|- candidate number||5523|
|- NTR Number||NTR1742|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-mrt-2009|
|- Secondary IDs||80-82315-98-09004 ZonMW|
|- Public Title||(Cost)-Effectiveness of two different strategies to improve the QUality of ANtibiotic use in patients with urinary Tract Infections (UTIs) in the hospital. |
|- Scientific Title||(Cost)-Effectiveness of two different strategies to improve the QUality of ANtibiotic use in patients with urinary Tract Infections (UTIs) in the hospital. A cluster-randomized controlled trial in 19 Dutch hospitals.|
|- Healt Condition(s) or Problem(s) studied||Urinary tract infections|
|- Inclusion criteria||Hospitals will be randomized. |
For baseline- and postintervention measurement data will be extracted from medical charts of patients.
Inclusion criteria for these patients are:
1. In- and outpatients from the departments Urology or Internal Medicine;
2. > 16 years;
3. Diagnosed and treated for a complicated UTI in 2008 (2007).
|- Exclusion criteria||1. No (treated) UTI;|
2. Uncomplicated UTI;
3. Nephro drain;
4. JJ catheter;
5. < 16 years;
6. Diagnosed and treated for a complicated UTI before 2007.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2008|
|- planned closingdate||1-dec-2011|
|- Target number of participants||19|
|- Interventions||After a baseline measurement, hospitals will be randomized between two implementation strategies: a theory-based and effective, but labour-intensive strategy (the 'state-of-the-art' strategy) versus a currently popular strategy of providing public comparative information on quality of antibiotic care (the 'public reporting' strategy). In a post-intervention measurement, quality of antibiotic use will be assessed again for these departments.|
|- Primary outcome||Quality of antibiotic use (measured by clinically validated indicators).|
|- Secondary outcome||1. Cost-effectiveness;|
2. Successful elements of the implementation strategy.
|- Timepoints||1. Baseline measurement (Jan-August 2009);|
2. Post-intervention measurement (Nov 2010-May 2011).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Arts-onderzoeker V. Spoorenberg|
|- CONTACT for SCIENTIFIC QUERIES||Arts-onderzoeker V. Spoorenberg|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||To improve appropriate use of antibiotics in UTI, implementation of the national guideline is necessary. In our previous study on the quality of UTI care in four Dutch hospitals, which we can consider as a pilot study for this study, we systematically developed quality indicators extracted from the national guideline. These were subsequently tested in four different Dutch hospitals. The indicators showed poor adherence to the guideline and a large room for improvement.
This study evaluates the cost-effectiveness of two strategies to improve adherence to the UTI guideline. It is a cluster-randomized controlled trial, including patients with complicated UTIs from two departments (Internal Medicine and Urology) in 19 participating hospitals.
After a baseline measurement in 50 patients from each department (1900 patients), using clinically validated indicators, hospitals will be randomized between two implementation strategies. A theory-based and effective, but labour-intensive strategy (the 'state-of-the-art' strategy) is compared to a currently popular strategy of providing public comparative information on quality of antibiotic care (the 'public reporting' strategy). In a post-intervention measurement, quality of antibiotic use will be assessed again for these departments (1900 patients). Effectiveness of the two implementation strategies will be evaluated using multilevel linear regression analysis, adjusting for the hierarchical structure (patients within departments and departments within hospitals) in the data. Data will be extracted from medical charts of patients.
|- Main changes (audit trail)|
|- RECORD||27-mrt-2009 - 23-sep-2009|