM
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas B White, MD, MAS
Phone
412-864-3757
Email
douglas.white@pitt.edu
First Name & Middle Initial & Last Name & Degree
Douglas White, MD, MAS
First Name & Middle Initial & Last Name & Degree
Yael Schenker, MD, MAS
First Name & Middle Initial & Last Name & Degree
Derek Angus, MD, MPH
First Name & Middle Initial & Last Name & Degree
Robert Arnold, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Seaman, PhD, RN
First Name & Middle Initial & Last Name & Degree
Joyce Chang, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
11532588
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.
Results Reference
background
PubMed Identifier
33822069
Citation
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.
Results Reference
background
PubMed Identifier
35595373
Citation
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.
Results Reference
derived

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Integrated Supportive and Palliative Care for Older Adults in the ICU

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