NCT03117088: Safe-SCOPE

Safe-SCOPE Pilot Study

Completed NA Last updated 9 January 2018

What this trial tests

NA trial testing Checklist ISBAR3 in Quality Assurance of Patient Safety in 7 participants. Completed in 30 November 2017.

Timeline

1 June 2017

Primary endpoint
30 November 2017

30 November 2017

Quick facts

Lead sponsor	RWTH Aachen University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	7
Start date	1 June 2017
Primary completion	30 November 2017
Estimated completion	30 November 2017
Sites	1 location across Germany

Drugs / interventions tested

• Checklist ISBAR3
• Checklist VICUR

Conditions studied

• Quality Assurance of Patient Safety — all drugs for Quality Assurance of Patient Safety →

Sponsor

RWTH Aachen University

Who can join

18 and older, any sex, with Quality Assurance of Patient Safety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Do Digital Handover Checklists Influence the Clinical Outcome Parameters of Intensive Care Unit Patients? A Randomized Controlled Pilot Study.
   Verholen N, Vogt L, Klasen M, Schmidt M, et al · · 2021 · cited 4× · PMID 33959627 · DOI 10.3389/fmed.2021.661343