Video-Based Treatment Options for Basal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if presenting treatment options to basal cell carcinoma patients in video format will improve efficiency and allow patients to receive consistent, comprehensive, visually-depicted treatment option information to improve patient quality of care. Patients can learn more about treatment options as they are depicted visually so as to better assist them in understanding treatment risks and benefits to confidently make a well-informed decision. Primarily, the study will evaluate efficiency when using the education video medium. The study will also evaluate the effectiveness of the video medium as an aid to decision making in addition to standard of care in comparison to the standard of care alone. Additionally, the study will evaluate both patients' and dermatologists' satisfaction of the educational intervention.

Detailed Description
-----------------
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).

Official Title
-----------------
The Efficiency and Effectiveness of Using Video-Based Treatment Option Education Medium for Basal Cell Carcinoma Patients

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Behavioral: Video-Based Informed Consent


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video Group<br>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. | Behavioral: Video-Based Informed Consent<br> <br> |
| No Intervention: Control Group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Paper surveys | Up to 1 hour (end of clinic visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians' satisfaction | Online satisfaction survey | Up to 10 hours (end of clinic day) | 
| Change in health knowledge | Paper surveys | Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit) | 
| Video Medium Effectiveness | Paper surveys | Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
video-based, informed consent