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Educational Intervention for Resident Education (PROMOTE Trial)

N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previous performance of less than 5 of each of the index procedures independently in the OR
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, on average 1 year
Awards & highlights

PROMOTE Trial Summary

This trial will explore if surgical skills learned in a lab can improve OR performance. Residents will be split into two groups & graded by a doctor.

Who is the study for?
This trial is for Obstetrics and Gynaecology residents, medical students, fellows, or junior staff in the UBC program, as well as General surgery residents who have performed fewer than 5 of certain surgeries independently in the OR. Those with more experience are excluded.Check my eligibility
What is being tested?
The study is testing if surgical lab training improves actual operating room skills for residents. Participants will be randomly assigned to either an intervention group that must pass specific training modules or a control group receiving regular instruction.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, there are no direct physical side effects expected from participating.

PROMOTE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have performed fewer than 5 of the specific surgeries by myself.

PROMOTE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
- investigation of whether procedure-specific skills acquired in surgical lab
Secondary outcome measures
1 - Improved Knowledge
2 - Less OR Time
3 - Implemention of modular training
+2 more

Side effects data

From 2018 Phase 4 trial • 320 Patients • NCT03068897
4%
Gastrointestinal complaint
3%
Drowsiness
1%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metaxalone
Baclofen
Placebo
Tizanidine

PROMOTE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Specific intervention: Modules for each of the above comprising: didactic lecture on indications and contraindications of procedure, surgical anatomy, patient positioning in the OR, anesthesia type, suture materials and suturing techniques; practical component with hands-on surgical skill training in basic and advanced techniques relevant to each procedure immediate feedback from dedicated educator on technical aspects post-test
Group II: Control -Placebo Group1 Intervention
This group receives regular instruction.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Educational intervention
2018
Completed Phase 4
~15170

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,467,018 Total Patients Enrolled
Royal College of Physicians and Surgeons of CanadaOTHER
6 Previous Clinical Trials
380 Total Patients Enrolled
University of CalgaryOTHER
792 Previous Clinical Trials
869,054 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate participant count for this clinical research initiative?

"Yes, the information on clinicaltrials.gov attests to this medical trial's ongoing recruitment of participants. The study was initially posted on June 13th 2011 and most recently updated on May 24th 2023. At present, 100 patients from a single location are being sought for enrolment in the trial."

Answered by AI

Are there any openings for volunteers at this clinical trial?

"Affirmative, the details hosted on clinicaltrials.gov demonstrate that this research endeavor is actively seeking participants. It was initially publicized on June 13th 2011 and last updated on May 24th 2023. There are plans to recruit a total of 100 individuals from 1 site for participation in this trial."

Answered by AI

Who else is applying?

What site did they apply to?
St. Paul's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Procedure-Specific Resident Objective Modular Training Evaluation
Roxana Geoffrion 2011. "Procedure-Specific Resident Objective Modular Training Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05887570.
~1 spots leftby Jul 2024
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