Depressive Symptoms Clinical Trial
Official title:
The Effectiveness of the Medicorp House Officer (HO) Preparatory Course for Medical Graduates on Confidence, Readiness, and Psychological Well-Being: A Quasi-Experimental Study
After completion of 5 years of medical school training, the next step of becoming a House
Officer is said to be associated with high levels of stress. It has been associated with
mental health problems amongst HOs and sometimes quitting the medical line altogether. In
Malaysia, the number of HOs not completing housemanship training within the allocated time is
slowly declining from 86.4% (2009) to 58.8% (2012). The dropout rate is said to be increasing
yearly.
This causes a lot of constraints on the HO, their family, sponsors, patients and also the
country. Amongst the reason for stress is the feeling of incompetency or "fear of making
mistakes". Other work-related issues include workload, time management, financial, colleague
and superior related issues.
Medicorp is a company that specializes in training for junior doctors and has come up with a
module to help medical graduates cope with these issues. The module is a 3-day-course named
the HO Preparatory Course. It was initially the brainchild of the Islamic Medical Association
of Malaysia (IMAM) but was later privatized to accommodate the demand and the running of the
module and courses. The module has been re-evaluated through feedback of participants and
trainers to cater to the needs and wants of the newly graduate; be it local or overseas.
Therefore, the investigators would like to assess whether this intervention module is
effective in addressing HO stress, therefore consequently reduce the risk of drop out and
extension in HO training.
METHODOLOGY
Study Setting:
This study will be conducted in International Youth Centre, Cheras. It has been the main
focal point of where most of the courses have been conducted. It is within easy reach and
centrally located near National University of Malaysia Hospital. Many participants will come
from all around Malaysia to attend. The centre is equipped with a lecture hall and boarding
for the participants.
Study Design:
This is a pre-post quasi-experimental study that will be conducted over 12 months duration.
Participants in this study will undergo a House Officer (HO) preparatory course. The level of
confidence, readiness and psychological wellbeing will be evaluated. There will be three
assessment time points: at baseline (before the course), immediately after the course (only
for level of confidence and readiness) and 1 month after working as HO. This study is unable
to have a control because of constraints in resources.
Study Duration:
This study will start from April 2018 - March 2019
Sampling of participants:
Recruitment
Participants who attend the Medicorp HO Preparatory Course from April 2018 -March 2019 will
be recruited into this study as the sampling frame. The eligibility criteria are based on the
following:
The sampling methods employed in this study will be taking all participants who fulfill the
eligibility criteria and agree to participate in this study.
Intervention:
The intervention in this study will be the Medicorp HO preparatory course which comprises of
a 3-day training touching on aspects of HO training that is needed practically for an HO to
function. The training will touch on the nature of the HO job, explaining about technical
details such as the shift and on-call system. The tagging period, and assessments that HOs
need to undergo during their training. They will be guided on how to clerk, review and
present common as well as emergency cases. Other aspects involved in clerking such as common
forms used in the wards and also how to refer cases is also discussed. Apart from that, soft
skills such as communication among staff, financed, balancing social life and future career
planning is incorporated in the training. There are hands-on training for participants for
common procedures such as continuous bladder drainage insertion and venepuncture. The
trainers are specialists, specialists in training, medical officers, and also house officers
who come to share their experience. Medicorp encourages their alumni to be part of their
training program. This module will be held on a 1-2 monthly basis. The Module Content is
moderated by Medicorp based on discussions with the board of directors, advisors and feedback
from participants. The training program is done as a lecture, tutorial and hands-on session.
Before commencing the course, participants will be included in a WhatsApp group, for easier
content sharing and updates of the course. They will continue this networking even after
completion of this course. They will be also be guided in the online applications of their
job through this application and also through Facebook. During the commencement of their job,
Medicorp will use their database to guide them into different WhatsApp groups according to
their place of work for additional support.
Sample size The sample size was calculated using G*Power 3.1 sample size calculator software.
Based on reports by confidence score from a study analysing pre and post-emergency department
posting in junior doctors was used. The mean overall confidence score was 56.475(24.67) at
the end of month 1 and 62.775(28.69) at the end of month 4(Williams et al., 1997). The
estimated sample size was 208 participants after accounting for the power of 80%,
significance level of 0.05% and 30% attrition.
INSTRUMENTS AND DATA COLLECTION
Intervention: The Medicorp HO Preparatory Module
Tools for assessment:
1. Baseline questionnaire The study instrument will be a set of questionnaire that will be
divided into sections A-E.
The English versions will be used.
1. Socio-demographic data :
This will include certain details of participants such as:
- Age
- Sex
- Religion
- Ethnicity
- Year of graduation
- University of Graduation
- Marital status
- Place of work (evaluation during 1 month post HO-ship)
2. Clinical Experience:
This will be adapted from the International Medical University (IMU)Student
Competency Survey. This will show participants past clinical experience on common
procedures during their undergraduate years.
