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

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04377971
Collaborator
(none)
40
1
2
22.7
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SOC education
  • Behavioral: Ask-tell-ask education
  • Other: Participant satisfaction survey
  • Other: Wound care adherence survey
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effectiveness of the Teach-back Method on Patient Satisfaction and Adherence to Wound Care Regimen After Mohs Micrographic Surgery: A Pilot Study
Actual Study Start Date :
Nov 9, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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.

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.

Behavioral: SOC education
Standard participant education from researcher

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

Outcome Measures

Primary Outcome Measures

  1. Wound care adherence as measured by wound care adherence survey [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).

Secondary Outcome Measures

  1. Patient experience as measured by participant satisfaction survey [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.

  2. Number of phone calls made post-operatively by participants [At 2 weeks]

    Number of phone calls made post-operatively by participants

  3. Complication incidence post-operatively [At 2 weeks]

    Complication incidence post-operatively

  4. Wound care adherence as measured by wound care adherence survey [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Cleveland Ohio United States 44106

Sponsors and Collaborators

  • Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Christina Wong, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT04377971
Other Study ID Numbers:
  • CASE1620
First Posted:
May 7, 2020
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Case Comprehensive Cancer Center

Study Results

No Results Posted as of Sep 8, 2021