Safe-SCOPE Pilot Study (Safe-SCOPE)

January 8, 2018 updated by: RWTH Aachen University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • RWTH Aachen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
admission and hour 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 30 days
Mortality rate
30 days
Duration on ICU
Time Frame: 30 days
Duration on ICU measured in days
30 days
Reuptake on ICU
Time Frame: 30 days
Reuptake on ICU and transferring ward
30 days
Handover duration patient
Time Frame: up to 3 months
Handover duration per single patient
up to 3 months
Handover duration entire
Time Frame: up to 3 months
entire handover duration
up to 3 months
Interruptions
Time Frame: up to 3 months
Interruptions during handover categories: none, < 5min, > 5min
up to 3 months
physicians satisfaction
Time Frame: through study completion, an average of 5 months
evaluation of satisfaction by questionnaire
through study completion, an average of 5 months
Change of SOFA Score at hour 72
Time Frame: baseline and hour 72
Change of SOFA Score to baseline (admission) and after 72 hours
baseline and hour 72
Change of SOFA Score at hour 120
Time Frame: baseline and hour 120
Change of SOFA Score to baseline (admission) and after 120 hours
baseline and hour 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Study Chair: Gernot Marx, Prof., Uniklinik RWTH Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTCA-16-164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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