Trial record 4 of 172 for:    Open Studies | "palliative care"

Emergency Department-Based Palliative Care for Advanced Cancer Patients

This study is currently recruiting participants.
Verified November 2013 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: November 11, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Advanced Cancer
Metastatic Cancer
Other: Early palliative care consultation
Other: Care as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Emergency Department-Based Palliative Care for Advanced Cancer Patients

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early palliative care consultation
Early palliative care consultation for ED patients with advanced cancer.
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
Care as usual, may or may not receive palliative care consultation
Other: Care as usual
Standard care as usual which may or may not include palliative care consultation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358110

Contacts
Contact: Joanna Ortiz 212-824-8085 Joanna.m.ortiz@mountsinai.org
Contact: Corita Grudzen, MD, MSHS 212-824-8063 Corita.Grudzen@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Joanna Ortiz    212-824-8085    Joanna.m.ortiz@mountsinai.org   
Contact: Corita Grudzen, MD, MSHS    212-824-8063    Corita.Grudzen@mountsinai.org   
Principal Investigator: Corita Grudzen, MD, MSHS         
Sponsors and Collaborators
Mount Sinai School of Medicine
American Cancer Society, Inc.
Investigators
Principal Investigator: Corita Grudzen, MD, MSHS Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01358110     History of Changes
Other Study ID Numbers: GCO 08-1234
Study First Received: May 19, 2011
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
palliative care
cancer
emergency medicine
end- of- life care

Additional relevant MeSH terms:
Emergencies
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Disease Attributes
Pathologic Processes
Neoplastic Processes

ClinicalTrials.gov processed this record on April 23, 2014