NCT00365430

SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes

SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pressure Ulcer
• Urinary Tract Infection
• Accidental Falls

Interventions

Type	Name	Description
BEHAVIORAL	safety program	Education, patient involvement, tailored implementation and a computerized registration system

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-08-17
• Last updated: 2009-01-23

Locations

10 sites across 1 country: Netherlands