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Clinical Trials/NCT03117088
NCT03117088CompletedNot Applicable

Safe-SCOPE Pilot Study: Standardized Checklist Of Patient Information Exchange

RWTH Aachen University2 sites in 1 country7 target enrollmentStarted: June 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
2
Primary Endpoint
Change of SOFA Score at hour 48

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Physicians:
  • all physicians working on ICU (department of Intensive Medicine and Intermediate Care) during data collection
  • existing written consent
  • All patients treated in the department of Intensive Care Medicine and Intermediate Care (OIM) during assessment period who passed at least two online form based handovers

Exclusion Criteria

  • Physicians:
  • missing written consent
  • Chief of the department of Intensive Care medicine and Intermediate Care
  • Colleagues involved in Safe- SCOPE Pilot Study protocol or group of experts
  • Age < 18 years
  • Pregnancy
  • ward shift within OIM and hereby associated cluster change

Arms & Interventions

Checklist ISBAR 3

Active Comparator

online-based checklist for standardized handovers

Intervention: Checklist ISBAR3 (Other)

Checklist VICUR

Placebo Comparator

comparator Checklist

Intervention: Checklist VICUR (Other)

Outcomes

Primary Outcomes

Change of SOFA Score at hour 48

Time Frame: admission and hour 48

Change of SOFA Score to baseline (admission) and 48 hours after admission

Secondary Outcomes

  • Duration on ICU(30 days)
  • Handover duration entire(up to 3 months)
  • Mortality rate(30 days)
  • Reuptake on ICU(30 days)
  • Handover duration patient(up to 3 months)
  • Interruptions(up to 3 months)
  • physicians satisfaction(through study completion, an average of 5 months)
  • Change of SOFA Score at hour 120(baseline and hour 120)
  • Change of SOFA Score at hour 72(baseline and hour 72)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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