Community Pharmacist Intervention to Address Lower Urinary Tract Symptoms in Older Adults: Progress of A Randomized Controlled Trial

Sadowski C1, Al Hamarneh Y1, So R1, Wagg A1, Hunter K1, Tsuyuki R1, Schulz J1

Research Type

Clinical

Abstract Category

Research Methods / Techniques

Abstract 464
Open Discussion ePosters
Scientific Open Discussion Session 15
Thursday 28th September 2023
10:25 - 10:30 (ePoster Station 5)
Exhibit Hall
Clinical Trial Gerontology Incontinence Outcomes Research Methods Questionnaire
1. University of Alberta
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
Lower urinary tract symptoms (LUTS), including urinary incontinence, are common in older adults, yet often unrecognized. Although pharmacists have knowledge regarding the therapeutics of LUTS, there are no randomized controlled trials demonstrating impact of their interventions on LUTS.  In the province of Alberta, Canada, pharmacists have one of the broadest scopes of practice, supporting assessment and prescribing activities.  A number of community-based pharmacist intervention studies have been conducted in Alberta, focuses on disease states or particular medications, but no studies have been conducted with geriatric syndromes.  The purpose of this project was to determine the impact of pharmacist case finding and intervention on LUTS in older adults.
Study design, materials and methods
The community pharmacies were identified through a pharmacy practice research network with EPICORE Centre, University of Alberta, and through email/social media invitations through the provincial pharmacy advocacy body.  Pharmacists received a review of therapeutics regarding LUTS and were oriented to the study procedures and data entry.  Patients were included if they were 60y and older, able to speak English, have an email address, and screen positive for LUTS symptoms.  Once enrolled the patients were randomly assigned to a control arm where they completed a baseline questionnaire, and another a follow-up questionnaire at 8 weeks or   an intervention arm where they completed a longer baseline questionnaire, met with the pharmacist for assessment and development of a care plan, and then completed another follow-up questionnaire at 8 weeks.  
For the patient bladder symptoms 3 validated tools are used, the Patient Perception of bladder Condition (PPBC), the Bladder Self-Assessment Questionnaire (B-SAQ), and the International Continence Questionnaire – Short Form (ICI-Q-SF), were measured at baseline and again at follow-up. The primary outcome was the PPBC.  Secondary outcomes include pharmacist feasibility through time spent.  Actions taken through the care plans are being captured.  
For pharmacist activity the payment is equivalent to a care plan and follow-up billing codes if the patients complete the study.
Results
The study was delayed due to COVID but launched in spring 2022.  To address concerns from the Research Ethics Board the study was adapted to allow for online delivery in order to protect participants from COVID exposure.  A total of 27 pharmacists were enrolled and 25 participated in the training.  Fifteen pharmacy students associated with the pharmacist sites were also trained.  A pharmacy student was involved in on-site patient recruitment.  In fall 2022 the recruitment was over 60 participants, but about 1/3 of patients had not completed their surveys.  After 10 months, in winter 2023, the recruitment was expanded to pharmacists working in primary care networks in Alberta.  Recruitment is ongoing and patient results expected in 2024.
Interpretation of results
There is interest in a LUTS intervention from a few selected pharmacists in the community setting.  In the midst of and following the acute phase of the COVID pandemic, there are challenges in community pharmacist engagement for assessment and management of LUTS.  Ongoing patient engagement is necessary to successfully complete this clinical trial.
Concluding message
Pharmacists are able to recruit older adults into a community-based LUTS intervention study but retention and ongoing recruitment are challenges.
Disclosures
Funding Pfizer Canada, ULC Clinical Trial Yes Registration Number ClinicalTrials.gov Record Pro00097144 RCT Yes Subjects Human Ethics Committee University of Alberta Health Research Ethics Board (Panel 3) Helsinki Yes Informed Consent Yes
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