We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Emergency Department-Based Palliative Care for Advanced Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358110
First Posted: May 23, 2011
Last Update Posted: June 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Icahn School of Medicine at Mount Sinai:

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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Repeat visits to the ED in 6 months [ Time Frame: 6 months from hospital discharge ]

Enrollment: 136
Study Start Date: May 2011
Study Completion Date: January 2015
Primary Completion Date: January 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358110


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
American Cancer Society, Inc.
Investigators
Principal Investigator: Corita Grudzen, MD, MSHS Icahn School of Medicine at Mount Sinai
  More Information

Publications:
Wiencke JK, Zheng S, Lafuente A, Lafuente MJ, Grudzen C, Wrensch MR, Miike R, Ballesta A, Trias M. Aberrant methylation of p16INK4a in anatomic and gender-specific subtypes of sporadic colorectal cancer. Cancer Epidemiol Biomarkers Prev. 1999 Jun;8(6):501-6.
Grudzen CR, Liddicoat R, Hoffman JR, Koenig W, Lorenz KA, Asch SM. Developing quality indicators for the appropriateness of resuscitation in prehospital atraumatic cardiac arrest. Prehosp Emerg Care. 2007 Oct-Dec;11(4):434-42. Review.
Chan GK. End-of-life models and emergency department care. Acad Emerg Med. 2004 Jan;11(1):79-86. Review.
McCusker J, Karp I, Cardin S, Durand P, Morin J. Determinants of emergency department visits by older adults: a systematic review. Acad Emerg Med. 2003 Dec;10(12):1362-70. Review.
Burge F, Lawson B, Johnston G. Family physician continuity of care and emergency department use in end-of-life cancer care. Med Care. 2003 Aug;41(8):992-1001.
A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8. Erratum in: JAMA 1996 Apr 24;275(16):1232.
Mohanty SA SS, Bodukum VK,Grudzen CR, Lorenz K, Asch SM. Assessing the Need for Integration of Palliative Care in a Public Sector Emergency Department. Paper presented at: Academy Health2008; Washington D.C.
Mahony SO, Blank A, Simpson J, Persaud J, Huvane B, McAllen S, Davitt M, McHugh M, Hutcheson A, Karakas S, Higgins P, Selwyn P. Preliminary report of a palliative care and case management project in an emergency department for chronically ill elderly patients. J Urban Health. 2008 May;85(3):443-51. doi: 10.1007/s11524-008-9257-z.
Alpert HR, Emanuel L. Comparing utilization of life-sustaining treatments with patient and public preferences. J Gen Intern Med. 1998 Mar;13(3):175-81.
Marco CA, Bessman ES, Schoenfeld CN, Kelen GD. Ethical issues of cardiopulmonary resuscitation: current practice among emergency physicians. Acad Emerg Med. 1997 Sep;4(9):898-904.
Lunney JR, Lynn J, Foley DJ, Lipson S, Guralnik JM. Patterns of functional decline at the end of life. JAMA. 2003 May 14;289(18):2387-92.
Covinsky KE, Eng C, Lui LY, Sands LP, Yaffe K. The last 2 years of life: functional trajectories of frail older people. J Am Geriatr Soc. 2003 Apr;51(4):492-8.
Partnership for Solutions. Chronic Conditions: Making the Case for Ongoing Care. Baltimore: Johns Hopkins University;2002.
Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. Erratum in: CA Cancer J Clin 2001 Mar-Apr;51(2):144.
McKinley ED, Garrett JM, Evans AT, Danis M. Differences in end-of-life decision making among black and white ambulatory cancer patients. J Gen Intern Med. 1996 Nov;11(11):651-6.
Field MJ, Cassel CK. Approaching death: improving care at the end of life. Health Prog. 2011 Jan-Feb;92(1):25.
Foley KM, Gelband H, National Cancer Policy Board (U.S.). Improving palliative care for cancer. Washington, D.C.: National Academy Press; 2001.
Institute of Medicine (U.S.). Committee on Palliative and End-of-Life Care for Children and Their Families. Ethical and legal issues. Washington, D.C.: Institute of Medicine, National Academies Press; 2003.
