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Completed

NCT Number: NCT01358110

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Early palliative care consultation

Other

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

Other

Standard care as usual which may or may not include palliative care consultation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 23, 2011
Registry last updated
Jun 26, 2015

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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