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Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (SIMPle)

NCT01913860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2577

Last updated 2014-12-05

No results posted yet for this study

Summary

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.

Conditions

  • Uncomplicated Urinary Tract Infection

Interventions

BEHAVIORAL

Improving GP antibiotics prescribing behaviour

GPs will be asked to code their UTI patients within their patient management software. Anonomysed coded patients will be electronically extracted and this information will be provided as an audit and feedback report of the GPs antibiotic prescribing practices.

Sponsors & Collaborators

  • Health Research Board, Ireland

    collaborator OTHER

  • National University of Ireland, Galway, Ireland

    lead OTHER

Principal Investigators

  • Akke Vellinga, PhD · NUI Galway

  • Andrew W Murphy, MD · NUI Galway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-03-31
Completion
2014-09-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01913860 on ClinicalTrials.gov