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

Primary Purpose

Pressure Ulcer, Urinary Tract Infection, Accidental Falls

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
safety program
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Patient safety, Adverse event, Prevention, Knowledge, Inpatient, Hospital, Nursing home, Long term care, Nurse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: patients on participating wards admitted for more than three days all nurses on participating wards Exclusion Criteria: students on participating wards

Sites / Locations

  • Alysis Zorggroep lokatie Rijnstate
  • Zorggroep Maas en Waal
  • Canisius Wilhelmina Ziekenhuis
  • Radboud University Nijmegen Medical Center
  • Stichting De Waalboog
  • Zorggroep Zuid-Gelderland
  • Universitair Longcentrum Dekkerswald
  • Stichting SVVE De Archipel
  • Stichting De Riethorst Stromenland
  • Zorggroep Noord-Limburg Venlo

Outcomes

Primary Outcome Measures

Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls

Secondary Outcome Measures

Utilization of preventive interventions and knowledge of nurses and caregivers

Full Information

First Posted
August 16, 2006
Last Updated
January 22, 2009
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00365430
Brief Title
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

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Urinary Tract Infection, Accidental Falls
Keywords
Patient safety, Adverse event, Prevention, Knowledge, Inpatient, Hospital, Nursing home, Long term care, Nurse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
safety program
Intervention Description
Education, patient involvement, tailored implementation and a computerized registration system
Primary Outcome Measure Information:
Title
Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls
Time Frame
nine months
Secondary Outcome Measure Information:
Title
Utilization of preventive interventions and knowledge of nurses and caregivers
Time Frame
nine months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theo van Achterberg, PhD
Organizational Affiliation
Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Nijmegen Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Alysis Zorggroep lokatie Rijnstate
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6800 TA
Country
Netherlands
Facility Name
Zorggroep Maas en Waal
City
Beneden-Leeuwen
State/Province
Gelderland
ZIP/Postal Code
6658EK
Country
Netherlands
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 GS
Country
Netherlands
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Stichting De Waalboog
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6503 CB
Country
Netherlands
Facility Name
Zorggroep Zuid-Gelderland
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6522 AS
Country
Netherlands
Facility Name
Universitair Longcentrum Dekkerswald
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6560 AB
Country
Netherlands
Facility Name
Stichting SVVE De Archipel
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5616 PZ
Country
Netherlands
Facility Name
Stichting De Riethorst Stromenland
City
Geertruidenberg
State/Province
Noord-Brabant
ZIP/Postal Code
4931 BP
Country
Netherlands
Facility Name
Zorggroep Noord-Limburg Venlo
City
Venlo
State/Province
Noord-Limburg
ZIP/Postal Code
5900 AR
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21419411
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.
Results Reference
derived
PubMed Identifier
20202633
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.
Results Reference
derived
PubMed Identifier
19338655
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.
Results Reference
derived
Links:
URL
http://www.decubitus.be
Description
Guideline pressure ulcer (Belgium)
URL
http://www.wip.nl/free_content/richtlijnen/11111111blaaskatheterisatie.pdf
Description
Guideline prevention urinary tract infection (The Netherlands)
URL
http://www.verpleeghuisartsen.nl
Description
Guideline Urinary Tracts Infections (The Netherlands)

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

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