- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02406963
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Ontario
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Hamilton, Ontario, Canadá, L8S 4K1
- McMaster Children's Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility Data- Recruitment Rate
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of ED/ unplanned clinic visits in the PEC group compared to those in TTC group
Prazo: One Year
|
One Year
|
|
|
Number of follow up phone calls received from each group
Prazo: One Year
|
One Year
|
|
|
Comparing family experience of both groups
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 15-169
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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