Clinical trial NCT05354921: Indwelling vs Intermittent Catheterization Pilot Study
Official title: Hip Fracture Patient and the Use of IndwElling vs IntermittEnt Catheterization Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urogenital
Urinary Tract Infections
Hip Fractures
Catheter Complications
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
First posted: 2022-05-02
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization. The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this pilot study trial and proceed towards a multi-center trial.

Detailed description: The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization.

The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this vanguard trial and proceed towards a multi-center trial.

Secondary objectives would be related to safety and patient activity that would be important endpoints for the definitive, large scale trial. These would include the following:

1. Is short term indwelling catheter use associated with reduced incidence of UTI compared to clean intermittent catheterization in patients with hip fracture.
2. How does patient experience compare between these two forms of treatment?

Eligible patients will be approached for consent at admission and, if willing to participate, will be randomized into Group A or Group B using a web-based, computer-generated randomization with permuted blocks of varying sizes.

Data Collection will include:

* Urinary symptoms at admission, pre-fracture
* Date and time of catheter insertion (indwelling or not)
* Date and time of surgery
* Type of anesthesia used
* Date and time of catheter removal
* Number of catheterizations performed during hospital stay
* Type of Antibiotic cover during per-operative period (typically 3 doses provided perioperatively)

A clinical research coordinator (CRC) will oversee study recruitment and assess number of study participants to the total number of patients admitted with a hip fracture which will allow for documentation of ability to recruit into the study. Furthermore, the CRC will prospectively record each patent's journey to assess whether enrolled patients are receiving the treatment they are randomized to. All enrolled patients will be asked to fill in a patient satisfaction score that has been in use already at our institution.

A CRC, blinded to the arm patients were randomized to, will be responsible for recording all outcome measures of interest prospectively in the study's database from the participant's electronic medical records. Validity of data extraction will be tested for a randomly selected 10% of the cohort by a second evaluator (CRC not previously involved in the study).

Data analyses will include:

Descriptive Statistics: Given the feasibility purpose of the vanguard trial, descriptive statistics will be used to summarize demographics and baseline prognostic factors of participants allocated to the two trial arms.

Analysis of Primary Outcome: Our primary endpoint is the rate of enrolment to ensure the ability to undertake a larger multi-centered trial. An average rate of 10 patients/month or greater will be considered as ideal for establishing feasibility. An enrollment of less than 5 patients/month will likely jeopardize the ability to feasibly recruit for the larger trial. Whereas, average monthly enrolment of 5 to 10 patients will require a re-evaluation of our recruitment strategy, intervention specifications, and/or eligibility criteria to improve enrolment.

Analysis of Secondary Outcomes: Given the vanguard nature of this trial, the investigators will not undertake inferential analyses of our secondary outcomes but rather these patients will be carried forward into the larger trial.

Eligibility criteria: Inclusion Criteria:

* Hip fracture (intertrochanteric, femoral neck, femoral head, sub-trochanteric) confirmed by imaging
* Age ≥50 years
* Operative treatment planned
* Admitted under Orthopaedic Surgery
* Willing and able to sign consent (substitute decision maker)

Exclusion Criteria:

* Periprosthetic hip fracture
* Polytrauma
* Multiple fractures of the lower limbs
* Previous lower urinary tract surgery
* Known (past or current) urogenital cancer (prostate, bladder)
* Urinary tract infection prior to randomization
* Indwelling catheter present on admission (chronic or placed at previous acute setting)

Primary outcomes:
measure: Study Feasibility - Enrollment
timeFrame: One year
measure: Study Feasibility - Screening
timeFrame: One year
measure: Study Feasibility - Retention
timeFrame: One year
measure: Study Feasibility - Follow-up
timeFrame: One year
Secondary outcomes:
measure: Safety-Related Outcomes - Rates of UTI
timeFrame: 30 days
measure: Safety-Related Outcomes - Rates of POUR
timeFrame: 30 days
measure: patient experience questionnaire
timeFrame: pre-operatively, and post-operative day six or at discharge
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: George Grammatopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital
name: Steven Papp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Health Quality Ontario, M.o.H.a.L.-T.C., Quality Based Procedures Clinical Handbook for Hip Fracture. 2013.
citation: Dodd AC, Bulka C, Jahangir A, Mir HR, Obremskey WT, Sethi MK. Predictors of 30-day mortality following hip/pelvis fractures. Orthop Traumatol Surg Res. 2016 Oct;102(6):707-10. doi: 10.1016/j.otsr.2016.05.016. Epub 2016 Aug 3.
citation: Skelly JM, Guyatt GH, Kalbfleisch R, Singer J, Winter L. Management of urinary retention after surgical repair of hip fracture. CMAJ. 1992 Apr 1;146(7):1185-9.
citation: Smith NK, Albazzaz MK. A prospective study of urinary retention and risk of death after proximal femoral fracture. Age Ageing. 1996 Mar;25(2):150-4. doi: 10.1093/ageing/25.2.150.
citation: Hedstrom M, Grondal L, Ahl T. Urinary tract infection in patients with hip fractures. Injury. 1999 Jun;30(5):341-3. doi: 10.1016/s0020-1383(99)00094-7.
citation: Kamdar A, Yahya A, Thangaraj L. Retrospective observational study of the incidence of short-term indwelling urinary catheters in elderly patients with neck of femur fractures. Geriatr Gerontol Int. 2009 Jun;9(2):131-4. doi: 10.1111/j.1447-0594.2008.00490.x.
citation: Schneider MA. Prevention of catheter-associated urinary tract infections in patients with hip fractures through education of nurses to specific catheter protocols. Orthop Nurs. 2012 Jan-Feb;31(1):12-8. doi: 10.1097/NOR.0b013e3182419619.
citation: Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
citation: Thomas S, Harris N, Dobransky J, Grammatopoulos G, Gartke K, Liew A, Papp S. Urinary catheter use in patients with hip fracture: Are current guidelines appropriate? A retrospective review. Can J Surg. 2021 Nov 25;64(6):E630-E635. doi: 10.1503/cjs.014620. Print 2021 Nov-Dec.
citation: Excellence, N.I.f.H.a.C., Hip fracture: management. 2011.