- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01024166
Patient-Reported Outcomes-Based Palliative and Hospice Care Practice: A Usability Study
A Usability Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Texas
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Houston, Texas, 미국, 77030
- UT MD Anderson Cancer Center
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- All patient/caregiver participants will be adults 21 years of age or older.
- Participants will be palliative care cancer patients and/or their designated caregivers.
- 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.
- 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:
- Patients or caregivers who are not able to report on symptom status using the electronic measurement system.
- Patient, caregivers, physicians, or nurses who do not agree to sign the study's informed consent documents.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Patient
Patient computer system use questionnaire
|
Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete.
Review session about use of computer system and suggested changes.
다른 이름들:
Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete.
Review session about use of computer system and suggested changes.
다른 이름들:
|
Caregiver
Caregiver computer system use questionnaire
|
Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete.
Review session about use of computer system and suggested changes.
다른 이름들:
Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete.
Review session about use of computer system and suggested changes.
다른 이름들:
|
Healthcare Provider
Physician and Nurse computer system use questionnaire
|
Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete.
Review session about use of computer system and suggested changes.
다른 이름들:
Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete.
Review session about use of computer system and suggested changes.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)
기간: Single assessment point
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Single assessment point
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공동 작업자 및 조사자
수사관
- 연구 의자: Michael A. Kallen, PhD, UT MD Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2009-0776
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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