search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


IMPACT study


- candidate number24266
- NTR NumberNTR5933
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-apr-2016
- Secondary IDsE2-170 METC
- Public TitleIMPACT study
- Scientific TitleAssessing the (cost)effectiveness of recommended strategies to evaluate and improve the quality of antibiotic use in Antimicrobial Stewardship programs
- ACRONYMIMPACT
- hypothesisThe primary objective of this study is to assess the (cost-)effectiveness of antimicrobial stewardship interventions in Dutch acute care hospitals with a special focus on the difference in effect between three methods to measure and feed back information in improving the quality of antibiotic use. Our second objective is to assess the influence on the outcome measures of additional factors improving the quality of antibiotic use, including hospital factors, A-team factors and factors regarding the locally tailored Stewardship interventions (e.g. type of intervention, number of interventions, time investment and use of the worksheet implementation steps).
- Healt Condition(s) or Problem(s) studiedAntimicrobial resistance
- Inclusion criteriathe hospital should have an antibiotic stewardship team
- Exclusion criteriano antibiotic stewardship team
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate1-nov-2017
- Target number of participants8500
- Interventionsfeedback and implementation in 42 clusters (21 hospitals)
- Primary outcomeLenth of hospital stay
- Secondary outcomelenth and ICU stay
hospital mortality
antibiotic use (days of therapy)
cost-effectiveness
- Timepointspre-assessments (February March April May 2015)
post-assessments (February March April May 2017)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marlot Kallen
- CONTACT for SCIENTIFIC QUERIES Marlot Kallen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryIn this multicentre RCT we aim to assess the (cost-)effectiveness of three different methods to measure/evaluate and , on the basis of feedback information, improve the quality of antibiotic use in various wards of the hospital. The primary endpoint for comparison of the methods is Length of hospital stay. Secondary endpoints are total antibiotic use, ICU admission and duration, mortality, costs.
- Main changes (audit trail)Summary
Antimicrobial resistance is an important health care problem. Antibiotic stewardship programs aim to curb the increasing antimicrobial resistance rate. Quality assurance of appropriate antibiotic use is one of the cornerstones of these programs. Various methods can be used to evaluate the current quality of antibiotic use in hospitals, ranging from continuously monitoring overall antibiotic use at an institutional level, to performing point-prevalence studies in which appropriate use in individual patients is assessed. These methods have never been compared and the (cost) effectiveness of these various options in measuring and feeding back information on antibiotic use is unknown. The question is whether monitoring of overall use suffices, or whether labor intensive and costly point prevalence studies are more effective and cost-effective in improving the quality of antibiotic use.

STUDY OBJECTIVE
The primary objective of this study is to assess the (cost-)effectiveness of antimicrobial stewardship interventions in Dutch acute care hospitals with a special focus on the difference in effect between three methods to measure and feed back information in improving the quality of antibiotic use:
1. OVERALL USE - Retrospectively collect data on overall antibiotic use (pharmacy data), including the use of "reserve" antibiotics, over a 12 month period. Drug use data will be standardized in DDDs and DOT and fed back per cluster.
2. PPS-QI: Perform point prevalence studies (PPS) to collect data on appropriate antibiotic use in individual patients as defined by a set of validated quality indicators for appropriate use of antibiotics (PPS-QI), as developed by our group. This information on the quality of antibiotic use will be fed back per cluster.
3. PPS ECDC-HAI: Perform a simplified point prevalence studies (PPS) at the various wards in which data are collected on a non-validated, simpler set of indicators (PPS-ECDC. This information on the quality of antibiotic use will be fed back per cluster.
Our second objective is to assess the influence on the outcome measures of additional factors improving the quality of antibiotic use, including hospital factors, A-team factors and factors regarding the locally tailored Stewardship interventions (e.g. type of intervention, number of interventions, time investment and use of the worksheet implementation steps)

