NCT04842357

Brief Summary

Due to the corona pandemia and the consecutive reduction of teaching students face to face the imparting of medical skills is limited. Video sequences may be an adequate alternative to educate selected practical skills. So, the investigators intend to explore this aspect as a first concerning two basic medical skills: Donati suture and intraosseous venous access.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

17 days

First QC Date

April 6, 2021

Last Update Submit

August 23, 2021

Conditions

Keywords

clinical skillsintraosseous accessDonati sutureimparting skillseducationundergraduate education

Outcome Measures

Primary Outcomes (2)

  • Donati suture: "Task-Specific Score"

    Score to quantify the particular skill: Minimum / worst performance 8, Max / best performance: 40

    1 week

  • Intraosseous venous access: "Intraosseous Access Performance Assessment Scale"

    Score to quantify the particular skill: Minimum / worst performance 0, Max / best performance: 17

    1 week

Study Arms (2)

video - then self-study

OTHER

Group A will be video recorded during the performance of the two skills on simulators (i.e. Donati suture and intraosseous venous access) (timepoint: T0). Then group A will watch a standardised video about the skills, then will be again video recorded during the performance of the two skills on simulators (timepoint: T1). After 1 to 2 weeks group A will do self-study, then will be again video recorded during the performance of the two skills on simulators (timepoint: T2).

Other: standardised video concerning clinical skill

self-study, then video

OTHER

Group B will be video recorded during the performance of the two skills on simulators (i.e. Donati suture and intraosseous venous access) (timepoint: T0). Then group B will do self-study, then will be again video recorded during the performance of the two skills on simulators (timepoint: T1). After 1 to 2 weeks group B will watch the standardised video about the skills, then will be again video recorded during the performance of the two skills on simulators (timepoint: T2).

Other: standardised video concerning clinical skill

Interventions

watching a video concerning clinical skills.

self-study, then videovideo - then self-study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medical student in the last year of the curriculum

You may not qualify if:

  • no medical student in the last year of the curriculum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Centre Mainz

Mainz, RLP, 55131, Germany

Location

Related Publications (6)

  • Levitan RM, Bortle CD, Snyder TA, Nitsch DA, Pisaturo JT, Butler KH. Use of a battery-operated needle driver for intraosseous access by novice users: skill acquisition with cadavers. Ann Emerg Med. 2009 Nov;54(5):692-4. doi: 10.1016/j.annemergmed.2009.06.012. Epub 2009 Jul 29.

    PMID: 19643511BACKGROUND
  • Lee JC, Boyd R, Stuart P. Randomized controlled trial of an instructional DVD for clinical skills teaching. Emerg Med Australas. 2007 Jun;19(3):241-5. doi: 10.1111/j.1742-6723.2007.00976.x.

    PMID: 17564692BACKGROUND
  • Shippey S, Handa VL, Chen TL, Chou B, Bowen CW. Validation of an instrument for evaluation of subcuticular suturing using a plastic tissue model. J Surg Educ. 2009 Jan-Feb;66(1):31-4. doi: 10.1016/j.jsurg.2008.09.001.

  • Shippey SH, Chen TL, Chou B, Knoepp LR, Bowen CW, Handa VL. Teaching subcuticular suturing to medical students: video versus expert instructor feedback. J Surg Educ. 2011 Sep-Oct;68(5):397-402. doi: 10.1016/j.jsurg.2011.04.006. Epub 2011 Jun 25.

  • Oriot D, Darrieux E, Boureau-Voultoury A, Ragot S, Scepi M. Validation of a performance assessment scale for simulated intraosseous access. Simul Healthc. 2012 Jun;7(3):171-5. doi: 10.1097/SIH.0b013e31824a5c20.

  • Ott T, Demare T, Mohrke J, Silber S, Schwab J, Reuter L, Westhphal R, Schmidtmann I, Dietz SO, Pirlich N, Ziebart A, Engelhard K. Does an instructional video as a stand-alone tool promote the acquisition of practical clinical skills? A randomised simulation research trial of skills acquisition and short-term retention. BMC Med Educ. 2024 Jul 2;24(1):714. doi: 10.1186/s12909-024-05714-6.

Study Officials

  • Sven-Oliver O. Dietz, M.D., Ph.D.

    Trauma Surgery / Zentrum für Orthopädie und Unfallchirurgie, Langebeckstr. 1, 55131 Mainz, Germany

    STUDY DIRECTOR
  • Thomas Ott, M.D.

    Department of Anaesthesiology / Klinik für Anästhesiologie, Langenbeckstr. 1, 55131 Mainz, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The participant cannot be masked because they realise if they are in group A or B
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The investigators will recruit last year medical students and randomise them into two groups: Group A and Group B. Both groups will be video recorded during the performance of the two skills on simulators (i.s. Donati suture and intraosseous venous access) (timepoint: T0). Then group A will watch a standardised video about the skills, and group B will do self-study. Then, both groups will be again video recorded during the performance of the two skills on simulators (timepoint: T1). After 1 week group B will watch the same standardised video about the skills, and group A will do self-study. Then both groups will be again video recorded during the performance of the two skills on simulators (timepoint: T2).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thomas Ott, M.D., DESA, Scientific consultant of the simulation center, Department of Anesthesiology, University Hospital Center

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 13, 2021

Study Start

May 25, 2021

Primary Completion

June 11, 2021

Study Completion

July 30, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

We will decide after ethical review board approval.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
expected 2022
Access Criteria
via journal access policies

Locations