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Patient-Reported Outcomes-Based Palliative and Hospice Care Practice: A Usability Study

6 de junio de 2013 actualizado por: M.D. Anderson Cancer Center

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

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

18

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • UT MD Anderson Cancer Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otros nombres:
  • Encuesta
  • Computer Program
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.
Otros nombres:
  • Encuesta
  • Computer Program
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.
Otros nombres:
  • Encuesta
  • Computer Program
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.
Otros nombres:
  • Encuesta
  • Computer Program
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.
Otros nombres:
  • Encuesta
  • Computer Program
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.
Otros nombres:
  • Encuesta
  • Computer Program

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)
Periodo de tiempo: Single assessment point
Single assessment point

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Michael A. Kallen, PhD, UT MD Anderson Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2009

Finalización primaria (Actual)

1 de junio de 2012

Finalización del estudio (Actual)

1 de junio de 2012

Fechas de registro del estudio

Enviado por primera vez

30 de noviembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

1 de diciembre de 2009

Publicado por primera vez (Estimar)

2 de diciembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de junio de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

6 de junio de 2013

Última verificación

1 de junio de 2013

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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