Uncomplicated Urinary Tract Infection Clinical Trial
— SIMPleOfficial title:
Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (SIMPle): Protocol for a Randomised Complex Intervention
Background The over use of antimicrobials is recognised as the main selective pressure
driving the emergence and spread of antimicrobial resistance in human bacterial pathogens.
Urinary Tract Infections (UTIs) are one of the most common infections presented in primary
care and empirical antimicrobial treatment is currently recommended. Previous research has
identified that a substantial proportion of Irish GPs prescribe antimicrobials for UTI that
are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in
Ireland.
Aim To design, implement and evaluate the effectiveness of a complex intervention on GP
antimicrobial prescribing and adult (18 years of age and over) patients' antimicrobial
consumption when presenting with a suspected UTI.
Methods The SIMPLE study is a randomised three armed intervention with practice level
randomisation. Adult patients presenting with suspected UTI in primary care will be included
in the study.
The intervention integrates components for both GPs and patients. For GPs the intervention
includes interactive workshops, audit and feedback reports and automated electronic prompts
summarising recommended first line antimicrobial treatment and, for one intervention arm, a
recommendation to consider delayed antimicrobial prescribing. For patients multimedia
applications and information leaflets are included. A minimum of 920 patients will be
recruited through 30 practices. The primary outcome is change in prescribing of first line
antimicrobials in accordance with the Guidelines for Antimicrobial Prescribing in Primary
Care in Ireland. The intervention will take place over 15 months. Data will be collected
through a remote electronic anonymised data extraction system (iPCRN), a text messaging
system and through GP and patient interviews and surveys. The intervention will be
strengthened by the implementation of a social marketing framework and an economic
evaluation.
Status | Completed |
Enrollment | 2577 |
Est. completion date | September 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult patients presenting with a suspected urinary tract infection to their general practitioner (GP) Exclusion Criteria: |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ireland | NUI Galway | Galway |
Lead Sponsor | Collaborator |
---|---|
National University of Ireland, Galway, Ireland | Health Research Board, Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | relative change in beliefs | To assess a change in cognitive beliefs (knowledge and attitudes) of GPs related to antimicrobial prescribing with qualitative survey | 0 and 9 months | No |
Other | Cost of intervention | conduct a cost-effectiveness evaluation of the SIMPle intervention | 9 months | No |
Other | Relative change in prescribing rates | compare the prescribing rates of the intervention arms with regional UTI antimicrobial prescribing rates | 9 months | No |
Primary | Relative number of prescriptions of first line antimicrobials | Increase in the relative number of prescribing (over all UTI consultations) of first line antimicrobials as recommended in the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland (2010), for suspected UTI in primary care by 10% in adult patients. | 3 and 9 months | No |
Secondary | Relative number of antimicrobial prescriptions for UTI | To compare the effect of the intervention on the frequency of antimicrobial prescribing and antimicrobial consumption in patients presenting with an UTI | 3 and 9 months | No |
Secondary | Number of delayed prescriptions for UTI | To measure the uptake delayed antimicrobial prescribing for UTI and the impact of this treatment approach on UTI GP reconsultation visits. | 3 and 9 months | No |
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