The PROHIBIT study: reducing patients' risk of developing a central venous catheter infection by improving catheter insertion and health care workers' hand hygiene compliance in European Intensive Care Units
| ISRCTN | ISRCTN24828982 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24828982 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/09/2015
- Registration date
- 15/09/2015
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
A central venous catheter (CVC) is a long, thin tube that is inserted into the major vein in the neck (jugular vein), chest (subclavian vein or axillary vein) or groin (femoral vein). CVC’s are considered to be one of the best ways to give long-term drug treatment, such as chemotherapy. The use of CVC’s has increased considerably in recent years and catheter-related bloodstream infections (CR-BSI) have become a recurrent complication. These infections can cause seriously ill patients with CVC’s to become even more ill or even die. It is thought that the amount of CR-BSI’s in hospitals is related to the way the catheters are inserted and cared for, as well as hand hygiene practices. The aim of this study is to find out whether applying new hand hygiene and CVC insertion and care programmes in hospitals can help to reduce the amount of CR-BSI’s.
Who can participate?
Adult patients with a CVC inserted in the hospital, on an ICU ward of a participating hospital.
What does the study involve?
In this study, each of the hospitals taking part is randomly allocated to take the different interventions (programmes) at different times. This means, that each hospital receives all of the different interventions though the course of the study. In a random order, each hospital implements their standard practices for CVC insertion and hand hygiene, the hand hygiene improvement programme, the CVC insertion and care programme or both of these programmes. Throughout the study, the number of CR-BSI’s are recorded every three months.
What are the possible benefits and risks of participating?
Participants are expected to benefit because improving hand hygiene practices and CVC insertion techniques, the chances of a CR-BSI will be lower. There are no risks of participating in the study.
Where is the study run from?
Fifteen hospitals in Europe.
When is the study starting and how long is it expected to run for?
December 2008 to June 2013
Who is funding the study?
Seventh Framework Programme (Belgium)
Who is the main contact?
Ms Tjallie van der Kooi
tjallie.van.der.kooi@rivm.nl
Contact information
Scientific
RIVM (National Institute for Public Health and the Environment)
Centre for Infectious Disease Control
Antonie van Leeuwenhoeklaan 9
Bilthoven
3721 MA
Netherlands
 ORCID ID |
0000-0002-5346-7224 |
|---|---|
| Phone | +31 30 2743395 |
| tjallie.van.der.kooi@rivm.nl |
Study information
| Study design | Multi-centre randomized controlled stepped-wedge design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomized controlled stepped-wedge design |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | The PROHIBIT (PRevention Of Hospital Infections By Intervention and Training ) intervention study: a randomized multi-centre study in Intensive Care Units in Europe to reduce central venous catheter-related bloodstream infections (CRBSIs) by improving hand hygiene (HH) and central venous catheter (CVC) insertion and care, measuring both CRBSI incidence density and HH and CVC insertion compliance |
| Study acronym | PROHIBIT WP5 |
| Study hypothesis | To test the efficacy of a hand hygiene programme (World Health Organization (WHO)) and a CVC insertion and care programme (University Hospitals of Geneva), or both in improving prevention of central venous catheter (CVC)-related bloodstream infections (CRBSI) in the heterogeneous European setting. |
| Ethics approval(s) | The Medical Ethics Review Committee of the University Medical Centre of Utrecht (Netherlands) concluded that ethics approval was not required, because the interventions consisted of best practice quality of care and patients did not receive a particular treatment, the Medical Research Involving Human Subjects Act (WMO) did not apply. Local Ethics Approvals: 1. Austria: Ethics Committee of the Medical University Vienna, 04/10/2011 2. Belgium: Medical Ethics Committee of the AZ Sint Lucas hospital, 14/02/2010 3. Greece: Scientific and Ethics Committee of the Evaggelismos General Hospital: 17/01/2011 4. Hungary: Bácks-Kiskun county teaching hospital: Research Ethics Committee of the Szeged University: 30/03/2011 5. Hungary: Research Ethics Committee of the Szent János hospital, Budapest:: , 21/7/2011 6. Ireland: Clinical Research Ethics Committee of Galway University Hospitals: , 02/11/2010 7. Ireland: Ethics and Medical Research Committee of the St. Vincent's Healthcare group, Dublin, 17/01/2011 8. Italy: Committee of Bio-ethics of the Riuniti hospital of Bergamo, 02/11/2010 9. Latvia: Clinical Research Ethics Committee of the Paul Stradins Clinical University Hospital, 01/12/2010 10. Poland: Hospital of Silesia, Cieszyn: the Beskidzka Medical Doctors Association, 15/12/2011 11. Poland: Legal advisor of the John Paul II Regional Teaching Hospital, Kraków, 20/01/2011 12. Romania: Ethics Committee of the Institute for emergency cardiovascular diseases "Prof. C.C. Iliescu", 02/11/2010 13. Slovenia: Medical Ethics Committee of the Republic of Slovenia, 27/12/2010 14. Spain: Clinical Research Ethics Committee of the Vall d'Hebron University Hospital, 28/01/2011 |
