- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686411
Evaluation of Satisfaction With Quality of Care on the Palliative Care Unit
A Prospective Evaluation of Satisfaction With Quality of Care on the Palliative Care Unit
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To determine the change of satisfaction with quality of care after an experience on the palliative care unit (PCU) for both patients and caregivers, as determined by the global rating survey.
SECONDARY OBJECTIVES:
I. To determine the change of the quality of care as determined by patients and caregivers utilizing validated assessment tools and a global rating survey assessing different aspects of care after PCU.
II. To determine domains of care that are strongly or poorly provided by the PCU, as reported by patient and caregiver opinions on quality of care.
III. To determine which demographic features (i.e. cancer diagnosis; time since diagnosis; reason for transfer to the PCU; gender; caregiver ethnic group; comfort with the idea of transfer to the PCU; Memorial Delirium Assessment Scale [MDAS], Edmonton Symptom Assessment Scale [ESAS], and distress thermometer) may correlate with patient and caregiver satisfaction with PCU care measured by global survey and with the family satisfaction with end-of-life care.
OUTLINE:
Patients and caregivers complete surveys over 5-10 minutes before and after care in the PCU.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (survey)
Patients and caregivers complete surveys over 5-10 minutes before and after care in the PCU.
|
Complete survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative satisfaction rate
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-1074 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-11433 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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