A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery
20 de septiembre de 2019 actualizado por: Cassandra Mierisch, Carilion Clinic
A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity.
The effect of this educational program on pain medications used, pain control efficacy, and other measures of satisfaction and recovery will be assessed.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Four hundred (400) adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be recruited by the surgeon-investigators. Patients will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity.
These patients will be encouraged to review the video online in the week before surgery. An intake enrollment form will be completed by an investigator using demographic information available in the chart.
Participants in both arms will complete their Patient Education Study Diary daily, for 7 days following their surgery. There are two versions of this diary: the Wound Education Version asks patients to report daily pain mediation use. The Pain Education Version does not include this section as patients in the pain management arm of the study record this information in their Recovery Diary.
The patient will be contacted again by phone and/or mail 1 year after surgery (12-14 months) using the contact information available in EPIC to determine the self-reported prevalence of chronic pain and pain medication use.
Tipo de estudio
Intervencionista
Inscripción (Actual)
221
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
-
-
Virginia
-
Roanoke, Virginia, Estados Unidos, 24014
- Institute for Orthopedics and Neurosciences
-
-
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:
- Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.
Exclusion Criteria:
- Patients unable or unwilling to provide informed consent
- Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
- Patients who are or suspect they may be pregnant.
- Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Wound Care Video
Wound Care Patient Education Video
|
Patient education video that were created in-house specifically for this project.
|
|
Experimental: Pain Management Video Group
Pain Management Patient Education Video
|
Patient education video that were created in-house specifically for this project.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Recovery 15 Score
Periodo de tiempo: 2 days after surgery
|
Score on the standardized Quality of Recovery 15 questionnaire How have you been feeling in the last 24 hours? (0 to 10, where 0= none of the time [poor] and 10=all of the time [excellent]) 0 1 2 3 4 5 6 7 8 9 10
|
2 days after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PROMIS
Periodo de tiempo: 3 days after surgery
|
PROMIS short forms administered on POD 3 - (GI belly pain 5a, GI nausea and vomiting 4a, Pain Intensity 3a, Pain Interference 4a, Sleep Disturbance 4a, Cognitive Function 4a)
|
3 days after surgery
|
|
number of narcotic pills used
Periodo de tiempo: 7 days after surgery
|
number of narcotic pills used
|
7 days after surgery
|
|
daily pain level
Periodo de tiempo: 7 days after surgery
|
0-10 rating scale
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control - pain management
Periodo de tiempo: 7 days after surgery
|
Today, I feel in control of my pain management.
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control- wound care
Periodo de tiempo: 7 days after surgery
|
Today, I feel in confident about how I am caring for my wound.
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control - pain management satisfaction
Periodo de tiempo: 7 days after surgery
|
Today, I would rate my satisfaction with my pain control as (circle)
|
7 days after surgery
|
|
number of pain-related calls/visits to a healthcare provider
Periodo de tiempo: 7 days after surgery
|
patient-reported
|
7 days after surgery
|
|
use of non-narcotic adjunct pain relief medication and modalities
Periodo de tiempo: 7 days after surgery
|
7 days after surgery
|
|
|
incidence of high risk activities - sedating medication polytherapy
Periodo de tiempo: 7 days after surgery
|
combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications
|
7 days after surgery
|
|
incidence of high risk activities - NSAID polytherapy
Periodo de tiempo: 7 days after surgery
|
combining prn NSAIDs with regularly dosed prescription NSAIDs
|
7 days after surgery
|
|
incidence of high risk activities - overdosing
Periodo de tiempo: 7 days after surgery
|
exceeding daily recommended doses of pain medication
|
7 days after surgery
|
|
incidence of side effects and adverse events - Nausea/V omitting
Periodo de tiempo: 7 days after surgery
|
Nausea/Vomiting
|
7 days after surgery
|
|
incidence of side effects and adverse events - Dizziness/balance problems
Periodo de tiempo: 7 days after surgery
|
Dizziness/balance problems
|
7 days after surgery
|
|
incidence of side effects and adverse events - fatigue or sedation
Periodo de tiempo: 7 days after surgery
|
fatigue or sedation
|
7 days after surgery
|
|
incidence of side effects and adverse events - headache
Periodo de tiempo: 7 days after surgery
|
headache
|
7 days after surgery
|
|
incidence of side effects and adverse events - visual changes
Periodo de tiempo: 7 days after surgery
|
visual changes
|
7 days after surgery
|
|
incidence of side effects and adverse events - stomach pain
Periodo de tiempo: 7 days after surgery
|
stomach pain
|
7 days after surgery
|
|
incidence of side effects and adverse events - constipation
Periodo de tiempo: 7 days after surgery
|
constipation
|
7 days after surgery
|
|
incidence of side effects and adverse events - diarrhea
Periodo de tiempo: 7 days after surgery
|
diarrhea
|
7 days after surgery
|
|
incidence of side effects and adverse events - fever
Periodo de tiempo: 7 days after surgery
|
fever
|
7 days after surgery
|
|
incidence of side effects and adverse events - rash
Periodo de tiempo: 7 days after surgery
|
rash
|
7 days after surgery
|
|
incidence of side effects and adverse events - hives
Periodo de tiempo: 7 days after surgery
|
hives
|
7 days after surgery
|
|
incidence of side effects and adverse events - swelling
Periodo de tiempo: 7 days after surgery
|
swelling
|
7 days after surgery
|
|
incidence of side effects and adverse events - difficulty breathing/shortness of breath
Periodo de tiempo: 7 days after surgery
|
difficulty breathing/shortness of breath
|
7 days after surgery
|
|
incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing
Periodo de tiempo: 7 days after surgery
|
heart palpitations/arrythmia/heart racing
|
7 days after surgery
|
|
incidence of side effects and adverse events - anaphylaxis
Periodo de tiempo: 7 days after surgery
|
anaphylaxis
|
7 days after surgery
|
|
incidence of side effects and adverse events - ringing in ears
Periodo de tiempo: 7 days after surgery
|
ringing in ears
|
7 days after surgery
|
|
incidence of side effects and adverse events - other
Periodo de tiempo: 7 days after surgery
|
other
|
7 days after surgery
|
|
demonstrated patient knowledge
Periodo de tiempo: 7 days after surgery
|
as measured by score on the follow-up quiz
|
7 days after surgery
|
|
prevalence of chronic opioid use
Periodo de tiempo: 1 year after surgery
|
patient reported
|
1 year after surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Cassandra Mierisch, MD, Carilion Clinic
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 (Actual)
30 de noviembre de 2017
Finalización primaria (Actual)
29 de noviembre de 2018
Finalización del estudio (Anticipado)
12 de junio de 2020
Fechas de registro del estudio
Enviado por primera vez
29 de noviembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
7 de diciembre de 2017
Publicado por primera vez (Actual)
8 de diciembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de septiembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
20 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2266
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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 Wound Care Patient Education Video
-
Imperial College Healthcare NHS TrustTerminado