Quality Assurance of Patient SafetySafe-SCOPENCT03117088
Safe-SCOPE Pilot Study
A study testing Checklist ISBAR3 and Checklist VICUR in people with Quality Assurance of Patient Safety, run by RWTH Aachen University at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality Assurance of Patient Safety
- What is being tested?
- Checklist ISBAR3 and Checklist VICUR
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
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
Read the 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.
- Conditions
- Quality Assurance of Patient Safety
- Being tested
- Checklist ISBAR3, Checklist VICUR
- Keywords
- Standardized handover, Online-based, SOFA-Score, ICU, ISBAR3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist ISBAR3Other
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 VICUROther
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
| Study group | Role | What they receive |
|---|---|---|
| Checklist ISBAR 3 | Active comparator | online-based checklist for standardized handovers Receives: Other: Checklist ISBAR3 |
| Checklist VICUR | Placebo comparator | comparator Checklist Receives: Other: Checklist VICUR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of SOFA Score at hour 48
Change of SOFA Score to baseline (admission) and 48 hours after admission
Measured: admission and hour 48
Secondary outcomes (9)
Mortality rate
Mortality rate
Measured: 30 days
Duration on ICU
Duration on ICU measured in days
Measured: 30 days
Reuptake on ICU
Reuptake on ICU and transferring ward
Measured: 30 days
Handover duration patient
Handover duration per single patient
Measured: up to 3 months
Handover duration entire
entire handover duration
Measured: up to 3 months
Interruptions
Interruptions during handover categories: none, < 5min, > 5min
Measured: up to 3 months
physicians satisfaction
evaluation of satisfaction by questionnaire
Measured: through study completion, an average of 5 months
Change of SOFA Score at hour 72
Change of SOFA Score to baseline (admission) and after 72 hours
Measured: baseline and hour 72
Change of SOFA Score at hour 120
Change of SOFA Score to baseline (admission) and after 120 hours
Measured: baseline and hour 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start1 Jun 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Quality Assurance of Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two armed cluster randomized crossover three periods prospective single centre pilot study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gernot Marx, Prof., Study chair, Uniklinik RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117088
- Sponsor's protocol ID
- CTCA-16-164
- Acronym
- Safe-SCOPE
- Status last verified
- Jan 2018
- First submitted
- 14 Mar 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19144931Keebler 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. doi: 10.1177/0018720816672309. Epub 2016 Oct 17.
PubMed 27821676Starmer 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. No abstract available.
PubMed 25629753Starmer 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.
PubMed 25372088Starmer 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.
PubMed 24302089Randmaa M, Swenne CL, Martensson G, Hogberg H, Engstrom 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.
PubMed 26760400Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754.
PubMed 11594901Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca 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. doi: 10.1007/BF01709751. No abstract available.
PubMed 8844239Kostoff 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.
PubMed 28090106Yee 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(S11):S121-4. doi: 10.5694/j.1326-5377.2009.tb02617.x.
PubMed 19485859Verholen 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.
PubMed 33959627
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe-SCOPE Pilot Study: Standardized Checklist Of Patient Information Exchange
- ClinicalTrials.gov ID
- NCT03117088
- Acronym / sponsor ID
- Safe-SCOPE / CTCA-16-164
- Conditions
- Quality Assurance of Patient Safety
- Keywords
- Standardized handover, Online-based, SOFA-Score, ICU, ISBAR3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two armed cluster randomized crossover three periods prospective single centre pilot study
| Arm | Type | Receives |
|---|---|---|
| Checklist ISBAR 3 | Active comparator | Other: Checklist ISBAR3online-based checklist for standardized handovers |
| Checklist VICUR | Placebo comparator | Other: Checklist VICURcomparator Checklist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checklist ISBAR3Checklist 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 | Other | Checklist ISBAR 3 |
| Checklist VICURChecklist 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 | Other | Checklist VICUR |
Primary outcome
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
9 secondary outcomes
Mortality rate
Time frame: 30 days
Duration on ICU
Time frame: 30 days
Reuptake on ICU
Time frame: 30 days
Handover duration patient
Time frame: up to 3 months
Handover duration entire
Time frame: up to 3 months
Interruptions
Time frame: up to 3 months
physicians satisfaction
Time frame: 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 at hour 120
Time frame: baseline and hour 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Background: PubMed 19144931Haynes 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.
- Background: PubMed 27821676Keebler 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. doi: 10.1177/0018720816672309. Epub 2016 Oct 17.
- Background: PubMed 25629753Starmer 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. No abstract available.
- Background: PubMed 25372088Starmer 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.
- Background: PubMed 24302089Starmer 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.
- Background: PubMed 26760400Randmaa M, Swenne CL, Martensson G, Hogberg H, Engstrom 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.
- Background: PubMed 11594901Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754.
- Background: PubMed 8844239Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca 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. doi: 10.1007/BF01709751. No abstract available.
- Background: PubMed 28090106Kostoff 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.
- Background: PubMed 19485859Yee 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(S11):S121-4. doi: 10.5694/j.1326-5377.2009.tb02617.x.
- Derived from this study: PubMed 33959627Verholen 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.
- Patient Safety World Health OrganisationLink provided by the sponsor.
- Data and Statistics Wold health OrganisationLink provided by the sponsor.
- Australian Commission on Safety and Quality in Health CareLink provided by the sponsor.
- Krankenhaus-ChecklisteLink provided by the sponsor.
- Uniklinik RWTH AachenLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gernot Marx, Prof. study chair
Uniklinik RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist ISBAR3 and Checklist VICUR in people with Quality Assurance of Patient Safety, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of SOFA Score at hour 48 (time frame: admission and hour 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117088, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.