Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001062314
Ethics application status
Approved
Date submitted
21/06/2017
Date registered
20/07/2017
Date last updated
20/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Education Training Program in Preventing Needle Stick Injury among Healthcare Workers in Health Clinics in Kuala Lumpur.
Scientific title
Effectiveness of Education Training Program in Preventing Needle Stick Injury among Healthcare Workers in Health Clinics in Kuala Lumpur.
Secondary ID [1] 290686 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Needle stick Injury 301221 0
Condition category
Condition code
Public Health 300979 300979 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an educational training program that aims to reduce the needle stick injuries. The intervention will be based on the Information-Motivation-Behavioral Skills (IMB) Model. The training program will be a one day workshop that will include the face to face lectures, group discussion and role play. The work shop will be modeled based on the literature search such as the recommendation of WHO and CDC. A training of trainers will be done by the researcher who is a medical officer with Masters in Public Health to selected health care workers from the clinics. The selected health care workers to conduct the workshop at their clinics.The workshop will be conducted at the health clinics by healthcare workers who will be trained using a standardized training manual developed for this study.
The workshop will begin with the ice breaking activity and introduction to the objectives of the workshop as well as ground rules for the participants. This will be followed by lectures to provide information on epidemiology of needle stick injury, blood borne disease and the prevention of needle stick injuries.
For the motivation construct, group discussions from case scenarios. This case scenarios will be of previous true cases.
Finally for the behavioral skill construct, problem solving activities based on daily practice encounters that increase needle stick injuries will be used. This will include both role plays and group discussion. The workshop will end with review of lessons learnt, take home messages and t evaluation of the workshop. Certificate of participation will be provides to the participants of the workshop.
Intervention code [1] 296568 0
Prevention
Comparator / control treatment
The control group will be the waiting list and undergo the usual care. The usual care will consist of the current practice of needle stick injury prevention training used by the infection control units of the clinics. The intervention training will be provided to the control group upon completion of the study, if the educational training intervention program is found to be effective, The control group is expected to wait for a period of 6 months.
Control group
Active

Outcomes
Primary outcome [1] 302496 0
Change in proportion of self reported needle stick injury as measured by questionnaire designed for this study.
Timepoint [1] 302496 0
Baseline, 1 month, 3 months and 6 months after the intervention commencement
Secondary outcome [1] 336214 0
Change in proportion of level of needle stick injury prevention knowledge as measured by questionnaire designed for this study.
Timepoint [1] 336214 0
Baseline, 1 month, 3 months and 6 months after the intervention commencement.
Secondary outcome [2] 336215 0
Change in proportion of level of needle stick injury prevention attitude as measured by questionnaire designed for this study.
Timepoint [2] 336215 0
Baseline, 1 month, 3 months and 6 months after the intervention commencement.
Secondary outcome [3] 336216 0
Change in proportion of level of needle stick injury prevention practice as measured by questionnaire designed for this study.
Timepoint [3] 336216 0
Baseline, 1 month, 3 months and 6 months after the intervention commencement.

Eligibility
Key inclusion criteria
All health care workers
1.Medical officers
2.Dental officers
3.Pharmacist
4.Paramedics
5.Nurses
6.Laboratory technologist
7. Dental technicians
8. Dental nurses
9. Attendants
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who are not available during the study period due to leave such as maternity and study leave.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation ratio is 1:1. Allocation into the two arms will only be done after obtaining the baseline data from the participants. Group allocation will then be concealed using sealed envelopes. Due to the nature of the educational intervention, the participants will not be blinded to the intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be done at the clinic level, using the computer generated random numbers by a statistician independent of the research team..A block randomization method using permuted block sizes of 2 and 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be entered into SPSS version 22 worksheet. The data will be entered as soon as participants are recruited during baseline, until the end of this study. Prior to data analysis, data cleaning will be done and all assumptions will be tested for. The data analysis will be done on the Intention to Treat (ITT) basis in which all the participants will be analyzed according to the group allocated irrespective they completed or loss to the 6 months follow up.
The statistical analysis of this study will be performed by using the SPSS version 22. For categorical data, Chi-square or Fisher’s exact test will be used while for continuous data an independent t test will be used. Generalized Estimating Equation method will be used to analysis the primary and the secondary outcomes of this study to account for clustering effect. The data will be reported as adjusted Odds Ratios (AOR), 95% confidence interval (95% CI) and P-values.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1440
Accrual to date
Final
Recruitment outside Australia
Country [1] 9005 0
Malaysia
State/province [1] 9005 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 297004 0
Self funded/Unfunded
Name [1] 297004 0
Country [1] 297004 0
Primary sponsor type
Individual
Name
Prem Kumar A Balakrishnan
Address
Department of Community Health,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
43400 Serdang,
Selangor
Country
Malaysia
Secondary sponsor category [1] 296007 0
None
Name [1] 296007 0
Address [1] 296007 0
Country [1] 296007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298020 0
JKEUPM (Ethic Committee For Research Involving Human Subject)
Ethics committee address [1] 298020 0
Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Ethics committee country [1] 298020 0
Malaysia
Date submitted for ethics approval [1] 298020 0
27/12/2016
Approval date [1] 298020 0
13/01/2017
Ethics approval number [1] 298020 0
FPSK(EXP15)P087
Ethics committee name [2] 298021 0
Medical Research Ethics Committee (MREC) of Ministry of Health Malaysia
Ethics committee address [2] 298021 0
Jawatankuasa Etika & Penyelidikan Perubatan (MREC)
Kementerian Kesihatan Malaysia,
d/a Institut Pengurusan Kesihatan,
Jalan Rumah Sakit,
Bangsar
59000 Kuala Lumpur
Ethics committee country [2] 298021 0
Malaysia
Date submitted for ethics approval [2] 298021 0
Approval date [2] 298021 0
24/11/2016
Ethics approval number [2] 298021 0
NMRR-16-2004-32960(IIR)

Summary
Brief summary
This educational training program is a cluster randomized control trial that aims to reduce the needle stick injury. The participants will be health care workers in the health clinics. Participants in this study are randomly allocated (by chance) to one of two groups.
Participants in the intervention group will attend one day workshop which will include face to face lectures, group discussion and roleplays by trained peer health care workers from their clinics. The content of the training program will include knowledge on needle stick injury and its prevention strategies, blood borne diseases transmitted by needle stick injury. Participants in the control group will be on the waiting list still the study is completed and will be exposed to the usual care of training on needle stick injury conducted by the infectious control unit of their clinics. If the training workshop is effective, the control group will receive the training upon completion of the study.
A self-administered questionnaire that will be validated and tested for reliability will be used to collect data from the participants. Participants from both groups will be asked to complete questionnaires before the training program begins (baseline), at 1 month, 3 month and again at 6 months, in order to determine the effect of the program on needle stick injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70550 0
Dr Prem Kumar A Balakrishnan
Address 70550 0
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra
Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 70550 0
Malaysia
Phone 70550 0
+60148652145
Fax 70550 0
Email 70550 0
[email protected]
Contact person for public queries
Name 70551 0
Dr Prem Kumar A Balakrishnan
Address 70551 0
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra
Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 70551 0
Malaysia
Phone 70551 0
+60148652145
Fax 70551 0
Email 70551 0
[email protected]
Contact person for scientific queries
Name 70552 0
Dr Prem Kumar A Balakrishnan
Address 70552 0
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra
Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 70552 0
Malaysia
Phone 70552 0
+60148652145
Fax 70552 0
Email 70552 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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