Outcomes of Urinary Tract Infection Management by Pharmacists

NCT03184818 | Completed

• 1 other identifier: Pro00072493
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (8)

• Antibacterials used

  2 weeks

• Pharmacist interventions

  2 weeks

• Adherence

  2 weeks

• Number of treatment failures

  2 weeks

• Reasons for treatment failures

  2 weeks

Study Arms (2)

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.

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.

Other: Advanced care

Interventions

Advanced care OTHER

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).

Antibacterial from other provider (Arm 2); No antibacterial from other provider (Arm 1)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to community pharmacies in New Brunswick, Canada with uncomplicated urinary tract infections.

You may qualify if:

• 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.

You may not qualify if:

• Patients with complicated urinary tract infections or symptoms suggestive of pyelonephritis or systemic illness.

Sponsors & Collaborators

• University of Alberta: lead
• Horizon Health Network: collaborator
• New Brunswick Pharmacists' Association: collaborator
• Loblaw Companies Ltd.: collaborator
• Pharmasave Drugs (Atlantic) Ltd.: collaborator
• Alberta Pharmacists Association: collaborator
• The Jean Coutu Group (PJC) Inc.: collaborator

Study Sites (1)

EPICORE Centre, University of Alberta

Edmonton, Alberta, T6G 2S2, Canada

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ross T Tsuyuki, BSc(Pharm), PharmD, MSc

  Department of Medicine, University of Alberta

  PRINCIPAL INVESTIGATOR

• Daniel J Smyth, MD

  Division of Infectious Diseases, Horizon Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Cardiology) and Director, EPICORE Centre, University of Alberta

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: June 16, 2017
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-05

Locations

CA (1)