| Condition | Catheter-related bloodstream infections |
| Intervention | The cluster-randomized stepped wedge design allowed all centres to implement the intervention and to account for time-related changes. The baseline period functions as control period. Hospitals were randomized to receive one of the interventions described below (HH, CVC or BOTH). After a baseline of six months the first randomization took place: per intervention one hospital was randomly selected to start. After three months the second randomization round took place. There were in total 5 randomization rounds. Control phase: Local practices regarding CVC insertion and hand hygiene are used. Intervention phase: One or both of the following interventions were implemented: Multimodal hand hygiene (HH) improvement programme (WHO): 1. System and infrastructure for HH (e.g. availability of hand alcohol at the bedside) 2. Training and education of healthcare workers 3. Evaluation and feedback to healtcare workers and management 4. Reminders in the workspace 5. Institutional safety climate CVC insertion and care programme based on the University of Geneva Hospitals (HUG) catheter project: 1. Work organization 2. Patient preparation 3. Skin antisepsis 4. Maximal sterile barrier precautions 5. Catheter fixation and dressing 6. After insertion: evaluation of ongoing need of the catheter After the start of the intervention hospitals would receive quarterly feedback reports on their CRBSI rates, HH compliance and/or CVC insertion compliance, depending on the intervention. Hospitals recorded their implementational activities throughout the study. |
| Intervention type | Behavioural |
| Primary outcome measure | Central venous catheter-related bloodstream infection (CRBSI) incidence density, measured as number of CRBSI per 1000 CVC days (CVC days of concurrent CVCdays were counted separately) every 3 months for 30 months. |
| Secondary outcome measures | 1. Hand hygiene complianceias measured by direct observation using the well-known WHO “My five moments for hand hygiene” strategy (Sax et al, AJIC 2009) every 3 months for 30 months 2. Catheter insertion practice is measured by observing CVC insertions using a form based on the CRBSI prevention strategy of the University of Geneva Hospitals (Zingg et al, PloS one, 2014) every 3 months for 30 months |
| Overall study start date | 02/12/2008 |
| Overall study end date | 30/06/2013 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | We aimed at including 15 centres: 5 per intervention, starting the intervention with 3 hospitals at the time, at 5 moments of time, 3 months apart. All hospitals collected data for 30 months. We expected that each hospital would contribute 10-15,000 CVC days per hospital per year. |
| Participant inclusion criteria | 1. ICU patients with CVCs in place for at least 24 hours 2. Aged 16 years or over |
| Participant exclusion criteria | 1. CVCs inserted outside the hospital 2. CVCs removed at the same day |
| Recruitment start date | 01/01/2011 |
| Recruitment end date | 30/06/2013 |
Locations
Countries of recruitment
- Austria
- Belgium
- Belize
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Poland
- Romania
- Slovenia
- Spain
Study participating centres
Vienna 1
1090
Austria
Ghent
B-9000
Belgium
Athens
10676
Greece
Kecskemét
6000
Hungary
Budapest
1097
Hungary
Galway
H91 YR71
Ireland
Dublin
4
Ireland
Bergamo
24127
Italy
Riga
1002
Latvia
Kraków
12 614 20 02
Poland
Cieszyn
43-400
Poland
Bucharest
022322
Romania
Ljubljana
1000
Slovenia
Barcelona
8035
Spain
Sponsor information
Government
Antonie van Leeuwenhoeklaan 9
Bilthoven
3721 MA
Netherlands
| Phone | +31 30 2743395 |
|---|---|
| tjallie.van.der.kooi@rivm.nl | |
| Website | http://www.rivm.nl/en |
"ROR" |
https://ror.org/01cesdt21 |
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publication through a peer-reviewed journal. Further dissemination via congresses (ECCMID 2014, ICPIC 2013 and ICPIC 2015). |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2018 | 18/01/2019 | Yes | No |
Editorial Notes
18/01/2019: Publication reference added
