NCT02686411

Brief Summary

This study examines the difference between the quality of care patients receive with palliative care consult services and the palliative care unit. This may help researchers learn how improvements can be made to the level of care provided in the palliative care unit and improve satisfaction with quality of care by patients and caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

February 17, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

6.2 years

First QC Date

February 17, 2016

Last Update Submit

May 6, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Relative satisfaction rate

    Defined as the percentage of patients that answered "Better" and "Much Better" to the first question in the global rating on "overall care". The relative satisfaction rate after palliative care unit (PCU) care in patients or caregivers will be estimated with 95% confidence interval.

    through study completion, an average of 1 year

  • Patient Global Survey/Caregiver Global Survey

    Assessed by Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale (MDAS) distress thermometer will be summarized by descriptive analysis and/or tabulation.

    through study completion, an average of 1 year

  • Distress thermometer

    Measured by Family Satisfaction with end-of-life care will be summarized descriptively for each time point and may be compared within patients and within caregivers before and after the PCU by Wilcoxon signed-rank test, when the outcome is on Likert ordinal scales with 3, 5 levels or even 10 levels and the differences in the scales can be considered as continuous variables.

    through study completion, an average of 1 year

  • Patients' and caregivers' opinions on quality of care

    Measured by Family Satisfaction with end-of-life care will be summarized descriptively for each time point and may be compared within patients and within caregivers before and after the PCU by Wilcoxon signed-rank test, when the outcome is on Likert ordinal scales with 3, 5 levels or even 10 levels and the differences in the scales can be considered as continuous variables.

    through study completion, an average of 1 year

Study Arms (1)

Observational (survey)

Patients and caregivers complete surveys over 5-10 minutes before and after care in the PCU.

Other: Survey Administration

Interventions

Complete survey

Observational (survey)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients and/or patients' caregivers who have completed at least 2 weekdays on an in-patient service together

You may qualify if:

  • Patients and/or patients' caregivers who have completed at least 2 weekdays on an in-patient service together with the assistance of the palliative care consult services (PCCS), and who then are transitioned to the care of the PCU team along with an admission order to that effect
  • A caregiver (if participating) must have been present with the patient during 2 weekdays on the inpatient service and present for at least 2 weekdays of care on the PCU
  • Both patient and caregiver participation is optional but both must be 18 years of age or older
  • A caregiver will be defined by the patient as "the person most involved with their care". However, if the patient lacks capacity, the caregiver will be decided via discussion with individuals indicated in the patient's Medical Power of Attorney or the Texas rule of law if this is not present
  • Both patient and caregiver (if participating) must understand, read and speak English
  • Both patient (if actively participating) and caregiver (if participating) must sign an informed consent form

You may not qualify if:

  • Patients or caregivers with physical limitations (visual or motor impairment) causing inability to read, complete or sign the consent form and surveys after considering appropriate aid and assistance
  • Patients or caregivers who the research staff, bedside nurse, or palliative care physician or mid-level provider deems unable to participate due to poor cognitive capacity or acute physical distress
  • Caregivers who are not able to attend the patient for at least 2 weekdays while on the PCU
  • Patients who are imminently dying as determined by the palliative physician (or designated advanced practice provider \[APP\]/fellow)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ahsan Azhar

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 19, 2016

Study Start

February 17, 2016

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations