Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a tailored multifaceted antibiotic stewardship intervention reduces antibiotic use for urinary tract infections in residential care homes and nursing homes attended by general practitioners. This will be evaluated in a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach.

Detailed Description
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Rationale: Almost 60% of antibiotics in frail elderly is prescribed for alleged UTI. About half of the antibiotics for UTI in this population are prescribed for non-specific signs and symptoms; a substantial part of these prescriptions might not be necessary. Research question: Does a tailored multifaceted antibiotic stewardship intervention reduce antibiotic use for UTI in residential care homes and nursing homes attended by general practitioners (GPs)? Study design, setting and population: A pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach. In the intervention group the latest UTI guidelines (which are standard care) are actively implemented at the level of the GP/caregivers. Residents ≥ 70 year with ADL dependency from 34 care homes + attending GP practices will participate in Norway, Sweden, Poland and the Netherlands. Methods: The study has two measurement periods; a baseline period (5 months) and a follow-up period (7 months). In between the antibiotic stewardship intervention will be tailored and implemented in intervention practices. GPs will prospectively register suspected UTIs on standardized registration forms and (study) nurses/assistants will follow-up patients at day 7 and day 21 for each UTI. Patients will be enrolled prior to the start of the study. June-August 2019: patient are recruited, informed consent is obtained, baseline characteristics of patients are recorded Sept 2019: study starts (from this moment onwards, the outcomes are being assessed). Data analysis: The primary analysis will be to assess the number of prescriptions of antibiotics for suspected UTI in the follow-up period, correcting for the baseline period and controlled for pre-specified confounders, using a generalized linear mixed model for Poisson distributions.

Official Title
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The Improving Rational Prescribing for Urinary Tract Infections in Frail Elderly (ImpresU) Project - Work Package 2 (WP2): a Cluster Randomised Multifaceted Antibiotic Stewardship Intervention Study

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Other: antibiotic stewardship intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: physical and/or mental disabilities and ADL dependency requiring residential care or nursing home care attended by general practitioners not on continuous prophylactic antibiotic use Exclusion Criteria: in hospice-care very limited life expectancy (≤1 month) no longer wish to participate start continuous antibiotic (prophylaxis) die or move away from the residential care home / nursing home If patients are excluded within 2 months after inclusion, they will be taken out of the study. In other words: patients need to be included for at least 2 months to contribute data to the study.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will perform a pragmatic cluster randomised controlled trial (cRCT). The targeted population consists of frail elderly residents of residential care homes and nursing homes attended by general practitioners. The clusters (care home + general practitioners) are assigned to intervention- or control group. In the intervention group, an antibiotic stewardship intervention is actively implemented at the level of the general practitioners and caregivers in the homes. The study has two measurement periods; a baseline period (5 months) and a follow-up period (7 months). In between there is an implementation period in which the intervention (i.e. active implementation) is started in the intervention homes [no measurements are taken].
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>The antibiotic stewardship intervention will encourage to prescribe according to the latest relevant UTI guidelines which promote more restrictive use of antibiotics in case of non-specific symptoms. | Other: antibiotic stewardship intervention<br>* The intervention is multifaceted, consisting of the implementation of an algorithm for restrictive use of antibiotics as proposed in recent guidelines (Verenso, Dutch guideline), tailored in close collaboration with local stakeholders to the specific implementation setting, by means of a modified participatory-action research (PAR) approach. To support the process of intervention-tailoring and -implementation, a toolbox comprising of materials, aids and actions is developed to be used at the discretion of the local stakeholders to support implementation of the algorithm.The algorithm is congruent with the Swedish and Norwegian guidelines, which also promote more restrictive use of antibiotics in case of non-specific symptoms, even though the algorithm is more detailed.<br>|
| No Intervention: control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI prescriptions | Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year | Assessed during the 7-month follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incorrect UTI prescriptions | Number of incorrect prescriptions of antibiotics for suspected UTI expressed per patient-year | Assessed during the 7-month follow-up period | 
| UTI suspicions | Incidence of suspected UTI expressed per patient-year | Assessed during the 7-month follow-up period | 
| Complications | Incidence of complications: delirium, pyelonephritis, sepsis and renal failure within 21 days after each UTI suspicion | Assessed during the 7-month follow-up period | 
| Hospital referral | Incidence of referral to a hospital within 21 days after each UTI suspicion | Assessed during the 7-month follow-up period | 
| Hospital admission | Incidence of hospital admission within 21 days after each UTI suspicion | Assessed during the 7-month follow-up period | 
| Mortality | Mortality | Assessed during the 7-month follow-up period | 
| Mortality after UTI suspicion | Mortality within 21 days after each UTI suspicion | Assessed during the 7-month follow-up period | 
| UTI prescriptions in office hours | Number of prescriptions of antibiotics for suspected UTI in office hours expressed per patient-year | Assessed during the 7-month follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cluster randomized trial, antibiotic stewardship, frail elderly