- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04377971
Teach-back Method on Patient Satisfaction and Adherence to Wound Care Regimen
The Effectiveness of the Teach-back Method on Patient Satisfaction and Adherence to Wound Care Regimen After Mohs Micrographic Surgery: A Pilot Study
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.
Study Overview
Status
Conditions
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ask-tell-ask method
Study team will provide participant education using the ask-tell-ask method.
Participants will receive a post-operative instruction sheet containing detailed information regarding wound care for reference and will receive a phone call at 1 week to inquire about wound care adherence.
Participants will come to clinic at 2 weeks to have wounds assessed in addition to answering surveys regarding wound care adherence and participant experience.
|
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.
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 administered at one week over the phone and at two weeks in person
|
|
Active Comparator: Standard of Care (SOC)
Participants will receive SOC education from the researcher.
Participants will receive a post-operative instruction sheet containing detailed information regarding wound care for reference and will receive a phone call at 1 week to inquire about wound care adherence.
Participants will come to clinic at 2 weeks to have wounds assessed in addition to answering surveys regarding wound care adherence and participant experience.
|
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 administered at one week over the phone and at two weeks in person
Standard participant education from researcher
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound care adherence as measured by wound care adherence survey
Time Frame: 1 week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient experience as measured by participant satisfaction survey
Time Frame: At 2 weeks
|
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
|
|
Number of phone calls made post-operatively by participants
Time Frame: At 2 weeks
|
Number of phone calls made post-operatively by participants
|
At 2 weeks
|
|
Complication incidence post-operatively
Time Frame: At 2 weeks
|
Complication incidence post-operatively
|
At 2 weeks
|
|
Wound care adherence as measured by wound care adherence survey
Time Frame: At 2 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina Wong, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CASE1620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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