Clinical trial NCT04921631: Integrated Supportive and Palliative Care for Older Adults in the ICU
Official title: Randomized Trial of Specialty Palliative Care Integrated With Critical Care for Critically Ill Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: Intensive care
Palliative care
Surrogate decision-making
Quality of communication
Patient-centered care
Anxiety
Depression
Post-traumatic stress disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: National Institute on Aging (NIA)
First posted: 2021-06-10
Enrollment: 1400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Patient and family centeredness of care
timeFrame: Measured at 3 months after hospital discharge
Secondary outcomes:
measure: Composite measure of goal-concordant care
timeFrame: Measured at 3 months
measure: Unmet palliative care needs
timeFrame: Measured at day 5 post-randomization
measure: Surrogates' prognostic awareness
timeFrame: Measured on study day 5
measure: Surrogates' clarity about patient values and preferences
timeFrame: Measured on study day 5
measure: Satisfaction with ICU care
timeFrame: Measured at 3 months
measure: Symptoms of anxiety and depression
timeFrame: Measured at 6 months
measure: Risk of post-traumatic stress disorder
timeFrame: Measured at 6 months
measure: Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization
timeFrame: Measured at 6 months
measure: Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care during index hospitalization
timeFrame: Measured at 6 months
measure: Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization
timeFrame: Measured at 6 months
measure: ICU and hospital length of stay
timeFrame: Measured at 6 months
measure: Duration of mechanical ventilation
timeFrame: Measured at 6 months
measure: Cost of index hospitalization
timeFrame: Measured at 6 months
measure: Resource utilization over 6-months follow-up
timeFrame: Measured at 3 months and 6 months
Other outcomes:
measure: Patient hospital survival
timeFrame: Measured at 6 months
measure: Duration of survival from hospital discharge through 6-month follow-up
timeFrame: Measured at 6 months
measure: Days alive outside healthcare facilities
timeFrame: Measured at 6 months
measure: Patients' functional status
timeFrame: Measured at 6 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Douglas B White, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Yael Schenker, MD, MAS, FAAHPM
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.