Email updates

Keep up to date with the latest news and content from BMC Health Services Research and BioMed Central.

Open Access Highly Accessed Study protocol

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

Betsie GI van Gaal1*, Lisette Schoonhoven1, Marlies EJL Hulscher1, Joke AJ Mintjes2, George F Borm3, Raymond TCM Koopmans4 and Theo van Achterberg1

Author Affiliations

1 IQ healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

2 Faculty of Health and Social Studies, HAN University of Applied Sciences, Nijmegen, the Netherlands

3 Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

4 Department of Primary and Community Care, Centre for family Medicine, Geriatric Care and Public Health Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

For all author emails, please log on.

BMC Health Services Research 2009, 9:58  doi:10.1186/1472-6963-9-58

Published: 1 April 2009

Abstract

Background

Patients in hospitals and nursing homes are at risk of the development of, often preventable, adverse events (AEs), which threaten patient safety. Guidelines for prevention of many types of AEs are available, however, compliance with these guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, it is difficult for organisations to implement all available guidelines. Another problem is lack of feedback about performance using quality indicators of guideline based care and lack of a recognisable, unambiguous system for implementation. A program that allows organisations to implement multiple guidelines simultaneously may facilitate guideline use and thus improve patient safety.

The aim of this study is to develop and test such an integral patient safety program that addresses several AEs simultaneously in hospitals and nursing homes. This paper reports the design of this study.

Methods and design

The patient safety program addresses three AEs: pressure ulcers, falls and urinary tract infections. It consists of bundles and outcome and process indicators based on the existing evidence based guidelines. In addition it includes a multifaceted tailored implementation strategy: education, patient involvement, and a computerized registration and feedback system. The patient safety program was tested in a cluster randomised trial on ten hospital wards and ten nursing home wards. The baseline period was three months followed by the implementation of the patient safety program for fourteen months. Subsequently the follow-up period was nine months. Primary outcome measure was the incidence of AEs on every ward. Secondary outcome measures were the utilization of preventive interventions and the knowledge of nurses regarding the three topics. Randomisation took place on ward level. The results will be analysed separately for hospitals and nursing homes.

Discussion

Major challenges were the development of the patient safety program including a digital registration and feedback system and the implementation of the patient safety program.

Trial registration

Trial registration: ClinicalTrials.gov ID [NCT00365430]