- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03815500
Patient Education at Dismissal After Surgical Procedure
August 12, 2022 updated by: Mayo Clinic
Patient Education at Dismissal After Surgical Procedure: Clinical Outcome Implications and Improvement Strategies
Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin D Zielinski, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
January 8, 2019
First Submitted That Met QC Criteria
January 21, 2019
First Posted (Actual)
January 24, 2019
Study Record Updates
Last Update Posted (Actual)
August 16, 2022
Last Update Submitted That Met QC Criteria
August 12, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-008124
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wound Infection
-
Pulmatrix Inc.TerminatedPost Operative Wound Infection | Postoperative Wound Infection-deepUnited States
-
Brigham and Women's HospitalRecruitingWound Infection and Wound HealingUnited States
-
PolyPid Ltd.CompletedPostoperative Wound Infection Superficial Incisional | Postoperative Wound Infection Deep Incisional Surgical SiteIsrael
-
Carilion ClinicSmith & Nephew, Inc.; DeRoyal Industries, Inc.CompletedImpaired Wound Healing | Postoperative Wound Infection-deepUnited States
-
Children's Healthcare of AtlantaWithdrawnPostoperative Wound InfectionUnited States
-
Military Medical AcademyRecruitingPostoperative Wound Infection Superficial Incisional | Postoperative Wound Infection Deep Incisional Surgical SiteBulgaria
-
Prof. Dr. Bülent M. ErtuğrulBaşakşehir Çam & Sakura City HospitalActive, not recruitingIdentification | Wound Infection BacterialTurkey (Türkiye)
-
PfizerCompletedSurgical Wound Infection | Postoperative Wound Infection
-
HITEC-Institute of Medical SciencesCompletedWound Infection | Wound Dehiscence | Wound Surgical | Wound BleedingPakistan
-
Universitat Internacional de CatalunyaHospital de GranollersCompletedSurgical Wound Infection | Postoperative Wound Infection | Postoperative Wound Infection Superficial Incisional | Preventive TherapySpain
Clinical Trials on Enhanced Education
-
Lynda Powell, PhD, MEdUniversity of Illinois at Chicago; Sinai Health System; John H. Stroger HospitalCompletedHeart Diseases | Cardiovascular Diseases | Heart Failure, CongestiveUnited States
-
University of ChicagoCompleted
-
McGill UniversityMcMaster University; University of Sydney; Institut National du Sport du QuebecRecruiting
-
University of California, DavisEnloe Regional Cancer CenterRecruitingSolid Tumor, AdultUnited States
-
Taipei Medical University WanFang HospitalTerminatedQuality of Life | Diabetes Mellitus | Latent Tuberculosis Infection | Continuous Glucose MonitoringTaiwan
-
Washington Regional Medical CenterCompletedIschemic StrokeUnited States
-
Women and Infants Hospital of Rhode IslandCompletedPregnancy Related | Aneuploidy | Genetic DiseaseUnited States
-
Vanderbilt UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedType 2 DiabetesUnited States
-
National University Hospital, SingaporeActive, not recruitingDown Syndrome | Aneuploidy | Pregnancy EarlySingapore
-
Athabasca UniversityUniversity of Alberta; Canadian Foundation for Dietetic Research (CFDR)Completed