Emergency Department-Based Palliative Care for Advanced Cancer Patients

Metastatic Cancer Clinical Trial

Official title:

Emergency Department-Based Palliative Care for Advanced Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358110
• Other study ID #: GCO 08-1234
• Status: Completed
• Phase: N/A
• First received: May 19, 2011
• Last updated: June 25, 2015
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Advanced Cancer
• Emergencies
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

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* Note: There are 83 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline	Comparison of life and quality of mental health from baseline to 6 weeks and 12 weeks.	at baseline, 6 weeks and 12 weeks	No
Secondary	Inpatient costs per day/cost of stay during hospitalization	Costs per day during incident admission and total cost of entire incident hospital stay	6 months after hospital discharge	No
Secondary	Hospital length of stay	Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates.	6 months after hospital discharge	No
Secondary	Survival	Survival days from day of enrollment to day of death or study termination	at time of enrollment	No
Secondary	Readmissions within 6 months of discharge		6 months from hospital discharge	No
Secondary	Repeat visits to the ED in 6 months		6 months from hospital discharge	No