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Patient Education at Dismissal After Surgical Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03815500
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Information provided by (Responsible Party):
Martin D. Zielinski, Mayo Clinic

Brief Summary:
Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection.

Condition or disease Intervention/treatment Phase
Wound Infection Post-Traumatic Wound Infection Wound Complication Wound Breakdown Wound Open Behavioral: Enhanced Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient Education at Dismissal After Surgical Procedure: Clinical Outcome Implications and Improvement Strategies
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Patients with open surgical wounds
Patients with open surgical wounds will undergo enhanced packing education with curriculum designed for learners with low literacy, dyslexia or associated learning disorders.
Behavioral: Enhanced Education
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 Measures :
  1. Utilization of education curriculum designed for learners with low literacy, dyslexia and associate learning disorders [ Time Frame: 6 months ]
    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 :
  1. Patient satisfaction with wound education [ Time Frame: 6 months ]
    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.

  2. shorter time to wound healing [ Time Frame: 1 year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03815500

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55901
Contact: Joy D Hughes, MD    507-255-9354   
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Martin D Zielinski Mayo Clinic

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Responsible Party: Martin D. Zielinski, Principal Investigator, Mayo Clinic Identifier: NCT03815500     History of Changes
Other Study ID Numbers: 18-008124
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Wound Infection
Surgical Wound Dehiscence
Wounds and Injuries
Postoperative Complications
Pathologic Processes