The Study Guide Cluster Randomized Control Trial

January 25, 2021 updated by: Roland Grad, Jewish General Hospital

Can an App Improve the Examination Scores of Family Medicine Residents? A Cluster Randomized Controlled Trial

Spaced education is a promising theory-driven strategy to improve clinical competence. Our aim is to improve the clinical competence of Family Physicians, an outcome associated with the quality of care delivered to Canadians.

Study Overview

Status

Completed

Conditions

Detailed Description

Research Question: Among family medicine residents, does enhanced feedback through an app providing alerts and test questions (spaced education), compared to the same app without alerts and enhanced feedback (no spaced education), improve competence as measured by the certification examination? In building this proposal for a definitive trial, the investigators have support from coast to coast. In addition to key clinician educators, the team includes knowledge users from the organization responsible for the certification examination in Family Medicine, methodologists and experienced researchers who study how mobile apps can promote engagement with clinical information. The team has the right blend of expertise in medical education and cluster randomized trials.

Approach and Methods: The investigators will follow an organizational participatory research approach, and propose a cluster randomized controlled trial. Setting: All incoming family medicine residents in Canada will be eligible to participate. Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education). Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education). The primary outcome will be scores on the certification examination. This routinely collected data will be provided to the team by the College of Family Physicians of Canada.

Expected Results and Conclusion: Spaced education will improve examination scores. This will inform educational practice by providing evidence to optimize the training of residents.

Study Type

Interventional

Enrollment (Actual)

634

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montréal, Quebec, Canada
        • McGill University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • incoming family medicine residents in Canada (July 2017)

Exclusion Criteria:

  • not a family medicine resident
  • did not start residency on July 1, 2017

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).
A spaced educational intervention will be provided to participants
NO_INTERVENTION: Control
Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores on the Certification Examination
Time Frame: 2 years
This is the score on the written component of the examination of the College of Family Physicians of Canada. This refers to the grade/score given to participants on the Short Answer Management Problems (SAMP) section of the exam ranging from 0 to 100. Higher values represent a better outcome. The score minimum observed was 53.9 and max is 84.4 for this study.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 18, 2017

Primary Completion (ACTUAL)

May 31, 2019

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 11, 2017

First Posted (ACTUAL)

October 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • The Study Guide Trial 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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