Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04495361 |
| Other study ID # |
16/136/108 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
December 30, 2020 |
Study information
| Verified date |
June 2024 |
| Source |
University of Edinburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Despite the availability of standard pneumonia management guidelines and multiple global
efforts, pneumonia continues to be the leading killer of children under five, accounting to
around 17% of the total under five deaths globally. In Pakistan, pneumonia contributes to 16%
of under five mortality in the country having a well-defined yet poorly functional healthcare
system.
Although, there are standard set of guidelines for management of pneumonia patients however,
the management practices of this illness are variable across the country. This could be
attributed to non-availability of work ready graduates which in turn is due to variations of
teaching methods across various institutions. Although the medical students across these
institutions do get exposed to clinical cases in the final year however, this exposure is
also variable. If this clinical experience is coupled with an adjunct capacity building mode
using an online platform. there is a possibility that students could be trained in a better
way.
Description:
The investigators plan to use e-learning portal in identification and management of under
five pneumonia cases as it is one of the leading killers of children under five which is
largely managed non-uniformly across the country. The investigators will use videos of
patients under five years of age with pneumonia and allow virtual performance of clinical
skills by medical students in an online platform. Such a platform can prove to be an adjunct
to standard clinical education rather than a substitute. The investigators propose that this
platform will help the medical students to prepare them for a range of clinical challenges as
it is an ideal strategy for the development, refinement, and rehearsal of skills in
recognition in a safe environment.
Primary Objective: To measure final year medical student's theoretical (knowledge) and
applied (virtual clinical performance) learning on under five pneumonia case management in an
e-learning package
Secondary Objective: To explore associations between student characteristics and outcomes
following exposure to the e-learning program
Study design: This will be a multi-center quasi experimental study with final year medical
students studying in various institutions in the twin cities of Pakistan
(Islamabad/Rawalpindi).
The design of the package will be based on the FIRST2ACT Web platform which is an e-learning
platform for medical students which focuses on exposure of the users to different adult
simulated case scenarios in the form of videos.
Three categories of case scenarios, based on WHO classification of pneumonia, will be
presented to the students. Thus case scenarios of patients with no pneumonia, pneumonia and
severe pneumonia will be presented.
Stages of study: The study will be conducted in the following three stages all of which will
be mostly conducted electronically.
Pre-intervention stage:
Piloting of existing resources: The case scenarios will be created of children under five
suffering from pneumonia. The host organization MNCHRN has an archive of different videos of
patients of pneumonia already available which have been developed as a part of another
activity. Consent forms from the caregivers of the patients in the videos including
permission to use them in future for other purposes are in the record. These videos after
testing will be incorporated in the program. If it is felt that the existing content does not
fulfil the purpose, then new videos will be recorded of under five pneumonia cases in a
hospital facility by taking consent from the caregivers.
Development of new cases: If required, new videos showing different types of pneumonia in
under five children visiting a clinic or admitted in a hospital will be recorded. Approval
from the clinic/ hospital will be taken to include their patients and to record videos in
their premises. Consent from the carers/parents to videotape their children would also be
taken. Details on the purpose of the study and their participation will be explained to them
and will also be provided in written form prior to signing the consent form.
Development and testing of portal: Who, how, where, what framework shall be employed for the
development and implementation of the e-learning package. An expert of IT will be recruited
for the development of portal. Portal will be tested by the research team, medical students
and paediatricians.
Invitation to institutions to participate: The heads of each institution will be approached
to provide permission for involvement of their final year medical students. Approval and
ethical clearance from institution's research committees will be taken.
Introductory seminar: After approval, seminars for final year medical students to facilitate
their participation in the study will be conducted in each institution. Purpose of the study
and the use of portal will be explained to them. Information sheets and consent forms will be
distributed to the students at the end of the seminar and they will be given one week to
consider the information and decide if they want to participate.
Participant's consent and enrolment: Name of the student and institution, age, gender, phone
number, email address will be taken from the interested students at the time of enrolment in
the study. Once enrolled, the students will be informed that a login ID to access the e
learning platform will be provided at their email addresses. The same login ID will be used
as the participant's identifier and the means of linking individual data throughout the
study.
The following online questionnaires will be filled in by the enrolled students after they log
on to the portal for the first time.
1. Demographic and clinical experience
2. Pre-test self-assessment of knowledge, skills, confidence, and competence
Study debriefing: Each participant will be able to access a narrated PowerPoint presentation
on the intervention with instructions within the portal. The briefing will describe the
approach and scenarios in general with examples the participants would see and instructions
on selecting clinical actions and receiving feedback. It will also explain the parameters
(number of attempts and time taken to complete the case scenario) that will be accounted in
the scoring.
Intervention stage:
Exposure on online clinical cases: This will be an online program; therefore the students
will be able to access it anywhere and anytime they feel convenient provided there is
internet connectivity. In case there is interruption of internet due to electricity shortage,
efforts will be made to keep the interface such that the students takes up from where they
left provided the shortage is not of more than one hour as the student might forget some
components of the training.
Students after log in to the portal will undergo a planned electronic encounter with an under
five patient suffering from pneumonia. For each case, students will have to identify the
category of pneumonia and the appropriate treatment/ management in a timed session The
interface will be developed such that upon login, the student will be given an opportunity to
select cases. Upon clicking on the icon of the age group, the participant will have a screen
popping up showing a typical case of either no pneumonia, pneumonia or severe pneumonia. The
video will run for around thirty seconds to one minute during and after which the students
will try to identify the case and select it from the drop down menu of whether it is no
pneumonia, pneumonia or severe pneumonia. There will be tabs for history, examination,
diagnosis and management. The student will select the best suited response from a range of
options.Based on the selection of the response and the time taken to do so, a score will be
generated. The student can take three attempts for each case scenario. The total score will
be an average of all attempts.
Feedback on the scored performance: Based on the score the student will be provided with
general formative feedback incorporating patient diagnosis and best practice management for
that case.
The intervention will continue for six months with instructions to log in every month.
Post-intervention stage: Participants will complete the knowledge post-test and a
self-evaluation of skills, competence and confidence in managing under five patients after
the intervention. The overall performance of each student will be scored and students will
receive a summarized feedback and provided with links to resources for further self-directed
learning. Finally, they will complete an evaluation of their experience and receive a
printable certificate of completion.
