- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University
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Decatur, Georgia, Stati Uniti, 30033
- Atlanta VA Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Patient Satisfaction
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Physicians' satisfaction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Suephy Chen, MD, Emory University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00058881
- DCOR-BCC (Altro identificatore: Other)
- IRB00074984 (VA IRB number) (Altro identificatore: Other)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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