Institute of General Practice, Goethe University Frankfurt am Main, , Frankfurt, Germany.
BMJ Qual Saf. 2014 Jan;23(1):35-46. doi: 10.1136/bmjqs-2013-001899. Epub 2013 Aug 16.
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.
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.
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.
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.
German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) No. DRKS00000145.
医疗保健领域的安全文化测量通常被认为是改进的第一步。法兰克福患者安全矩阵（FraTrix）旨在基于安全文化的自我评估，使医疗保健团队能够改善其组织中的安全文化。在这项研究中，我们评估了 FraTrix 对一般实践中安全文化的影响。
我们在 60 家普通诊所进行了一项开放性随机对照试验。在干预诊所的三个小组会议中，FraTrix 在 9 个月的时间内应用。在基线和 12 个月后，根据实践结构和流程（指标）、安全氛围和患者安全事件报告来分配安全文化的得分。主要结果是错误管理指标。
在团队会议期间，实践团队反思了他们的安全文化，并为每个实践决定了大约 10 个改进安全文化的行动。在 12 个月后，干预组和对照组在错误管理（竞争概率=0.48，95%置信区间 0.34 至 0.63，p=0.823）、11 个进一步的患者安全文化指标和安全氛围量表方面没有发现显著差异。干预实践报告了更多的患者安全事件，反映在更高数量的事件报告（平均（SD）4.85（4.94）与 3.10（5.42），p=0.045）和更高质量的事件报告（评分 2.27（1.93）与 1.49（1.67），p=0.038）比对照组。
作为一种用于评估安全文化的基于团队的工具，FraTrix 并没有导致错误管理的可衡量改善。具有更积极结果的可比研究设计更为稳健。在未来的研究中，需要使用经过验证的综合方法来测量安全文化。此外，应更加关注评估过程参数。实施的行动和事件报告可能是更合适的目标终点。
德国临床试验注册处（Deutsches Register Klinischer Studien，DRKS）编号 DRKS00000145。
