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Trial registered on ANZCTR


Registration number
ACTRN12614000068662
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
21/01/2014
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient safety in Public Primary Care Clinics in Malaysia
Scientific title
A Community Trial using Multi-pronged Systems-based Interventions to Improve Medical Errors In Ministry of Health Primary Care Clinics with comparison clinics
Secondary ID [1] 283795 0
NMRR-07-770-1042
(Registered in www.nmrr.gov.my)
Universal Trial Number (UTN)
U111111513983
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient Safety 290773 0
Condition category
Condition code
Public Health 291136 291136 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intention of developing the intervention package was to reduce or to prevent medical errors in primary care. This included diagnostic errors and management errors. The research team emphasised practicality and sustainability of the intervention package for the improvement of care in primary care setting.

The intervention package consisted of the following: training, audit process, pharmacy safe netting and materials specially designed for use during the implementation of the intervention.

The intervention package consisted of educational training, structured process change, additional review methods and patient education. The educational training was a 3-day workshop to the intervention group. Structured process changes included a clinic desktop flip chart (with rapid diagnostic and management guides), formatted paper records (new case sheet, continuation, asthma record sheet, hypertension record sheet, hypertension follow-up record), provision of peak flow meters, and carbon paper for copying prescriptions onto records. The Integrated Management of Childhood Illnesses ‘Mother’s card’, an educational pamphlet on child health to improve parents’ recognition of danger symptoms and signs in children, were given when applicable.

Prescription safety net was done to identify errors and to provide immediate feedback to prescribers. Monthly clinical audit by primary care physicians with health care providers were used for review with immediate feedback to rectify errors and monitoring and to reinforce intervention. Personnel were interviewed to provide feedback on the intervention package.

Fidelity checks on processes and the availability of materials were conducted monthly throughout the intervention. Three months after the intervention implementation, medical records were randomly sampled from 12 clinics and expert panel sessions were convened to review the medical records for errors.

The total duration of the intervention was 3 months.
Intervention code [1] 288479 0
Other interventions
Comparator / control treatment
Current Usual practice
Control group
Active

Outcomes
Primary outcome [1] 291119 0
Diagnostic errors: Errors deemed to have occurred when the history or physical examination did not match the problem or diagnosis stated in the medical records.

Random samples of outpatient records were selected and reviewed by trained family physicians (expert panel review).
Timepoint [1] 291119 0
3 months post implementation of intervention package
Primary outcome [2] 291240 0
Management errors: Errors deemed to have occurred if there was an error in investigation, medication or in the decision making process.

Random samples of outpatient records were selected and reviewed by trained family physicians (expert panel review).
Timepoint [2] 291240 0
3 months post implementation of intervention
Secondary outcome [1] 306024 0
Likelihood of errors to cause serious morbidity/mortality for both short and long term complications, as assessed for each record by a team of two expert panel reviewers.

Random samples of outpatient records were selected and reviewed by trained family physicians (expert panel review).
Timepoint [1] 306024 0
3 months post implementation of intervention
Secondary outcome [2] 306317 0
Preventability of error: Assessed on a 6-point scale from ‘virtually no evidence for preventability’ to ‘virtually certain of evidence for preventability’.
Random samples of outpatient records were selected and reviewed by trained family physicians (expert panel review).
Timepoint [2] 306317 0
3 months post implementation of intervention

Eligibility
Key inclusion criteria
Primary care centres were selected based on the stratification criteria (geographical location: Peninsular Malaysia and Sabah/Sarawak; highest category of personnel manning the clinic: Family Medicine Specialists, Medical Officers and Assistant Medical Officers [Medical Assistants]).
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Did not consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A community trial, intervention was allocated to specific clinics, and all patients/health care providers and managers at the participating clinics received the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A health systems research that involved multipronged interventions targetted mainly at modifying the behaviours of the health care providers and managers
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
Proportions and confidence intervals, with pooled estimated across centres using meta analysis.

Sampling:
The participating regions were conveniently selected due to cost concern, but within each region, the intervention clinics were randomly chosen, with the corresponding control clinics selected to match the intervention clinics in terms of clinic type and general set up.

