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

NCT01913860 | Completed DMC

• 1 other identifier: ICE/2011/10
• Study Type: interventional
• Target: 2,577
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncomplicated Urinary Tract Infection

Keywords

UTI; antibiotics; prescribing; primary care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Relative number of antimicrobial prescriptions for UTI

  3 and 9 months

• Number of delayed prescriptions for UTI

  3 and 9 months

Other Outcomes (3)

• relative change in beliefs

  0 and 9 months

• Cost of intervention

  9 months

• Relative change in prescribing rates

  9 months

Study Arms (3)

Control

NO INTERVENTION

Control group will receive usual care

Improve GP prescribing behaviour

ACTIVE COMPARATOR

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

Improved delayed GP prescribing

ACTIVE COMPARATOR

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

Interventions

Improving GP antibiotics prescribing behaviour BEHAVIORAL

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.

Improve GP prescribing behaviour; Improved delayed GP prescribing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

NUI Galway

Galway, Galway, Ireland

Location

Related Publications (5)

• Duane S, Tandan M, Murphy AW, Vellinga A. Using Mobile Phones to Collect Patient Data: Lessons Learned From the SIMPle Study. JMIR Res Protoc. 2017 Apr 25;6(4):e61. doi: 10.2196/resprot.6389.

  PMID: 28442451 DERIVED

• Duane S, Domegan C, Callan A, Galvin S, Cormican M, Bennett K, Murphy AW, Vellinga A. Using qualitative insights to change practice: exploring the culture of antibiotic prescribing and consumption for urinary tract infections. BMJ Open. 2016 Jan 11;6(1):e008894. doi: 10.1136/bmjopen-2015-008894.

  PMID: 26754175 DERIVED

• Tandan M, Duane S, Vellinga A. Do general practitioners prescribe more antimicrobials when the weekend comes? Springerplus. 2015 Nov 24;4:725. doi: 10.1186/s40064-015-1505-6. eCollection 2015.

  PMID: 26636013 DERIVED

• Vellinga A, Galvin S, Duane S, Callan A, Bennett K, Cormican M, Domegan C, Murphy AW. Intervention to improve the quality of antimicrobial prescribing for urinary tract infection: a cluster randomized trial. CMAJ. 2016 Feb 2;188(2):108-115. doi: 10.1503/cmaj.150601. Epub 2015 Nov 16.

  PMID: 26573754 DERIVED

• Duane S, Callan A, Galvin S, Murphy AW, Domegan C, O'Shea E, Cormican M, Bennett K, O'Donnell M, Vellinga A. Supporting the improvement and management of prescribing for urinary tract infections (SIMPle): protocol for a cluster randomized trial. Trials. 2013 Dec 23;14:441. doi: 10.1186/1745-6215-14-441.

  PMID: 24359543 DERIVED

Related Links

• Simple Study website

Study Officials

• Akke Vellinga, PhD

  NUI Galway

  STUDY DIRECTOR

• Andrew W Murphy, MD

  NUI Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer Primary Care

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 1, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

IE (1)