Urinary Tract InfectionsRxOUTMAPNCT03184818
Outcomes of Urinary Tract Infection Management by Pharmacists
An observational study of Urinary Tract Infections, run by University of Alberta at 1 site in Canada.
Trial summary
Pharmacists in some Canadian jurisdictions have recently been granted the ability to prescribe for uncomplicated urinary tract infections (UTIs). Therefore, the purpose of this study is to assess the impact that community pharmacists can have on the management of UTIs. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Advanced care
- How many people
- 750 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2017to 27 Apr 2018
- How long will I take part?
- 2 Weeks
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to community pharmacies in New Brunswick, Canada with uncomplicated urinary tract infections.
Who may be able to join
- Patients presenting without a prescription for antibacterials from another health care practitioner with symptoms of urinary tract infection that is found to be uncomplicated. Or patients presenting with a prescription for an antibacterial from another health care practitioner that is found to either have uncomplicated urinary tract infection or asymptomatic bacteriuria.
Who cannot join
- Patients with complicated urinary tract infections or symptoms suggestive of pyelonephritis or systemic illness.
Trial locations and contacts
1 site in 1 country.
About this study
Pharmacists in some Canadian jurisdictions have recently been granted the ability to prescribe for uncomplicated urinary tract infections (UTIs). Therefore, the purpose of this study is to assess the impact that community pharmacists can have on the management of UTIs.
Pharmacists will identify potential study participants (patients) when they either present with symptoms of a UTI (such as difficulty or painful urination, increased frequency or urgency of urination) without a prescription for an antibiotic from another health care provider, or when they present with a prescription for an antibiotic from another health care provider to treat a UTI. For patients who consent to participate in the study, the pharmacist will screen for eligibility and assess for appropriateness of treatment.
If the patient does not already have a prescription for an antibiotic from another health care provider, the pharmacist will prescribe this for them if they meet certain criteria. If they do already have a prescription from another health care provider, the pharmacist will assess the appropriateness of the prescription and work with the patient to potentially change it to make it more appropriate, if necessary. If the pharmacist identifies any complicating factors that require a physician's assessment, the patient will be referred to their physician. The enrolled patients will also have a 2-week follow-up to assess for resolution of symptoms, unintended effects, and adherence to the treatment regimen. All data will be collected in a web-based registry that will maintain the patient's confidentiality outside of the pharmacy (i.e. patient initials, date of birth, and study identification (ID) number will be the only patient identifiers collected by the researchers). A patient satisfaction survey will also be administered via email.
Read the detailed description
UTIs produce symptoms that may be unpleasant and distressing for patients and have the potential to lead to complications. It is also commonly misdiagnosed and treated inappropriately, resulting in unnecessary antimicrobial exposure and increased potential for adverse effects (including secondary infections, such as Clostridium difficile), as well as the selection of resistant pathogens. The incidence of UTI in women is 12% annually, with 50% of women reporting to have had a UTI by 32 years of age. Recurrence of infection occurs in 25% of women within 6 months of the first UTI, and this rate increases when more than one prior UTI has been experienced. In the elderly, the prevalence of asymptomatic bacteriuria (ASB) increases, with up to 20% of women at the age of 75 or older affected and up to 50% of institutionalized, non-catheterized elderly women affected, a finding that often results in the overuse of antibiotics. With bacterial resistance on the rise and a limited pipeline of antibacterials with novel mechanisms of action, antimicrobial stewardship has become imperative to maintain the effectiveness of available antimicrobials. Pharmacists are accessible primary care professionals that are well-positioned to take on a larger role in the management of medical conditions, including UTIs, and have an important role to play in antimicrobial stewardship. Therefore, it would be of great value to quantify the real-world impact of pharmacists providing care to patients with UTI, and then disseminate this information to inform best practice and policy change.
Design: prospective web-based registry Setting: ~40 community pharmacies in New Brunswick, Canada Patients: Any adult patient presenting to a pharmacy with symptoms suggestive of urinary tract infection (UTI) and assessed to be uncomplicated; or those presenting with a prescription for antibiotics from another healthcare provider for a UTI that are assessed to be uncomplicated or asymptomatic bacteriuria.