3. Confidence level: Adapted from the IMU student competency questionnaire as
explained in study outcome measures
4. Readiness : Adapted from the IMU student competency questionnaire as explained in
study outcome measures
5. Psychological well -being : DASS as explained in study outcome measures
2. Post course questionnaire (immediate)
1. Level of confidence
2. Readiness
3. Case report form Conducted via telephone call at 1 month after starting work as HO
Content will include
1. Level of confidence
2. Readiness
3. DASS
4. Work place information: which hospital and posting
5. Any suggestions to improve the course based on your current working experience?
All the questionnaires will be pilot tested by testing this on 30 medical graduates before
using the questionnaire.
Data collection
A pre-tested self-administered questionnaire which includes baseline socio-demography,
adaptation of the IMU Student Competency Survey, and the Depression Anxiety Stress Scale will
be used. 1 month follow-up will be done by telephone. After the participants have completed
the course, their level of readiness and confidence will again be assessed via a
self-administered questionnaire. This will be done on the last day of the course.
The participants will later be followed up 1 month after they have been working as a HO in
their respective hospitals. The organisers will keep track of placements of all participants
via social media applications as part of the course is still maintaining connections and
informal training after the course has ended and as participants start the process of job
application and working.
Ethical considerations
This study's approval for ethical clearance will be obtained from JETHIC COMMITTEE FOR
RESEARCH INVOLVING HUMAN SUBJECT University Putra Malaysia ETHIC COMMITTEE FOR RESEARCH
INVOLVING HUMAN SUBJECT (JKEUPM) ) and National Medical Research Register (NMRR); Medical
Research and Ethics Committee (MREC) as the participants will be working in Ministry of
Health facilities during the 1 month follow up. This study will also be registered in the
National Institute of Health (NIH) as a trail registration.
Informed consent will be obtained from each study participant and they will be told the right
not to respond to the questions they don't want to respond to or to withdraw from the study
at any time. All data obtained will be kept confidentially and for research purposes only.
The benefits of the study includes assessing issues in relations to HO wellbeing and to
assess what is needed in training a functional HO. The potential risk, discomforts and
inconvenience is almost none. However, should the DASS score be suggestive of depression or
anxiety, team members of the research team will refer the participant appropriately. Should
participants choose to withdraw from study, they will be allowed to do so.
Data Analysis
The data will be analysed using IBM Social Package for Social Science (SPSS) version 24. A
descriptive analysis of the demographic characteristics of the participants, clinical
experience and baseline level of confidence, readiness and psychological wellbeing will be
reported using means and standard deviations (SD) or median and inter-quartile range (IQR)
for continuous variables (depending on the data distribution) and as frequencies and
percentages for categorical data. An analysis to compare between participants who completed
and withdrew from the study will be made using Chi-square or Exact test (for unbalanced data)
for categorical variables and independent t-test for continuous data.
A repeated measures ANOVA will be conducted to determine the effectiveness of the
intervention within the groups across the study periods (baseline, immediately after
intervention and at 1 month after working). Controlling for baseline measures will be done to
determine the change over time on the measured outcomes (level of confidence, readiness and
psychological wellbeing). All analyses conducted are two-tailed with significant level set at
p value <0.05.
Operational Definitions of terms
1. Medical Graduates/Participants - Those that have obtained a medical degree be it MD,
MBBCh BAO, MBBS or the same level
2. Socio-demography - the components of description of a population
1. Age - based on the year a person was born
2. Sex- male or female
3. Marital Status - single, married, separated or divorced
4. Ethnicity - background of a person's race
5. Religion - the religion based on identification card (I.C)
6. Year of graduation - year they receive their certificates of qualification
7. University- institution of higher learning they graduated from
8. Confidence -a feeling of self-assurance arising from an appreciation of one's own
abilities or qualities
9. Readiness - the state of being fully prepared for something.
10. Psychosocial well-being - the state of, affecting, or arising in the mind; related
to the mental and emotional state of a person.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
Completed |
NCT05702086 -
Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Recruiting |
NCT06100146 -
Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls
|
N/A | |
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Completed |
NCT05376397 -
Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
|
N/A | |
Terminated |
NCT04367636 -
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19
|
N/A | |
Completed |
NCT04403126 -
To Increase Psychological Well-being by the Implementation of Forgiveness Education
|
N/A | |
Recruiting |
NCT05078424 -
Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
|
N/A | |
Recruiting |
NCT06053775 -
Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Recruiting |
NCT04082052 -
Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
|
N/A | |
Completed |
NCT04011540 -
Digital Data in Mental Health Therapy
|
N/A | |
Not yet recruiting |
NCT06413849 -
Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers
|
N/A | |
Not yet recruiting |
NCT03659591 -
Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost
|
N/A | |
Not yet recruiting |
NCT02133170 -
"Mindfulness vs Psychoeducation in Bipolar Disorder"
|
N/A | |
Completed |
NCT02314390 -
Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial
|
N/A | |
Completed |
NCT01628016 -
The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms
|
N/A |