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- Ensaio Clínico NCT02158650
Video-Based Treatment Options for Basal Cell Carcinoma
The Efficiency and Effectiveness of Using Video-Based Treatment Option Education Medium for Basal Cell Carcinoma Patients
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Currently, verbal consultation is the widespread practice in presenting treatment options for basal cell carcinoma patients. This method, although personable and direct, is often incomplete and subject to variability.
The Emory Department of Dermatology has created an educational video involving treatment options for patients with newly diagnosed basal cell carcinoma as part of routine clinical care. The purpose of this study is to determine the effectiveness of the video format in improving efficiency and workflow. Many studies have shown that multimedia tools improve patient education and have been more efficient than in-office verbal discussions alone. In addition, educational videos have been documented to increase patient satisfaction as well as decrease patient stress level and anxiety. Other advantages of educational videos are for the repetition and reinforcement that would benefit the patient.
Moreover, with the utilization of video, patients will receive the same comprehensive information, making the delivery reproducible and controlled. With verbal communication, there is usually no standardized interaction between staff and patients to ensure that the patient is receiving all pertinent information regarding their options. For example, a study designed to examine retention rates for verbal and written instructions, including 10 potential complications, in patients undergoing Mohs micrographic surgery showed an overall poor retention rate of only 26.5% just 20 minutes after being informed. It is obvious then that educational protocols need additional modalities in order to improve overall retention rates. This then suggests that information presented in video format increases knowledge retention in patients, even weeks after initial delivery of information.
Study participants will be randomly assigned to the control (Group I) - or video- (Group II) group. Participants will be randomized by clinic. Patients randomized to Group II will complete a pre-video knowledge assessment followed by viewing of the BCC educational video. Patients will complete a post-video knowledge assessment following video viewing. Group II patients will then undergo discussion of treatment options with their physician as per standard of care. After the treatment discussion, Group II patients will complete an additional knowledge assessment. After the treatment visit is complete, patients will complete a satisfaction survey. Patients randomized to Group I will not view the educational video. Group I patients will complete a pre-knowledge assessment before their standard of care discussion of treatment options with their physician. Similar to Group II, patients in Group I complete an additional knowledge assessment after the treatment discussion and a satisfaction survey at the conclusion of the treatment visit.
If there is failure of completion of a satisfaction survey in the dermatology clinic, patients (group I and group II) may be contacted via phone to complete the survey.
Physicians will be recruited to complete a satisfaction survey at the end of the day only if they provided treatment to a Group II patient (patients who viewed the video).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Decatur, Georgia, Estados Unidos, 30033
- Atlanta VA Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Newly diagnosed basal cell carcinoma (BCC) patients aged 18 or above for which treatment of Mohs surgery is not necessary and who agree to voluntarily participate in the study
Exclusion Criteria:
- Newly diagnosed basal cell carcinoma patients with an aggressive histologic subtype of BCC or for which treatment by Mohs surgery is deemed necessary based on clinician assessment
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 |
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Experimental: Video Group
Patients randomized to Group II will be emailed the educational video, pre- and post- knowledge assessments, and patient satisfaction survey with instructions on what order to fill them out.
Group II patients will report to the treatment visit and undergo discussion of options and treatment as per standard of care.
An additional knowledge assessment survey will be administered to Group II patients after discussion with treating physician.
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Sem intervenção: Control Group
Patients randomized to Group I will be come to the clinic for the treatment visit and discuss options and treatment as per standard of care.
Pre- and post- discussion knowledge assessments and satisfaction surveys will be administered at the time of the treatment visit.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Patient Satisfaction
Prazo: Up to 1 hour (end of clinic visit)
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Paper surveys
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Up to 1 hour (end of clinic visit)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Physicians' satisfaction
Prazo: Up to 10 hours (end of clinic day)
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Online satisfaction survey
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Up to 10 hours (end of clinic day)
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Change in health knowledge
Prazo: Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)
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Paper surveys
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Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)
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Video Medium Effectiveness
Prazo: Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)
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Paper surveys
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Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Suephy Chen, MD, Emory University
Publicações e links úteis
Publicações Gerais
- Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making. 2011 Jan-Feb;31(1):151-73. doi: 10.1177/0272989X10364247. Epub 2010 Mar 31.
- Armstrong AW, Alikhan A, Cheng LS, Schupp C, Kurlinkus C, Eisen DB. Portable video media for presenting informed consent and wound care instructions for skin biopsies: a randomized controlled trial. Br J Dermatol. 2010 Nov;163(5):1014-9. doi: 10.1111/j.1365-2133.2010.10067.x.
- Eggers C, Obliers R, Koerfer A, Thomas W, Koehle K, Hoelscher AH, Bollschweiler E. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity (Silver Spring). 2007 Nov;15(11):2866-73. doi: 10.1038/oby.2007.340.
- Fleischman M, Garcia C. Informed consent in dermatologic surgery. Dermatol Surg. 2003 Sep;29(9):952-5; discussion 955. doi: 10.1046/j.1524-4725.2003.29251.x.
- Migden M, Chavez-Frazier A, Nguyen T. The use of high definition video modules for delivery of informed consent and wound care education in the Mohs Surgery Unit. Semin Cutan Med Surg. 2008 Mar;27(1):89-93. doi: 10.1016/j.sder.2008.02.001.
- Shukla AN, Daly MK, Legutko P. Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2012 Jan;38(1):80-4. doi: 10.1016/j.jcrs.2011.07.030. Epub 2011 Nov 6.
- Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns. 1997 Mar;30(3):239-45. doi: 10.1016/s0738-3991(96)00968-8.
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
- IRB00058881
- DCOR-BCC (Outro identificador: Other)
- IRB00074984 (VA IRB number) (Outro identificador: Other)
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