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Psychological StressNCT03510195

Effectiveness of Medicorp HO Preparatory Course

A study testing MEDICORP HO PREPARATORY MODULE in people with Psychological Stress and Depressive Symptoms, run by Universiti Putra Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
MEDICORP HO PREPARATORY MODULE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
1 siteMalaysia
Study dates
27 Apr 2018to 31 Oct 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1. Participants that have registered to attend the Medicorp HO Preparatory Course

Who cannot join

  • Participants declared to have psychiatric illness
  • Participants who have not completed a medical degree (medical students)
  • Participants already working as a H

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • FRIM

    Kepong, Selangor, 52109

Other trials in Malaysia

About this study

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.

Read more

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.

Read the detailed description

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.
  2. 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)
  1. 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.
  2. Confidence level: Adapted from the IMU student competency questionnaire as explained in study outcome measures
  3. Readiness : Adapted from the IMU student competency questionnaire as explained in study outcome measures
  4. Psychological well -being : DASS as explained in study outcome measures
  5. Post course questionnaire (immediate)
  6. Level of confidence
  7. Readiness
  8. Case report form Conducted via telephone call at 1 month after starting work as HO Content will include
  9. Level of confidence
  10. Readiness
  11. DASS
  12. Work place information: which hospital and posting
  13. 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
  3. Age - based on the year a person was born
  4. Sex- male or female
  5. Marital Status - single, married, separated or divorced
  6. Ethnicity - background of a person's race
  7. Religion - the religion based on identification card (I.C)
  8. Year of graduation - year they receive their certificates of qualification
  9. University- institution of higher learning they graduated from
  10. Confidence -a feeling of self-assurance arising from an appreciation of one's own abilities or qualities
  11. Readiness - the state of being fully prepared for something.
  12. Psychosocial well-being - the state of, affecting, or arising in the mind; related to the mental and emotional state of a person.
Being tested
MEDICORP HO PREPARATORY MODULE
Medical subject headings
Stress, Psychological, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDICORP HO PREPARATORY MODULEOther

    3 DAY course module to prepare medical graduates to become house officers

Study groups in NCT03510195
Study groupRoleWhat they receive
MEDICORP HO PREPARATORY MODULEExperimentalThe participants that will have intervention which is the module
Receives: Other: MEDICORP HO PREPARATORY MODULE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Confidence Level

    This will be adapted from the IMU Student Competency Survey (Appendix 2) as there are no published studies on the confidence level of medical graduates before beginning HO-ship. The questionnaire comprises of 5 sections. The first 4 sections asses on generic skills, practical tasks, soft skills and their confidence as a whole, using a Likert scale assessment. Scoring is a mean score of 1-5 and the higher the score, the higher the confidence. The last section asks on the one daunting aspect of being a HO out of a list of 7 things, this section is descriptive.

    Measured: pre intervention, immediately after intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)

Secondary outcomes (4)
  1. Change in Readiness Level

    This is also adapted from the IMU competency survey and is asked on a likert scale of 1 to 5 for their level of readiness. It is assessed after the confidence section. The higher the score, the higher the level of readiness

    Measured: pre intervention, immediately post intervention (after 3 days of intervention)

  2. Change in Psychological Well Being - Depression

    This is using the Depression Anxiety Stress Scale (DASS): This questionnaire is used to asses Depression, Anxiety and Stress. It uses a likert scale. The scores indicate normal, mild, moderate, severe and extremely severe for each of the domains. The higher the scores, indicates the more severe the conditions.

    Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia.

    Minimum score: 0 Maximum score: 42

    Normal: 0-9 Mild: 10-13 Moderate: 14-20 Severe: 21-27 Exteremely severe: 28+

    Measured: pre intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)

  3. Change in Psychological Well Being - Anxiety

    This is using the Depression Anxiety Stress Scale (DASS): This questionnaire is used to asses Depression, Anxiety and Stress. It uses a likert scale. The scores indicate normal, mild, moderate, severe and extremely severe for each of the domains. The higher the scores, indicates the more severe the conditions.

    Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect.

    Minimum score: 0 Maximum score: 48

    Normal: 0-7 Mild: 8-9 Moderate: 10-14 Severe: 15-19 Extremely severe: 20+

    Measured: pre intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)

  4. Change in Psychological Well Being - Stress

    This is using the Depression Anxiety Stress Scale (DASS): This questionnaire is used to asses Depression, Anxiety and Stress. It uses a likert scale. The scores indicate normal, mild, moderate, severe and extremely severe for each of the domains. The higher the scores, indicates the more severe the conditions.

    Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

    Minimum score: 0 Maximum score: 48

    Normal: 0-14 Mild: 15-18 Moderate: 19-25 Severe: 26-33 Extremely severe: 34+

    Measured: pre intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2018
  2. Study start27 Apr 2018
  3. Primary completion30 Sep 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510195
Sponsor's protocol ID
upm/uctc/900/3/2/ktgs0518012
Status last verified
Jun 2020
First submitted
8 Apr 2018
Last updated
16 Jun 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rashid AA, Shariff Ghazali S, Mohamad I, Mawardi M, Roslan D, Musa H. Quasi-experimental study on the effectiveness of a house officer preparatory course for medical graduates on self-perceived confidence and readiness: a study protocol. BMJ Open. 2019 Aug 10;9(8):e024488. doi: 10.1136/bmjopen-2018-024488.

    PubMed 31401588

Questions about this trial

What is this clinical trial studying?

A study testing MEDICORP HO PREPARATORY MODULE in people with Psychological Stress and Depressive Symptoms, run by Universiti Putra Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Confidence Level (time frame: pre intervention, immediately after intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03510195, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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