Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03184818
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2017-06-07
Brief Title:
Outcomes of Urinary Tract Infection Management by Pharmacists
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Outcomes of Urinary Tract Infection Management by Pharmacists
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RxOUTMAP
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 physicians 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 patients confidentiality outside of the pharmacy ie 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
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 physicians 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 patients confidentiality outside of the pharmacy ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None