Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities
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|ClinicalTrials.gov Identifier: NCT03715062|
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Other: Dialogue tool||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster randomized controlled study, where each Long-term care facility is one cluster.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||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.|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
Experimental: Intervention group
Receives education in diagnosing urinary tract infection and use of observation, reflection and communication tool.
Other: Dialogue tool
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 Name: Observation, reflection and communication tool
No Intervention: Control group
- Prescription of antibiotics for urinary tract infection [ Time Frame: 17 weeks ]The number of antibiotic prescriptions for urinary tract infections pr resident days
- Hospitalization [ Time Frame: 17 weeks ]The number of hospitalizations caused by urinary tract infections pr resident days
- Death [ Time Frame: 17 weeks ]The number of deaths caused by urinary tract infections pr resident days
- Appropriate prescription of antibiotics for urinary tract infections [ Time Frame: 17 weeks ]The number of treatments with adequate symptoms and observations for treatment pr resident days
- Symptoms [ Time Frame: 17 weeks ]The number of symptoms observed in each arm
- Observations [ Time Frame: 17 weeks ]The number of observations observed in each arm
- Contact to doctor [ Time Frame: 17 weeks ]Number of times the doctor was contacted pr resident
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715062
|Contact: Sif Helene Arnoldfirstname.lastname@example.org|
|Research Unit of General Practice||Recruiting|
|Copenhagen, Denmark, 1014|
|Contact: Sif Helene Arnold|
|Study Chair:||Lars Bjerrum, MD, PHD||Professor|