NCT07305077

Brief Summary

Intervention Model: Parallel Assignment Model Description: Cluster-randomized by preceptor (30 clusters; 15 OMP/15 control). Outcomes at student level; 15 students per cluster. Adequate OMP exposure is defined a priori as ≥2 structured OMP feedback encounters (≥5 minutes each) delivered across ≥2 separate weeks of the rotation. Masking: Outcomes Assessor

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

December 26, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 21, 2025

Last Update Submit

December 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mini-Clinical Evaluation Exercise (mini-CEX) Total Score

    Total score on the mini-CEX, ranging from 1 to 5. Higher scores indicate better bedside teaching performance as rated by student participants. Measure Type: Continuous.

    8 - 12 weeks

Secondary Outcomes (1)

  • Student Satisfaction Score

    8-12 weeks

Study Arms (2)

OMP

EXPERIMENTAL

One-Minute Preceptor training: 90-min workshop + pocket card + coaching + fidelity checklist.

Behavioral: One-Minute Preceptor (OMP)

Control

NO INTERVENTION

Usual bedside teaching; OMP offered after trial completion.

Interventions

Faculty development workshop (90 min), pocket card, coaching, audit with OMP 5-step fidelity checklist.

Also known as: OMP
OMP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A. Student participants (outcome level):
  • Aged ≥18 years at enrollment.
  • Enrolled Year 4-medical students assigned to one of the participating preceptor-led bedside teaching groups during the study period.
  • Expected to attend the rotation for 8-12 weeks (or the site's standard rotation length).
  • Able to provide informed consent (and agree to be observed/assessed via mini-CEX).
  • \- B. Preceptor clusters (randomized units):
  • Resident physicians serving as bedside teaching preceptors in participating departments.
  • Will supervise approximately 15 students during the study period.
  • Agree not to cross over to teach students in the opposite trial arm during the trial period.
  • Able to attend OMP training and permit fidelity observation (checklist) if allocated to the intervention.

You may not qualify if:

  • A. Student participants:
  • Prior exposure to formal OMP-based teaching within the past 6 months in the same department.
  • Not expected to remain on the rotation long enough to be assessed (e.g., planned absence \>2 weeks or early withdrawal).
  • Declines or withdraws informed consent.
  • Severe communication barrier that precludes valid assessment (e.g., language barrier without support).
  • \- B. Preceptor clusters:
  • Formal OMP training within the past 12 months (to avoid contamination), or role as an OMP trainer for other faculty during the study period.
  • Planned cross-coverage that would result in teaching students from both arms during the trial period.
  • Anticipated extended leave making fidelity and outcome assessments infeasible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho Children Hospital

Can Tho, Province, 900000, Vietnam

RECRUITING

Study Officials

  • Quang C Ngo

    Can Tho University Medicine and Pharmacy

    STUDY CHAIR

Central Study Contacts

Quang Chi Ngo, Master Degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster-randomized by preceptor (n=30 clusters; 15 OMP vs 15 control); outcomes at student level
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 26, 2025

Study Start

August 20, 2025

Primary Completion

December 15, 2025

Study Completion

April 10, 2026

Last Updated

December 26, 2025

Record last verified: 2025-11

Locations