- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02406963
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study design will be a pilot randomized controlled trial. Consent for this study will be obtained within the circle of care immediately before the patient is discharged home following surgery. The families will be instructed to contact the NP by telephone with any post-operative questions or concerns they have about their child. Once the family initiates contact with the NP, they will be randomized into either the experimental (PEC) group or the control (TTC) group.
Once randomization has occurred, the NP will obtain all necessary information from the parent by addressing all points in expertise based script developed by the Pediatric Urology Team for both groups. Those randomized to the control group (TTC) will be provided recommendations based on information obtained during the standard telephone call. Families who are randomized into the PEC (experimental) group will be required to send a digital photograph of the child's surgical site to the professional email address of NP. Should they agree to send digital photographs they will be required to give consent for email correspondence, which will be emailed to them by the NP. Once they have consented they may send digital photographs to the NP of their child's surgical site, which will be assessed by both NPs using an expertise-based assessment tool. This information will be entered into REDCap. The NPs will come to a unanimous decision regarding advice to be provided and this will be communicated to the parents. Upon completion of the interaction with the NP the RA will contact the family to complete the family/patient experience survey over the telephone. Family/patient experience will be measured using an adapted validated tool "Nurse Practitioner Satisfaction Survey" consisting of 10 questions directly related to telephone interaction with the NP. This survey consists of a Likert Scale with scores ranging from 1-5 with 5 being the most positive response. Follow up telephone calls for both groups will be logged in MediTech as well as the RedCAP database. All telephone calls will be documented within the MediTech system and included in patient's chart in order to maintain current standard of care. All digital photos will be printed and placed in the patient's chart and deleted from the email server, which is the current process for those engaging in PEC.
Recruitment for this study will occur for 7 months with the aim of recruiting 40 patients per arm in order to obtain the feasibility data. However, a sample size calculation has been carried out and assuming 75% power and an alpha error of 5% using a one sided test, the required sample size to answer the definitive research question is 114 patients per group.
Data will be analyzed by comparing the number of ED and unplanned clinic visits for both groups, as well as the number of follow up phone calls received. This will be done using descriptive statistics and a t-test for independent means. Family/patient experience will also be measured between the two groups (PEC and TTC) using descriptive statistics and a t-test for independent means. Subgroup analysis will be done to determine which subgroup of post-operative patients benefit most from PEC (i.e., penile surgeries).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Ontario
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Hamilton, Ontario, Canadá, L8S 4K1
- McMaster Children's Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children aged 0-17 years who have undergone urological surgery.
- Children within the immediate post-operative period (0-14 days).
- Children with concerns directly related to operative site including, but not limited to catheters, stents, rashes and urine output.
Exclusion Criteria:
- Surgical patients outside the immediate post-operative period.
- Those families who are unwilling or unable to email digital photographs.
- Concerns related to issues other than the operative site (medications, follow up appointments, return to activities).
- Inability to understand written consent due to language barrier
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: TTC
Current standard of care- a telephone call with the NP in the event of a post-operative concern where advice/interventions/reassurance is provided based on information provided by family
|
Standard telephone call with the nurse practitioner
|
|
Experimental: PEC
Experimental arm, the standard telephone call with the NP and the addition of a digital photograph of the surgical site for assessment prior to the administration of advice
|
Standard telephone call with the nurse practitioner
A digital photograph sent by the family of the surgical site
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility Data- Recruitment Rate
Periodo de tiempo: 7 Months
|
Recruitment rate over 7 month enrollment period to help determine whether recruitment for a larger scale trial will be feasible
|
7 Months
|
|
Feasibility Data- Survey Completion
Periodo de tiempo: One Year
|
Participants compliance with completing the patient experience questionnaire after discussion with the NP.
|
One Year
|
|
Feasibility Data- Engagement rate of participants in sending photos via email
Periodo de tiempo: One Year
|
Measuring the compliance and willingness of participants to send digital photos of surgical site to NP in order to determine if larger scale trial is feasible
|
One Year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of ED/ unplanned clinic visits in the PEC group compared to those in TTC group
Periodo de tiempo: One Year
|
One Year
|
|
|
Number of follow up phone calls received from each group
Periodo de tiempo: One Year
|
One Year
|
|
|
Comparing family experience of both groups
Periodo de tiempo: One Year
|
Families will complete validated questionnaire after speaking to the NP on teh phone to evaluate experience.
Both groups will complete this questionnaire and responses compared.
|
One Year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mandy Rickard, MN-NP, McMaster Children's Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-169
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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