Safe-SCOPE Pilot Study

Quality Assurance of Patient Safety Clinical Trial

— Safe-SCOPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117088
• Other study ID #: CTCA-16-164
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: January 8, 2018
• Start date: June 1, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: January 2018
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality Assurance of Patient Safety

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	RWTH Aachen University	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (10)

Ferreira FL, Bota DP, Bross A, Mélot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. — View Citation

Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14. — View Citation

Keebler JR, Lazzara EH, Patzer BS, Palmer EM, Plummer JP, Smith DC, Lew V, Fouquet S, Chan YR, Riss R. Meta-Analyses of the Effects of Standardized Handoff Protocols on Patient, Provider, and Organizational Outcomes. Hum Factors. 2016 Dec;58(8):1187-1205. Epub 2016 Oct 17. — View Citation

Kostoff M, Burkhardt C, Winter A, Shrader S. An Interprofessional Simulation Using the SBAR Communication Tool. Am J Pharm Educ. 2016 Nov 25;80(9):157. doi: 10.5688/ajpe809157. — View Citation

Randmaa M, Swenne CL, Mårtensson G, Högberg H, Engström M. Implementing situation-background-assessment-recommendation in an anaesthetic clinic and subsequent information retention among receivers: A prospective interventional study of postoperative handovers. Eur J Anaesthesiol. 2016 Mar;33(3):172-8. doi: 10.1097/EJA.0000000000000335. — View Citation

Starmer AJ, Landrigan CP; I-PASS Study Group. Changes in medical errors with a handoff program. N Engl J Med. 2015 Jan 29;372(5):490-1. doi: 10.1056/NEJMc1414788. — View Citation

Starmer AJ, Sectish TC, Simon DW, Keohane C, McSweeney ME, Chung EY, Yoon CS, Lipsitz SR, Wassner AJ, Harper MB, Landrigan CP. Rates of medical errors and preventable adverse events among hospitalized children following implementation of a resident handoff bundle. JAMA. 2013 Dec 4;310(21):2262-70. doi: 10.1001/jama.2013.281961. — View Citation

Starmer AJ, Spector ND, Srivastava R, West DC, Rosenbluth G, Allen AD, Noble EL, Tse LL, Dalal AK, Keohane CA, Lipsitz SR, Rothschild JM, Wien MF, Yoon CS, Zigmont KR, Wilson KM, O'Toole JK, Solan LG, Aylor M, Bismilla Z, Coffey M, Mahant S, Blankenburg RL, Destino LA, Everhart JL, Patel SJ, Bale JF Jr, Spackman JB, Stevenson AT, Calaman S, Cole FS, Balmer DF, Hepps JH, Lopreiato JO, Yu CE, Sectish TC, Landrigan CP; I-PASS Study Group. Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014 Nov 6;371(19):1803-12. doi: 10.1056/NEJMsa1405556. — View Citation

Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. — View Citation

Yee KC, Wong MC, Turner P. "HAND ME AN ISOBAR": a pilot study of an evidence-based approach to improving shift-to-shift clinical handover. Med J Aust. 2009 Jun 1;190(11 Suppl):S121-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of SOFA Score at hour 48	Change of SOFA Score to baseline (admission) and 48 hours after admission	admission and hour 48
Secondary	Mortality rate	Mortality rate	30 days
Secondary	Duration on ICU	Duration on ICU measured in days	30 days
Secondary	Reuptake on ICU	Reuptake on ICU and transferring ward	30 days
Secondary	Handover duration patient	Handover duration per single patient	up to 3 months
Secondary	Handover duration entire	entire handover duration	up to 3 months
Secondary	Interruptions	Interruptions during handover categories: none, < 5min, > 5min	up to 3 months
Secondary	physicians satisfaction	evaluation of satisfaction by questionnaire	through study completion, an average of 5 months
Secondary	Change of SOFA Score at hour 72	Change of SOFA Score to baseline (admission) and after 72 hours	baseline and hour 72
Secondary	Change of SOFA Score at hour 120	Change of SOFA Score to baseline (admission) and after 120 hours	baseline and hour 120

External Links

•   Australian Commission on Safety and Quality in Health Care
•   Data and Statistics Wold health Organisation
•   Krankenhaus-Checkliste
•   Patient Safety World Health Organisation
•   Uniklinik RWTH Aachen
•   WHO surgical safety checklist and implementation manual