METHODS AND DESIGN
To assess the (cost) effectiveness of these various methods, a cluster randomized, multicenter trial (clustered RCT) will be performed in 21 Dutch hospitals. Each hospital will be divided into two clusters: surgical and non-surgical. A total of 42 clusters will be randomly allocated to one of three methods, stratified by hospital (i.e. in each hospital, each strategy will be allocated to no more than one cluster).
We will retrospectively collect from patient charts, four times with one month interval before and four times after the measurements with the subsequent Antibiotic team (A-team) interventions, data on 25 patients per cluster treated with antibiotics for >24hours: age, sex, co-morbidity, type of infection, length of hospital stay (LOS), ICU admission, hospital mortality and antibiotic use (agents, route and treatment duration). By means of a questionnaire we will collect information on hospital characteristics, A-team characteristics and specifications on the implemented stewardship activities, including type of activity and time investment.

MEASUREMENTS & FEEDBACK
In all three scenarios, information is collected (respectively on overall antibiotic use, results of the PPS-QI and PPS-ECDC), compared with similar clusters from other hospitals and fed back to the local A-teams in the form of a report. This way, it is likely that clusters with high respectively low overall antibiotic use (scenario 1) or high respectively low quality of antibiotic use (scenario 2 and 3) are easily recognizable in the report.

MULTI-FACETED IMPROVEMENT STRATEGY
A Multi-Faceted Strategy (MFS), including one educational meeting, provision of feedback reports and worksheets, one outreach visit and reminders, is used to support participating hospitals to systematically develop and implement tailored Stewardship interventions in order to improve the appropriateness of antibiotic use in their hospital.
A face to face educational meeting is organized, in which antibiotic teams receive instructions on the interpretation of feedback reports and usage of the worksheet. The worksheet is provided to systematically guide A-teams through the process of identifying improvement foci, assessing local barriers and defining tailored Stewardship interventions to overcome these barriers and improve the appropriateness of antibiotic use in their hospital. A-teams receive the feedback reports together with the worksheet after the educational meeting.
Throughout the intervention period, the study team (D-team) guides and advices on the implementation of improvement strategies based on the needs of the local A-teams. One outreach visit is organized, during which the D-team and A-teams use academic detailing to discuss local barriers and help to define an improvement plan, containing tailored Stewardship activities that can be implemented on the participating departments. Email reminders are sent and advice is given by phone or email if requested by the A-team.

OUCOMES
The primary endpoint for evaluation of study outcomes and comparison of study arms is length of hospital stay (LOS). Secondary endpoints are: total antibiotic use and use of restricted antibiotics, expressed in DOT per 100 admissions or per 100 patient-days (agents, route and treatment duration), admission to and duration of intensive care unit (ICU) stay, hospital mortality, and costs (costs associated with health care utilization, costs related to the measurement of antibiotic use resp. performance of the PPS (D-team) and costs related to the stewardship interventions (A-team)).

ANALYSIS: SAMPLE SIZE AND STATISTICS
With 21 hospitals with each 2 clusters, with 4 times 25 patients per cluster before and 4 times 25 patients per cluster after, the total sample size will be 8400 patients. Assuming a within cluster correlation (ICC) of 0.20 and a baseline Length of Stay (LOS) of 9 days (SD 6.2) (based on length of stay in recent studies), this study will have a power of approximately 80% to demonstrate a reduction in geometric mean LOS of 0.8 day (-9%) with an alpha of 0.05.
Differences between the pre- and post-intervention periods, with a focus on differences between the three study methods, will be evaluated for length of stay and other numerical endpoints using mixed linear models. These models account for within-cluster dependencies, and allow adjustment for confounders. For dichotomous outcomes generalized estimating equation models will be used.

The effect of additional factors (including hospital factors, A-team factors and factors regarding the locally tailored Stewardship interventions) on LOS and secondary outcome measures will be evaluated for those factors that show a sufficient (>15%) variation between hospitals. The key question for the economic evaluation is to estimate the costs associated with the three different strategies to measure antibiotic use in the hospital setting, differentiating between study costs, implementation costs and operational costs, and to offset these costs with potential benefits of more labor intensive strategies in terms of improved antibiotic prescribing and shorter hospital stays.
- RECORD19-apr-2016 - 29-dec-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl