title: Effects of a team-based assessment and intervention on patient safety culture in general practice: an open randomised controlled trial.
abstract: BACKGROUND
  The measurement of safety culture in healthcare is generally regarded as a first step towards improvement. Based on a self-assessment of safety culture, the Frankfurt Patient Safety Matrix (FraTrix) aims to enable healthcare teams to improve safety culture in their organisations. In this study we assessed the effects of FraTrix on safety culture in general practice.
  
  
  METHODS
  We conducted an open randomised controlled trial in 60 general practices. FraTrix was applied over a period of 9 months during three facilitated team sessions in intervention practices. At baseline and after 12 months, scores were allocated for safety culture as expressed in practice structure and processes (indicators), in safety climate and in patient safety incident reporting. The primary outcome was the indicator error management.
  
  
  RESULTS
  During the team sessions, practice teams reflected on their safety culture and decided on about 10 actions per practice to improve it. After 12 months, no significant differences were found between intervention and control groups in terms of error management (competing probability=0.48, 95% CI 0.34 to 0.63, p=0.823), 11 further patient safety culture indicators and safety climate scales. Intervention practices showed better reporting of patient safety incidents, reflected in a higher number of incident reports (mean (SD) 4.85 (4.94) vs 3.10 (5.42), p=0.045) and incident reports of higher quality (scoring 2.27 (1.93) vs 1.49 (1.67), p=0.038) than control practices.
  
  
  CONCLUSIONS
  Applied as a team-based instrument to assess safety culture, FraTrix did not lead to measurable improvements in error management. Comparable studies with more positive results had less robust study designs. In future research, validated combined methods to measure safety culture will be required. In addition, more attention should be paid to evaluation of process parameters. Implemented actions and incident reporting may be more appropriate target endpoints.
  
  
  BACKGROUND
  German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) No. DRKS00000145.
authors: Institute of General Practice, Goethe University Frankfurt am Main, , Frankfurt, Germany.
authors: B
authors: B
authors: Hoffmann
authors: V
authors: V
authors: Müller
authors: J
authors: J
authors: Rochon
authors: M
authors: M
authors: Gondan
authors: B
authors: B
authors: Müller
authors: Z
authors: Z
authors: Albay
authors: K
authors: K
authors: Weppler
authors: M
authors: M
authors: Leifermann
authors: C
authors: C
authors: Mießner
authors: C
authors: C
authors: Güthlin
authors: D
authors: D
authors: Parker
authors: G
authors: G
authors: Hofinger
authors: F M
authors: FM
authors: Gerlach
mesh_terms: D058006:General Practice; D005858:Germany; D006126:Group Processes; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control; D015403:Nursing Evaluation Research; D015279:Organizational Culture; D010043:Outcome and Process Assessment, Health Care / Q000592:standards* / Q000706:statistics & numerical data; D010348:Patient Care Team; D061214:Patient Safety; D011365:Professional Practice Location; D019984:Quality Indicators, Health Care / Q000592:standards* / Q000706:statistics & numerical data; D018401:Sample Size; D012647:Self-Assessment; D013997:Time Factors