Pressure Injury、Caregiver、Knowledge Translation

March 20, 2024 updated by: Yi-Syuan Lai

Evaluate Knowledge Translation Care Plan on Knowledge, Attitude, and Practice of Caregivers and Care Effects of Patients With Pressure Injury

Background and importance:

In 2003, a pressure injury is listed as one of the indicators of care quality in clinical setting by Taiwan joint commission on hospital accreditation. That reflects that a pressure injury is a significant heath care issue. Nowadays, it still constantly happens at hospitals, home, and nursing homes: Pressure injuries cause pain, and increase length of hospital stay, rehospitalization rate, and death rate. In current clinical practice, standardized guidelines and basic principles are followed for pressure injury management, and it is found that most of the caregivers are unsure about what are the consequences of having pressure injuries and how to manage and prevent them. Therefore, the caregivers are more passive, and feel nervous and confused. In literature, there are guidelines for pressure injury prevention and management. However, they are primarily designed for heath professionals. As a result, to achieve evidence-based practice and knowledge translation, I hope to make individual management plans for each patient, provide caring support, and follow up with patients. And caregivers can benefit from knowledge, attitude, practice, and caring effect.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Goals:

The study aims to achieve knowledge translation in nursing for pressure injury care. The caregivers of patients with pressure injuries and their family can benefit from translating of knowledge, attitude, and practice, and they can have more knowledge related to pressure injuries, and learn how to react to and care for patients. In this way, it will be possible to promote wound healing and prevent recurrence of pressure injuries.

Method:

This study is a randomized controlled trial. There are seventy participants. The experimental group receives care plans in which knowledge translation is applied, and the control group receives usual care. Generalized estimating equations, GEE, is used to assess the effectiveness of care plans with knowledge translation for patients and family with pressure injuries.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Zhongzheng District
      • Keelung, Zhongzheng District, Taiwan
        • Recruiting
        • Vivian
        • Contact:
          • Y-isyuan Lai

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Grade 1-3 pressure injury diagnosed by medical staff.
  2. The patient needs to have a caregiver.
  3. The patient and the caregiver need to be older than 20 years old, (4) The informed consent of this study.

(5) The caregiver Those who understand the content of health education (MMSE>24 points)

Exclusion Criteria:

  1. The patient has >3 disease diagnoses,
  2. The patient is diagnosed by a doctor as a terminally ill patient or the life expectancy is less than 3 months,
  3. There is a life-threatening acute problem (active bleeding site, acute myocardial infarction, acute bronchitis, etc. ),
  4. pressure injury caused by invasive pipeline placement,
  5. need to wear non-invasive positive pressure respirator, (6) need to stay in intensive care center for a long time (>10 days),
  6. need a long time For surgical patients, each operation takes > 5 hours,
  7. the caregiver has dementia,
  8. the caregiver has mental illness or alcohol and drug addiction,
  9. no caregiver.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: knowledge translation in nursing for pressure injury care
Using guideline and evidence based practice for pressure injury. The experimental group has received knowledge translation in nursing for pressure injury care with precaution teaching plan by using self-designed teaching materials, manuals, videoes, multimedia tools (power point, LINE official account, LINE one-on-one lesson, virtual lesson), in-person assistance and assessment in 12weeks.
Behavioral: knowledge translation in nursing for pressure injury care
Pressure injury's knowledge and healing of wound.
Placebo Comparator: Regular care
The controlled group maintained the regular nursing intervention.
Behavioral: knowledge translation in nursing for pressure injury care
Pressure injury's knowledge and healing of wound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound healing
Time Frame: 6 weeks and 12 weeks
PUSH tool. Measure Length x Width, Exudate Amount and Tissue Type in pressure injury.
6 weeks and 12 weeks
caregiver's knowledge
Time Frame: 6 weeks and 12 weeks
Using a self-made questionnaire, the informal caregivers' knowledge of pressure injuries, such as: how does a pressure injury form, what are the care methods for a pressure injury, what should be prepared for wound care, methods to prevent a pressure injury, etc.
6 weeks and 12 weeks
caregiver's attitude
Time Frame: 6 weeks and 12 weeks
Use the self-made questionnaire to understand the caregivers' attitudes towards pressure injuries, such as whether they have motivation to care for them, whether they think it is important to prevent pressure injuries, whether they are confident that they can take good care of them, etc.
6 weeks and 12 weeks
caregiver's practice
Time Frame: 6 weeks and 12 weeks
Using a self-made questionnaire, the caregiver actually evaluates the situation of caring for the crush injury, such as: body positioning, repositioning, nutritional supply status, wound dressing change, wound grading assessment, body cleanliness, whether the protrusion of the bone is paid attention to, reducing Pressure equipment, etc.
6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recurrence rate of pressure injury three months after intervention
Time Frame: 12 weeks
Patients with reoccurrence of pressure injury/Total number of experimental group or control group*100%
12 weeks
The rehospitalization rate
Time Frame: 12 weeks
Number of patients re-admitted for pressure injuries /Total number of experimental group or control group *100%
12 weeks
The mortality rate
Time Frame: 12 weeks
The number of Patient deaths/Total number of experimental group or control group *100%
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi-Syuan Lai

Investigators

  • Study Chair: Yi-Syuan Lai, Student

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.

General Publications

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)

October 1, 2020

Primary Completion (Actual)

March 2, 2024

Study Completion (Estimated)

June 2, 2024

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pressureinjury853121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Evaluate on the wound healing, knowledge and caring behaviors of hospitalized patients with pressure injury

IPD Sharing Time Frame

When I will complete the research, that can be sharing forever.

IPD Sharing Access Criteria

Anyone have pressure injury's problem

IPD Sharing Supporting Information Type

  • CSR

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.

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