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OpenTrials
Completed

NCT Number: NCT03263143

Palliative Care in the ICU

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Palliative Care

Other

Palliative Care Consultation within 24 to 48 hours after admission

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Early Palliative Care in the Medical Intensive Care Unit

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2017
Registry last updated
Jan 24, 2019

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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