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

January 22, 2009 updated by: Radboud University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: safety program

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.

Study Type

Interventional

Enrollment (Actual)

3000

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- Gelderland
  - Arnhem, Gelderland, Netherlands, 6800 TA
    - Alysis Zorggroep lokatie Rijnstate
  - Beneden-Leeuwen, Gelderland, Netherlands, 6658EK
    - Zorggroep Maas en Waal
  - Nijmegen, Gelderland, Netherlands, 6500 HB
    - Radboud University Nijmegen Medical Center
  - Nijmegen, Gelderland, Netherlands, 6500 GS
    - Canisius Wilhelmina Ziekenhuis
  - Nijmegen, Gelderland, Netherlands, 6503 CB
    - Stichting De Waalboog
  - Nijmegen, Gelderland, Netherlands, 6522 AS
    - Zorggroep Zuid-Gelderland
  - Nijmegen, Gelderland, Netherlands, 6560 AB
    - Universitair Longcentrum Dekkerswald
- Noord-Brabant
  - Eindhoven, Noord-Brabant, Netherlands, 5616 PZ
    - Stichting SVVE De Archipel
  - Geertruidenberg, Noord-Brabant, Netherlands, 4931 BP
    - Stichting De Riethorst Stromenland
- Noord-Limburg
  - Venlo, Noord-Limburg, Netherlands, 5900 AR
    - Zorggroep Noord-Limburg Venlo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

students on participating wards

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls Time Frame: nine months	nine months

Secondary Outcome Measures

Outcome Measure	Time Frame
Utilization of preventive interventions and knowledge of nurses and caregivers Time Frame: nine months	nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)