To detect the difference of 10% between 2 study groups (case and controls): P0=0.05 (5% improvement in control group) and P1=0.15 (15% improvement in intervention group) , with alpha 0.05 and power of 80%, we need a sample size of 140 in each group. With consideration of dropout rate of 10-15%, we decide to take 160 in each group .
Details of the parameters used in the calculation are below:
P0=0.05 (5% improvement)
P1=0.15 (15% improvement)
alpha= 0.05, Power= 80%
M=1 (equal sample size for 2 study groups), Ratio of 2 groups = 1:1
N1= 140 (intervention) + 10% = 154 (round up to 160)
N2= 140 (control) + 10% = 164 (round up to 160)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5689 0
Malaysia
State/province [1] 5689 0

Funding & Sponsors
Funding source category [1] 288451 0
Government body
Name [1] 288451 0
NIH Research Grant, Ministry of Health Malaysia
Address [1] 288451 0
National Institutes of Health Secretariat
Ministry of Health Malaysia,
Institute for Health management
Jalan RUmah Sakit Bangsar
50590 Kuala LUmpur
Malaysia
Country [1] 288451 0
Malaysia
Primary sponsor type
Government body
Name
Ministry of Health Malaysia
Address
National Institutes of Health Secretariat
Ministry of Health Malaysia,
Institute for Health Management
Jalan RUmah Sakit Bangsar
50590 Kuala LUmpur
Malaysia
Country
Malaysia
Secondary sponsor category [1] 287271 0
None
Name [1] 287271 0
Address [1] 287271 0
Country [1] 287271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290323 0
Medical Research & Ethics Committee, Malaysia
Ethics committee address [1] 290323 0
Medical Research & Ethics Committee, Malaysia
NIH Secretariat,
Institute for Health Management
Jalan Rumah Sakit Bangsar'
50590 Kuala LUmpur
Malaysia
Ethics committee country [1] 290323 0
Malaysia
Date submitted for ethics approval [1] 290323 0
Approval date [1] 290323 0
18/06/2007
Ethics approval number [1] 290323 0
MREC MRG-07-LOI-HSR-1

Summary
Brief summary
A controlled interventional study was conducted in 12 conveniently selected health centres. A preliminary managerial clinical audit done April 2007 had showed numerous deficiencies.

Results were used to design an intervention package that emphasized sustainability, supervision and incorporation of existing systems/mechanisms. This intervention was implemented in 6 clinics from March to May 2008.

Three months post intervention, medical records were randomly sampled from each clinic from May to June 2008. A second expert panel session was convened to review the medical records selected post-intervention. Medical records were retrieved and assessed. Each medical record was reviewed by two Family Medicine Specialists (expert panel review) for diagnostic and management errors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45086 0
Prof Khoo Ee Ming
Address 45086 0
Department of Primary Care Medicine,
University of Malaya Primary Care Research Group,
Faculty of Medicine,
University of Malaya,
Jalan Lembah Pantai,
50590 Kuala Lumpur
Country 45086 0
Malaysia
Phone 45086 0
+60379581376
Fax 45086 0
+603-79577941
Email 45086 0
khooem@um.edu.my
Contact person for public queries
Name 45087 0
Dr Sondi Sararaks
Address 45087 0
Health Outcomes Research
Institute for Health Systems Research
Ministry of Health Malaysia
Suites. 55-1, 55-2, 55-4, 55-4 Setia Avenue,
No. 2 Jalan Setia Prima S U13/S
Seksyen U13 Setia Alam
40170 Shah Alam,
Selangor
Country 45087 0
Malaysia
Phone 45087 0
+603-3359 6006
Fax 45087 0
+603-3359 6015
Email 45087 0
sararaks.s@ihsr.gov.my
Contact person for scientific queries
Name 45088 0
Prof Khoo Ee Ming
Address 45088 0
Department of Primary Care Medicine,
University of Malaya Primary Care Research Group,
Faculty of Medicine,
University of Malaya,
Jalan Lembah Pantai,
50590 Kuala Lumpur
Malaysia
Country 45088 0
Malaysia
Phone 45088 0
+60379581376
Fax 45088 0
+603-79577941
Email 45088 0
khooem@um.edu.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary