Teach-back Method on Patient Satisfaction and Adherence to Wound Care Regimen

April 30, 2025 updated by: Case Comprehensive Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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
Other: Wound care adherence survey
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.
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
Other: Wound care adherence survey
Wound care adherence survey administered at one week over the phone and at two weeks in person
Behavioral: SOC education
Standard participant education from researcher

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina Wong, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASE1620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share IPD in order to protect the identity of the research participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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