Intervention: Pharmacists will assess symptoms and prescribe antibiotics or perform prescription adaptation or therapeutic substitution, as necessary. They will also discontinue antibiotics for asymptomatic bacteriuria in cases where treatment is unnecessary. Follow-up will occur at 2 weeks to assess for clinical cure, as well as adverse reactions, adherence to the treatment regimen, early recurrence of infection, and other outcomes. Additional follow-up will occur as needed, and will also be captured in the registry.
Outcomes: The primary outcome will be clinical cure at 2 weeks. Secondary outcomes will include medications used, number and nature of pharmacist interventions, follow-ups conducted, patient adherence to initial recommendations and follow up, adverse events, treatment failures (including reasons for; such as adherence, delay in accessing care, missed baseline complicating factors, presence of a resistant organism, and complications such as pyelonephritis), and patient satisfaction.
Quality assurance: Data will be collected via a secure web-based portal. Data quality will be monitored by EPICORE Centre, University of Alberta, and site audits will be performed periodically.
Analytical plan: Most outcomes will be descriptive in nature. Target sample size of 750 patients over 8 months; this is a bit more than necessary for the primary outcome, but the intention is to also have enough power for analyses of some of the secondary outcomes.
- Conditions
- Urinary Tract Infections
- Being tested
- Advanced care
- 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.
Advanced careOther
The pharmacist will assess for symptoms of urinary tract infection and, for patients in Arm 1, prescribe antibacterials when appropriate. For patients in Arm 2, pharmacists will ensure optimal therapy and adapt or perform therapeutic substitution when appropriate (or work with the patient to discontinue therapy or just put the prescription on file in instances where the patient is assessed to have asymptomatic bacteriuria for which treatment is inappropriate).
| Study group | Role | What they receive |
|---|---|---|
| No antibacterial from other provider (Arm 1) | Patients with symptomatic, uncomplicated urinary tract infection presenting without a prescription for an antibacterial from another health care practitioner. Receives: Other: Advanced care | |
| Antibacterial from other provider (Arm 2) | Patients with symptomatic, uncomplicated urinary tract infection or asymptomatic bacteriuria presenting with a prescription for an antibacterial from another health care practitioner. Receives: Other: Advanced care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients achieving clinical cure
Number of patients achieving sustained, full resolution of UTI symptoms, as described by the patient. This will be extracted from the registry database.
Measured: 2 weeks
Secondary outcomes (8)
Antibacterials used
The name of antibacterials used to treat infection and the number of instances that each antibacterial was used. This will be extracted from the registry database.
Measured: 2 weeks
Pharmacist interventions
Number of pharmacist interventions collectively and individually by the following types: antibacterial initiation, modification of antibacterial regimen, discontinuation of antibacterial regimen, and referral to physician. These will be extracted from the registry database.
Measured: 2 weeks
Adherence
Patient adherence to initial recommendations and follow up. Pharmacists will ask and document if the patient took the antibacterial as prescribed, if they missed one or two doses, if they missed 50% or more doses, or if they didn't take at all. The number of patients reporting each of these will be extracted from the registry database.
Measured: 2 weeks
Number of treatment failures
Number of patients experiencing either treatment failure or recurrence of symptoms
Measured: 2 weeks
Reasons for treatment failures
The likely contributory factors of the patients experiencing treatment failures, such as less than ideal adherence, missed baseline complicating factor, resistant pathogen, complication (such as pyelonephritis), delay in accessing care, other, or no identifiable reason. The number of times that each of these were considered potentially contributory to treatment failure will be extracted from the registry database.
Measured: 2 weeks
Patient satisfaction as determined by the modified consultation satisfaction questionnaire
Satisfaction of patients with the service provided by the pharmacists as determined by patients' responses to survey questions on a likert scale.
