NCT01358110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

3.7 years

First QC Date

May 19, 2011

Last Update Submit

June 25, 2015

Conditions

Advanced CancerMetastatic Cancer

Keywords

palliative carecanceremergency medicineend- of- life care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Inpatient costs per day/cost of stay during hospitalization

    6 months after hospital discharge

  • Hospital length of stay

    6 months after hospital discharge

  • Survival

    at time of enrollment

  • Readmissions within 6 months of discharge

    6 months from hospital discharge

  • Repeat visits to the ED in 6 months

    6 months from hospital discharge

Study Arms (2)

Early palliative care consultation

EXPERIMENTAL

Early palliative care consultation for ED patients with advanced cancer.

Other: Early palliative care consultation

Care as usual

OTHER

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

Other: Care as usual

Interventions

Early palliative care consultationOTHER

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.

Early palliative care consultation
Care as usualOTHER

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

Care as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years age
  • Speak English or Spanish
  • ED patient with an advanced solid malignancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (88)

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  • Grudzen CR, Richardson LD, Johnson PN, Hu M, Wang B, Ortiz JM, Kistler EA, Chen A, Morrison RS. Emergency Department-Initiated Palliative Care in Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2016 May 1;2(5):591-598. doi: 10.1001/jamaoncol.2015.5252.

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  • Kistler EA, Sean Morrison R, Richardson LD, Ortiz JM, Grudzen CR. Emergency department-triggered palliative care in advanced cancer: proof of concept. Acad Emerg Med. 2015 Feb;22(2):237-9. doi: 10.1111/acem.12573. Epub 2015 Jan 29.

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  • Kandarian B, Morrison RS, Richardson LD, Ortiz J, Grudzen CR. Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial. Trials. 2014 Jun 25;15:251. doi: 10.1186/1745-6215-15-251.

    PMID: 24962353DERIVED

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Corita Grudzen, MD, MSHS

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2011

First Posted

May 23, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

US(1)