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

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00365430
First received: August 16, 2006
Last updated: January 22, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Pressure Ulcer
Urinary Tract Infection
Accidental Falls
Behavioral: safety program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls [ Time Frame: nine months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Utilization of preventive interventions and knowledge of nurses and caregivers [ Time Frame: nine months ] [ Designated as safety issue: Yes ]

Enrollment: 3000
Study Start Date: September 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: safety program
    Education, patient involvement, tailored implementation and a computerized registration system
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • students on participating wards
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365430

Locations
Netherlands
Alysis Zorggroep lokatie Rijnstate
Arnhem, Gelderland, Netherlands, 6800 TA
Zorggroep Maas en Waal
Beneden-Leeuwen, Gelderland, Netherlands, 6658EK
Universitair Longcentrum Dekkerswald
Nijmegen, Gelderland, Netherlands, 6560 AB
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
Stichting De Waalboog
Nijmegen, Gelderland, Netherlands, 6503 CB
Zorggroep Zuid-Gelderland
Nijmegen, Gelderland, Netherlands, 6522 AS
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands, 6500 GS
Stichting SVVE De Archipel
Eindhoven, Noord-Brabant, Netherlands, 5616 PZ
Stichting De Riethorst Stromenland
Geertruidenberg, Noord-Brabant, Netherlands, 4931 BP
Zorggroep Noord-Limburg Venlo
Venlo, Noord-Limburg, Netherlands, 5900 AR
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Theo van Achterberg, PhD Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Nijmegen Medical Center
  More Information

Additional Information:
No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theo van Achterberg, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00365430     History of Changes
Other Study ID Numbers: SoS245119, 54010002
Study First Received: August 16, 2006
Last Updated: January 22, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Patient safety
Adverse event
Prevention
Knowledge
Inpatient
Hospital
Nursing home
Long term care
Nurse

Additional relevant MeSH terms:
Pressure Ulcer
Urinary Tract Infections
Infection
Skin Diseases
Skin Ulcer
Urologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014