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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04377971
Other study ID # CASE1620
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2020
Est. completion date July 31, 2024

Study information

Verified date April 2024
Source Case Comprehensive Cancer Center
Contact Christina Wong, MD
Phone 1-800-641-2422
Email CTUReferral@UHhospitals.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine a different way to educate patients about taking care of their wound and see how this method affects patient satisfaction, compliance to the wound care regimen, and patient experience. The teach-back method is delivered using the ask-tell-ask method. Investigators will ask the patient about their knowledge of wound care healing, provide the patient educational component, then ask the patient to repeat what was said. If the answer is wrong or incomplete, the researcher will go over the information again with the patient to clear up any misunderstandings.


Description:

Patients undergoing Mohs Micrographic surgery for skin cancers on the lower extremities for the first time that are left to heal by secondary intention are randomized either to receive a scripted teach-back session or a standard of care wound care education. This study wishes to compare wound care adherence, patient experience, wound complications, and the number of phone calls made by patients to the office between the two cohorts primary objective is to determine whether study participants who have received the teach-back method have an increase wound care adherence at one week post-operatively, compared to those who received the standard of care. To characterize differences in the patient experience between the two interventional groups 2 weeks after surgery. To determine whether the number of phone calls made post-operatively by patients will decrease in a 2 week follow-up time period. To characterize the differences in patient wound care adherence at 2 weeks after surgery. To determine whether there is a difference in complication incidence post-operatively


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Presenting to outpatient Mohs clinic at University Department of Dermatology, Two Chagrin Highlands for the first time - Have excision(s) from Mohs Micrographic Surgery on the lower extremities that are left to heal by secondary intention - English-speaking Exclusion Criteria: - Non-English speaking - A clinical diagnosis of mental, learning, and visual disabilities - A clinical diagnosis of dementia - Those who have received Mohs Micrographic Surgery before regardless of area

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SOC education
Standard participant education from researcher
Ask-tell-ask education
Participant education using the ask-tell-ask method. First the researcher will ask a question about participant understanding of wound care and after hearing the participant's answer, the researcher will then proceed to tell the patient how to best take care of their wound using a standardized script. After the educational portion, the researcher will then ask the patient to repeat the information that was shared. If the participant's answer is wrong or incomplete, the researcher will then explain the instructions again to ensure that the participant understands the steps needed.
Other:
Participant satisfaction survey
Participant satisfaction survey using components of the 16 item Skindex questionnaire and the 18 item version Patient Satisfaction Survey, adapted for treatment of skin cancer to characterize patient experience administered at two weeks post-operatively in person
Wound care adherence survey
Wound care adherence survey administered at one week over the phone and at two weeks in person

Locations

Country Name City State
United States University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound care adherence as measured by wound care adherence survey Wound care adherence as measured by a wound care adherence survey with scale values ranging from 3-15, with a higher score indicating greater compliance
Independent two-sample two-sided t-tests to compare wound care adherence scores between the intervention group (receiving the "teach-back method") and the control group (receiving the standard of care).
1 week
Secondary Patient experience as measured by participant satisfaction survey Patient experience as measured by participant satisfaction survey, which uses components of the 16 item Skindex questionnaire and the 18 item version Patient Satisfaction Survey, adapted for treatment of skin cancer to characterize patient experience. The survey scale ranges from 4-20, with a higher score indicating a greater patient experience. At 2 weeks
Secondary Number of phone calls made post-operatively by participants Number of phone calls made post-operatively by participants At 2 weeks
Secondary Complication incidence post-operatively Complication incidence post-operatively At 2 weeks
Secondary Wound care adherence as measured by wound care adherence survey Wound care adherence as measured by a wound care adherence survey with scale values ranging from 3-15, with higher scores indicating greater compliance.
Independent two-sample two-sided t-tests to compare wound care adherence scores between the intervention group (receiving the "teach-back method") and the control group (receiving the standard of care)
At 2 weeks
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