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Video-Based Treatment Options for Basal Cell Carcinoma

Primary Purpose

Basal Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video-Based Informed Consent
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Basal Cell Carcinoma focused on measuring informed consent, video-based

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University
  • Atlanta VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Video Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient Satisfaction
Paper surveys

Secondary Outcome Measures

Physicians' satisfaction
Online satisfaction survey
Change in health knowledge
Paper surveys
Video Medium Effectiveness
Paper surveys

Full Information

First Posted
June 2, 2014
Last Updated
August 13, 2015
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02158650
Brief Title
Video-Based Treatment Options for Basal Cell Carcinoma
Official Title
The Efficiency and Effectiveness of Using Video-Based Treatment Option Education Medium for Basal Cell Carcinoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
informed consent, video-based

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video-Based Informed Consent
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
Paper surveys
Time Frame
Up to 1 hour (end of clinic visit)
Secondary Outcome Measure Information:
Title
Physicians' satisfaction
Description
Online satisfaction survey
Time Frame
Up to 10 hours (end of clinic day)
Title
Change in health knowledge
Description
Paper surveys
Time Frame
Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)
Title
Video Medium Effectiveness
Description
Paper surveys
Time Frame
Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suephy Chen, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20977443
Citation
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.
Results Reference
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PubMed Identifier
18070779
Citation
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.
Results Reference
background
PubMed Identifier
12930338
Citation
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.
Results Reference
background
PubMed Identifier
18486030
Citation
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.
Results Reference
background
PubMed Identifier
20357225
Citation
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.
Results Reference
background
PubMed Identifier
22062774
Citation
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.
Results Reference
background
PubMed Identifier
9104380
Citation
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.
Results Reference
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Video-Based Treatment Options for Basal Cell Carcinoma

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