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Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients

27 de octubre de 2015 actualizado por: Case Comprehensive Cancer Center

Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients: A Pilot Study

This randomized pilot clinical trial studies tailored patient educational intervention or standard education in assessing perceived risk for falls in hospitalized oncology patients. A tailored patient educational intervention may be more beneficial than standard education in preventing patients from falling by increasing the patient's knowledge of the risk factors for falling routinely and then providing education in deficit areas. Making patients more aware of the risk factors for falling may lead to greater engagement in preventative activities.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

PRIMARY OBJECTIVES:

I. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on perceived risk for falls in hospitalized hematology-oncology patients.

II. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on confidence to minimize falls in hospitalized hematology-oncology patients.

III. To evaluate the relationship between patients' perceived risk for falling and their willingness to call for assistance with ambulation.

SECONDARY OBJECTIVES:

I. To evaluate the relationship between patients' perceived risk for falls and nursing risk assessments when using the standard hospital assessment tool and the investigator-designed perceived risk survey.

II. To evaluate the relationship between a patients' perceived risk for falls and sustaining a fall.

III. To evaluate patient satisfaction with the intervention.

OUTLINE:

All participants complete the Perceived Risk Survey comprising the participants' perceived risk for falls, their confidence to prevent a fall, and their willingness to ask for assistance at baseline and at 24 and 72 hours (or at discharge if stay is less than 72 hours) post-intervention. Patients are then randomized to 1 of 2 arms.

ARM I: Participants receive tailored education comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception. Participants also receive printed education sheets based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk.

ARM II: Participants receive a generic educational instruction sheet on falls prevention and receive standard care by nurses comprising a falls risk assessment and verbal education.

Tipo de estudio

Intervencionista

Inscripción (Actual)

91

Fase

  • No aplica

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

    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive 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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of cancer
  • Admitted to the third floor of Seidman Cancer Center (SCC)
  • Cognitively intact (alert, oriented to self, place, and time, and able to participate in the intervention)
  • Ability to speak, read, and comprehend English

Exclusion Criteria:

  • Nonmalignant diagnosis
  • Actively dying
  • Patients with a physician order for bed rest

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

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm I (Tailored education intervention)
Participants receive a tailored educational intervention on the risk of falls comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception. Participants also receive tailored printed educational information concerning hospital falls based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk. Participants also complete an investigator-constructed satisfaction survey at 24 and 72 hours post-intervention.
Receive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks
Comparador activo: Arm II (standard fall care)
Participants receive standard care by nurses comprising a falls risk assessment and verbal education and receive an educational instruction sheet on falls prevention.
Patient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Perceived risk for falls grouped according to the nurses assessment of risk using the University Hospitals (UH) Falls Assessment Tool
Periodo de tiempo: Up to 8 weeks
Changes in pre vs post survey for the High Risk/Low Perception group will be compared to all others using a paired McNemar's test for both those receiving the intervention and controls. Pre and post scores will be compared between those receiving the intervention and controls using chi square tests.
Up to 8 weeks
Confidence to minimize falls assessed using the UH Falls Assessment Tool and the investigator-constructed Perceived Risk Survey (Nurse version)
Periodo de tiempo: Up to 8 weeks
Pre vs post survey changes will be compared in confidence group using a paired McNemar's test for both those receiving the intervention and controls. Pre and post scores will be compared between those receiving the intervention and controls using chi square tests.
Up to 8 weeks
Willingness to call for assistance
Periodo de tiempo: Up to 8 weeks
An eight-point Likert scale will be used. Pre vs post survey changes in willingness group will be compared using a paired McNemars test. Relationship between Risk/Perception group status and Willingness group will be assessed using a chi-square test stratified by pre or post survey results for both those receiving the intervention and controls.
Up to 8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Relationship between patients perceived risk for falls and nurses risk assessments
Periodo de tiempo: Up to 8 weeks
Descriptive statistics will be used to compare scores self-perceived risks of falling with a nurse's assessment of a patient falling
Up to 8 weeks
Patient's satisfaction of the intervention using the final questions on the Perceived Risk Post-Survey
Periodo de tiempo: Up to 8 weeks
Descriptive statistics will be used by the distribution of pre vs post perceived risk values.
Up to 8 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Megan Kuhlenschmidt, Case Comprehensive 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 febrero de 2014

Finalización primaria (Actual)

1 de septiembre de 2015

Finalización del estudio (Actual)

1 de septiembre de 2015

Fechas de registro del estudio

Enviado por primera vez

5 de marzo de 2014

Primero enviado que cumplió con los criterios de control de calidad

5 de marzo de 2014

Publicado por primera vez (Estimar)

7 de marzo de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

28 de octubre de 2015

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

27 de octubre de 2015

Última verificación

1 de octubre de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CASE18Z13
  • P30CA043703 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2014-00388 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • CASE 18Z13 (Otro identificador: Case Comprehensive Cancer Center)

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. .

Ensayos clínicos sobre Tailored education intervention

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