Urinary Tract InfectionsNCT03700060
Communication and Compliance for Antibiotic Prescribing by General Practice to Nursing Home Residents With Suspected UTI
An observational study of Urinary Tract Infections and Communication, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
Trial summary
Antibiotic resistance is becoming a bigger problem. If the problem remains unsolved, the WHO predicts a return to the pre-antibiotic era. Overtreatment with antibiotics drives development of resistant bacteria and adverse events in patients, thus identification and rectifying factors leading to unnecessary antibiotic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections, Communication, Compliance, Medication
- How many people
- 459 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Apr 2018to 30 Jun 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nursing Home residents, who are living permanently in a nursing home and exhibits signs or symptoms of acute UTI according to themselves, nursing home staff or the GP
Who may be able to join
- The general practices included in this study must all be from the Capital Region of Denmark.
- Each practice must have as many patients in the target population that an estimated five registered contacts during the registration period is feasible.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Communication and Compliance With Guidelines for Antibiotic Prescribing by General Practice to Nursing Home Residents With Suspected Urinary Tract Infections -A Research Protocol for a Cross-Sectional Study in the Primary Care Sector
Antibiotic resistance is becoming a bigger problem. If the problem remains unsolved, the WHO predicts a return to the pre-antibiotic era. Overtreatment with antibiotics drives development of resistant bacteria and adverse events in patients, thus identification and rectifying factors leading to unnecessary antibiotic prescriptions are a public health problem.
Urinary Tract Infections (UTIs) are the most commonly diagnosed infection in nursing homes (NH). A prevalence study showed that in up to 76% of all antibiotic prescriptions in Danish NHs the indication was UTI. In this particular group of patients with suspected UTI, the literature has repeatedly shown that a vast amount of these antibiotic courses are inappropriate.
Read more
As people age, the prevalence of asymptomatic bacteriuria increases significantly. Asymptomatic bacteriuria is a condition that should not be treated with antibiotics. Thus, the treatment decision in this group should not rely on the result of urinary testing and should only commence, when classical urinary symptoms are present. Urinary testing of NH residents is one of the drivers of overtreatment. Therefore, a recent Danish guideline from Institute of Rational Pharmacology (IRF) on elderly with suspected UTI suggest that urine culture should only be performed when typical urinary symptoms are present and that antibiotic prescribing should be delayed until the result of the culture is available whenever possible. It is unknown to what extent Danish GPs follows these guidelines.
NH residents are often immobile, therefore; the diagnostic process of UTI in NH residents differs from the norm, which could also explain some part of the inappropriate prescribing. Immobility introduces physical distance between patient and GP because the patient is unable to visit the General Practitioners office. Because home visits are rare, when a UTI is suspected, NH staff usually contacts the GP in writing, over the phone and occasionally in person to relate the patient history and physical findings.
When another link in the communication chain between patient and GP is added, clinical information passes through additional health professionals and the risk of communication error and misunderstanding increases. Some forms of communications may be more suited to fit this setting than others. When communicating in person, it is possible to take non-verbal cues into account and immediately clear up insecurities. Communication by phone eliminates non-verbal cues, but a dialog about unclarified aspects is still attainable. Written communication, however, has none of the clarifying traits of the former, and to elaborate on the content the GP will have to contact the NH, which takes time in an already packed schedule.
The investigators hypothesize that the more direct the contact form, the better the quality of clinical information, which leads to increased compliance with guidelines. Thus by proxy, our hypothesis becomes that compliance to guidelines increases with directness of contact form. The aim of this study is to investigate to which degree the guidelines on antibiotic prescribing for NH residents with suspected UTI are followed and how the communication form affects adherence to guidelines.
- Medical subject headings
- Urinary Tract Infections, Communication, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Practice | Volunteering General Practices who registers contacts from nursing homes on residents with suspected UTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
How many suspected UTIs in nursing home residents are treated in accordance with guidelines?
For each suspected UTI, it must be determined if the GP handles the patient according to guidelines. The answer to this question will be in percent of all suspected UTIs with a subanalysis of why the reason why they are not treated in accordance (e.g. no urinary symptoms)
Measured: 3rd of april - 30th of june
Secondary outcomes (1)
Is mode of communication associated compliance to the guideline?
A logistic regression model will be developed, where the outcome variable states if the suspected UTI is treated according to the guideline or not. The dependent variables are contact form from nursing home to GP and contact form from GP to nursing home.
