SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
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|ClinicalTrials.gov Identifier: NCT00365430|
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : January 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer Urinary Tract Infection Accidental Falls||Behavioral: safety program||Not Applicable|
Background Patients in hospitals and nursing homes are at risk for the development of, often preventable, somatic complications. However, preventive care is not always optimal. Although guidelines are available for many complications, compliance with the guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is also associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, organisations can never implement all available guidelines. Another problem is lack of feedback about performance using clear quality indicators and lack of a recognizable, unambiguous system for implementation.
Aim The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.
Participants Patients and nurses will be recruited from ten hospital wards and ten nursing home wards in the Netherlands. All nurses and all adult patients who are admitted for more than three days, will be asked for informed consent.
Method This study consists of two phases. In the first phase the program will be developed. The content of the program is based on the evidence based guidelines on pressure ulcers, urinary tract infections and falls. The program consists of a computerized registration and feedback system, an educational program for nurses and caregivers, and educational material for the patients.
In the second phase the program will be tested in a cluster randomised clinical trial. The program will be implemented on ten wards (5 hospital wards and 5 nursing home wards), i.e. the intervention group. The control group will continue to give care as usual.
Outcome measures Primary outcome measure: incidence of pressure ulcers, urinary tract infections and falls Secondary outcome measures: Utilization of preventive interventions and knowledge of nurses and caregivers regarding the complications and their prevention.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
- Behavioral: safety program
Education, patient involvement, tailored implementation and a computerized registration system
- Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls [ Time Frame: nine months ]
- Utilization of preventive interventions and knowledge of nurses and caregivers [ Time Frame: nine months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365430
|Alysis Zorggroep lokatie Rijnstate|
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Zorggroep Maas en Waal|
|Beneden-Leeuwen, Gelderland, Netherlands, 6658EK|
|Canisius Wilhelmina Ziekenhuis|
|Nijmegen, Gelderland, Netherlands, 6500 GS|
|Radboud University Nijmegen Medical Center|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Stichting De Waalboog|
|Nijmegen, Gelderland, Netherlands, 6503 CB|
|Nijmegen, Gelderland, Netherlands, 6522 AS|
|Universitair Longcentrum Dekkerswald|
|Nijmegen, Gelderland, Netherlands, 6560 AB|
|Stichting SVVE De Archipel|
|Eindhoven, Noord-Brabant, Netherlands, 5616 PZ|
|Stichting De Riethorst Stromenland|
|Geertruidenberg, Noord-Brabant, Netherlands, 4931 BP|
|Zorggroep Noord-Limburg Venlo|
|Venlo, Noord-Limburg, Netherlands, 5900 AR|
|Study Director:||Theo van Achterberg, PhD||Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Nijmegen Medical Center|