Ignite Creation Date:
2024-05-06 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03510195
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2018-04-08
Brief Title:
Effectiveness of Medicorp HO Preparatory Course
Sponsor:
Universiti Putra Malaysia
Organization:
Universiti Putra Malaysia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 In Malaysia the number of HOs not completing housemanship training within the allocated time is slowly declining from 864 2009 to 588 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
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
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 GPower 31 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 564752467 at the end of month 1 and 627752869 at the end of month 4Williams et al 1997 The estimated sample size was 208 participants after accounting for the power of 80 significance level of 005 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 IMUStudent 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 studys 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 dont 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 005
Operational Definitions of terms
1 Medical GraduatesParticipants - 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 persons race
5 Religion - the religion based on identification card IC
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 ones 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
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 GPower 31 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 564752467 at the end of month 1 and 627752869 at the end of month 4Williams et al 1997 The estimated sample size was 208 participants after accounting for the power of 80 significance level of 005 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 IMUStudent 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 studys 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 dont 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 005
Operational Definitions of terms
1 Medical GraduatesParticipants - 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 persons race
5 Religion - the religion based on identification card IC
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 ones 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None