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Trial registered on ANZCTR


Registration number
ACTRN12618001636246
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
3/10/2018
Date last updated
3/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Price Display on Primary Care Doctors’ Laboratory Test Ordering Behavior in the Public Health Clinics at Wilayah Persekutuan Kuala Lumpur– A Vignette-based Randomized Controlled Study
Scientific title
The Effect of Price Display on Primary Care Doctors’ Laboratory Test Ordering Behavior in the Public Health Clinics at Wilayah Persekutuan Kuala Lumpur– A Vignette-based Randomized Controlled Study
Secondary ID [1] 296158 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inappropriate diagnostic tests ordering behavior 309779 0
Condition category
Condition code
Public Health 308571 308571 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess the effect of providing price information to doctors when ordering laboratory tests to compare the cost and number of tests orderings before and after the intervention. This was conducted in all the public healths clinics ( 12 public health clinics) at Wilayah Persekutuan Kuala Lumpur.

Once obtained the permission from the heads of pulbic healths clinics, the doctors’ list was reshuffled according to alphabetical order, and balloted from a box containing numbers by an independent person into either the control or intervention group. All the doctors in the public health clinics were approached individually by the investigator and explained about the study by using Participants Information Sheet. They were encouraged to participate and those consented were recruited in this study.

Both the control and intervention groups were given a self-administered study instrument consisted of 3 sections, i.e. sociodemographic data, participant’s profiles and 4 vignette cases in an envelope, given by the investigator face- to-face. The participants were asked to select the appropriate investigations from a list of investigation based on the vignette cases. The intervention group was tendered with the investigation lists with price display, the control group without. The investigations listed in the study instrument consisted of common laboratory investigations ordered in the primary care clinics in Malaysia, e.g. full blood count, renal profile, liver function test, fasting blood sugar, fasting lipid profile etc.This study instrument was designed specifically for this study after reviewing by an expert panel group consisted of four specialists.

The study instrument took approximately 15 minutes to complete. This set of study instrument was to be put back into the envelope, sealed it and was collected from the participated doctor at the end of the day.

The doctors were encouraged to return the answered study instrument on the same day. Those who could not complete the study instrument on the same day were given reminders, either by calls or by frequent visits to the public health clinics to remind the doctors personally. The study period for each public health clinics was 30 days, from the first day of the distribution of the study instrument. The doctor was considered as a “drop-out” from the study if the study instrument failed to be collected within the 30-days period.
Intervention code [1] 312488 0
Behaviour
Comparator / control treatment
Once obtained the permission from the heads of pulbic healths clinics, the doctors’ list was reshuffled according to alphabetical order, and balloted from a box containing numbers by an independent person into either the control or intervention group equally.

The intervention group was given a set of study instrument with price display whereas the control group without.
Control group
Active

Outcomes
Primary outcome [1] 307529 0
The effect of price display as assessed by the change of the cost of laboratory tests in between the control and intervention group.
Timepoint [1] 307529 0
At the time of completed answering the study instrument.
Primary outcome [2] 307530 0
The effect of price display as assessed by the change of the number of laboratory tests in between the control and intervention group.
Timepoint [2] 307530 0
At the time of completed answering the study instrument.
Secondary outcome [1] 352237 0
To determine the effect of price display on the number of appropriate and inappropriate tests ordering as assessed by the frequency of doctors ordering the appropriate and inappropriate tests.

The appropriate and inappropriate tests are the composite outcome.

Appropriate test is defined as the minimum tests which were indicated for that particular case vignette in order to aid in diagnosis and subsequent management. The indicated tests were determined by the expert panel group based on local practice guidelines.
Timepoint [1] 352237 0
At the time of completed answering the study instrument.

Eligibility
Key inclusion criteria
All doctors who are servicing at public health clinics in Wilayah Persekutuan Kuala Lumpur
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.Doctors who are absent during the data collection period.
2.Doctors who were involved in the expert panel group during study instrument validation.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by an independent person using balloting method. He or she would ballot from a sealed box containing numbers, into either the control or intervention group. The numberings were based on a reshuffled doctors' list obtaining from the head of public health clinics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated based on a study by Rudy et al, using Power and Sample Size Program Version 3.1.2. Based on this literature, the mean difference between the intervention and control group was 908 and a standard deviation of 998.
By using the power of 0.95 and a Type 1 error probability associated with null hypothesis was 0.05, a total of 66 doctors were needed.
In this study, universal sampling involving all the public health clinics doctors at Wilayah Persekutuan Kuala Lumpur was used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/04/2018
Date of last participant enrolment
Anticipated
Actual
2/05/2018
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
66
Accrual to date
Final
225
Recruitment outside Australia
Country [1] 20866 0
Malaysia
State/province [1] 20866 0
Wilayah Persekutuan Kuala Lumpur

Funding & Sponsors
Funding source category [1] 300751 0
University
Name [1] 300751 0
University of Malaya
Country [1] 300751 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 300342 0
None
Name [1] 300342 0
Address [1] 300342 0
Country [1] 300342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301528 0
Medical Research & Ethics Committee Malaysia
Ethics committee address [1] 301528 0
Ethics committee country [1] 301528 0
Malaysia
Date submitted for ethics approval [1] 301528 0
18/12/2017
Approval date [1] 301528 0
14/03/2018
Ethics approval number [1] 301528 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87298 0
Dr KHAW CHWIN KHAI
Address 87298 0
Primary Care department, University Malaya Medical Centre, Lembah Pantai, 59100 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country 87298 0
Malaysia
Phone 87298 0
+60124547655
Fax 87298 0
Email 87298 0
[email protected]
Contact person for public queries
Name 87299 0
KHAW CHWIN KHAI
Address 87299 0
Primary Care department, University Malaya Medical Centre, Lembah Pantai, 59100 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country 87299 0
Malaysia
Phone 87299 0
+60124547655
Fax 87299 0
Email 87299 0
[email protected]
Contact person for scientific queries
Name 87300 0
KHAW CHWIN KHAI
Address 87300 0
Primary Care department, University Malaya Medical Centre, Lembah Pantai, 59100 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country 87300 0
Malaysia
Phone 87300 0
+60124547655
Fax 87300 0
Email 87300 0
[email protected]

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