Clinical trial NCT00365430: SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
Official title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Urinary Tract Infection
Accidental Falls
Keywords: Patient safety
Adverse event
Prevention
Knowledge
Inpatient
Hospital
Nursing home
Long term care
Nurse
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2006-08-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* students on participating wards

Primary outcomes:
measure: Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls
timeFrame: nine months
Secondary outcomes:
measure: Utilization of preventive interventions and knowledge of nurses and caregivers
timeFrame: nine months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Alysis Zorggroep lokatie Rijnstate
state: Gelderland
city: Beneden-Leeuwen
country: Netherlands
facility: Zorggroep Maas en Waal
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Stichting De Waalboog
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Zorggroep Zuid-Gelderland
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Universitair Longcentrum Dekkerswald
state: Gelderland
city: Eindhoven
country: Netherlands
facility: Stichting SVVE De Archipel
state: Noord-Brabant
city: Geertruidenberg
country: Netherlands
facility: Stichting De Riethorst Stromenland
state: Noord-Brabant
city: Venlo
country: Netherlands
facility: Zorggroep Noord-Limburg Venlo
state: Noord-Limburg
Study officials:
affiliation: Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Nijmegen Medical Center
name: Theo van Achterberg, PhD
role: STUDY_DIRECTOR
References:
citation: van Gaal BG, Schoonhoven L, Mintjes JA, Borm GF, Hulscher ME, Defloor T, Habets H, Voss A, Vloet LC, Koopmans RT, van Achterberg T. Fewer adverse events as a result of the SAFE or SORRY? programme in hospitals and nursing homes. part i: primary outcome of a cluster randomised trial. Int J Nurs Stud. 2011 Sep;48(9):1040-8. doi: 10.1016/j.ijnurstu.2011.02.017. Epub 2011 Mar 17.
citation: van Gaal BG, Schoonhoven L, Vloet LC, Mintjes JA, Borm GF, Koopmans RT, van Achterberg T. The effect of the SAFE or SORRY? programme on patient safety knowledge of nurses in hospitals and nursing homes: a cluster randomised trial. Int J Nurs Stud. 2010 Sep;47(9):1117-25. doi: 10.1016/j.ijnurstu.2010.02.001. Epub 2010 Mar 3.
citation: van Gaal BG, Schoonhoven L, Hulscher ME, Mintjes JA, Borm GF, Koopmans RT, van Achterberg T. The design of the SAFE or SORRY? study: a cluster randomised trial on the development and testing of an evidence based inpatient safety program for the prevention of adverse events. BMC Health Serv Res. 2009 Apr 1;9:58. doi: 10.1186/1472-6963-9-58.