NCT03700060

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

April 9, 2018

Last Update Submit

October 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    3rd of april - 30th of june

Secondary Outcomes (1)

  • Is mode of communication associated compliance to the guideline?

    3rd of april - 30th of june

Study Arms (1)

General Practice

Volunteering General Practices who registers contacts from nursing homes on residents with suspected UTI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit of General Practice

Copenhagen, 1014, Denmark

Location

MeSH Terms

Conditions

Urinary Tract InfectionsCommunicationMedication Adherence

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2018

First Posted

October 9, 2018

Study Start

April 3, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

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.

Locations