NIH State-of-the-Science Conference Statement on improving end-of-life care. NIH Consens State Sci Statements. 2004 Dec 6-8;21(3):1-26. Review.
Lubitz JD, Riley GF. Trends in Medicare payments in the last year of life. N Engl J Med. 1993 Apr 15;328(15):1092-6.
American Cancer Society. Cancer Facts and Figures. 2008; http://www.cancer.org/docroot/STT/content/STT_1x_Cancer_Facts_and_Figures_2008.asp. Accessed October 2, 2008.
DeFrances CJ, Hall MJ. 2002 National Hospital Discharge Survey. Adv Data. 2004 May 21;(342):1-29.
American Academy of Hospice and Palliative Medicine; Center to Advance Palliative Care; Hospice and Palliative Nurses Association; Last Acts Partnership; National Hospice and Palliative Care Organization. National Consensus Project for Quality Palliative Care: Clinical Practice Guidelines for quality palliative care, executive summary. J Palliat Med. 2004 Oct;7(5):611-27. Review.
Block SD. Perspectives on care at the close of life. Psychological considerations, growth, and transcendence at the end of life: the art of the possible. JAMA. 2001 Jun 13;285(22):2898-905.
Portenoy RK, Frager G. Pain management: pharmacological approaches. Cancer Treat Res. 1999;100:1-29. Review.
Bruera E. ABC of palliative care. Anorexia, cachexia, and nutrition. BMJ. 1997 Nov 8;315(7117):1219-22. Review.
Tulsky JA. Doctor-Patient Communication. In: Morrison RS, Meier DE, eds. Geriatric Palliative Care. New York: Oxford University Press; 2003.
Fallowfield L, Jenkins V. Communicating sad, bad, and difficult news in medicine. Lancet. 2004 Jan 24;363(9405):312-9.
Emanuel EJ, Fairclough DL, Slutsman J, Emanuel LL. Understanding economic and other burdens of terminal illness: the experience of patients and their caregivers. Ann Intern Med. 2000 Mar 21;132(6):451-9.
Tolle SW, Tilden VP, Rosenfeld AG, Hickman SE. Family reports of barriers to optimal care of the dying. Nurs Res. 2000 Nov-Dec;49(6):310-7.
Quill TE. Perspectives on care at the close of life. Initiating end-of-life discussions with seriously ill patients: addressing the "elephant in the room". JAMA. 2000 Nov 15;284(19):2502-7.
Lo B, Quill T, Tulsky J. Discussing palliative care with patients. ACP-ASIM End-of-Life Care Consensus Panel. American College of Physicians-American Society of Internal Medicine. Ann Intern Med. 1999 May 4;130(9):744-9. Review.
Quill TE, Arnold RM, Platt F. "I wish things were different": expressing wishes in response to loss, futility, and unrealistic hopes. Ann Intern Med. 2001 Oct 2;135(7):551-5.
von Gunten CF, Ferris FD, Emanuel LL. The patient-physician relationship. Ensuring competency in end-of-life care: communication and relational skills. JAMA. 2000 Dec 20;284(23):3051-7.
Singer PA, Martin DK, Kelner M. Quality end-of-life care: patients' perspectives. JAMA. 1999 Jan 13;281(2):163-8.
Bass DM, Noelker LS, Rechlin LR. The moderating influence of service use on negative caregiving consequences. J Gerontol B Psychol Sci Soc Sci. 1996 May;51(3):S121-31.
Levine C. The loneliness of the long-term care giver. N Engl J Med. 1999 May 20;340(20):1587-90.
McClain CS, Rosenfeld B, Breitbart W. Effect of spiritual well-being on end-of-life despair in terminally-ill cancer patients. Lancet. 2003 May 10;361(9369):1603-7.
Meier DE, Thar W, Jordan A, Goldhirsch SL, Siu A, Morrison RS. Integrating case management and palliative care. J Palliat Med. 2004 Feb;7(1):119-34.
Bass DM, Bowman K, Noelker LS. The influence of caregiving and bereavement support on adjusting to an older relative's death. Gerontologist. 1991 Feb;31(1):32-42.
Billings JA. What is palliative care? J Palliat Med. 1998 Spring;1(1):73-81.
Meier DE, Morrison RS, Cassel CK. Improving palliative care. Ann Intern Med. 1997 Aug 1;127(3):225-30.
Morrison RS, Meier DE. Clinical practice. Palliative care. N Engl J Med. 2004 Jun 17;350(25):2582-90. Review.
