Quality Assurance of Patient Safety Clinical Trial
Official title:
Safe-SCOPE Pilot Study: Standardized Checklist Of Patient Information Exchange
Study Title Safe- SCOPE Pilot Study Standardized Checklist of Patient Information Exchange
Short Title Safe- SCOPE Pilot Study
Study Design: Single centre two armed cluster randomised crossover pilot study
Study duration: 5 months
Objectives:
- Influence of standardised checklists on medical/ physician handovers on an Intensive
Care Unit -ICU and its influence on patient safety
- Satisfaction survey in physicians group
Number of patients:
All patients treated on OIM during assessment period
Checklist Intervention
- All physicians working in the department of Intensive Care Medicine and Intermediate
Care are informed and enlightened about Safe-SCOPE Pilot Study. After written consent
participating physicians will use an online form ISBAR3 Checklist or alternative
Checklist for handovers twice a day.
- Handover times/schedule:
OIM 1,2,3,5, und 6: 7:30 am and 7:30 pm OIM 4 und WEA 1: 7:30 am and 2:00 pm
- ISBAR3 Checklist
- VICUR Checklist wash- out Phase:
- No checklists for one month
Efficacy:
Patients:
- Mortality rate
- Duration on ICU
- Reuptake on ICU
- SOFA Score on admission to ICU, 48h, 72h and 120h after admission
- Handover duration per patient
- Number of enclosed patients
Handover:
- Entire handover duration
- Interruptions during handover
The simplest definition of patient safety is the prevention of errors and adverse events to
patient associated with health care. While health care has become more effective it has also
become more complex, with greater use of new technologies, medicines and treatments. Health
services treat older and sicker patients who often present with significant co- morbidities
requiring more and more difficult decisions as to health care priorities.
European data, mostly from European Union Member States, consistently show that medical
errors and health care related adverse events occur in 8-12% of hospitalization. For example,
the United Kingdom Department of health, in its 2000 report "An organisation with a memory",
estimated about 850 000 adverse events a year (10% of hospital admissions). Spain (in its
2005 national study of adverse events) and France and Denmark have published incidence
studies with similar results.
While 23% of European Union citizens claim to have been directly affected by medial errors,
18% claim to have experienced a serious medical error in a hospital and 11% to be prescribed
wrong medication. Evidence on medial errors shows that 50% to 70,2% of such harm can be
prevented through comprehensive systematic approaches to patient safety.
Statistics of the World Health Organisation (WHO) show further more that strategies to reduce
the rate of adverse events in the European Union alone would lead to the prevention of more
than 750 000 harm-inflicted medial errors per year, leading in turn to over 3,2 million fewer
days of hospitalization, 260 000 fewer incidents of permanent disability, and 95 000 fewer
deaths per years. Our working group clarifies this as very impressive data and statistics.
In aviation checklists are an established instrument to avoid adverse events and so to
improve safety. Like in the cockpit also in operating room checklists and briefings can be
useful to reduce perceived risks and improve collaboration among operating rooms personnel by
controlling safety standards, availability of required sources and responsibility assignment.
The World Health Organisation WHO in 2009 established checklist (Save Surgery Saves Lives) is
a feasible task increasingly used with individual adaptation. The Implementation has to be
ingrained in a hospital wide safety culture with patient safety- related behaviour and
perceived personal empowerment. The safe surgery saves lives campaign showed in eight
hospitals worldwide with different socio- ecological backgrounds that in around 8. 000
operations mortality and infections rate decreased significantly after using the safe surgery
saves lives checklist in operating theatres.
Checklists are efficient working tools used as a reminder or to structure processes. They
guarantee that processes are objective and reproducible and therefore increase patient-
safety. Especially in stress and emergency situations as they exist on an Intensive Care Unit
checklists can help to avoid mind mistakes and demonstrate possible decisions.
Related to these data and statistics and on that important background we are planning a
multi-centre main trial on improving patient safety: Standardized Checklist of Patient
Information Exchange. Because there is no information about the magnitude of checklist
effects on patient data and there is no risk for the patients we use the Safe SCOPE Pilot
study to estimate the effects size of the checklists and to investigate the feasibility of
the main trial.
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