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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01913860
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
Akke Vellinga, National University of Ireland, Galway, Ireland

Brief 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.


Condition or disease Intervention/treatment Phase
Uncomplicated Urinary Tract Infection Behavioral: Improving GP antibiotics prescribing behaviour Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2577 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (SIMPle): Protocol for a Randomised Complex Intervention
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Control group will receive usual care
Active Comparator: Improve GP prescribing behaviour
Improve GP prescribing behaviour will be promoted through personalised audit and feedback reports, delivered through face to face workshops within practice.
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.

Active Comparator: Improved delayed GP prescribing
Improved delayed GP prescribing will be promoted through the antibiotic prescribing guidelines and personalised audit and feedback reports. Additional scientific evidence will be provided related to delayed prescribing.
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.




Primary Outcome Measures :
  1. Relative number of prescriptions of first line antimicrobials [ Time Frame: 3 and 9 months ]
    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.


Secondary Outcome Measures :
  1. Relative number of antimicrobial prescriptions for UTI [ Time Frame: 3 and 9 months ]
    To compare the effect of the intervention on the frequency of antimicrobial prescribing and antimicrobial consumption in patients presenting with an UTI

  2. Number of delayed prescriptions for UTI [ Time Frame: 3 and 9 months ]
    To measure the uptake delayed antimicrobial prescribing for UTI and the impact of this treatment approach on UTI GP reconsultation visits.


Other Outcome Measures:
  1. relative change in beliefs [ Time Frame: 0 and 9 months ]
    To assess a change in cognitive beliefs (knowledge and attitudes) of GPs related to antimicrobial prescribing with qualitative survey

  2. Cost of intervention [ Time Frame: 9 months ]
    conduct a cost-effectiveness evaluation of the SIMPle intervention

  3. Relative change in prescribing rates [ Time Frame: 9 months ]
    compare the prescribing rates of the intervention arms with regional UTI antimicrobial prescribing rates



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adult patients presenting with a suspected urinary tract infection to their general practitioner (GP)

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913860


Locations
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Ireland
NUI Galway
Galway, Ireland
Sponsors and Collaborators
National University of Ireland, Galway, Ireland
Health Research Board, Ireland
Investigators
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Study Director: Akke Vellinga, PhD NUI Galway
Principal Investigator: Andrew W Murphy, MD NUI Galway
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Akke Vellinga, Senior Lecturer Primary Care, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT01913860    
Other Study ID Numbers: ICE/2011/10
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Akke Vellinga, National University of Ireland, Galway, Ireland:
UTI
antibiotics
prescribing
primary care
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents