Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (SIMPle)
NCT ID: NCT01913860
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2577 participants
INTERVENTIONAL
2013-09-30
2014-09-30
Brief Summary
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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.
Detailed Description
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Urinary tract infections are predominantly caused by a bacteria; Escherichia coli, and are generally treated empirically, prior to the results of antimicrobial susceptibility testing. Antimicrobial resistance is now a critical factor in the treatment of UTIs, the second most common bacterial infection in primary care.
Social marketing is the conceptual framework that guided the development of this intervention. Formative (qualitative) research explored the culture of antimicrobial prescribing from both the GP's and the patient's perspective. Through a series of interviews with GPs (n = 15) and focus groups with patients (n = 35), the predictors of a GP's decision to prescribe an antimicrobial and the patient's expectation to receive an antimicrobial were explored.
The aim of SIMPle was 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. The primary outcome was to increase the number of first-line antimicrobial prescriptions, as recommended in the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland (2011), for suspected UTIs in primary care by 10% in adult patients.
Methods The cluster for this intervention is the practice, and all GPs within each practice will be invited to participate. The baseline population for recruitment of patients will be formed by all practices in the West of Ireland who submit urine samples to the Galway University Hospitals (GUH) laboratory. The most popular patient management software system was chosen, because the SIMPle study builds on remote data extraction, the provision of audit and feedback reports and computer prompts integrated within the GP's patient management software system. This study will be undertaken in four phases: Phase 1, baseline data collection; Phase 2, GP intervention; Phase 3, patient intervention and Phase 4, endpoint data collection. Computerized remote data extraction is facilitated by the Irish Primary Care Research Network (iPCRN) and patient data are identified through the appropriate coding of suspected UTI consultations in the patient management software system. To promote and encourage consultation coding, which is currently not routine practice, the intervention will be preceded by a coding workshop at the beginning of Phase 1. All practices will be required to register with the iPCRN during or before the coding workshop. Practices will be monitored for two months after the delivery of the workshop to establish uptake of coding, whilst also facilitating a baseline data collection period (Phase 1). Phase 2 will begin with an interactive workshop (intervention arms A and B), which will introduce the intervention components specific to each arm. Phase 3 will see the roll-out of the patient education in all of the practices. The antimicrobial prescribing within each practice will be monitored for six months during Phases 2 and 3 through audit and feedback reports. Evaluation of the impact of the intervention will be carried out in Phase 4.
All patients are eligible if aged 18 years and over and presenting with symptoms of an UTI, as determined by the GP through the consultation coding.
Previous research has established that 56% of UTI patients receive an antimicrobial, with only 38% of prescription made out for the recommended first-line treatment.
Sample size calculations are based on an absolute 10% increase in first-line prescriptions according to guidelines (primary outcome). Additional assumptions for sample size calculations include power of 80% and α of 5%, Practice attrition is dependent on the completeness of consultation coding, which will be monitored and corrected during Phase 1.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Control
Control group will receive usual care
No interventions assigned to this group
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
Yes
Sponsors
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Health Research Board, Ireland
OTHER
National University of Ireland, Galway, Ireland
OTHER
Responsible Party
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Akke Vellinga
Senior Lecturer Primary Care
Principal Investigators
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Akke Vellinga, PhD
Role: STUDY_DIRECTOR
NUI Galway
Andrew W Murphy, MD
Role: PRINCIPAL_INVESTIGATOR
NUI Galway
Locations
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NUI Galway
Galway, Galway, Ireland
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Simple Study website
Other Identifiers
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ICE/2011/10
Identifier Type: -
Identifier Source: org_study_id