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Emergency Department-Based Palliative Care for Advanced Cancer Patients

This study is currently recruiting participants.
Verified October 2012 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01358110
First received: May 19, 2011
Last updated: October 3, 2012
Last verified: October 2012
History of Changes

May 19, 2011
October 3, 2012
May 2011
June 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Comparison of life and quality of mental health from baseline to 6 weeks and 12 weeks.
Quality of life and quality of mental health [ Time Frame: 12 weeks after baseline recruitment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01358110 on ClinicalTrials.gov Archive Site
  • Inpatient costs per day/cost of stay during hospitalization [ Time Frame: 6 months after hospital discharge ] [ Designated as safety issue: No ]
    Costs per day during incident admission and total cost of entire incident hospital stay
  • Hospital length of stay [ Time Frame: 6 months after hospital discharge ] [ Designated as safety issue: No ]
    Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates.
  • Survival [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    Survival days from day of enrollment to day of death or study termination
  • Readmissions within 6 months of discharge [ Time Frame: 6 months from hospital discharge ] [ Designated as safety issue: No ]
  • Repeat visits to the ED in 6 months [ Time Frame: 6 months from hospital discharge ] [ Designated as safety issue: No ]
  • Inpatient costs per day/cost of stay during hospitalization [ Time Frame: 6 months after hospital discharge ] [ Designated as safety issue: No ]
    Costs per day during incident admission and total cost of entire incident hospital stay
  • Hospital length of stay [ Time Frame: 6 months after hospital discharge ] [ Designated as safety issue: No ]
    Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates.
  • Change in pain score from admission to discharge [ Time Frame: at time of admission to hospital (day 1) ] [ Designated as safety issue: No ]
  • Change in pain score from admission to discharge [ Time Frame: 6 months after hospital discharge ] [ Designated as safety issue: No ]
  • Readmission within 6 months of discharge [ Time Frame: 6 months from hospital discharge ] [ Designated as safety issue: No ]
  • repeat visits to the ER in 6 months [ Time Frame: 6 months from hospital discharge ] [ Designated as safety issue: No ]
  • disposition [ Time Frame: 6 months after incident ED visit ] [ Designated as safety issue: No ]
    Assess whether patient was admitted, discharged home, discharged to hospice, discharged to nursing home, or expired.
Not Provided
Not Provided
 
Emergency Department-Based Palliative Care for Advanced Cancer Patients
Emergency Department-Based Palliative Care for Advanced Cancer Patients

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
  • Advanced Cancer
  • Metastatic Cancer
  • Other: Early palliative care consultation for ED patients with advanced cancer
    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.
  • Other: Care as usual
    Standard care as usual which may or may not include palliative care consultation
  • Experimental: Early palliative care consultation
    Early palliative care consultation for ED patients with advanced cancer.
    Intervention: Other: Early palliative care consultation for ED patients with advanced cancer
  • Care as usual
    Care as usual, may or may not receive palliative care consultation
    Intervention: Other: Care as usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Joanna Ortiz 212-824-8085 Joanna.m.ortiz@mountsinai.org
Contact: Corita Grudzen, MD, MSHS 212-824-8063 Corita.Grudzen@mountsinai.org
United States
 
NCT01358110
GCO #08-1234
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
American Cancer Society, Inc.
Principal Investigator: Corita Grudzen, MD, MSHS Mount Sinai School of Medicine
Mount Sinai School of Medicine
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP