- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03715062
Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities
Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities With a Complex Intervention Targeted at Nursing Home Staff -A Protocol for a Cluster Randomized Controlled Trial.
Study Overview
Detailed Description
Healthcare-associated infections due to antimicrobial use in long-term care facilities (LTCF) is an increasing problem in europe. It is well established that there exists a positive correlation between the amount of antibiotics used in treatment and resistant bacteria in both individual patients and society as a whole. A point-prevalence audit from 2017 in LTCFs showed that 10.5% of all LTCF residents in Denmark are treated with an antibiotic agent. In 78% of the cases, the cause for treatment was urinary tract infection (UTI). In addition, this group of elderly are particularly vulnerable to healthcare-associated infections, drug interactions and adverse effects. Thus, there are persuasive reasons for reducing antibiotic use in this specific group.
In the diagnostic process for UTI in a LTCF resident, there are several non-clinical factors influencing the diagnosis and leading to unnecessary treatment. First, because of dementia, sequelae from apoplexies, difficulties walking and other ailments, the typical LTCF resident is unable to express symptoms clearly and attend the GPs office. Consequently, the diagnosis is based on observations made by LTCF staff, which are then communicated to the General Practitioner (GP). Second, the prevalence of asymptomatic bacteriuria is up to 50% in this particular group. Though several studies have found that asymptomatic bacteriuria is a benign condition, it continues to be treated. Third, unspecific symptoms such as mental status change, falls or decreased function are unlikely to be caused by UTI. However, unspecific symptoms are still driving diagnosis and treatment of UTI. These factors may influence diagnosis and treatment in the Danish LTCF setting and therefore, a significant portion of the prescribed antibiotics for UTI could be due to overtreatment.
There is some evidence suggesting that antibiotic stewardship programs focusing on education of LTCF staff decreases antibiotic prescriptions and increases adherence to guidelines. In addition, there is moderate evidence that the widely used communication tool ISBAR (Identification, Situation, Background, Analysis, Recommendation) improves patient safety by improving interprofessional communication especially when communicating over the phone. Thus, if LTCF staff were educated on relevant observation, how to approach ASB, unspecific symptoms and structured handover of clinical information, the impact of these factors on diagnosis and treatment of UTI in LTCF residents may decrease. Overall, antibiotic stewardship programs in LTCF are somewhat effective. However, most of these were targeted at prescribers only or prescribers and nurses and some were also prone to bias because of the choice of study design. At present, there exists no cluster Randomized Controlled Trials (cRCT) targeting only LTCF staff with nursing tasks through a combined education- and communication-centered intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 1014
- Research Unit of General Practice
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- LTCFs eligible for inclusion have common service areas with attending staff 24 hours a day and they cannot be specialized i.e. not psychiatric LTCFs or LTCFs for the blind, except for LTCFs specialized in dementia. The residents living in these types of facilities requires a level of care that typically ensures that the LTCF staff handles all contact with the GP on behalf of the resident, while the LTCF residents remains a somewhat homogenous group.
- We include only social and health helpers, social and health assistants and nurses, who have a permanent contract at the LTCF and do day- or evening shifts for the educational session. It is optional for the LTCF to use the educational material to educate LTCF staff in nightshifts. However, a UTI is rarely observed and reported during the night, which is why we chose this pragmatic approach. Usually, if a UTI is suspected, the night shift will report to the day shift, who then reevaluates and contacts the GP if necessary. We also target the permanently employed, as they are the majority of employees with nursing responsibilities and set the standard for the temporary staff.
- All incidents of suspected UTI in LTCF residents or antibiotic prescriptions for UTI must be registered. All registrations must be made on LTCF residents above 65 years of age and with a permanent address at the LTCF, otherwise the incidence of ASB is different than assumed in preparing the intervention.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control group
No intervention
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Experimental: Intervention group
Receives education in diagnosing urinary tract infection and use of observation, reflection and communication tool.
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The intervention has two parts: an educational session and a dialogue tool.
The educational session consists of 75 minutes of education in diagnosing urinary tract infection.
The dialogue tool consists of 1) a checking box for the most important symptoms and observations for urinary tract infection 2) an algorithm to evaluate if urinary tract infection is likely based on the present symptoms and observations 3) a list of reflection points to evaluate with a collegue 4) a specialized ISBAR (communication tool) if long-term care facility staff finds it appropriate to contact the General Practicioner
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prescription of antibiotics for urinary tract infection
Time Frame: 17 weeks
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The number of antibiotic prescriptions for urinary tract infections pr resident days
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17 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalization
Time Frame: 17 weeks
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The number of hospitalizations caused by urinary tract infections pr resident days
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17 weeks
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Death
Time Frame: 17 weeks
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The number of deaths caused by urinary tract infections pr resident days
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17 weeks
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Appropriate prescription of antibiotics for urinary tract infections
Time Frame: 17 weeks
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The number of treatments with adequate symptoms and observations for treatment pr resident days
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17 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Symptoms
Time Frame: 17 weeks
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The number of symptoms observed in each arm
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17 weeks
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Observations
Time Frame: 17 weeks
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The number of observations observed in each arm
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17 weeks
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Contact to doctor
Time Frame: 17 weeks
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Number of times the doctor was contacted pr resident
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17 weeks
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Collaborators and Investigators
Investigators
- Study Chair: Lars Bjerrum, MD, PHD, Professor
Publications and helpful links
General Publications
- Arnold SH, Nygaard Jensen J, Bjerrum L, Siersma V, Winther Bang C, Brostrom Kousgaard M, Holm A. Effectiveness of a tailored intervention to reduce antibiotics for urinary tract infections in nursing home residents: a cluster, randomised controlled trial. Lancet Infect Dis. 2021 Nov;21(11):1549-1556. doi: 10.1016/S1473-3099(21)00001-3. Epub 2021 Jul 22.
- Arnold SH, Jensen JN, Kousgaard MB, Siersma V, Bjerrum L, Holm A. Reducing Antibiotic Prescriptions for Urinary Tract Infection in Nursing Homes Using a Complex Tailored Intervention Targeting Nursing Home Staff: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2020 May 8;9(5):e17710. doi: 10.2196/17710.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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