Safety in primary care (SAP-C): A randomised, controlled feasibility study in two different healthcare systems

Abstract

Background: Patient safety research is conducted predominantly in hospital settings, with a dearth of insight from primary care, despite suggestions that 2.2% of primary care consultations result in a patient safety incident. This study aimed to assess the feasibility of an intervention intended to improve patient safety in general practice. Methods: A randomised controlled feasibility study was conducted with general practices in the Republic of Ireland (N = 9) and Northern Ireland (N = 2), randomly assigned to the intervention (N = 5) or control (N = 6) group. The nine-month intervention consisted of: 1) repeated safety climate (SC) measurement (using GP-SafeQuest questionnaire) and feedback (comparative anonymised practice-level SC data), and 2) patient record reviews using a specialised trigger tool to identify instances of undetected patient harm. For control practices, SC was measured at baseline and study end only. The intervention's perceived usefulness and feasibility were explored via an end-of-study questionnaire and semi-structured interviews. Results: Thirteen practices were invited; 11 participated; 10 completed the study. At baseline, 84.8% of intervention practice staff (39/46) and 77.8% (42/54) of control practice staff completed the SC questionnaire; at the study terminus, 78.3% (36/46) of intervention practice staff and 68.5% (37/54) of control practice staff did so. Changes in SC scores, indicating improvement, were observed among the intervention practices but not in the control group. The trigger tool was applied to 188 patient records; patient safety incidents of varying severity were detected in 19.1% (36/188). Overall, 59% of intervention practice team members completed the end-of-study questionnaire, with the majority in both healthcare systems responding positively about the intervention. Interviews (N = 9) identified the intervention's usefulness in informing practice management and patient safety issues, time as a barrier to its use, and the value of group discussion of feedback. Conclusion: This feasibility study suggests that a definitive randomised controlled trial of the intervention is warranted. Our findings suggest that the intervention is feasible, useful, and sustainable. Practices were willing to be recruited into the study, response and retention rates were acceptable, and there is possible evidence of a positive effect of the intervention. Trial registration: The trial registration number is: ISRCTN11426121 (retrospectively registered 12th June 2018).