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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00365430
Enrollment
3000
Registered
2006-08-17
Start date
2006-09-30
Completion date
2008-12-31
Last updated
2009-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls, Pressure Ulcer, Urinary Tract Infection

Keywords

Patient safety, Adverse event, Prevention, Knowledge, Inpatient, Hospital, Nursing home, Long term care, Nurse

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.

Interventions

BEHAVIORALsafety program

Education, patient involvement, tailored implementation and a computerized registration system

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* patients on participating wards admitted for more than three days * all nurses on participating wards

Exclusion criteria

* students on participating wards

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Fallsnine months

Secondary

MeasureTime frame
Utilization of preventive interventions and knowledge of nurses and caregiversnine months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026