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

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]