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Pressure Injury、Caregiver、Knowledge Translation

Sponsor
Yi-Syuan Lai (Other)
Overall Status
Recruiting
CT.gov ID
NCT06128005
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
38.6
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: knowledge translation in nursing for pressure injury care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluate Knowledge Translation Care Plan on Knowledge, Attitude, and Practice of Caregivers and Care Effects of Patients With Pressure Injury
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Dec 20, 2023
Anticipated Study Completion Date :
Dec 20, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. wound healing [6 weeks and 12 weeks]

    PUSH tool. Measure Length x Width, Exudate Amount and Tissue Type in pressure injury.

  2. caregiver's knowledge [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.

  3. caregiver's attitude [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.

  4. caregiver's practice [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.

Secondary Outcome Measures

  1. The recurrence rate of pressure injury three months after intervention [12 weeks]

    Patients with reoccurrence of pressure injury/Total number of experimental group or control group*100%

  2. The rehospitalization rate [12 weeks]

    Number of patients re-admitted for pressure injuries /Total number of experimental group or control group *100%

  3. The mortality rate [12 weeks]

    The number of Patient deaths/Total number of experimental group or control group *100%

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vivian Keelung Zhongzheng District Taiwan

Sponsors and Collaborators

  • Yi-Syuan Lai

Investigators

  • Study Chair: Yi-Syuan Lai, Student

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yi-Syuan Lai, nurse, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier:
NCT06128005
Other Study ID Numbers:
  • pressureinjury853121
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yi-Syuan Lai, nurse, National Defense Medical Center, Taiwan
caregiver
nursing plan
Additional relevant MeSH terms:
Pressure Ulcer
Wounds and Injuries
Crush Injuries

Study Results

No Results Posted as of Nov 13, 2023