NCT04377971

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

May 4, 2020

Last Update Submit

April 30, 2025

Conditions

Keywords

Mohs Micrographic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient experience as measured by participant satisfaction survey

    At 2 weeks

  • Number of phone calls made post-operatively by participants

    At 2 weeks

  • Complication incidence post-operatively

    At 2 weeks

  • Wound care adherence as measured by wound care adherence survey

    At 2 weeks

Study Arms (2)

Ask-tell-ask method

EXPERIMENTAL

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 educationOther: Participant satisfaction surveyOther: Wound care adherence survey

Standard of Care (SOC)

ACTIVE COMPARATOR

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.

Behavioral: SOC educationOther: Participant satisfaction surveyOther: Wound care adherence survey

Interventions

SOC educationBEHAVIORAL

Standard participant education from researcher

Standard of Care (SOC)

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.

Ask-tell-ask method

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

Ask-tell-ask methodStandard of Care (SOC)

Wound care adherence survey administered at one week over the phone and at two weeks in person

Ask-tell-ask methodStandard of Care (SOC)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

  • Christina Wong, MD

    University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

November 9, 2020

Primary Completion

July 5, 2022

Study Completion

July 5, 2022

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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

Locations