Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Emergency Medicine Palliative Care Access (EMPallA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03325985
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : February 8, 2022
Sponsor:
Collaborators:
William Beaumont Hospitals
Brigham and Women's Hospital
Ohio State University
University of Florida Health
Yale New Haven Health System Center for Healthcare Solutions
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
NYU Langone Health

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or end-stage organ failure (New York Heart Association (NYHA) Class III or IV Heart Failure, End Stage Renal Disease defined as GFR < 15 ml/min/m2; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as FEV1 < 50% or the mMRC dyspnea scale) who present to the Emergency Department (ED), along with 675 of their informal caregivers. Investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.

Condition or disease Intervention/treatment Phase
Advanced Cancer End Stage Organ Failure Behavioral: Nurse-led telephonic case management Behavioral: Facilitated,outpatient specialty palliative care Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2025 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Estimated Enrollment (1350 patients, 675 caregivers)
Primary Purpose: Supportive Care
Official Title: Emergency Medicine Palliative Care Access (EMPallA)
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Nurse-led telephonic case management
  • Telephonic nurses will contact patients within 72 hours of enrollment
  • Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
 Behavioral: Nurse-led telephonic case management
Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
Active Comparator: Facilitated, outpatient specialty palliative care
  • Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
  • Clinic visits will be scheduled the same day as other specialty appointments if possible
 Behavioral: Facilitated,outpatient specialty palliative care
In-person palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in quality of life for patients, as measured by the FACT-G [ Time Frame: 6 Months ]
    Measured by change from enrollment to 6 months


Secondary Outcome Measures :
  1. Patient Level: Healthcare Utilization, as measured by self-report and EHR abstraction [ Time Frame: 12 Months ]
    Measured by change from enrollment to 12 months (e.g., ED revisits, hospital admissions, hospice use)

  2. Loneliness, as measured by the Three-Item Loneliness Scale [ Time Frame: 6 Months ]
    • Used to measure how often a person feels disconnected from others
    • Three questions total
    • 4-point rating scale (1 = never; 2 = rarely; 3 = sometimes; 4 = always).
    • Reverse-code the positively worded items so that high values mean more loneliness, and then calculate a score for each respondent by averaging their ratings.

  3. Symptom burden, as measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) [ Time Frame: 6 Months ]
    • Used to measure severity of symptoms
    • 10 questions
    • 0-10 scale (0= none to 10 worst possible)
    • Total score

  4. Caregiver-Level: Quality of Life, as measured by the Patient-Reported Outcome Measurement Information System [ Time Frame: 6 Months ]
    • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and global mental health scale. Both scales had internal consistency scores of α=0.81 and α=0.86, respectively.
    • Scored by reverse coding with a raw score totaling up to 20

  5. Caregiver Bereavement, as measured by the Texas Inventory of Grief [ Time Frame: 3 Months ]
    Measured by 3 months post-patient death


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients:

  • English or Spanish-speaking patients ages 50 years and older
  • Qualifying serious, life-limiting conditions and who are scheduled for ED discharge, observation status, or admission for two midnights or less.
  • Qualifying conditions include: advanced cancer (defined as metastatic solid tumor) or end-stage organ failure (New York Heart Association (NYHA) Class III or IV Heart Failure, End Stage Renal Disease defined as GFR < 15 ml/min/m2; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as FEV1 < 50% or the mMRC dyspnea scale)
  • Patients must have health insurance, reside within the geographical area, and have a working telephone.

Informal Caregivers:

  • English or Spanish-speaking caregivers ages 18 years and older who care for and accompany an enrolled patient. Informal caregivers must possess a working telephone.

Exclusion Criteria:

  • Patients with dementia identified in the EHR, who received hospice services in the last six months, who have received 2 or more palliative care visits in the last 6 months, and those who reside in a skilled nursing or assisted living facility and chronic care hospital.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03325985


Contacts
Layout table for location contacts
Contact: Corita Grudzen, MD 646-501-0565 Corita.Grudzen@nyulangone.org
Contact: Kaitlyn Van Allen 212-263-8631 Kaitlyn.VanAllen@nyulangone.org

Locations
Layout table for location information
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Karen Jubanyik, MD    203-494-6068    Karen.Jubanyik@yale.edu   
Principal Investigator: Karen Jubanyik, MD         
United States, Florida
University of Florida Health Recruiting
Gainesville, Florida, United States, 32611
Contact: Marie-Carmelle Elie, MD    352-265-5911 ext 31485    Elie@ufl.edu   
Principal Investigator: Marie-Carmelle Elie, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kei Ouchi, MD    607-732-5636    Kei_Ouchi@dfci.harvard.edu   
Principal Investigator: Kei Ouchi, MD         
United States, Michigan
William Beaumont Hospital, Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Robert Swor, DO    248-898-1970    Robert.Swor@beaumont.edu   
Principal Investigator: Robert Swor, DO         
William Beaumont Hospital, Troy Recruiting
Troy, Michigan, United States, 48085
Contact: Robert Swor, DO    248-898-1970    Robert.Swor@beaumont.edu   
Principal Investigator: Robert Swor, DO         
United States, New York
NYU Langone Hospital- Brooklyn Recruiting
Brooklyn, New York, United States, 11220
Contact: Jeanne Cho, MPH    212-263-1276    Jeanne.Cho@nyulangone.org   
Principal Investigator: Corita Grudzen, MD         
Bellevue Hospital Recruiting
New York, New York, United States, 10016
Contact: Jeanne Cho, MPH    212-263-1276    Jeanne.Cho@nyulangone.org   
Principal Investigator: Corita Grudzen, MD         
New York University Langone Tisch Hospital Recruiting
New York, New York, United States, 10016
Contact: Jeanne Cho, MPH    212-263-1276    Jeanne.Cho@nyulangone.org   
Principal Investigator: Corita Grudzen, MD         
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Lauren Southerland, MD    614-293-8305    Lauren.Southerland@osumc.edu   
Principal Investigator: Lauren Southerland, MD         
Sponsors and Collaborators
NYU Langone Health
William Beaumont Hospitals
Brigham and Women's Hospital
Ohio State University
University of Florida Health
Yale New Haven Health System Center for Healthcare Solutions
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Corita Grudzen, MD NYU Langone Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03325985    
Other Study ID Numbers: 17-01211
R-1609-36306 ( Other Grant/Funding Number: PCORI )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes