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Safe-SCOPE Pilot Study (Safe-SCOPE)

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ClinicalTrials.gov Identifier: NCT03117088
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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

Condition or disease Intervention/treatment Phase
Quality Assurance of Patient Safety Other: Checklist ISBAR3 Other: Checklist VICUR Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: two armed cluster randomized crossover three periods prospective single centre pilot study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safe-SCOPE Pilot Study: Standardized Checklist Of Patient Information Exchange
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

Arm Intervention/treatment
Active Comparator: Checklist ISBAR 3
online-based checklist for standardized handovers
Other: Checklist ISBAR3

Checklist ISBAR 3

Use of an online based checklist for handovers with the following items:

Identification Situation Background Assessment Recommendation Read- back Risk

Established Checklist as communication tool


Placebo Comparator: Checklist VICUR
comparator Checklist
Other: Checklist VICUR

Checklist Vicur

Use of an online based alternative checklist for handovers with the following items:

Vaccination status Insurance status Contact person Utilisation Rehabilitation Organ donor? Patient decree?

alternative checklist missing communication tool





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mortality rate [ Time Frame: 30 days ]
    Mortality rate

  2. Duration on ICU [ Time Frame: 30 days ]
    Duration on ICU measured in days

  3. Reuptake on ICU [ Time Frame: 30 days ]
    Reuptake on ICU and transferring ward

  4. Handover duration patient [ Time Frame: up to 3 months ]
    Handover duration per single patient

  5. Handover duration entire [ Time Frame: up to 3 months ]
    entire handover duration

  6. Interruptions [ Time Frame: up to 3 months ]
    Interruptions during handover categories: none, < 5min, > 5min

  7. physicians satisfaction [ Time Frame: through study completion, an average of 5 months ]
    evaluation of satisfaction by questionnaire

  8. Change of SOFA Score at hour 72 [ Time Frame: baseline and hour 72 ]
    Change of SOFA Score to baseline (admission) and after 72 hours

  9. Change of SOFA Score at hour 120 [ Time Frame: baseline and hour 120 ]
    Change of SOFA Score to baseline (admission) and after 120 hours



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117088


Locations
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Germany
RWTH Aachen University
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Study Chair: Gernot Marx, Prof. Uniklinik RWTH Aachen

Additional Information:
Publications:

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03117088     History of Changes
Other Study ID Numbers: CTCA-16-164
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RWTH Aachen University:
Standardized handover
Online-based
SOFA-Score
ICU
ISBAR3