National Quality Forum. A national framework and preferred practices for palliative and hospice care quality : a consensus report. Washington, DC: National Quality Forum; 2006.
Clinical Practice Guidelines for Quality Palliative Care. National Consensus Project for Quality Palliative Care 2004; www.nationalconsensusproject.org. Accessed November 8, 2009.
Byock I. Completing the continuum of cancer care: integrating life-prolongation and palliation. CA Cancer J Clin. 2000 Mar-Apr;50(2):123-32. Review.
Center for the Evaluative Clinical Sciences. Dartmouth Atlas of Health Care. 1999; 2001:http://www.dartmouthatlas.org/atlases/2006_Atlas_Exec_Summary.pdf.
Lynn J, Wilkinson AM. Quality end of life care: the case for a MediCaring demonstration. Hosp J. 1998;13(1-2):151-63. Review.
Lynn J. Perspectives on care at the close of life. Serving patients who may die soon and their families: the role of hospice and other services. JAMA. 2001 Feb 21;285(7):925-32.
Lynn J. Learning to care for people with chronic illness facing the end of life. JAMA. 2000 Nov 15;284(19):2508-11.
Eng C, Pedulla J, Eleazer GP, McCann R, Fox N. Program of All-inclusive Care for the Elderly (PACE): an innovative model of integrated geriatric care and financing. J Am Geriatr Soc. 1997 Feb;45(2):223-32.
Center to Advance Palliative Care. A Guide to Developing a Hospital-Based Palliative Care Program. New York: Center to Advance Palliative Care; 2004.
von Gunten CF. Secondary and tertiary palliative care in US hospitals. JAMA. 2002 Feb 20;287(7):875-81.
McMillan SC, Small BJ. Using the COPE intervention for family caregivers to improve symptoms of hospice homecare patients: a clinical trial. Oncol Nurs Forum. 2007 Mar;34(2):313-21.
Brumley R, Enguidanos S, Jamison P, Seitz R, Morgenstern N, Saito S, McIlwane J, Hillary K, Gonzalez J. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc. 2007 Jul;55(7):993-1000.
Rummans TA, Clark MM, Sloan JA, Frost MH, Bostwick JM, Atherton PJ, Johnson ME, Gamble G, Richardson J, Brown P, Martensen J, Miller J, Piderman K, Huschka M, Girardi J, Hanson J. Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: a randomized controlled trial. J Clin Oncol. 2006 Feb 1;24(4):635-42.
Engelhardt JB, McClive-Reed KP, Toseland RW, Smith TL, Larson DG, Tobin DR. Effects of a program for coordinated care of advanced illness on patients, surrogates, and healthcare costs: a randomized trial. Am J Manag Care. 2006 Feb;12(2):93-100.
Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):211-7.
Hughes SL, Weaver FM, Giobbie-Hurder A, Manheim L, Henderson W, Kubal JD, Ulasevich A, Cummings J; Department of Veterans Affairs Cooperative Study Group on Home-Based Primary Care. Effectiveness of team-managed home-based primary care: a randomized multicenter trial. JAMA. 2000 Dec 13;284(22):2877-85.
Moore S, Corner J, Haviland J, Wells M, Salmon E, Normand C, Brada M, O'Brien M, Smith I. Nurse led follow up and conventional medical follow up in management of patients with lung cancer: randomised trial. BMJ. 2002 Nov 16;325(7373):1145. Erratum in: BMJ 2002 Dec 14;325(7377):1386.
Ciemins EL, Blum L, Nunley M, Lasher A, Newman JM. The economic and clinical impact of an inpatient palliative care consultation service: a multifaceted approach. J Palliat Med. 2007 Dec;10(6):1347-55.
Cowan JD. Hospital charges for a community inpatient palliative care program. Am J Hosp Palliat Care. 2004 May-Jun;21(3):177-90.
Norton SA, Hogan LA, Holloway RG, Temkin-Greener H, Buckley MJ, Quill TE. Proactive palliative care in the medical intensive care unit: effects on length of stay for selected high-risk patients. Crit Care Med. 2007 Jun;35(6):1530-5.
Twaddle ML, Maxwell TL, Cassel JB, Liao S, Coyne PJ, Usher BM, Amin A, Cuny J. Palliative care benchmarks from academic medical centers. J Palliat Med. 2007 Feb;10(1):86-98.
O'Mahony S, Blank AE, Zallman L, Selwyn PA. The benefits of a hospital-based inpatient palliative care consultation service: preliminary outcome data. J Palliat Med. 2005 Oct;8(5):1033-9.
