- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893562
Evaluating Nine-Year Sustainability After Implementing Evidence-Based Practices to Prevent Urinary Tract Infections and Overfilling of the Bladder in Patients With Hip Fracture
Nine-Year Sustainability After Implementing Measures to Prevent Catheter- Associated Urinary Tract Infections and Bladder Distension in Patients With Hip Fracture
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Västra Götaland County
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Mölndal, Västra Götaland County, Sweden, 43180
- Sahlgrenska Academy, Sahlgrenska University hospital/Mölndal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
-Hip fracture surgery at the study site, age 65 years and older and cared for in the ortho-geriatric wards.
Exclusion Criteria:
-No catheterisation during hospital stay
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients undergoing hip fracture surgery year nine after the intervention started.
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Evaluating changes in urinary tract infections and bladder distension nine-year after implementing preventive measures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Describe changes in the incidence of in-hospital urinary catheter-associated infections; Year 9 will be compared with previously published data from Years 1-5
Time Frame: For one year
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Definition: Urinary tract infection with onset on day 3 after admission with prior urinary catheterisation. A physician prescribed antimicrobial agents for a urinary tract infection during the hospital stay. Data will be collected from patients' medical records. Logistic regression analysis will be performed |
For one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the incidence of in-hospital acquired bladder distension will be compared; Year 9 will be compared to previously published data from Years 1-5.
Time Frame: For one year.
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Definition: Bladder distension is defined according to the national marker for point prevalence measurement when assessing adverse events.
Bladderscan volume from patients' medical records.
|
For one year.
|
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Changes in urine volume of 500ml and more during hospital stay. Year nine will be compared yera 1-5, previous published data
Time Frame: For one year
|
Bladderscan volume from patients' medical records.
|
For one year
|
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Changes in catheterization methods during the hospital stay will be compared, with data from Year 9 compared to previously published data from Years 1-5
Time Frame: For one year
|
Data will be collected from patients' medical records.
|
For one year
|
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Changes in urinary catheter-related documentation in Year 9 will be compared to previously published data from Years 1-5.
Time Frame: For one year
|
Catheter-related documentation will be collected from patients' medical records.
|
For one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Annette Erichsen, Associate Professor, Gothenburg University, Sahlgrenska University Hospital
Publications and helpful links
General Publications
- Erichsen Andersson A, Gillespie BM, Karlsson M, Malchau H, Nellgard B, Wikstrom E, Rogmark C, Tillander J. Reduction of early surgical site and other care related infections in 3553 hip fracture patients: lessons learned from the 5-year Safe Hands project. Antimicrob Resist Infect Control. 2022 Sep 5;11(1):113. doi: 10.1186/s13756-022-01153-4.
- Wikstrom E, Dellenborg L, Wallin L, Gillespie BM, Erichsen Andersson A. The Safe Hands Study: Implementing aseptic techniques in the operating room: Facilitating mechanisms for contextual negotiation and collective action. Am J Infect Control. 2019 Mar;47(3):251-257. doi: 10.1016/j.ajic.2018.08.024. Epub 2018 Nov 16.
- Erichsen Andersson A, Frodin M, Dellenborg L, Wallin L, Hok J, Gillespie BM, Wikstrom E. Iterative co-creation for improved hand hygiene and aseptic techniques in the operating room: experiences from the safe hands study. BMC Health Serv Res. 2018 Jan 4;18(1):2. doi: 10.1186/s12913-017-2783-1.
- Frodin M, Nellgard B, Rogmark C, Gillespie BM, Wikstrom E, Andersson AE. A co-created nurse-driven catheterisation protocol can reduce bladder distension in acute hip fracture patients - results from a longitudinal observational study. BMC Nurs. 2022 Oct 12;21(1):276. doi: 10.1186/s12912-022-01057-z.
- Frodin M, Ahlstrom L, Gillespie BM, Rogmark C, Nellgard B, Wikstrom E, Erichsen Andersson A. Effectiveness of implementing a preventive urinary catheter care bundle in hip fracture patients. J Infect Prev. 2022 Mar;23(2):41-48. doi: 10.1177/17571774211060417. Epub 2022 Feb 15.
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
- Urogenital Diseases
- Wounds and Injuries
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Infections
- Leg Injuries
- Fractures, Bone
- Femoral Fractures
- Hip Injuries
- Hip Fractures
- Urinary Tract Infections
- Urinary Retention
Other Study ID Numbers
- 2025-00397-01
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
product manufactured in and exported from the U.S.
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