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Trial record 31 of 3482 for:    Facility

Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03715062
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : June 4, 2019
Ministry of the Interior and Health, Denmark
Velux Fonden
Herlev Hospital
Information provided by (Responsible Party):
Sif Helene Arnold, Research Unit Of General Practice, Copenhagen

Brief Summary:
This cluster randomized controlled study evaluates the effect of a tailored observation, reflection and communication tool on used by long-term care facility staff on antibiotic prescription for urinary tract infection in long-term care facility residents.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Other: Dialogue tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled study, where each Long-term care facility is one cluster.
Masking: None (Open Label)
Masking Description: Statistical analysis is masked.
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
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
No intervention

Primary Outcome Measures :
  1. Prescription of antibiotics for urinary tract infection [ Time Frame: 17 weeks ]
    The number of antibiotic prescriptions for urinary tract infections pr resident days

Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: 17 weeks ]
    The number of hospitalizations caused by urinary tract infections pr resident days

  2. Death [ Time Frame: 17 weeks ]
    The number of deaths caused by urinary tract infections pr resident days

  3. 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

Other Outcome Measures:
  1. Symptoms [ Time Frame: 17 weeks ]
    The number of symptoms observed in each arm

  2. Observations [ Time Frame: 17 weeks ]
    The number of observations observed in each arm

  3. Contact to doctor [ Time Frame: 17 weeks ]
    Number of times the doctor was contacted pr resident

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03715062

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Research Unit of General Practice
Copenhagen, Denmark, 1014
Sponsors and Collaborators
Research Unit Of General Practice, Copenhagen
Ministry of the Interior and Health, Denmark
Velux Fonden
Herlev Hospital
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Study Chair: Lars Bjerrum, MD, PHD Professor

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Responsible Party: Sif Helene Arnold, Medical Doctor, Research Unit Of General Practice, Copenhagen Identifier: NCT03715062     History of Changes
Other Study ID Numbers: 111
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sif Helene Arnold, Research Unit Of General Practice, Copenhagen:
Long-term care facility
Antibiotic stewardship
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents