Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly (ImpresU-WP2)
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|ClinicalTrials.gov Identifier: NCT03970356|
Recruitment Status : Suspended (Study paused due to Covid-19 outbreak)
First Posted : May 31, 2019
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Other: antibiotic stewardship intervention||Not Applicable|
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.
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.
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||680 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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] (4 months).
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||January 22, 2021|
|Estimated Study Completion Date :||January 22, 2021|
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
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.
No Intervention: control
- UTI prescriptions [ Time Frame: Assessed during the 7-month follow-up period ]Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year
- Incorrect UTI prescriptions [ Time Frame: Assessed during the 7-month follow-up period ]Number of incorrect prescriptions of antibiotics for suspected UTI expressed per patient-year
- UTI suspicions [ Time Frame: Assessed during the 7-month follow-up period ]Incidence of suspected UTI expressed per patient-year
- Complications [ Time Frame: Assessed during the 7-month follow-up period ]Incidence of complications: delirium, pyelonephritis, sepsis and renal failure within 21 days after each UTI suspicion
- Hospital referral [ Time Frame: Assessed during the 7-month follow-up period ]Incidence of referral to a hospital within 21 days after each UTI suspicion
- Hospital admission [ Time Frame: Assessed during the 7-month follow-up period ]Incidence of hospital admission within 21 days after each UTI suspicion
- Mortality [ Time Frame: Assessed during the 7-month follow-up period ]Mortality
- Mortality after UTI suspicion [ Time Frame: Assessed during the 7-month follow-up period ]Mortality within 21 days after each UTI suspicion
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): NCT03970356
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CG|
|University of Oslo|
|Oslo, Norway, 1130|
|Medical University of Lodz|
|Łódź, Poland, 90-153|
|Research and Development Primary Health Care, Region Västra Götaland|
|Borås, Sweden, SE-503 38|
|Principal Investigator:||Cees MP Hertogh, prof. dr.||VU University Medical Center|
|Principal Investigator:||Theo JM Verheij, prof. dr.||UMC Utrecht|
|Principal Investigator:||Maciek Godycki-Cwirko, prof.dr.||Medical University of Lodz|
|Principal Investigator:||Morten Lindbæk, prof. dr.||University of Oslo|
|Principal Investigator:||Pär-Daniel Sundvall, MD PhD||Göteborg University|