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.