- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07553026
ADDIE-Based Training Program for Nurses on Medical Device-Related Pressure Injuries
Development and Evaluation of an ADDIE Model-Based Training Program to Improve Nursing Care Practices for Medical Device-Related Pressure Injuries: A Pre-Experimental Study
Medical device-related pressure injuries (MDRPIs) are a significant and increasing problem in clinical settings, particularly in intensive care units, adversely affecting patient outcomes and increasing healthcare costs. Nurses play a critical role in the prevention and management of MDRPIs; however, previous studies have shown that their knowledge and practices in this area are often insufficient.
This study aims to develop an ADDIE (Analysis, Design, Development, Implementation, Evaluation) model-based training program for nurses and to evaluate its effect on their knowledge and care practices related to MDRPIs. The study is designed as a single-group pretest-posttest pre-experimental study and will be conducted with nurses working in intensive care units.
Data will be collected at three time points: before the training (pretest), immediately after the training (posttest), and one month after the training (follow-up). The training program will be delivered face-to-face using structured educational materials. Outcomes will include changes in nurses' knowledge levels and their evaluations of the training program.
The findings are expected to contribute to improving nursing care practices and enhancing patient safety by supporting effective prevention and management of MDRPIs.
Study Overview
Status
Intervention / Treatment
Detailed Description
Medical device-related pressure injuries (MDRPIs) are localized damage to the skin or underlying tissue resulting from sustained pressure caused by medical devices used for diagnostic or therapeutic purposes. These injuries are increasingly reported across healthcare settings, particularly in intensive care units, where patients are exposed to prolonged device use and multiple risk factors. MDRPIs negatively affect patient safety, prolong hospital stays, and increase healthcare costs.
Previous studies have demonstrated that nurses' knowledge and practices regarding MDRPI prevention and management are often insufficient. Factors such as lack of structured education, limited clinical training, and inadequate awareness contribute to suboptimal care practices. Therefore, developing evidence-based and structured educational interventions is essential to improve nurses' competencies in this area.
The ADDIE model (Analysis, Design, Development, Implementation, Evaluation) is a systematic instructional design framework widely used to develop effective educational programs. This model allows for the identification of learning needs, structured content development, and evaluation of learning outcomes.
The aim of this study is to develop an ADDIE model-based training program for nurses on MDRPI prevention and care and to evaluate its effectiveness. The study is designed as a single-group pretest-posttest pre-experimental study.
The study will be conducted in the intensive care units of a state hospital with nurses who meet the inclusion criteria and provide informed consent. The training program will be delivered face-to-face using structured educational materials, including presentations, case examples, and supporting documents.
Data will be collected at three time points: before the intervention (pretest), immediately after the intervention (posttest), and one month after the intervention (follow-up). Data collection tools will include a nurse information form, a validated MDRPI knowledge scale, and a training evaluation questionnaire.
The primary outcome of the study is the change in nurses' knowledge levels regarding MDRPIs. Secondary outcomes include the relationship between knowledge levels and selected demographic and professional variables, as well as participants' satisfaction with the training program.
The results of this study are expected to contribute to improving nursing care quality and patient safety by enhancing nurses' knowledge and supporting the prevention and effective management of MDRPIs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
şehitkamil
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Gaziantep, şehitkamil, Turkey (Türkiye), 27090
- Gaziantep University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Nurses working in the intensive care units of the study hospital Having at least 6 months of continuous work experience in the intensive care unit Voluntarily agreeing to participate in the study Providing written informed consent Agreeing to attend the training program and complete all measurement time points (pretest, posttest, and follow-up)
Exclusion Criteria:
Nurses who are transferred to another unit or leave the institution during the study period Nurses who do not fully attend the training program Nurses who fail to complete any of the data collection tools at any measurement time point Nurses who withdraw from the study at any stage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ADDIE-Based Training Program
Participants in this arm will receive an ADDIE (Analysis, Design, Development, Implementation, Evaluation) model-based training program designed to improve nurses' knowledge and care practices related to medical device-related pressure injuries.
The training will be delivered face-to-face using structured educational materials, including presentations, case examples, and supporting documents.
