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Management of Acute Uncomplicated UTIs in Adults by Community Pharmacists ([UTI])

Primary Purpose

Urinary Tract Infections, Urinary Tract Infection Lower Acute

Status
Recruiting
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Educational training
Sponsored by
University of Ibadan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Urinary Tract Infections focused on measuring Urinary Tract Infections, Pharmacist, Mystery Patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The superintendent pharmacist, or the pharmacist manager or any other post National Youth Service Corps pharmacist

Exclusion Criteria:

  • Interns, and pharmacists undergoing the mandatory National Youth Service Corps program.

Sites / Locations

  • University of IbadanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharmacists in the intervention group

Pharmacists in the control group

Arm Description

The pharmacist will be given an online educational training on management of acute uncomplicated urinary tract infections

pharmacists in this group will not be trained, until after the completion of the study.

Outcomes

Primary Outcome Measures

Questioning skill score
Expert Panels' Relevant Questions - Through 80% consensus the expert panel picked 50 relevant questions. The minimum score is "0" and the maximum score is "50". The higher the score the better the questioning skill.
Correct diagnosis of Acute Uncomplicated Urinary Tract Infection
using the Infectious Disease Society of America treatment guideline, the pharmacists should be able to reach a diagnosis of Acute Uncomplicated Urinary Tract Infection. Appropriate diagnosis will be classified as "Correct diagnosis" and inappropriate diagnosis will be classified as "Incorrect diagnosis". Proportion will be used to describe the number of community pharmacists who got the diagnosis Correct and Incorrect.
Appropriate management of urinary tract infection
Infectious Disease Society of America treatment guideline

Secondary Outcome Measures

Full Information

First Posted
May 7, 2022
Last Updated
May 26, 2022
Sponsor
University of Ibadan
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1. Study Identification

Unique Protocol Identification Number
NCT05399797
Brief Title
Management of Acute Uncomplicated UTIs in Adults by Community Pharmacists
Acronym
[UTI]
Official Title
Impact of Online Counselling Training For Pharmacists on The Management of Acute Uncomplicated Urinary Tract Infections in Adults; A Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ibadan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is to be conducted in community pharmacies. It involves the use of trained mystery patients to evaluate community pharmacists at baseline and post intervention. The pharmacists will be divided into control and intervention groups using computer generated codes. Those in the intervention group will receive an online training by clinical pharmacists. The training will employ the use of didactic teaching and the use of case studies and simulations covering the diagnosis and management of acute uncomplicated urinary tract infections in adults. Post intervention, mystery patients will revisit the community pharmacists in the control and intervention groups for re-assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Urinary Tract Infection Lower Acute
Keywords
Urinary Tract Infections, Pharmacist, Mystery Patient

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The pharmacists in the interventional group will receive educational training after baseline assessment while those in the control group will receive the same training at the end of the study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participating pharmacists, the mystery patient and the investigator will not know who is in the control or the intervention group
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacists in the intervention group
Arm Type
Experimental
Arm Description
The pharmacist will be given an online educational training on management of acute uncomplicated urinary tract infections
Arm Title
Pharmacists in the control group
Arm Type
No Intervention
Arm Description
pharmacists in this group will not be trained, until after the completion of the study.
Intervention Type
Other
Intervention Name(s)
Educational training
Intervention Description
Pharmacists in the intervention group will given detailed online educational training on how to recognize and manage acute uncomplicated urinary tract infections in adults.
Primary Outcome Measure Information:
Title
Questioning skill score
Description
Expert Panels' Relevant Questions - Through 80% consensus the expert panel picked 50 relevant questions. The minimum score is "0" and the maximum score is "50". The higher the score the better the questioning skill.
Time Frame
Through the study completion (an average of 6 months)
Title
Correct diagnosis of Acute Uncomplicated Urinary Tract Infection
Description
using the Infectious Disease Society of America treatment guideline, the pharmacists should be able to reach a diagnosis of Acute Uncomplicated Urinary Tract Infection. Appropriate diagnosis will be classified as "Correct diagnosis" and inappropriate diagnosis will be classified as "Incorrect diagnosis". Proportion will be used to describe the number of community pharmacists who got the diagnosis Correct and Incorrect.
Time Frame
Through the study completion (an average of 6 months)
Title
Appropriate management of urinary tract infection
Description
Infectious Disease Society of America treatment guideline
Time Frame
Through the study completion (an average of 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The superintendent pharmacist, or the pharmacist manager or any other post National Youth Service Corps pharmacist Exclusion Criteria: Interns, and pharmacists undergoing the mandatory National Youth Service Corps program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulhafiz T Taofiq, B.Pharm.
Phone
+2347063798732
Email
taofiq32@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Segun J Showande, Ph.D.
Phone
+2348027887608
Email
pharmsegg@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Segun J Showande, Ph.D.
Organizational Affiliation
University of Ibadan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Ibadan
City
Ibadan
State/Province
Oyo
ZIP/Postal Code
200284
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taofiq T Abdulhafiz, B.Pharm
Phone
+2347063798732
Email
taofiq32@gmail.com
First Name & Middle Initial & Last Name & Degree
Segun J Showande, Ph.D.
Phone
+2348027887608
Email
sj.showande@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Management of Acute Uncomplicated UTIs in Adults by Community Pharmacists

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