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Opioids Titration in Hospice Patients

29 de marzo de 2013 actualizado por: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Opioid Titration In the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part B

RATIONALE: Opioids lessen pain caused by cancer. Titration of opioids in the hospice setting is suboptimal due to numerous barriers. Order sets may help to provide timely and effective medical and pharmaceutical intervention.

PURPOSE: The purpose of this study was to identify barriers to good pain control in the hospice setting and to develop an order set that would safely address these barriers.

Descripción general del estudio

Descripción detallada

Objective 1:

To assess barriers to pain control in the hospice setting.

Using a mixed methods approach, key stakeholders including physicians, nurses, patients and caregivers were queried about pain control in the hospice setting, barriers to pain control and the desirability of an order set to address this issue.

Objective 2:

To develop and conduct pilot testing of an order set designed to improve pain control in the hospice setting.

An opioid titration order sheet based on our previous R0-1 was modified based on the information derived from the interviews and questionnaires completed by the physicians, nurses, patients and caregivers.

A cohort of 20 patients were enrolled on the first phase of the pilot study in order to test the modified pain assessment form and the feasibility administration of the study materials to be completed by the patient and caregiver. Forms are as follows:

  • Patient assessment: At baseline, patients provide demographic data and complete the Pain Assessment Form and the Pain Communication Survey. The pain assessment form addresses average pain, worst pain, pain relief, hours in pain, pain-related distress, and barriers to pain control. Patients are asked to rate pain control. Patients also complete the Pain Communication Survey to assess how they communicate with healthcare providers about their pain. After the baseline assessment is completed, patients complete the Pain Assessment form on a daily basis. Pain is also assessed by the research nurse at least 3 times weekly (1 home visit* and 2 telephone interviews). Patients are followed until the time of death.

NOTE: *If a patient is hospitalized or transferred to the inpatient hospice facility, the patient interview will take place there.

  • Caregiver assessment: At baseline, caregivers complete a demographic survey, a Pain Assessment Form, the Pain Communication Survey, Caregiver Self-Efficacy in Pain Management Scale (CSEPMS), Caregiver Pain Management Questionnaire (CPMQ), and the Stressful Caregiver Adult Reactions to Experiences of Dying (SCARED). Caregivers are then interviewed by the study nurse using the Pain Assessment Form as a guideline to obtain more detailed information about adequacy of the patient's pain control, side effects of medication, barriers to pain control, and caregiver concerns and burden. Follow-up data from caregivers is obtained through completion of CSEPMS, CPMQ, and SCARED questionnaires and their assessment of patient's pain form at the end of weeks 1, 2, and 3.
  • Chart review: A research nurse conducts a chart review after patient's death. Cancer and cancer-related treatment data is obtained and documentation about pain management is recorded. From the time of study entry, all staff notes are reviewed to document pain assessment, calls to physician or other support personnel (including pharmacy calls), identified barriers to pain control, and treatment modifications (including medications to treat side effects).

After 20 patients, it was deemed not feasible to complete the study forms and to recruit adequately for the trial. The study was suspended.

Tipo de estudio

De observación

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

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Out-patient hospice patients.

Descripción

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Outpatient at the Alive Hospice in the State of Tennessee

      • Diagnosed with carcinoma
      • Pain requiring fixed-dose opioids
    • Caregiver for an Alive Hospice patient

      • Any caregiver who is identified by the patient is eligible

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Able to speak/comprehend English
  • Lives within a 60-mile radius of Alive Hospice

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To obtain determine the safety and feasibility of an opioid titration order sheet in the hospice setting.
Periodo de tiempo: at 4 weeks
Pain assessments will be completed at baseline and daily for 4 weeks. Survey instruments will be completed at the end of weeks 1, 2, and 3.
at 4 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center

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 junio de 2008

Finalización primaria (Actual)

1 de mayo de 2009

Finalización del estudio (Actual)

1 de mayo de 2009

Fechas de registro del estudio

Enviado por primera vez

3 de noviembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

3 de noviembre de 2009

Publicado por primera vez (Estimar)

4 de noviembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de abril de 2013

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

29 de marzo de 2013

Última verificación

1 de marzo de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • VICC SUPP 0822
  • P30CA068485 (Subvención/contrato del NIH de EE. UU.)
  • VU-VICC-SUPP-0822
  • VU-VICC-IRB-IRB-080370

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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