The Effect of Digital Interactive and Face-to-Face Peer Support on Medical Students' Clinical Skill Performance, Reflection Skills, and Retention of Clinical Skills
Phase: NA
Conditions: Clinical Skills Education, Peer Support Interventions, Medical Students, Objective Structured Clinical Examination, Clinical Competence, Education, Medical, Undergraduate, Students, Medical, Social Support
Sponsor: Çanakkale Onsekiz Mart University

COVER PAGE
OFFICIAL TITLE
The Effect of Digital Interactive and Face-to-Face Peer Support on Medical Students' C
NCT NUMBER
not assigned
DOCUMENT TYPE
Study Protocol and Statistical Analysis Plan
DOCUMENT DATE
16 Sep 2025
UNIQUE PROTOCOL ID
2023-YÖNP-0719
VERSION
v1.0
LANGUAGE
English

Study Protocol and Statistical Analysis Plan
Official Title: The Effect of Digital Interactive and Face-to-Face Peer Support on
Medical Students' Clinical Skill Performance, Reflection Skills, and Retention of
Clinical Skills
NCT Number: not assigned
Unique Protocol ID: 2023-YÖNP-0719
Document Date: 16 Sep 2025 — Version: v1.0
1. Synopsis
• Design: Interventional, randomized, parallel-group, three-arm educational trial.
• Arms: (A) Digital interactive peer support; (B) Face-to-face peer support; (C)
Standard training (control).
• Primary Endpoint: Objective Structured Clinical Examination (OSCE) total score
immediately post-intervention (points; higher is better).
• Secondary Endpoints: Reflection skills scale total score immediately
post-intervention; Retention assessed by a follow-up OSCE at a predefined
interval (e.g., 8–12 weeks).
• Setting: Clinical Skills Laboratory within a Faculty of Medicine in Türkiye.
• Population: Adult medical students meeting eligibility criteria.
• Allocation: Approximately 1:1:1; no masking.
• Estimated/Actual Enrollment: About 100 participants (retrospective registration
of a completed trial).
2. Background and Rationale
Peer support is widely used in health professions education to promote practice,
feedback, and reflection. Digital interactive platforms may expand access and
flexibility compared with traditional face-to-face sessions. This study evaluates
whether structured digital peer support is non-inferior or superior to face-to-face
peer support, and whether either approach improves clinical skill performance
compared with standard training.
3. Objectives
Primary Objective. Compare post-intervention clinical skill performance between
arms using OSCE total scores.
Secondary Objectives. Compare reflection skills between arms immediately
post-intervention; evaluate retention of clinical skills at follow-up OSCE; explore
relationships between outcomes and exposure to peer support.
4. Endpoints

Primary Endpoint. OSCE total score immediately post-intervention (points; higher
scores indicate better performance).
Secondary Endpoints. (i) Reflection skills total score immediately post-intervention
(points; higher is better); (ii) Follow-up OSCE total score at a predefined interval to
assess retention.
5. Trial Design
Individually randomized, parallel assignment with three arms. Participants are
assigned in approximately equal numbers to the digital, face-to-face, or standard
training arms. Interventions occur within routine clinical skills teaching sessions.
No masking is used.
6. Study Setting
University-based Clinical Skills Laboratory and associated teaching rooms in
Türkiye.
7. Eligibility Criteria
Inclusion Criteria
• Enrolled medical students [specify year(s)].
• Age ≥18 and able to provide informed consent.
• Sufficient proficiency in the language of instruction.
• Access to the digital platform (for allocation to the digital arm).
• Availability for post-intervention and follow-up assessments.
Exclusion Criteria
• Prior formal certification or extensive training in the targeted clinical skills.
• Inability to attend scheduled peer-support sessions (digital or face-to-face).
• Conditions preventing participation in OSCE/assessment procedures.
8. Interventions
Digital Interactive Peer Support (Behavioral). Structured peer learning via an
online platform (modules, quizzes, discussion forums, and peer feedback).
Face-to-Face Peer Support (Behavioral). Structured in-person peer sessions with
guided practice, observation, and formative feedback.
Standard Training (Control; Behavioral). Usual curriculum-based clinical skills
training without additional structured peer support.
9. Procedures and Schedule
Following consent and baseline administrative checks, students receive instruction
according to allocation. Outcome assessments include an immediate
post-intervention OSCE and a validated reflection skills questionnaire. A follow-up
OSCE is administered at a predefined interval (e.g., 8–12 weeks) to assess
retention. Assessors use standardized checklists and instructions. No

investigational products are used.
10. Data Management and Confidentiality
Data are recorded using de-identified codes and stored on secure institutional
systems. Only authorized personnel have access to identifiable information.
Aggregated results may be disseminated in publications without personal
identifiers.
11. Ethics and Oversight
The study was reviewed by an institutional ethics committee. Participation is
voluntary, and students may withdraw at any time without academic penalty. The
study involves minimal risk educational procedures. A Data Monitoring Committee
is not planned for this low-risk trial.

Statistical Analysis Plan (SAP)
This SAP prespecifies analysis populations, endpoints, statistical tests, missing data
handling, and multiplicity control. Analyses will be conducted using a two-sided
significance level of 0.05.
12. Analysis Populations
Intent-to-Treat (ITT): All randomized students with at least one post-intervention
assessment.
Per-Protocol (PP): Subset without major protocol deviations.
13. Descriptive Statistics
Continuous variables will be summarized with mean, standard deviation, median,
minimum, and maximum; categorical variables with counts and percentages.
14. Primary Endpoint Analysis
Between-arm comparison of immediate post-intervention OSCE total scores: if
assumptions are met, one-way ANOVA; otherwise, Kruskal–Wallis test. If the
omnibus test is significant, perform pairwise comparisons with multiplicity
adjustment (e.g., Bonferroni or Holm).
15. Secondary Endpoint Analyses
Reflection skills total score will be analyzed analogously to the primary endpoint.
Retention of skills will be evaluated by comparing follow-up OSCE total scores
between arms at the predefined time point using ANOVA or Kruskal–Wallis as
appropriate.
16. Covariate-Adjusted Analyses (Exploratory)
If available, models may adjust for prespecified covariates such as prior academic
performance, baseline checklist items, or attendance. Model diagnostics will be
examined; if assumptions are violated, robust or nonparametric alternatives will be
considered.
17. Missing Data
Patterns of missingness will be described. Primary analyses will use available cases.
Sensitivity analyses may include multiple imputation or nonparametric methods
consistent with the primary analysis framework.
18. Multiplicity
For multiple pairwise comparisons following a significant omnibus test, p-values
will be adjusted (e.g., Bonferroni/Holm) to control the family-wise error rate.
19. Statistical Software

Analyses will be performed using standard statistical software (e.g., SPSS, R, or
Python).

20. Administrative Information
Sponsor/Institution: [University / Faculty of Medicine]. Study officials and contacts
are listed in the trial registry record. This public document does not include
participant names or personally identifiable information.
Any deviations from this plan will be documented in the results submission. This
version supersedes prior versions as of the Document Date.