Urinary Tract InfectionsImpresU-WP2NCT03970356
Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly
A study testing antibiotic stewardship intervention in people with Urinary Tract Infections, run by Cees Hertogh at 4 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- antibiotic stewardship intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,146 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Sep 2019to 21 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Sweden1 site
Research and Development Primary Health Care, Region Västra Götaland
Borås, SE-503 38
About this study
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
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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- antibiotic stewardship intervention
- Keywords
- cluster randomized trial, antibiotic stewardship, frail elderly
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic stewardship interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 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. Receives: Other: antibiotic stewardship intervention |
| control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
UTI prescriptions
Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year
Measured: Assessed during the 7-month follow-up period
Secondary outcomes (8)
Incorrect UTI prescriptions
Number of incorrect prescriptions of antibiotics for suspected UTI expressed per patient-year
Measured: Assessed during the 7-month follow-up period
UTI suspicions
Incidence of suspected UTI expressed per patient-year
Measured: 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
Measured: Assessed during the 7-month follow-up period
Hospital referral
Incidence of referral to a hospital within 21 days after each UTI suspicion
Measured: Assessed during the 7-month follow-up period
Hospital admission
Incidence of hospital admission within 21 days after each UTI suspicion
Measured: Assessed during the 7-month follow-up period
Mortality
Mortality
Measured: Assessed during the 7-month follow-up period
Mortality after UTI suspicion
Mortality within 21 days after each UTI suspicion
Measured: 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
Measured: Assessed during the 7-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 Sep 2019
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cees Hertogh
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Medical University of Lodz, University of Oslo, Vastra Gotaland Region, Göteborg University
- Responsible party
- Sponsor-investigator, Cees Hertogh, Amsterdam UMC, location VUmc
- Investigators
- Cees MP Hertogh, prof. dr., Principal investigator, Amsterdam UMC, location VUmcTheo JM Verheij, prof. dr., Principal investigator, UMC UtrechtMaciek Godycki-Cwirko, prof.dr., Principal investigator, Medical University of LodzMorten Lindbæk, prof. dr., Principal investigator, University of OsloPär-Daniel Sundvall, MD PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970356
- Sponsor's protocol ID
- 2005035
- Other IDs
- 25 (2017), 549003002, 2017/25/Z/NZ7/03024, 2017-05975, 284253, 2017
- Acronym
- ImpresU-WP2
- Status last verified
- May 2022
- First submitted
- 26 May 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartman EAR, Groen WG, Heltveit-Olsen SR, Lindbaek M, Hoye S, Lithen SS, Sundvall PD, Sundvall S, Snaebjornsson Arnljots E, Gunnarsson R, Kowalczyk A, Godycki-Cwirko M, van de Pol AC, Platteel TN, Monnier AA, Verheij TJM, Hertogh CMPM. Implementation of a tailored multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for urinary tract infections in frail older adults (ImpresU) in four European countries: a process evaluation alongside a pragmatic cluster randomized controlled trial. Trials. 2024 Oct 18;25(1):691. doi: 10.1186/s13063-024-08545-4.
PubMed 39425170Hartman EAR, van de Pol AC, Heltveit-Olsen SR, Lindbaek M, Hoye S, Lithen SS, Sundvall PD, Sundvall S, Arnljots ES, Gunnarsson R, Kowalczyk A, Godycki-Cwirko M, Platteel TN, Groen WG, Monnier AA, Zuithoff NP, Verheij TJM, Hertogh CMPM. Effect of a multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for suspected urinary tract infections in frail older adults (ImpresU): pragmatic cluster randomised controlled trial in four European countries. BMJ. 2023 Feb 22;380:e072319. doi: 10.1136/bmj-2022-072319.
PubMed 36813284Hartman 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.
PubMed 34620666
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03970356
- Acronym / sponsor ID
- ImpresU-WP2 / 2005035
- Conditions
- Urinary Tract Infections
- Keywords
- cluster randomized trial, antibiotic stewardship, frail elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,146 participants (actual)
- Lead sponsor
- Cees HertoghUniversity, hospital or other
- Collaborators
- UMC Utrecht, Medical University of Lodz, University of Oslo, Vastra Gotaland Region, Göteborg University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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].
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: antibiotic stewardship interventionThe 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. |
| control | No intervention | –Usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic stewardship interventionThe 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. | Other | intervention |
Primary outcome
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
8 secondary outcomes
Incorrect UTI prescriptions
Time frame: Assessed during the 7-month follow-up period
UTI suspicions
Time frame: Assessed during the 7-month follow-up period
Complications
Time frame: Assessed during the 7-month follow-up period
Hospital referral
Time frame: Assessed during the 7-month follow-up period
Hospital admission
Time frame: Assessed during the 7-month follow-up period
Mortality
Time frame: Assessed during the 7-month follow-up period
Mortality after UTI suspicion
Time frame: Assessed during the 7-month follow-up period
UTI prescriptions in office hours
Time frame: Assessed during the 7-month follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 39425170Hartman EAR, Groen WG, Heltveit-Olsen SR, Lindbaek M, Hoye S, Lithen SS, Sundvall PD, Sundvall S, Snaebjornsson Arnljots E, Gunnarsson R, Kowalczyk A, Godycki-Cwirko M, van de Pol AC, Platteel TN, Monnier AA, Verheij TJM, Hertogh CMPM. Implementation of a tailored multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for urinary tract infections in frail older adults (ImpresU) in four European countries: a process evaluation alongside a pragmatic cluster randomized controlled trial. Trials. 2024 Oct 18;25(1):691. doi: 10.1186/s13063-024-08545-4.
- Derived from this study: PubMed 36813284Hartman EAR, van de Pol AC, Heltveit-Olsen SR, Lindbaek M, Hoye S, Lithen SS, Sundvall PD, Sundvall S, Arnljots ES, Gunnarsson R, Kowalczyk A, Godycki-Cwirko M, Platteel TN, Groen WG, Monnier AA, Zuithoff NP, Verheij TJM, Hertogh CMPM. Effect of a multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for suspected urinary tract infections in frail older adults (ImpresU): pragmatic cluster randomised controlled trial in four European countries. BMJ. 2023 Feb 22;380:e072319. doi: 10.1136/bmj-2022-072319.
- Derived from this study: PubMed 34620666Hartman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cees MP Hertogh, prof. dr. principal investigator
Amsterdam UMC, location VUmc
Theo JM Verheij, prof. dr. principal investigator
UMC Utrecht
Maciek Godycki-Cwirko, prof.dr. principal investigator
Medical University of Lodz
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiotic stewardship intervention in people with Urinary Tract Infections, run by Cees Hertogh at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Norway, Poland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UTI prescriptions (time frame: Assessed during the 7-month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03970356, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.