Management of LUTS by Community Pharmacists

Study Overview
=================
Brief Summary
-----------------
Many older adults have urinary incontinence. They often seek treatments, such as diapers, pads, or medications, from the community pharmacy. Pharmacists are trained to assist seniors with therapies that treat urinary incontinence. Our study will determine how much benefit there is if pharmacists try to provide more assistance for seniors with incontinence. Over a period of months, half of the people who talk to the pharmacist about their incontinence will be given general information about health and aging. The other half of the people will have a longer assessment and complete a questionnaire with the pharmacist. Then the pharmacist will call and have a follow-up visit to see how the incontinence symptoms have improved. We will compare both groups to see whose symptoms were improved.

Detailed Description
-----------------
This randomized controlled trial is designed to determine the effect of a pharmacist intervention to manage lower urinary tract symptoms (LUTS) in the community. The objectives of the study are to determine the effect of the pharmacist as measured by the Patient Perception of Bladder Condition (PPBC) (primary objective), the Bladder Self-Assessment Questionnaire (B-SAQ), and the International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF) (as secondary objectives). The pharmacists at community pharmacies will be recruited through the networks already established within Alberta for pharmacy practice research, and the Pharmacists Association of Alberta. The pharmacists must have advanced prescribing authorization with their professional license. The patients will be recruited with the posting of shelf-talkers by the incontinence and menstrual products section of the pharmacy and with leaflets in prescription bags. If a patient obtains a LUTS product or if the patient presents him/herself in response to the shelf-talker, the pharmacist will screen the patient to determine if LUTS are present.The patients will be eligible to participate if they are at least 60 years of age, report LUTS, can communicate in English, and provide consent. The patient will be randomized to either a control or intervention. Those assigned to the control group will be eligible to receive the intervention following the follow-up period. Both the control and intervention group will have a baseline PPBC, B-SAQ, and ICI-Q-SF questionnaires, in addition to demographics and a medical history. The control group will receive a healthy aging pamphlet and will be called back at 8 weeks to have the questionnaires repeated. The intervention is based on the published guide for LUTS for pharmacists (Gabriel, et al. 2015). The pharmacist will assess the patient's LUTS and determine an appropriate intervention plan, which may include education, lifestyle, behavioural, or medication modification. The patient will be given a summary of the plan and the primary care provider will also receive a summary. At 4 weeks the patient will be contacted by phone or in person (per patient preference), with a review of the plan and repeated bladder questionnaires. At 8 weeks the patient will complete the final interaction with the pharmacist and will complete the bladder questionnaires for the final time. The primary outcome is the change in PPBC from baseline to 8 weeks, and secondary outcomes include the change from baseline until 8 weeks in the B-SAQ, ICI-Q, and health system use (including referrals to physicians, specialists, and pharmacist billing). We plan to enroll 100 patients (50 in each group). All analyses will be by intention to treat.

Official Title
-----------------
A Project to Address Lower Urinary Tract Symptoms (LUTS) by Pharmacists in the Community

Conditions
-----------------
Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Other: Pharmacist review of LUTS
* Other: Pharmacist Provision of healthy aging leaflets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥60 years Report lower urinary tract symptoms (LUTS) Read and communicate in English Exclusion Criteria: Age ≤ 59 years Deny LUTS Refuse to consent Unavailable or unable to participate in follow-up visits

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Intervention<br>Pharmacist assessment of LUTS, with recommendations and education regarding lifestyle, behaviour, and/or medications related to bladder health. Follow-up at 3 and 6 weeks. | Other: Pharmacist review of LUTS<br>* Pharmacist review and recommendations, including education, behaviour, lifestyle, or medications<br>|
| Active Comparator: Control<br>Pharmacist questions regarding presence of LUTS, with provision of healthy aging literature. Follow-up at 6 weeks. | Other: Pharmacist Provision of healthy aging leaflets<br>* Pharmacist will inquire about presence of LUTS and provide patient with healthy aging leaflets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Perception of Bladder Condition (PPBC) | Questionnaire to assess patient perception of LUTS severity Scored from 1-6; 1 = problems, 6=severe problems | Change from baseline to 8 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bladder Self-Assessment Questionnaire (B-SAQ) | Self-administered questionnaire to assess types of symptoms and extent of bother Scored for Bother 0-12; 0=no bother, 12 = bothers a great deal Scored for Symptoms 0-12; 0=no symptoms, 3=severe symptoms | Change from baseline to 8 weeks post-intervention | 
| Change in International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF) | Self- administered questionnaire to describe extent and severity of LUTS Scored from 0-21; 0= no impact or leakage; 21 = severe leakage and interference | Change from baseline to 8 weeks post-intervention |