Ignite Creation Date:
2024-05-06 @ 1:50 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01913860
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2013-07-26
Brief Title:
Supporting the Improvement and Management of Prescribing for Urinary Tract Infections SIMPle
Sponsor:
National University of Ireland Galway Ireland
Organization:
National University of Ireland Galway Ireland
Study Overview
Official Title:
Supporting the Improvement and Management of Prescribing for Urinary Tract Infections SIMPle Protocol for a Randomised Complex Intervention
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMPle
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
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:
Today 80 of antimicrobial prescribing takes place in the community by general practitioners GPs Ireland is one of only three countries in Europe where the level of outpatient antimicrobial prescribing is increasing Within this context the inappropriate and overprescription of antimicrobials by GPs is a recognized factor contributing to the spread of AMR The Guidelines for Antimicrobial Prescribing in Primary Care in Ireland provide advice on the selection of antimicrobial drugs for common infections and recommend the use of specific antimicrobials with reserved drugs for more serious infections However despite the widespread availability of these guidelines recent research has identified that less than 40 of outpatient prescriptions for urinary tract infections UTIs are made out according to first-line recommendations
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 GPs and the patients perspective Through a series of interviews with GPs n 15 and focus groups with patients n 35 the predictors of a GPs decision to prescribe an antimicrobial and the patients 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 GPs 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
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 GPs and the patients perspective Through a series of interviews with GPs n 15 and focus groups with patients n 35 the predictors of a GPs decision to prescribe an antimicrobial and the patients 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 GPs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None