NCT06893562

Brief Summary

This study focuses on evaluating the long-term sustainability of a urinary catheter care bundle designed to prevent urinary tract infections and bladder distension in patients undergoing surgery for hip fractures. The intervention, which included two key innovations-a urinary catheter certificate and a nurse-driven urinary catheter protocol, was implemented between 2015 and 2020 and successfully reduced urinary tract infections and bladder distension, previously published. However, due to the pandemic, the initiative was paused and had to be reintroduced in 2022. Now, the study aims to assess the effectiveness of these preventive measures 9 years after their initial implementation. The research will analyze changes in the incidence of urinary tract infections, bladder distension, catheterisation methods, and documentation practices in patients aged 65 and older. The findings will help inform healthcare policies and may have broader implications for preventing adverse events in other surgical patient groups

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 11, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

Sustainability of InnovationsHip fractureUrinary RetentionCatheter Associated Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (4)

  • 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.

    For one year.

  • Changes in urine volume of 500ml and more during hospital stay. Year nine will be compared yera 1-5, previous published data

    For one year

  • 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

    For one year

  • Changes in urinary catheter-related documentation in Year 9 will be compared to previously published data from Years 1-5.

    For one year

Study Arms (1)

Patients undergoing hip fracture surgery year nine after the intervention started.

Behavioral: Safe Hands and Safe Bladder intervention

Interventions

Evaluating changes in urinary tract infections and bladder distension nine-year after implementing preventive measures

Patients undergoing hip fracture surgery year nine after the intervention started.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 65 years and older undergoing hip fracture surgery at a university hospital in Sweden.

You may qualify if:

  • Hip fracture surgery at the study site, age 65 years and older and cared for in the ortho-geriatric wards.

You may not qualify if:

  • No catheterisation during hospital stay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska Academy, Sahlgrenska University hospital/Mölndal

Mölndal, Västra Götaland County, 43180, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 36064457BACKGROUND
  • 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.

    PMID: 30449454BACKGROUND
  • 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.

    PMID: 29301519BACKGROUND
  • 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.

    PMID: 36224550BACKGROUND
  • 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.

    PMID: 35340925BACKGROUND

MeSH Terms

Conditions

Urinary RetentionHip FracturesUrinary Tract Infections

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesInfections

Study Officials

  • Annette Erichsen, Associate Professor

    Gothenburg University, Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 25, 2025

Study Start

May 5, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations