Patient Education at Dismissal After Surgical Procedure
Primary Purpose
Wound Infection Post-Traumatic, Wound Infection, Wound Complication
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Education
Sponsored by
About this trial
This is an interventional supportive care trial for Wound Infection Post-Traumatic
Eligibility Criteria
Inclusion Criteria:
- Adult patients on the general surgery service with open wounds requiring packing
Exclusion Criteria:
- Patients with wound vacs
- Patients receiving exclusively professional wound care or home health services
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with open surgical wounds
Arm Description
Patients with open surgical wounds will undergo enhanced packing education with curriculum designed for learners with low literacy, dyslexia or associated learning disorders.
Outcomes
Primary Outcome Measures
Utilization of education curriculum designed for learners with low literacy, dyslexia and associate learning disorders
Nursing surveys answering the question, "Have you been trained to teach wound care to patients with dyslexia or learning disabilities?" Were answered "No," by 43/46 (93%) respondents. We seek to have a 90% rate of affirmative ("Yes") answers to this survey after implementation of our curriculum.
Secondary Outcome Measures
Patient satisfaction with wound education
Survey of patients' wound education experiences should indicate that they are being offered curriculum suitable for learners with low literacy, dyslexia and associated learning disorders. We will utilize a scale of "Definitely satisfied, somewhat satisfied, somewhat dissatisfied, definitely dissatisfied" as our measure.
shorter time to wound healing
After implementation of new curriculum, it is anticipated that wound complication rates and time to wound healing would decrease. We will calculate the "time" based on the date of wound creation to their final clinic appointment indicated the wound is satisfactorily healed with "days" as our unit of measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03815500
Brief Title
Patient Education at Dismissal After Surgical Procedure
Official Title
Patient Education at Dismissal After Surgical Procedure: Clinical Outcome Implications and Improvement Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
PI no longer with the organization, no subjects enrolled
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection.
Detailed Description
The investigators seek to address the specific educational needs of patients and caregivers with low-literacy, dyslexia and related learning disabilities in the context of properly performing wound care for patients with surgical wounds. Specific aims include both improving care by decreasing wound complications and improving patient satisfaction by using techniques designed for this population. Objectives include utilizing surveys to determine the incidence of dyslexia among the patients' and caregivers' within the general surgery service as well as the perception of our current educational offerings, to design a new dismissal package with enhanced educational offerings, to re-measure this effect on the patient experience with survey data, and to compare wound infection rates before and after implementing the new curriculum. Dyslexia and associated learning disabilities are common and likely impact the health literacy among this population due to the ubiquitous literacy-based documentation of hospital course and dismissal instructions. Adults with dyslexia may be reluctant to disclose any inability to understand written instructions. There is currently no mechanism within the dismissal system to specifically identify and address the unique needs of this population. The impact on clinical outcomes of proper wound packing is substantial, and if performed incorrectly can lead to slow wound healing and infections that often require readmission, multiple courses of antibiotics, and reoperation. In severe cases, improper wound care can lead to severe infection, sepsis, and death. By enhancing the educational offerings of proper wound care to this population, the investigators hope to reduce these complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection Post-Traumatic, Wound Infection, Wound Complication, Wound Breakdown, Wound Open
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with open surgical wounds
Arm Type
Experimental
Arm Description
Patients with open surgical wounds will undergo enhanced packing education with curriculum designed for learners with low literacy, dyslexia or associated learning disorders.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Education
Intervention Description
Enhanced educational curriculum will involve learning modalities including 3D modeling, video, and visual-aid enhanced text for references to improve caregiver and patient understanding of wound packing techniques.
Primary Outcome Measure Information:
Title
Utilization of education curriculum designed for learners with low literacy, dyslexia and associate learning disorders
Description
Nursing surveys answering the question, "Have you been trained to teach wound care to patients with dyslexia or learning disabilities?" Were answered "No," by 43/46 (93%) respondents. We seek to have a 90% rate of affirmative ("Yes") answers to this survey after implementation of our curriculum.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient satisfaction with wound education
Description
Survey of patients' wound education experiences should indicate that they are being offered curriculum suitable for learners with low literacy, dyslexia and associated learning disorders. We will utilize a scale of "Definitely satisfied, somewhat satisfied, somewhat dissatisfied, definitely dissatisfied" as our measure.
Time Frame
6 months
Title
shorter time to wound healing
Description
After implementation of new curriculum, it is anticipated that wound complication rates and time to wound healing would decrease. We will calculate the "time" based on the date of wound creation to their final clinic appointment indicated the wound is satisfactorily healed with "days" as our unit of measure.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients on the general surgery service with open wounds requiring packing
Exclusion Criteria:
Patients with wound vacs
Patients receiving exclusively professional wound care or home health services
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin D Zielinski
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Patient Education at Dismissal After Surgical Procedure
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