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

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Prof Claudia D. Spies

ORCID ID

Contact details

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

N/A

Scientific title

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

Acronym

Study hypothesis

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

Study design

Prospective observational study

Primary study design

Observational

Secondary study design

Case-control study

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Condition

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

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.

Secondary outcome measures

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.

Overall study start date

01/01/2006

Overall study end date

01/10/2010

Reason abandoned (if study stopped)

Participant inclusion criteria

All patients admitted to five ICUs at Universitaetsmedizin Charite at Campus Mitte and Campus Virchow-Klinikum

Participant type(s)

Patient

Age group

Adult

Sex

Both

Target number of participants

8000 participants

Participant exclusion criteria

1. Patients under age of 18
2. Length of ICU stay less than 36 hours
3. Non-existing guideline for particular disease

Recruitment start date

01/01/2006

Recruitment end date

01/10/2010

Countries of recruitment

Germany

Study participating centre

Charite-Universitaetsmedizin Berin
Berlin
13353
Germany

Organisation

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Sponsor details

Campus Virchow-Klinikum
Augustenburger Platz 1
Berlin
13383
Germany
-
claudia.spies@charite.de

Sponsor type

Hospital/treatment centre

Website

http://www.charite.de/

ROR

https://ror.org/001w7jn25

Funder type

Hospital/treatment centre

Funder name

Charité Universitätsmedizin Berlin

Alternative name(s)

Medical School - Charité - University Medicine Berlin

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

Germany

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs