Evaluating an Intelligent Module for Pressure Injury Nursing Management

NCT07208747 | Completed

• 1 other identifier: HAXM-MEC-20250815-069-01
• Study Type: observational
• Target: 75,263
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study conducted in a hospital to evaluate whether applying an intelligent information technology can help nurses better prevent and manage bedsores (also known as pressure injuries) in hospitalized patients. Bedsores are a serious skin problem for patients who are bedridden for long periods. The researchers will compare the situation before and after using the intelligent program to see if it has an impact on the occurrence and outcomes of pressure injuries. We invite eligible hospitalized patients to participate. Participants' nursing data will be anonymously recorded and analyzed to evaluate the effectiveness of this intelligent program.

Conditions

Pressure Injury

Keywords

Pressure injury；Nursing management system；Intelligent module

Outcome Measures

Primary Outcomes (3)

• Braden scale assessment timeliness rate(≤2hours from admission)

  1.Number of newly admitted patients assessed within 2 h: The system automatically pulls timestamps from the Nursing Management System-start time = patient's arrival timestamp; end time = nurse's submission timestamp of the Braden assessment. Records with an interval ≤ 2 h are counted as "timely." 2.Total newly admitted patients in the period: The system extracts the total number of patients who completed admission procedures. 3.Formula:Braden Risk Assessment Timeliness Rate = (number of newly admitted patients assessed within 2 h ÷ total newly admitted patients in the period) × 100%

  The time frame for data collection is from January 2023 to December 2024, with data collected monthly.

• Braden Assessment omission rate

  1.The required assessments based on the patient's Braden score: ≥19 (no risk): once on admission and once on discharge 15-18 (low risk): once per week 13-14 (moderate risk): twice per week (re-assessed on Tuesday and Friday) 10-12 (high risk): once per day 0-9 (very high risk): once per nursing shift (three shifts) Actual assessments: The assessments recorded in the nursing system. Missed assessments= required assessments - actual assessments 2.Formula:Braden Assessment Omission Rate =Missed assessments (required count - actual count) ÷ Required count

  The time frame for data collection is from January 2023 to December 2024, with data collected monthly.

• Accuracy rate in PI staging determination

  1.The system automatically pulls from the Nursing Management Information System all in-hospital and community-acquired pressure injury (PI) reports submitted every month. The wound-care specialists then identify-per NPUAP/EPUAP staging criteria-those records whose initial stage was judged "incorrect." 2.Total Reports: The system simultaneously extracts the total number of all PI reports submitted during the same month. 3.Formula: PI staging accuracy (%) = (correctly staged cases ÷ total reported cases) × 100%.

  The time frame for data collection is from January 2023 to December 2024, with data collected monthly.

Secondary Outcomes (2)

• Hospital-Acquired Pressure Injury (HAPI) Incidence Rate

  The time frame for data collection is from January 2023 to December 2024, with data collected monthly.

• Wound outcome classification

  The time frame for data collection is from January 2023 to December 2024, with data collected annually.

Study Arms (2)

Exposed Cohort

The nursing staff routinely used the intelligent pressure-injury management module as part of standard care throughout 2024.

Routine Care Cohort

The nursing staff provided routine pressure-injury care without the use of the intelligent module throughout 2023.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients admitted to the Xiamen Humanity Hospital during 2023 and 2024.

You may qualify if:

• Length of stay ≥ 2 hours after admission

You may not qualify if:

• : Terminal condition (expected survival time \< 48 hours) 2: Refusal to participate in data collection

Sponsors & Collaborators

• Xiamen Humanity Hospital: lead

Study Sites (1)

Xiamen Humanity Hospital

Xiamen, Fujian, 361000, China

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Nurse

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting documents will become available after the publication of the primary results manuscript for a period of at least 5 years.
• Access Criteria: Data will be available to researchers who provide a scientifically sound research proposal that has been approved by an independent review committee. Proposals should be directed to the corresponding author (water1427@sina.com). Access will be granted after the signing of a data access agreement that includes commitments to: 1) use the data only for the specified research purpose; 2) not attempt to re-identify participants; 3) secure the data appropriately.

Locations

CN (1)