title: The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study.
abstract: BACKGROUND
  Research on patient safety has focused largely on secondary care settings, and there is a dearth of knowledge relating to safety culture or climate, and safety climate improvement strategies, in the context of primary care. This is problematic given the high rates of usage of primary care services and the myriad of opportunities for clinical errors daily. The current research programme aimed to assess the effectiveness of an intervention derived from the Scottish Patient Safety Programme in Primary Care. The intervention consists of safety climate measurement and feedback and patient chart audit using the trigger review method. The purpose of this paper is to describe the background to this research and to present the methodology of this feasibility study in preparation for a future definitive RCT.
  
  
  METHODS
  The SAP-C study is a feasibility study employing a randomised controlled pretest-posttest design that will be conducted in 10 general practices in the Republic of Ireland and Northern Ireland. Five practices will receive the safety climate intervention over a 9-month period. The five practices in the control group will continue care as usual but will complete the GP-SafeQuest safety climate questionnaire at baseline (month 1) and at the terminus of the intervention (month 9). The outcomes of the study include process evaluation metrics (i.e. rates of participant recruitment and retention, rates of completion of safety climate measures, qualitative data regarding participants' perceptions of the intervention's potential efficacy, acceptability, and sustainability), patient safety culture in intervention and control group practices at posttest, and instances of undetected patient harm identified through patient chart audit using the trigger review method.
  
  
  CONCLUSIONS
  The planned study investigates an intervention to improve safety climate in Irish primary care settings. The resulting data may inform our knowledge of the frequency of undetected patient safety incidents in primary care, may contribute to improved patient safety practices in primary care settings, and may inform future research on patient safety improvement initiatives.
authors.affiliation: Discipline of General Practice, National University of Ireland, Galway, Ireland.
authors.forename: Sinéad
authors.initials: S
authors.lastname: Lydon
authors.affiliation: Department of General Practice and Primary Care, School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, UK ; UKCRC Centre of Excellence for Public Health Research (NI), Queen's University, Belfast, UK.
authors.forename: Margaret E
authors.initials: ME
authors.lastname: Cupples
authors.affiliation: Department of General Practice and Primary Care, School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, UK.
authors.forename: Nigel
authors.initials: N
authors.lastname: Hart
authors.affiliation: Discipline of General Practice, National University of Ireland, Galway, Ireland.
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Murphy
authors.affiliation: Discipline of General Practice, National University of Ireland, Galway, Ireland.
authors.forename: Aileen
authors.initials: A
authors.lastname: Faherty
authors.affiliation: Discipline of General Practice, National University of Ireland, Galway, Ireland.
authors.forename: Paul
authors.initials: P
authors.lastname: O'Connor
keywords: Audit; General practice; Intervention; Patient safety; Primary care; Questionnaire; Safety climate; Safety culture