Pressure InjuryIM-PINMNCT07208747
Evaluating an Intelligent Module for Pressure Injury Nursing Management
An observational study of Pressure Injury, run by Xiamen Humanity Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Injury
- How many people
- 75,263 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatients admitted to the Xiamen Humanity Hospital during 2023 and 2024.
Who may be able to join
- Length of stay ≥ 2 hours after admission
Who cannot join
- 1: Terminal condition (expected survival time < 48 hours) 2: Refusal to participate in data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction and Application of an Intelligent Module for Pressure Injury Nursing Management System
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.
Read the detailed description
Background：Pressure injuries are common nursing complications in clinical practice, and their occurrence can reduce patients' quality of life, affect rehabilitation, and increase medical costs. This project aims to utilize information technology to build a comprehensive and intelligent pressure injury care management platform, providing scientific evidence for clinical decision-making and supporting standardized management of pressure injuries and improvement in nursing quality.
Objective：To construct an intelligent module for the pressure injury nursing management system and to explore its application effects in pressure injury management.
Methods：Based on the hospital nursing information system, an intelligent module was constructed to achieve functions such as intelligent decision-making for pressure injury risk assessment, intelligent staging judgment, visual online assessment and review, outcome tracking，and home care linkage, as well as monitoring quality control indicators.
- Conditions
- Pressure Injury
- Keywords
- Pressure injury；Nursing management system；Intelligent module
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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
Measured: 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%.
Measured: 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
1."Monthly incident cases": Automatically extracted each month from the Nursing Management System-counts all newly acquired pressure injuries that have been reported during the month. "Total inpatient episodes for the same period": Simultaneously extracted the total cumulative inpatient episodes for the month, including transfers and deaths; same-day readmissions are counted only once. 3.Formula: Hospital-acquired pressure injury incidence (%) = (monthly new hospital-acquired cases ÷ monthly total inpatient episodes) × 100%.
Measured: The time frame for data collection is from January 2023 to December 2024, with data collected monthly.
Wound outcome classification
- Annual wound outcome records: The system automatically pulls the wound outcome fields (healed / improved / unchanged / deteriorated) for all discharged patients with PIs in per year. 2.Total number of PI patients: The sum of all hospital-acquired plus community-acquired pressure injury cases in the same year, denoted as N. 3.Formula: • Healing rate (%) = (number of healed cases ÷ N) × 100% Improvement rate (%) = (number of improved cases ÷ N) × 100% Unchanged rate (%) = (number of unchanged cases ÷ N) × 100% Deterioration rate (%) = (number of deteriorated cases ÷ N) × 100%
Measured: The time frame for data collection is from January 2023 to December 2024, with data collected annually.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75,263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Humanity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAO JING, Xiamen Humanity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208747
- Sponsor's protocol ID
- HAXM-MEC-20250815-069-01
- Acronym
- IM-PINM
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. De-identified individual participant data that underlie the results reported in this article will be shared after the publication of the primary findings. 2. Researchers who provide a methodologically sound proposal will be granted access. Proposals should be directed to water1427@sina.com. To gain access, requestors will need to sign a data access agreement. 3. The data will be made available for at least 5 years. We aim to provide data within 5 business days of request approval.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of an Intelligent Module for Pressure Injury Nursing Management System
- ClinicalTrials.gov ID
- NCT07208747
- Acronym / sponsor ID
- IM-PINM / HAXM-MEC-20250815-069-01
- Conditions
- Pressure Injury
- Keywords
- Pressure injury；Nursing management system；Intelligent module
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75,263 participants (actual)
- Lead sponsor
- Xiamen Humanity HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background：Pressure injuries are common nursing complications in clinical practice, and their occurrence can reduce patients' quality of life, affect rehabilitation, and increase medical costs. This project aims to utilize information technology to build a comprehensive and intelligent pressure injury care management platform, providing scientific evidence for clinical decision-making and supporting standardized management of pressure injuries and improvement in nursing quality.
Objective：To construct an intelligent module for the pressure injury nursing management system and to explore its application effects in pressure injury management.
Methods：Based on the hospital nursing information system, an intelligent module was constructed to achieve functions such as intelligent decision-making for pressure injury risk assessment, intelligent staging judgment, visual online assessment and review, outcome tracking，and home care linkage, as well as monitoring quality control indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients admitted to the Xiamen Humanity Hospital during 2023 and 2024.
Key inclusion criteria (1 listed)
- Length of stay ≥ 2 hours after admission
Key exclusion criteria (1 listed)
- 1: Terminal condition (expected survival time < 48 hours) 2: Refusal to participate in data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Braden scale assessment timeliness rate(≤2hours from admission)
Time frame: The time frame for data collection is from January 2023 to December 2024, with data collected monthly.
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%
Braden Assessment omission rate
Time frame: The time frame for data collection is from January 2023 to December 2024, with data collected monthly.
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
Accuracy rate in PI staging determination
Time frame: The time frame for data collection is from January 2023 to December 2024, with data collected monthly.
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%.
2 secondary outcomes
Hospital-Acquired Pressure Injury (HAPI) Incidence Rate
Time frame: The time frame for data collection is from January 2023 to December 2024, with data collected monthly.
Wound outcome classification
Time frame: The time frame for data collection is from January 2023 to December 2024, with data collected annually.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Yes. 1. De-identified individual participant data that underlie the results reported in this article will be shared after the publication of the primary findings. 2. Researchers who provide a methodologically sound proposal will be granted access. Proposals should be directed to water1427@sina.com. To gain access, requestors will need to sign a data access agreement. 3. The data will be made available for at least 5 years. We aim to provide data within 5 business days of request approval.
Related trials for Pressure Injury
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Injury, run by Xiamen Humanity Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Braden scale assessment timeliness rate(≤2hours from admission) (time frame: The time frame for data collection is from January 2023 to December 2024, with data collected monthly.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.