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Palliative Care in the ICU

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ClinicalTrials.gov Identifier: NCT03263143
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Marin Kollef, Washington University School of Medicine

Brief Summary:
The study compares early palliative care consultation to standard of care in the medical intensive care unit (ICU). The study will assess if the intervention leads to an increased proportion of clearly delineated goals of care and examine if this intervention leads to decreased healthcare resource utilization such as length of stay, duration of intensive treatments including mechanical ventilation, and hospital re-admissions.

Condition or disease Intervention/treatment Phase
Palliative Care Other: Palliative Care Not Applicable

Detailed Description:
  • The medical intensive care unit will be split into two groups, assigned as either early palliative care consultation or standard of care. Current standard of care in the ICU is that primary clinician providers determine the need and time for palliative care consultation, which can occur approximately 5 - 14 days after admission.
  • A palliative care screening tool will be used to determine if a newly admitted patient is eligible for palliative care consultation.
  • Up to two patients per ICU per weekday will be enrolled into the study, due to workload limitations on the palliative care consult team.
  • For patients in the intervention group, a palliative care consultation will be performed within 48 hours of ICU admission and patients will be followed throughout their hospitalization.
  • Patients in the standard of care group will receive usual care. Palliative care may be consulted at the primary team's clinical discretion.
  • The two medical ICU groups will be crossed over after three months with a washout period of six weeks, for a total of approximately eight months of study
  • Electronic medical records will be reviewed after patient discharge to collect data on clinical outcomes as described elsewhere

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Early Palliative Care in the Medical Intensive Care Unit
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : June 9, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
No Intervention: Standard of Care
Early Palliative Care Consultation Other: Palliative Care
Palliative Care Consultation within 24 to 48 hours after admission




Primary Outcome Measures :
  1. Change in code status to do-not-resuscitate/do-not-intubate [ Time Frame: Through patient admission until discharge, charts reviewed an average of one month after discharge ]
    As determined by code status orders in the electronic medical record


Secondary Outcome Measures :
  1. Number of participants with Cardiopulmonary Resuscitation (CPR) performed [ Time Frame: Through study completion, an average of 6 months ]
  2. Mechanical Ventilation usage and duration [ Time Frame: After date of discharge, charts reviewed an average of one month after discharge ]
  3. Hospital Length of Stay [ Time Frame: After date of discharge, charts reviewed an average of one month after discharge ]
  4. ICU Length of Stay [ Time Frame: After date of discharge, charts reviewed an average of one month after discharge ]
  5. In-hospital mortality [ Time Frame: After date of discharge, charts reviewed an average of one month after discharge ]
    Excluding patients transitioned to hospice prior to death

  6. 30-day mortality [ Time Frame: One to two months after patient discharge, verified at study completion ]
    Including all patients, including those on hospice

  7. Hospice transition or discharge [ Time Frame: Through patient admission until discharge, charts reviewed an average of one month after discharge ]
  8. Post-discharge ER visits and/or readmissions [ Time Frame: One to two months after patient discharge, verified at study completion ]
    Determined by review of the BJC healthcare system electronic medical record

  9. Total hospital operating cost [ Time Frame: Through study completion, an average of 6 months ]
  10. Vasopressor usage and duration [ Time Frame: After date of discharge, charts reviewed an average of one month after discharge ]
  11. Antibiotic usage and duration [ Time Frame: After date of discharge, charts reviewed an average of one month after discharge ]
  12. Number of participants treated with hemodialysis [ Time Frame: Through study completion, an average of six months ]
  13. Number of participants with tracheostomy performed during hospital stay [ Time Frame: Through study completion, an average of six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to the ICU in the last 24 hours
  • Admitted from Skilled nursing facility (SNF), long term acute care (LTAC)facility, long term ventilator care (vent LTC) unit, or home care with private duty nursing with activity of daily living (ADL) dependencies
  • End-stage dementia, amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis
  • Advanced or Metastatic Cancer
  • Cardiac or respiratory arrest with neurological compromise
  • Multi- organ system failure (more than 2 organ failures)
  • Known diagnosis of end stage organ disease including cirrhosis, end-stage renal disease, congestive heart failure New York Heart Association >III, chronic obstructive pulmonary disease on home O2
  • Shock requiring > 6 hours of vasopressors or inotropes
  • Acute Respiratory failure requiring intubation or BiPAP
  • Admitted to ICU with hospital length of stay of more than 5 days or ICU readmission with the same diagnosis in 30 days.

Exclusion Criteria:

  • All stem cell transplant patients, for solid organ transplant, if undergoing evaluation for solid organ transplant or within 1 year post-transplant.
  • Patients who do not speak English if interpreter is unavailable
  • Patients without capacity to participate in palliative care discussions without a surrogate available
  • Patients or patient surrogate refusal of palliative care consultation
  • Prior Palliative Care Consultation during the same hospitalization
  • For purposes of primary outcome analysis, patients determined to already be DNR/DNI at time of ICU admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263143


Locations
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United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marin Kollef, Professor, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03263143    
Obsolete Identifiers: NCT03210116
Other Study ID Numbers: 201707067
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No