Clinical trial NCT01024166: Patient-Reported Outcomes-Based Palliative and Hospice Care Practice: A Usability Study
Official title: A Usability Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancers
Keywords: Cancer
Patient-Reported Outcomes Computer System
PRO
Palliative Care
Symptoms
Questionnaire
Patients
Caregivers
Palliative Care Physicians
Palliative Care Nurses
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Palliative care patients receiving care at University of Texas MD Anderson Cancer Center and their caregivers, physicians and nurses, all over the age of 21.

Brief summary: The goal of this research study is to learn if palliative care patients or caregivers, and palliative care physicians or nurses can use a computer program designed to provide information about the symptoms and overall health of cancer patients.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)
timeFrame: Single assessment point
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Michael A. Kallen, PhD
role: STUDY_CHAIR
References: