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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Withdrawn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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wound Infection Post-Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 8, 2019
    Last Updated
    August 12, 2022
    Sponsor
    Mayo Clinic
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    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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