Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly (ImpresU-WP2)

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Other: antibiotic stewardship intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CG
    • University Medical Center Utrecht
• Norway
  • Oslo, Norway, 1130
    • University of Oslo
• Poland
  • Łódź, Poland, 90-153
    • Medical University of Lodz
• Sweden
  • Borås, Sweden, SE-503 38
    • Research and Development Primary Health Care, Region Västra Götaland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervention; 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; Usual care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cees Hertogh
• Collaborators: University of Oslo; Göteborg University; UMC Utrecht; Medical University of Lodz; Vastra Gotaland Region
• Investigators: Principal Investigator: Cees MP Hertogh, prof. dr., Amsterdam UMC, location VUmc; 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

Publications and helpful links

General Publications

• Hartman EAR, Groen WG, Heltveit-Olsen SR, Lindbaek M, Hoye S, Sundvall PD, Gunnarsson R, Skoglund I, Snaebjornsson Arnljots E, Godycki-Cwirko M, Kowalczyk A, Platteel TN, Zuithoff NPA, Monnier AA, Verheij TJM, Hertogh CMPM, van de Pol AC. Multifaceted antibiotic stewardship intervention using a participatory-action-research approach to improve antibiotic prescribing for urinary tract infections in frail elderly (ImpresU): study protocol for a European qualitative study followed by a pragmatic cluster randomised controlled trial. BMJ Open. 2021 Oct 7;11(10):e052552. doi: 10.1136/bmjopen-2021-052552.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): July 21, 2021
• Study Completion (ACTUAL): July 21, 2021

Study Registration Dates

• First Submitted: May 26, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (ACTUAL): May 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: antibiotic stewardship; frail elderly; cluster randomized trial
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2005035; 25 (2017) (OTHER_GRANT: JPIAMR); 549003002 (OTHER_GRANT: ZonMW, Netherlands); 2017/25/Z/NZ7/03024 (OTHER_GRANT: National Science Centre, Poland); 2017-05975 (OTHER_GRANT: The Swedish Research Council); 284253 (OTHER_GRANT: The Research Council of Norway)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No