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Emergency Department-Based Palliative Care for Advanced Cancer Patients

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ClinicalTrials.gov Identifier: NCT01358110
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : June 26, 2015
American Cancer Society, Inc.
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Other: Early palliative care consultation Other: Care as usual Not Applicable

Detailed Description:
As the population ages, the number of individual living with cancer will continue to rise, and the number of Emergency Department (ED) visits for this population will continue to increase. Cancer patients visit EDs because symptoms, such as pain or vomiting, can't be controlled at home, in an assisted living facility, or in their provider's office. The ED is often the only place that can provide the necessary treatments as well as immediate access to technologically advanced testing for those with cancer. However, palliative care (PC) services, such as relief of burdensome symptoms), attention to spiritual or social concerns, and establishing goals of care, is not standard care in the ED outside of a few medical centers. Most patients do not have well-defined goals of care, and are often subjected to painful and marginally effective tests and procedures, not because they are consistent with their goals but because it is less time-consuming than discussing other options and has less perceived legal risk. Until recently little emphasis has been placed on education, research, or guidelines for the delivery of PC services in this important setting. While emergency providers could provide some of these services themselves, knowledge and skills regarding PC as well as staffing are currently inadequate to provide comprehensive services. In addition to further decreasing days spent in the hospital and health care costs, consultation by a PC team for ED cancer patients might also reduce pain and other symptoms, aid in complex medical decision-making regarding testing and treatments, and facilitate transfer to hospice or home with visiting nurse services. To enable PC consultation for ED cancer patients, the investigators will first determine who could benefit from emergent consultation, what services they need, and what characteristics of emergency providers and hospitals are preventing them from being offered. To determine what affect PC consultation for patients with advanced cancer has on symptoms, discussions with patients and families about goals of care, and how long patients spend in the ED, the investigators will then randomly assign 200 ED cancer patients to targeted PC consultation versus usual or standard care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Emergency Department-Based Palliative Care for Advanced Cancer Patients
Study Start Date : May 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Early palliative care consultation
Early palliative care consultation for ED patients with advanced cancer.
Other: Early palliative care consultation
Patients will have symptoms assessed, have goals of care discussion with family and team present, and surrogate designated, as well as coordination of care and home services.

Care as usual
Care as usual, may or may not receive palliative care consultation
Other: Care as usual
Standard care as usual which may or may not include palliative care consultation

Primary Outcome Measures :
  1. Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline [ Time Frame: at baseline, 6 weeks and 12 weeks ]
    Comparison of life and quality of mental health from baseline to 6 weeks and 12 weeks.

Secondary Outcome Measures :
  1. Inpatient costs per day/cost of stay during hospitalization [ Time Frame: 6 months after hospital discharge ]
    Costs per day during incident admission and total cost of entire incident hospital stay

  2. Hospital length of stay [ Time Frame: 6 months after hospital discharge ]
    Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates.

  3. Survival [ Time Frame: at time of enrollment ]
    Survival days from day of enrollment to day of death or study termination

  4. Readmissions within 6 months of discharge [ Time Frame: 6 months from hospital discharge ]
  5. Repeat visits to the ED in 6 months [ Time Frame: 6 months from hospital discharge ]

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

Inclusion Criteria:

  • ≥ 18 years age
  • Speak English or Spanish
  • ED patient with an advanced solid malignancy

Exclusion Criteria:

  • Have already been seen by palliative care team
  • Cognitive deficits
  • Children or adolescents
  • No confirmed history of active cancer
  • Do not speak English or Spanish
  • Reside outside the US

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): NCT01358110

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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
American Cancer Society, Inc.
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Principal Investigator: Corita Grudzen, MD, MSHS Icahn School of Medicine at Mount Sinai
Mohanty SA SS, Bodukum VK,Grudzen CR, Lorenz K, Asch SM. Assessing the Need for Integration of Palliative Care in a Public Sector Emergency Department. Paper presented at: Academy Health2008; Washington D.C.
Partnership for Solutions. Chronic Conditions: Making the Case for Ongoing Care. Baltimore: Johns Hopkins University;2002.
Institute of Medicine (U.S.). Committee on Palliative and End-of-Life Care for Children and Their Families. Ethical and legal issues. Washington, D.C.: Institute of Medicine, National Academies Press; 2003.
American Cancer Society. Cancer Facts and Figures. 2008; http://www.cancer.org/docroot/STT/content/STT_1x_Cancer_Facts_and_Figures_2008.asp. Accessed October 2, 2008.
Tulsky JA. Doctor-Patient Communication. In: Morrison RS, Meier DE, eds. Geriatric Palliative Care. New York: Oxford University Press; 2003.
National Quality Forum. A national framework and preferred practices for palliative and hospice care quality : a consensus report. Washington, DC: National Quality Forum; 2006.
Clinical Practice Guidelines for Quality Palliative Care. National Consensus Project for Quality Palliative Care 2004; www.nationalconsensusproject.org. Accessed November 8, 2009.
Center for the Evaluative Clinical Sciences. Dartmouth Atlas of Health Care. 1999; 2001:http://www.dartmouthatlas.org/atlases/2006_Atlas_Exec_Summary.pdf.
Center to Advance Palliative Care. A Guide to Developing a Hospital-Based Palliative Care Program. New York: Center to Advance Palliative Care; 2004.
Improving Palliative Care for Cancer. Washington D.C.: Institute of Medicine and National Research Council; National Academy Press; 2001.
American Cancer Society: Strategic Plan and Progress Report. 2007; http://www.cancer.org/downloads/AA/2007_Strategic_Plan_Progress_Report.pdf. Accessed October 6, 2008.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01358110    
Other Study ID Numbers: GCO 08-1234
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Keywords provided by Icahn School of Medicine at Mount Sinai:
palliative care
emergency medicine
end- of- life care
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes