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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03210116
Other study ID # 201705046
Secondary ID
Status Withdrawn
Phase N/A
First received June 25, 2017
Last updated July 26, 2017
Start date July 2017
Est. completion date August 2018

Study information

Verified date July 2017
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A quality improvement project compares automatic palliative care consultation compared 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 quality of life and examine if this intervention leads to decreased length of days in the ICU, Hospital, and on mechanical ventilation.


Description:

- The medical intensive care unit will be split into two groups, assigned as either automatic palliative care consultation or standard of care.

- A palliative care screening tool will be used to determine if a newly admitted patient is eligible for palliative care consultation. For patients in the standard of care group, medical records will be reviewed.

- The two medical ICU groups will be crossed over to the after 3 months for a total of 6 months of study.

- Participants will be followed through his or her hospitalization.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Admitted to 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 non invasive positive pressure ventilation

- 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:

- Solid organ or stem cell transplant patients

- Patients who do not speak English if interpreter is unavailable

- Patients without capacity to participate in palliative care discussions without a surrogate available

- Patient or patient surrogate refusal of palliative care consultation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Palliative Care
Palliative Care Consultation

Locations

Country Name City State
United States Barnes Jewish Hospital Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (6)

Adelson K, Paris J, Horton JR, Hernandez-Tellez L, Ricks D, Morrison RS, Smith CB. Standardized Criteria for Palliative Care Consultation on a Solid Tumor Oncology Service Reduces Downstream Health Care Use. J Oncol Pract. 2017 May;13(5):e431-e440. doi: 10.1200/JOP.2016.016808. Epub 2017 Mar 17. — View Citation

Aslakson R, Cheng J, Vollenweider D, Galusca D, Smith TJ, Pronovost PJ. Evidence-based palliative care in the intensive care unit: a systematic review of interventions. J Palliat Med. 2014 Feb;17(2):219-35. doi: 10.1089/jpm.2013.0409. Review. — View Citation

Hsu-Kim C, Friedman T, Gracely E, Gasperino J. Integrating Palliative Care into Critical Care: A Quality Improvement Study. J Intensive Care Med. 2015 Sep;30(6):358-64. doi: 10.1177/0885066614523923. Epub 2014 Mar 5. — View Citation

Khandelwal N, Kross EK, Engelberg RA, Coe NB, Long AC, Curtis JR. Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review. Crit Care Med. 2015 May;43(5):1102-11. doi: 10.1097/CCM.0000000000000852. Review. — View Citation

Kyeremanteng K, Gagnon LP, Thavorn K, Heyland D, D'Egidio G. The Impact of Palliative Care Consultation in the ICU on Length of Stay: A Systematic Review and Cost Evaluation. J Intensive Care Med. 2016 Aug 31. pii: 0885066616664329. [Epub ahead of print] — View Citation

Penrod JD, Pronovost PJ, Livote EE, Puntillo KA, Walker AS, Wallenstein S, Mercado AF, Swoboda SM, Ilaoa D, Thompson DA, Nelson JE. Meeting standards of high-quality intensive care unit palliative care: clinical performance and predictors. Crit Care Med. 2012 Apr;40(4):1105-12. doi: 10.1097/CCM.0b013e3182374a50. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ICU Length of Stay Through study completion, an average of 1 year
Primary Hospital length of stay Through study completion, an average of 1 year
Primary Cardiopulmonary resuscitation (CPR) performed Through study completion, an average of 1 year
Primary Days on Mechanical Ventilation Through study completion, an average of 1 year
Secondary Transition to comfort care or discharge to hospice Through study completion, an average of 1 year
Secondary Total hospital stay cost Through study completion, an average of 1 year
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