Measured: 2 weeks
Access to care
Time to seen by a pharmacist (Arm 1) or physician (Arm 2)
Measured: 2 weeks
Adverse events
Adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start16 Jun 2017
- Primary completion27 Apr 2018
- Study completion27 Apr 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.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- 750 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon Health Network, New Brunswick Pharmacists' Association, Loblaw Companies Ltd., Pharmasave Drugs (Atlantic) Ltd., Alberta Pharmacists Association, The Jean Coutu Group (PJC) Inc.
- Responsible party
- Principal investigator, Ross T. Tsuyuki, University of Alberta
- Investigators
- Ross T Tsuyuki, BSc(Pharm), PharmD, MSc, Principal investigator, Department of Medicine, University of AlbertaDaniel J Smyth, MD, Principal investigator, Division of Infectious Diseases, Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184818
- Sponsor's protocol ID
- Pro00072493
- Acronym
- RxOUTMAP
- Status last verified
- May 2018
- First submitted
- 7 Jun 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Urinary Tract Infection Management by Pharmacists
- ClinicalTrials.gov ID
- NCT03184818
- Acronym / sponsor ID
- RxOUTMAP / Pro00072493
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Horizon Health Network, New Brunswick Pharmacists' Association, Loblaw Companies Ltd., Pharmasave Drugs (Atlantic) Ltd., Alberta Pharmacists Association, The Jean Coutu Group (PJC) Inc.
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 14 Jun 2017 (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.
Pharmacists in some Canadian jurisdictions have recently been granted the ability to prescribe for uncomplicated urinary tract infections (UTIs). Therefore, the purpose of this study is to assess the impact that community pharmacists can have on the management of UTIs.
Pharmacists will identify potential study participants (patients) when they either present with symptoms of a UTI (such as difficulty or painful urination, increased frequency or urgency of urination) without a prescription for an antibiotic from another health care provider, or when they present with a prescription for an antibiotic from another health care provider to treat a UTI. For patients who consent to participate in the study, the pharmacist will screen for eligibility and assess for appropriateness of treatment.
If the patient does not already have a prescription for an antibiotic from another health care provider, the pharmacist will prescribe this for them if they meet certain criteria. If they do already have a prescription from another health care provider, the pharmacist will assess the appropriateness of the prescription and work with the patient to potentially change it to make it more appropriate, if necessary. If the pharmacist identifies any complicating factors that require a physician's assessment, the patient will be referred to their physician. The enrolled patients will also have a 2-week follow-up to assess for resolution of symptoms, unintended effects, and adherence to the treatment regimen. All data will be collected in a web-based registry that will maintain the patient's confidentiality outside of the pharmacy (i.e. patient initials, date of birth, and study identification (ID) number will be the only patient identifiers collected by the researchers). A patient satisfaction survey will also be administered via email.
Detailed description
UTIs produce symptoms that may be unpleasant and distressing for patients and have the potential to lead to complications. It is also commonly misdiagnosed and treated inappropriately, resulting in unnecessary antimicrobial exposure and increased potential for adverse effects (including secondary infections, such as Clostridium difficile), as well as the selection of resistant pathogens. The incidence of UTI in women is 12% annually, with 50% of women reporting to have had a UTI by 32 years of age. Recurrence of infection occurs in 25% of women within 6 months of the first UTI, and this rate increases when more than one prior UTI has been experienced. In the elderly, the prevalence of asymptomatic bacteriuria (ASB) increases, with up to 20% of women at the age of 75 or older affected and up to 50% of institutionalized, non-catheterized elderly women affected, a finding that often results in the overuse of antibiotics. With bacterial resistance on the rise and a limited pipeline of antibacterials with novel mechanisms of action, antimicrobial stewardship has become imperative to maintain the effectiveness of available antimicrobials. Pharmacists are accessible primary care professionals that are well-positioned to take on a larger role in the management of medical conditions, including UTIs, and have an important role to play in antimicrobial stewardship. Therefore, it would be of great value to quantify the real-world impact of pharmacists providing care to patients with UTI, and then disseminate this information to inform best practice and policy change.