Measured: 3rd of april - 30th of june
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start3 Apr 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Unit Of General Practice, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sif Helene Arnold, Research Unit Of General Practice, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700060
- Sponsor's protocol ID
- UTI in nursing homes
- Status last verified
- Oct 2018
- First submitted
- 9 Apr 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD is anonomous when it leaves the General Practice and can therefore freely be shared with other researchers. The project group will register the protocol on clinicaltrial.gov and publish research papers on the collected data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication and Compliance With Guidelines for Antibiotic Prescribing by General Practice to Nursing Home Residents With Suspected Urinary Tract Infections -A Research Protocol for a Cross-Sectional Study in the Primary Care Sector
- ClinicalTrials.gov ID
- NCT03700060
- Acronym / sponsor ID
- UTI in nursing homes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Research Unit Of General Practice, CopenhagenUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 9 Oct 2018 (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.
Antibiotic resistance is becoming a bigger problem. If the problem remains unsolved, the WHO predicts a return to the pre-antibiotic era. Overtreatment with antibiotics drives development of resistant bacteria and adverse events in patients, thus identification and rectifying factors leading to unnecessary antibiotic prescriptions are a public health problem.
Urinary Tract Infections (UTIs) are the most commonly diagnosed infection in nursing homes (NH). A prevalence study showed that in up to 76% of all antibiotic prescriptions in Danish NHs the indication was UTI. In this particular group of patients with suspected UTI, the literature has repeatedly shown that a vast amount of these antibiotic courses are inappropriate.
As people age, the prevalence of asymptomatic bacteriuria increases significantly. Asymptomatic bacteriuria is a condition that should not be treated with antibiotics. Thus, the treatment decision in this group should not rely on the result of urinary testing and should only commence, when classical urinary symptoms are present. Urinary testing of NH residents is one of the drivers of overtreatment. Therefore, a recent Danish guideline from Institute of Rational Pharmacology (IRF) on elderly with suspected UTI suggest that urine culture should only be performed when typical urinary symptoms are present and that antibiotic prescribing should be delayed until the result of the culture is available whenever possible. It is unknown to what extent Danish GPs follows these guidelines.
NH residents are often immobile, therefore; the diagnostic process of UTI in NH residents differs from the norm, which could also explain some part of the inappropriate prescribing. Immobility introduces physical distance between patient and GP because the patient is unable to visit the General Practitioners office. Because home visits are rare, when a UTI is suspected, NH staff usually contacts the GP in writing, over the phone and occasionally in person to relate the patient history and physical findings.
When another link in the communication chain between patient and GP is added, clinical information passes through additional health professionals and the risk of communication error and misunderstanding increases. Some forms of communications may be more suited to fit this setting than others. When communicating in person, it is possible to take non-verbal cues into account and immediately clear up insecurities. Communication by phone eliminates non-verbal cues, but a dialog about unclarified aspects is still attainable. Written communication, however, has none of the clarifying traits of the former, and to elaborate on the content the GP will have to contact the NH, which takes time in an already packed schedule.
The investigators hypothesize that the more direct the contact form, the better the quality of clinical information, which leads to increased compliance with guidelines. Thus by proxy, our hypothesis becomes that compliance to guidelines increases with directness of contact form. The aim of this study is to investigate to which degree the guidelines on antibiotic prescribing for NH residents with suspected UTI are followed and how the communication form affects adherence to guidelines.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Practice | – | –Volunteering General Practices who registers contacts from nursing homes on residents with suspected UTI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nursing Home residents, who are living permanently in a nursing home and exhibits signs or symptoms of acute UTI according to themselves, nursing home staff or the GP
Key inclusion criteria (2 listed)
- The general practices included in this study must all be from the Capital Region of Denmark.
- Each practice must have as many patients in the target population that an estimated five registered contacts during the registration period is feasible.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
How many suspected UTIs in nursing home residents are treated in accordance with guidelines?
Time frame: 3rd of april - 30th of june
For each suspected UTI, it must be determined if the GP handles the patient according to guidelines. The answer to this question will be in percent of all suspected UTIs with a subanalysis of why the reason why they are not treated in accordance (e.g. no urinary symptoms)
1 secondary outcome
Is mode of communication associated compliance to the guideline?
Time frame: 3rd of april - 30th of june
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 9 Oct 2018.
- Individual participant dataSharing planned: No. The IPD is anonomous when it leaves the General Practice and can therefore freely be shared with other researchers. The project group will register the protocol on clinicaltrial.gov and publish research papers on the collected data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections and Communication, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
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 2 inclusion and 1 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
How many suspected UTIs in nursing home residents are treated in accordance with guidelines? (time frame: 3rd of april - 30th of june). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2018.