Pressure Ulcer Clinical Trial
Official title:
SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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