Data will be collected at three time points: before the intervention (pretest), immediately after the intervention (posttest), and one month after the intervention (follow-up).
|
The intervention consists of an ADDIE (Analysis, Design, Development, Implementation, Evaluation) model-based training program developed to improve nurses' knowledge and care practices related to medical device-related pressure injuries. In the analysis phase, nurses' educational needs are identified through literature review and assessment of baseline knowledge levels. In the design and development phases, structured educational content, including presentations, case examples, and supporting materials, is prepared based on identified needs and expert input. In the implementation phase, the training program is delivered face-to-face in a classroom setting and lasts approximately 40-60 minutes. In the evaluation phase, the effectiveness of the training is assessed using repeated measurements of knowledge levels before the intervention (pretest), immediately after the intervention (posttest), and one month after the intervention (follow-up). Additionally, participants' satisfaction wi |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Nurses' Knowledge Levels on Medical Device-Related Pressure Injuries
Time Frame: From baseline (pretest) to immediately after the intervention (posttest) and 1 month after the intervention (follow-up)
|
Nurses' knowledge levels will be assessed using a validated Medical Device-Related Pressure Injury Knowledge Scale.
The scale consists of multiple items with a total score range from 0 to 25, where higher scores indicate greater knowledge.
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From baseline (pretest) to immediately after the intervention (posttest) and 1 month after the intervention (follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Between Perceived Training Effectiveness and Knowledge Outcomes
Time Frame: Baseline (pretest)
|
Spearman's rank correlation analysis will be conducted to examine the relationship between perceived training effectiveness (assessed via a structured Likert-type questionnaire) and knowledge outcomes (total scores obtained from the MDRPI knowledge scale) at post-test and follow-up time points.
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Baseline (pretest)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- [1] Makic MBF, "Medical device- related pressure ulcers and intensive care patients," Journal of PeriAnesthesia Nursing , vol. 30, no. 4, pp. 336-337, 2015. [2] Dyer A., "Ten top tips: preventing device-related pressure ulcers," Wounds International 2015;1(5):7-9.; , vol. 5, no. 1, pp. 7-9, 2015. [3] Cooper KL., " Evidence-based prevention of pressure ulcers in the intensive care unit," Crit Care Nurse, vol. 33, no. 6, pp. 57-66, 2013. [4] Galetto SGS, Nascimento ERP, Hermida PMV, and Malfussi LBH, " Medical device-related pressure ınjuries: An integrative literature review," Rev Bras Enferm, vol. 72, no. 2, pp. 505-512, 2019. [5] Jackson D, Sarki AM, Betteridge R, and Brooke J, "Medical devicerelated pressure ulcers: A systematic review and metaanalysis," International Journal of Nursing Studies , vol. 92, pp. 109-120, 2019. [6] A. Parvizi et al., "A systematic review of nurses' knowledge and related factors towards the prevention of medical device-related pressure ulcers," Sep. 01, 2023, John Wiley and Sons Inc. doi: 10.1111/iwj.14122. [7] F. Fu, L. Zhang, J. Fang, X. Wang, and F. Wang, "Knowledge of intensive care unit nurses about medical device-related pressure injury and analysis of influencing factors," Int Wound J, vol. 20, no. 4, pp. 1219-1228, Apr. 2023, doi: 10.1111/iwj.13981. [8] N. Tayyib et al., "The effectiveness of the SKINCARE bundle in preventing medical-device related pressure injuries in critical care units: A clinical trial," Adv Skin Wound Care, vol. 34, no. 2, pp. 75-80, Feb. 2021, doi: 10.1097/01.ASW.0000725184.13678.80. [9] P. Özyürek and Ö. Gürlek Kisacik, "Medical device-related pressure injuries prevention practices of intensive care unit nurses: A cross-sectional study in Turkey," J Tissue Viability, vol. 33, no. 2, pp. 262-268, May 2024, doi: 10.1016/J.JTV.2024.03.013. [10] Ö. Erbay Dallı and N. Kelebek Girgin, "Medical Device-Related Pressure Injury Care and Prevention Training Program (DevICeU): Effects on intensive care nurses' knowl
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/101 (Registry Identifier: Hasan Kalyoncu University Non-Interventional Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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