Web-based program for anti-infective treatment using evidence-based algorithms adapted to local resistance rates

ISRCTN	ISRCTN54598675
DOI	https://doi.org/10.1186/ISRCTN54598675
Protocol serial number	N/A
Sponsor	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Funder	Charité Universitätsmedizin Berlin

Submission date: 17/08/2007
Registration date: 04/10/2007
Last edited: 22/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claudia D. Spies
Scientific

Charite-Universitaetsmedizin Berin
Campus Virchow-Klinikum
Dept. of Anesthesiology and Intensiv Care
Augustenburger Platz 1
Berlin
13353
Germany

Email	claudia.spies@charite.de

Study information

Primary study design	Observational
Study design	Prospective observational study
Secondary study design	Case-control study
Scientific title	Web-based program for anti-infective treatment using evidence-based algorithms adapted to local resistance rates
Study objectives	Hypotheses of this study are: evidence-based anti-infective Standard Operating Procedures (SOPs), adapted to the local resistance rates and to the patient's special risk profile in computerised form: 1. Enhances the adherence rate to SOPs 2. Improves outcome: 2.1. Reduced organ dysfunction, Intensive Care Unit (ICU) stay and mortaliy rates 2.2. Reduces the resistance rates (local rates and national benchmarks) 2.3. Reduces the need (national benchmark) and costs for anti-infectives and the expense for isolation 2.4. Reduces the incidence of Post-Traumatic Stress Disorder (PTSD) after ICU stay (PTSD score) 2.5. Improves the perceived health related quality of life and cost-effectiveness
Ethics approval(s)	Charite - Universitatsmedizin Berlin Ethics Committee, 06/09/2007, ref: EA1/127/07
Health condition(s) or problem(s) studied	Critical illness
Intervention	Intended duration: 36 months - 1. 12 months: conversion of the user-accepted SOPs into a web-based version for each participating centre including evidence-based medicine and local resistance rates 2. 12 months: assessment of the implementation rate before and after support by the user-accepted web based versions plus evaluation of the ICU stay and mortality rate with and without SOP adherence 3. 12 months: benchmarking between eight centres and ICU registered national databases for patient outcome and development of resistance rates. Assessment of Health-Related Quality of Life (HRQoL) and Quality-Adjusted Life Years (QALYs) for surviving patients after web-based SOP implementation Follow up: The entire duration of the trial is four years, starting January 2006 and ending December 2009.
Intervention type	Other
Primary outcome measure(s)	1. Implementation rate of SOPs before and after support of web-based computer program 2. Mortality rate with and without adherence to SOPs Proof of the two primary endpoints in the sense of multiple testing with alpha/2 = 2.5% (Bonferroni's adjustment), i.e., with an error of the first kind of 2.5% each. A drop-out of 10% will be incorporated. Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment.
Key secondary outcome measure(s)	1. Infections with multi-resistant bacteria 2. Beginning and duration of anti-infective therapy 3. Length of infection induced organ failure (ventilator days, Sequential Organ Failure Assessment [SOFA] scores) 4. Duration of ICU treatment including rate of admissions to other ICUs 5. Length of ICU stay Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment. An exploratory data analysis is planned for the assessment of the secondary outcome measures and risk factor analysis.
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	8000
Key inclusion criteria	All patients admitted to five ICUs at Universitaetsmedizin Charite at Campus Mitte and Campus Virchow-Klinikum
Key exclusion criteria	1. Patients under age of 18 2. Length of ICU stay less than 36 hours 3. Non-existing guideline for particular disease
Date of first enrolment	01/01/2006
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

Germany

Study participating centre

Charite-Universitaetsmedizin Berin

Berlin
13353
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/06/2014		Yes	No
Results article	results	22/12/2014		Yes	No