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A Usability Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record


N/A
21 Years
N/A
Not Enrolling
Both
Advanced Cancers

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Trial Information

A Usability Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record


The Patient-Reported Outcomes (PRO) Computer System:

The PRO computer system used in this study has been designed to help doctors and nurses
check the symptoms and overall health status of patients with cancer by reviewing the
computer entries of patients and caregivers. The system has also been designed to help
doctors and nurses make decisions about how to care for patients based on the computer
entries.

Questionnaire and Review Session:

If you agree to take part in this study, you will have an questionnaire and review session
at the Palliative Care outpatient clinic. The session will be conducted by a research staff
member, but the study chair and/or other study staff members may also attend the session.
The questionnaire and review session will have 3 steps, which are described below:

- If you are a patient receiving palliative care, you will use the PRO computer system to
complete 2 questionnaires about any symptoms you may be experiencing and your overall
health. If you are a caregiver for someone who is receiving palliative care, you will
use the PRO computer system to complete 2 questionnaires about any symptoms that the
patient you are caring for may be experiencing and their overall health. The study
staff will instruct you on how to use the PRO computer system.

- If you are a physician or nurse, you will use the PRO computer system to complete 4
questionnaires about the symptoms and overall health of patients who are receiving
palliative care. The study staff will instruct you on how to use the PRO computer
system.

- You will then look at the results of the questionnaires you have completed, which will
be shown to you in both number and graph form. You will also be shown other features
and potential uses of the PRO computer system.

- Last, you will be asked about how easily you were able to use the computer system. You
will also be asked about any changes you think could make the program easier to use.

The questionnaire and review session should take about 30 minutes to complete.

Study Data:

Your responses to the questionnaires will be destroyed after the questionnaire and review
session. The responses you give when asked about the use of the PRO computer system will be
kept after the questionnaire and review session. Only the study staff will have access to
your responses. However, your responses will be coded with a study ID number, not by your
name. Your saved responses will be stored in password-protected files that are available
only to the study staff for 3 years.

Length of Study:

Your participation in this study will be over after you complete the questionnaire and
review session.

This is an investigational study.

Up to 9 patients and 9 caregivers will take part in this study. All will be enrolled at M.
D. Anderson.

Up to 9 physicians and nurses (4-5 of each) will take part in this study. All will be
enrolled at M. D. Anderson.


Inclusion Criteria:



1. All patient/caregiver participants will be adults 21 years of age or older.

2. Participants will be palliative care cancer patients and/or their designated
caregivers.

3. Participating patients should be receiving palliative care at the MD Anderson Cancer
Center as an inpatient or have attended at least one outpatient appointment;
participating caregivers should have provided care to their patient during an
inpatient stay or have attended at least one outpatient appointment with their
patient.

4. Physicians and nurses who are experts in palliative care will be eligible for study
participation. For this study's purposes, a physician or nurse with a minimum of four
years of experience working in a palliative care setting will be considered an expert
in palliative care.

Exclusion Criteria:

1. Patients or caregivers who are not able to report on symptom status using the
electronic measurement system.

2. Patient, caregivers, physicians, or nurses who do not agree to sign the study's
informed consent documents.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)

Outcome Time Frame:

Single assessment point

Safety Issue:

No

Principal Investigator

Michael A. Kallen, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0776

NCT ID:

NCT01024166

Start Date:

November 2009

Completion Date:

June 2012

Related Keywords:

  • Advanced Cancers
  • Cancer
  • Patient-Reported Outcomes Computer System
  • PRO
  • Palliative Care
  • Symptoms
  • Questionnaire
  • Patients
  • Caregivers
  • Palliative Care Physicians
  • Palliative Care Nurses
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030