SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
- Conditions
- Urinary Tract InfectionPressure UlcerAccidental Falls
- Registration Number
- NCT00365430
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
- patients on participating wards admitted for more than three days
- all nurses on participating wards
- students on participating wards
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls nine months
- Secondary Outcome Measures
Name Time Method Utilization of preventive interventions and knowledge of nurses and caregivers nine months
Trial Locations
- Locations (10)
Stichting De Waalboog
🇳🇱Nijmegen, Gelderland, Netherlands
Zorggroep Maas en Waal
🇳🇱Beneden-Leeuwen, Gelderland, Netherlands
Alysis Zorggroep lokatie Rijnstate
🇳🇱Arnhem, Gelderland, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Gelderland, Netherlands
Zorggroep Zuid-Gelderland
🇳🇱Nijmegen, Gelderland, Netherlands
Radboud University Nijmegen Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands
Stichting SVVE De Archipel
🇳🇱Eindhoven, Noord-Brabant, Netherlands
Zorggroep Noord-Limburg Venlo
🇳🇱Venlo, Noord-Limburg, Netherlands
Stichting De Riethorst Stromenland
🇳🇱Geertruidenberg, Noord-Brabant, Netherlands
Universitair Longcentrum Dekkerswald
🇳🇱Nijmegen, Gelderland, Netherlands