Hanson LC, Usher B, Spragens L, Bernard S. Clinical and economic impact of palliative care consultation. J Pain Symptom Manage. 2008 Apr;35(4):340-6. doi: 10.1016/j.jpainsymman.2007.06.008. Epub 2008 Feb 8.
Penrod JD, Deb P, Luhrs C, Dellenbaugh C, Zhu CW, Hochman T, Maciejewski ML, Granieri E, Morrison RS. Cost and utilization outcomes of patients receiving hospital-based palliative care consultation. J Palliat Med. 2006 Aug;9(4):855-60. Erratum in: J Palliat Med. 2006 Dec;9(6):1509.
Axelsson B, Christensen SB. Evaluation of a hospital-based palliative support service with particular regard to financial outcome measures. Palliat Med. 1998 Jan;12(1):41-9.
Hughes SL, Cummings J, Weaver F, Manheim L, Braun B, Conrad K. A randomized trial of the cost effectiveness of VA hospital-based home care for the terminally ill. Health Serv Res. 1992 Feb;26(6):801-17.
Zimmer JG, Groth-Juncker A, McCusker J. Effects of a physician-led home care team on terminal care. J Am Geriatr Soc. 1984 Apr;32(4):288-92.
Kane RL, Wales J, Bernstein L, Leibowitz A, Kaplan S. A randomised controlled trial of hospice care. Lancet. 1984 Apr 21;1(8382):890-4.
Jordhøy MS, Fayers P, Loge JH, Ahlner-Elmqvist M, Kaasa S. Quality of life in palliative cancer care: results from a cluster randomized trial. J Clin Oncol. 2001 Sep 15;19(18):3884-94.
McCorkle R, Benoliel JQ, Donaldson G, Georgiadou F, Moinpour C, Goodell B. A randomized clinical trial of home nursing care for lung cancer patients. Cancer. 1989 Sep 15;64(6):1375-82.
Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004 Jan 12;164(1):83-91.
Pantilat SZ, Billings JA. Prevalence and structure of palliative care services in California hospitals. Arch Intern Med. 2003 May 12;163(9):1084-8.
Billings JA, Pantilat S. Survey of palliative care programs in United States teaching hospitals. J Palliat Med. 2001 Fall;4(3):309-14.
Pan CX, Morrison RS, Meier DE, Natale DK, Goldhirsch SL, Kralovec P, Cassel CK. How prevalent are hospital-based palliative care programs? Status report and future directions. J Palliat Med. 2001 Fall;4(3):315-24.
Morrison RS, Maroney-Galin C, Kralovec PD, Meier DE. The growth of palliative care programs in United States hospitals. J Palliat Med. 2005 Dec;8(6):1127-34.
Morrison RS, Penrod JD, Cassel JB, Caust-Ellenbogen M, Litke A, Spragens L, Meier DE; Palliative Care Leadership Centers' Outcomes Group. Cost savings associated with US hospital palliative care consultation programs. Arch Intern Med. 2008 Sep 8;168(16):1783-90. doi: 10.1001/archinte.168.16.1783.
Osta BE, Palmer JL, Paraskevopoulos T, Pei BL, Roberts LE, Poulter VA, Chacko R, Bruera E. Interval between first palliative care consult and death in patients diagnosed with advanced cancer at a comprehensive cancer center. J Palliat Med. 2008 Jan-Feb;11(1):51-7. doi: 10.1089/jpm.2007.0103.
Scalise D. The American Hospital Association 2004 NOVA Award winners. Trustee. 2004 Sep;57(8):21-5.
Goldsmith B, Dietrich J, Du Q, Morrison RS. Variability in access to hospital palliative care in the United States. J Palliat Med. 2008 Oct;11(8):1094-102. doi: 10.1089/jpm.2008.0053.
Improving Palliative Care for Cancer. Washington D.C.: Institute of Medicine and National Research Council; National Academy Press; 2001.
American Cancer Society: Strategic Plan and Progress Report. 2007; http://www.cancer.org/downloads/AA/2007_Strategic_Plan_Progress_Report.pdf. Accessed October 6, 2008.
Donnelly S, Walsh D. The symptoms of advanced cancer. Semin Oncol. 1995 Apr;22(2 Suppl 3):67-72.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01358110     History of Changes
Other Study ID Numbers: GCO 08-1234
First Submitted: May 19, 2011
First Posted: May 23, 2011
Last Update Posted: June 26, 2015
Last Verified: June 2015

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

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


To Top