Clinical trial NCT03117088: Safe-SCOPE Pilot Study
Official title: Safe-SCOPE Pilot Study: Standardized Checklist Of Patient Information Exchange
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality Assurance of Patient Safety
Keywords: Standardized handover
Online-based
SOFA-Score
ICU
ISBAR3
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two armed cluster randomized crossover three periods prospective single centre pilot study
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

Physicians:

* all physicians working on ICU (department of Intensive Medicine and Intermediate Care) during data collection
* existing written consent

Patients:

* 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

Patients:

* Age \< 18 years
* Pregnancy
* ward shift within OIM and hereby associated cluster change

Primary outcomes:
measure: Change of SOFA Score at hour 48
timeFrame: admission and hour 48
Secondary outcomes:
measure: Mortality rate
timeFrame: 30 days
measure: Duration on ICU
timeFrame: 30 days
measure: Reuptake on ICU
timeFrame: 30 days
measure: Handover duration patient
timeFrame: up to 3 months
measure: Handover duration entire
timeFrame: up to 3 months
measure: Interruptions
timeFrame: up to 3 months
measure: physicians satisfaction
timeFrame: through study completion, an average of 5 months
measure: Change of SOFA Score at hour 72
timeFrame: baseline and hour 72
measure: Change of SOFA Score at hour 120
timeFrame: baseline and hour 120
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University
state: NRW
Study officials:
affiliation: Uniklinik RWTH Aachen
name: Gernot Marx, Prof.
role: STUDY_CHAIR
References:
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citation: Verholen N, Vogt L, Klasen M, Schmidt M, Beckers S, Marx G, Sopka S. Do Digital Handover Checklists Influence the Clinical Outcome Parameters of Intensive Care Unit Patients? A Randomized Controlled Pilot Study. Front Med (Lausanne). 2021 Apr 20;8:661343. doi: 10.3389/fmed.2021.661343. eCollection 2021.