Evaluation of Satisfaction With Quality of Care on the Palliative Care Unit

May 6, 2022 updated by: M.D. Anderson Cancer Center

A Prospective Evaluation of Satisfaction With Quality of Care on the Palliative Care Unit

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.

Study Overview

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

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2016

Primary Completion (Actual)

April 29, 2022

Study Completion (Actual)

April 29, 2022

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Hematopoietic and Lymphoid Cell Neoplasm

Clinical Trials on Survey Administration

Subscribe