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Clinical Trials/NCT01358110
NCT01358110
Completed
Not Applicable

Emergency Department-Based Palliative Care for Advanced Cancer Patients

Icahn School of Medicine at Mount Sinai1 site in 1 country136 target enrollmentMay 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Cancer
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
136
Locations
1
Primary Endpoint
Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Status
Completed
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Repeat visits to the ED in 6 months(6 months from hospital discharge)
  • Hospital length of stay(6 months after hospital discharge)
  • Readmissions within 6 months of discharge(6 months from hospital discharge)
  • Survival(at time of enrollment)
  • Inpatient costs per day/cost of stay during hospitalization(6 months after hospital discharge)

Study Sites (1)

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