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Emergency Department-Based Palliative Care for Advanced Cancer Patients

Primary Purpose

Advanced Cancer, Metastatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early palliative care consultation
Care as usual
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Advanced Cancer focused on measuring palliative care, cancer, emergency medicine, end- of- life care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early palliative care consultation

Care as usual

Arm Description

Early palliative care consultation for ED patients with advanced cancer.

Care as usual, may or may not receive palliative care consultation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Inpatient costs per day/cost of stay during hospitalization
Costs per day during incident admission and total cost of entire incident hospital stay
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.
Survival
Survival days from day of enrollment to day of death or study termination
Readmissions within 6 months of discharge
Repeat visits to the ED in 6 months

Full Information

First Posted
May 19, 2011
Last Updated
June 25, 2015
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01358110
Brief Title
Emergency Department-Based Palliative Care for Advanced Cancer Patients
Official Title
Emergency Department-Based Palliative Care for Advanced Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Metastatic Cancer
Keywords
palliative care, cancer, emergency medicine, end- of- life care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early palliative care consultation
Arm Type
Experimental
Arm Description
Early palliative care consultation for ED patients with advanced cancer.
Arm Title
Care as usual
Arm Type
Other
Arm Description
Care as usual, may or may not receive palliative care consultation
Intervention Type
Other
Intervention Name(s)
Early palliative care consultation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Description
Standard care as usual which may or may not include palliative care consultation
Primary Outcome Measure Information:
Title
Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Description
Comparison of life and quality of mental health from baseline to 6 weeks and 12 weeks.
Time Frame
at baseline, 6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Inpatient costs per day/cost of stay during hospitalization
Description
Costs per day during incident admission and total cost of entire incident hospital stay
Time Frame
6 months after hospital discharge
Title
Hospital length of stay
Description
Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates.
Time Frame
6 months after hospital discharge
Title
Survival
Description
Survival days from day of enrollment to day of death or study termination
Time Frame
at time of enrollment
Title
Readmissions within 6 months of discharge
Time Frame
6 months from hospital discharge
Title
Repeat visits to the ED in 6 months
Time Frame
6 months from hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corita Grudzen, MD, MSHS
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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Emergency Department-Based Palliative Care for Advanced Cancer Patients

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