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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Charite-Universitaetsmedizin Berin
Campus Virchow-Klinikum
Dept. of Anesthesiology and Intensiv Care
Augustenburger Platz 1
Berlin
13353
Germany
| claudia.spies@charite.de |
Study information
| Study design | Prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 8000 participants |
| 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
13353
Germany
Sponsor information
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Campus Virchow-Klinikum
Augustenburger Platz 1
Berlin
13383
Germany
| claudia.spies@charite.de | |
| Website | http://www.charite.de/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
