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Trial registered on ANZCTR


Registration number
ACTRN12614000641695
Ethics application status
Approved
Date submitted
9/06/2014
Date registered
18/06/2014
Date last updated
18/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
An interventional study on physicians’ adherence to hypertension guidelines
Scientific title
Effect of a complex intervention involving primary care doctors on blood pressure control in patients with hypertension
Secondary ID [1] 283778 0
Nil known
Universal Trial Number (UTN)
U1111-1150-8720
Trial acronym
Implementing, Innovation, In-Practice Study (IIIP) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 290754 0
Condition category
Condition code
Cardiovascular 291115 291115 0 0
Hypertension
Public Health 292514 292514 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a before-and-after study using clinical support tools and health care professional training. Assessments are done at 0-3 months post intervention for immediate effect of intervention and 3-6 months post interventions for sustainability of intervention.

The intervention package consists of :

1. A training session conducted by senior academicians to modify the primary care physicians' practice according to guidelines recommendations pre intervention

2. A quick reference guide summarising recommendations from the guideline to put on desktops as well as online on computers of each consultation room for easy access and reference for doctors throughout the study duration

3. At patient's first visit:
(i) Patients have to fill self assessment forms prior to consultation with doctor
(ii) Patients' anthropometric parameters (weight, height and waist circumference) are measured by nurses
(iii) A personalized checklist for the doctors is placed in the patient's medical record to be utilized as a quick reference and reminder to the doctor on the essential parameters that are required for evaluation. The checklist includes documentation of cardiovascular risk factors and comorbidities, secondary causes, investigations ordered, target organ damage, patient's estimated cardiovascular risk, medications, BP measurement and physcical examination findings.
(iv) Sets of investigations forms are placed in the medical records as reminder for doctors and for ease of administration

4. At patients' follow up visits at 3 to 6 months, a checklist is placed in the medical records that includes documentation of weight, blood pressure, investigations ordered, medications, presence of target organ damage and complications.
Intervention code [1] 288464 0
Early detection / Screening
Intervention code [2] 288465 0
Prevention
Intervention code [3] 289542 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291107 0
Primary outcome is the proportion of patients with controlled blood pressure. Controlled blood pressure is defined as blood pressure less than 140/90mmHg and measured using mercury sphygmomanometer by the doctors.
Timepoint [1] 291107 0
0 to 3 months post intervention for immediate effect of intervention, 3 to 6 months post intervention for sustainability of intervention
Secondary outcome [1] 306009 0
The rates of documentation of process indicators and outcome indicators from the checklist provided in the medical records: these include the rate of documentation of process indicators (BP, weight measurement, assessment of cardiovascular risk factors, target organ damage and comorbidities, examinations, investigatory tests ordered) and the rate of documentation of outcome indicators (medication use)
Timepoint [1] 306009 0
0 to 3 months post intervention for immediate effect of intervention, 3 to 6 months post intervention for sustainability of intervention

Eligibility
Key inclusion criteria
All primary care physician working at the Primary Care Clinic at the University Malaya Medical Centre (UMMC) who are treating the cohort of patients with hypertension from earlier phase of this study (patient with hypertension for at least a year and have been followed up at the Primary Care Clinic).

Earlier phase of the study is a retrospective review of records and it is not registered as it is not an intervention trial. We have published a paper from earlier phase of the study :

Liew et al.: Statins use is associated with poorer
glycaemic control in a cohort of hypertensive patients with diabetes and without diabetes. Diabetology & Metabolic Syndrome 2014 6:53. doi:10.1186/1758-5996-6-53
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All primary care physician working at the Primary Care Clinic at the University Malaya Medical Centre (UMMC) who are not treating the cohort of patients with hypertension from earlier phase of the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All primary care physician working at the Primary Care Clinic at the University Malaya Medical Centre (UMMC) who are treating the cohort of patients with hypertension from earlier phase of the study are approached to participate the study and informed consent obtained. In addition, all patients with hypertension for at least 1 year and has been followed up in this clinic and are in the earlier phase of the study cohort who attended the clinic during the study period are approached to participate in the study. A patient information sheet would be given and consent sought.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomized. All doctors who fulfill the criteria are included
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
sample size calculation:
We estimate the change of proportion of patients from uncontrolled blood pressure to controlled blood pressure is 10% while the change of proportion of patients from controlled blood pressure to uncontrolled blood pressure is 5%; for a power of 0.8 and significance level set at 0.05, a sample size of 469 is needed. To account for an estimate of 20% drop out, 570 are recruited.

For analysis of study data, chi square tests, paired t test, repeated measures of ANOVA tests will be used.

Recruitment
Recruitment status
Active, not recruiting
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] 5684 0
Malaysia
State/province [1] 5684 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 288443 0
University
Name [1] 288443 0
University Malaya Research Grant (UMRG) 315- 11 HTM, Institute of Research Management and Monitoring (IPPP), University of Malaya, Malaysia
Address [1] 288443 0
University of Malaya, Jalan Lembah Pantai, 50603, Kuala Lumpur, Malaysia
Country [1] 288443 0
Malaysia
Funding source category [2] 289412 0
University
Name [2] 289412 0
University Malaya Research Grant (UMRG) 513- 13 HTM, Institute of Research Management and Monitoring (IPPP), University of Malaya, Malaysia
Address [2] 289412 0
University of Malaya, Jalan Lembah Pantai, 50603, Kuala Lumpur, Malaysia
Country [2] 289412 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
University of Malaya, Jalan Lembah Pantai, 50603, Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 287146 0
None
Name [1] 287146 0
Address [1] 287146 0
Country [1] 287146 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290317 0
Medical Ethics Committee, University Malaya Medical Centre (UMMC)
Ethics committee address [1] 290317 0
University Malaya Medical Centre, Lembah pantai, 59100, Kuala Lumpur
Ethics committee country [1] 290317 0
Malaysia
Date submitted for ethics approval [1] 290317 0
25/10/2011
Approval date [1] 290317 0
23/11/2011
Ethics approval number [1] 290317 0
890.14

Summary
Brief summary
The purpose of this study is to find out whether an intervention including training of doctors, and using forms to collect and document necessary information and assessment on high blood pressure according to guidelines from patient and doctors will improve blood pressure control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45022 0
Prof Ee Ming Khoo
Address 45022 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Lembah Pantai
50603, Kuala Lumpur
Country 45022 0
Malaysia
Phone 45022 0
+603 79492306
Fax 45022 0
+603 79577941
Email 45022 0
khooem@um.edu.my
Contact person for public queries
Name 45023 0
Prof Ee Ming Khoo
Address 45023 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Lembah Pantai
50603, Kuala Lumpur,
Country 45023 0
Malaysia
Phone 45023 0
+603 79492306
Fax 45023 0
+603 79577941
Email 45023 0
khooem@um.edu.my
Contact person for scientific queries
Name 45024 0
Prof Ee Ming Khoo
Address 45024 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Lembah Pantai
50603, Kuala Lumpur,
Country 45024 0
Malaysia
Phone 45024 0
+603 79492306
Fax 45024 0
+603 79577941
Email 45024 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