Design: prospective web-based registry Setting: ~40 community pharmacies in New Brunswick, Canada Patients: Any adult patient presenting to a pharmacy with symptoms suggestive of urinary tract infection (UTI) and assessed to be uncomplicated; or those presenting with a prescription for antibiotics from another healthcare provider for a UTI that are assessed to be uncomplicated or asymptomatic bacteriuria.
Intervention: Pharmacists will assess symptoms and prescribe antibiotics or perform prescription adaptation or therapeutic substitution, as necessary. They will also discontinue antibiotics for asymptomatic bacteriuria in cases where treatment is unnecessary. Follow-up will occur at 2 weeks to assess for clinical cure, as well as adverse reactions, adherence to the treatment regimen, early recurrence of infection, and other outcomes. Additional follow-up will occur as needed, and will also be captured in the registry.
Outcomes: The primary outcome will be clinical cure at 2 weeks. Secondary outcomes will include medications used, number and nature of pharmacist interventions, follow-ups conducted, patient adherence to initial recommendations and follow up, adverse events, treatment failures (including reasons for; such as adherence, delay in accessing care, missed baseline complicating factors, presence of a resistant organism, and complications such as pyelonephritis), and patient satisfaction.
Quality assurance: Data will be collected via a secure web-based portal. Data quality will be monitored by EPICORE Centre, University of Alberta, and site audits will be performed periodically.
Analytical plan: Most outcomes will be descriptive in nature. Target sample size of 750 patients over 8 months; this is a bit more than necessary for the primary outcome, but the intention is to also have enough power for analyses of some of the secondary outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No antibacterial from other provider (Arm 1) | – | Other: Advanced carePatients with symptomatic, uncomplicated urinary tract infection presenting without a prescription for an antibacterial from another health care practitioner. |
| Antibacterial from other provider (Arm 2) | – | Other: Advanced carePatients with symptomatic, uncomplicated urinary tract infection or asymptomatic bacteriuria presenting with a prescription for an antibacterial from another health care practitioner. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to community pharmacies in New Brunswick, Canada with uncomplicated urinary tract infections.
Key inclusion criteria (1 listed)
- Patients presenting without a prescription for antibacterials from another health care practitioner with symptoms of urinary tract infection that is found to be uncomplicated. Or patients presenting with a prescription for an antibacterial from another health care practitioner that is found to either have uncomplicated urinary tract infection or asymptomatic bacteriuria.
Key exclusion criteria (1 listed)
- Patients with complicated urinary tract infections or symptoms suggestive of pyelonephritis or systemic illness.
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 |
|---|---|---|
| Advanced careThe pharmacist will assess for symptoms of urinary tract infection and, for patients in Arm 1, prescribe antibacterials when appropriate. For patients in Arm 2, pharmacists will ensure optimal therapy and adapt or perform therapeutic substitution when appropriate (or work with the patient to discontinue therapy or just put the prescription on file in instances where the patient is assessed to have asymptomatic bacteriuria for which treatment is inappropriate). | Other | Antibacterial from other provider (Arm 2), No antibacterial from other provider (Arm 1) |
Primary outcome
Number of patients achieving clinical cure
Time frame: 2 weeks
Number of patients achieving sustained, full resolution of UTI symptoms, as described by the patient. This will be extracted from the registry database.
8 secondary outcomes
Antibacterials used
Time frame: 2 weeks
Pharmacist interventions
Time frame: 2 weeks
Adherence
Time frame: 2 weeks
Number of treatment failures
Time frame: 2 weeks
Reasons for treatment failures
Time frame: 2 weeks
Patient satisfaction as determined by the modified consultation satisfaction questionnaire
Time frame: 2 weeks
Access to care
Time frame: 2 weeks
Adverse events
Time frame: 2 weeks
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 2 May 2018.
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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.
Ross T Tsuyuki, BSc(Pharm), PharmD, MSc principal investigator
Department of Medicine, University of Alberta
Daniel J Smyth, MD principal investigator
Division of Infectious Diseases, Horizon Health Network
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, run by University of Alberta at 1 site in Canada.
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 1 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 2 May 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 Canada. 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?
Number of patients achieving clinical cure (time frame: 2 weeks). 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 2 May 2018.