Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000056796
Ethics application status
Approved
Date submitted
15/01/2013
Date registered
16/01/2013
Date last updated
16/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding clinical decision making in the management of hypertension in Australian general practice
Scientific title
Understanding clinical decision making in the management of hypertension in Australian general practice
Secondary ID [1] 281772 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 288087 0
Clinical decision making 288088 0
Lifestyle risk factors 288089 0
Condition category
Condition code
Public Health 288462 288462 0 0
Other public health
Cardiovascular 288478 288478 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study - video recordings of routine general practice consultations.

GPs will be recruited into the study. 1-4 sessions with the GP will be videorecorded. Patients presenting during that session will be invited to participate.

Basic data from each video will be collected to provide a snapshot of general practice consultations e.g. number of presenting problems, consultation length etc.

Consultations involving the diagnosis, measurement, management or discussion of blood pressure, cardiovascular risk or lifestyle risk factors will be analysed in more depth using video-tagging software. Data collected will include: frequency, content and quality of BP management consultations.

For these consultations a video-elicited semi-structured interview will be conducted with the GP. Information collected here will include: relevant background context, previous treatments, reasons for cessation/change, etc.

For the cases selected above, a review of the patient file will be conducted looking for details relevant to the consultation e.g. specialist referral and blood test results to help provide context to what is otherwise only a snapshot of management seen in one consultation.
Intervention code [1] 286315 0
Not applicable
Comparator / control treatment
Observational study - no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288625 0
Describe the clinical decision making of Australian general practitioners involved in the management of blood pressure. Describe the frequency, content and quality of BP management e.g. how is BP measured; frequency, content and quality of lifestyle counselling; scripts dispensed; what are the major influences in management decisions; are they GP or patient driven etc
Timepoint [1] 288625 0
Observation during consultation plus/minus video-elicited interview with GP and patient case note review
Secondary outcome [1] 300646 0
Explore barriers and facilitators to management of blood pressure in Australian general practice
Timepoint [1] 300646 0
Observation during consultation plus/minus video-elicited interview with GP and patient case note review

Eligibility
Key inclusion criteria
Key inclusion criteria into the study (Want to capture routine general practice so GP and patient will be unaware of the condition under review).

GP - GP or GP in training

Patient >18yo and able to provide informed consent

For analysis - consultations chosen where the patient or the GP mentions BP or HT, BP is measured or the patient has a relevant medical condition e.g. diabetes
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient - unable to provide informed consent or <18 years

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 286553 0
Charities/Societies/Foundations
Name [1] 286553 0
National Heart Foundation
Country [1] 286553 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute Tasmania, University of Tasmania
Address
17 Liverpool St, Hobart, Tasmania, 7000
Country
Australia
Secondary sponsor category [1] 285341 0
None
Name [1] 285341 0
Address [1] 285341 0
Country [1] 285341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288624 0
Tasmania Social Sciences Human Research Ethics Committee
Ethics committee address [1] 288624 0
University of Tasmania, Private Bag 01 Hobart Tas 7001
Ethics committee country [1] 288624 0
Australia
Date submitted for ethics approval [1] 288624 0
Approval date [1] 288624 0
Ethics approval number [1] 288624 0
H0012702

Summary
Brief summary
The primary purpose of this study is to explore and describe the clinical decision making of Australian general practitioners involved in the management of blood pressure: how is BP being measured? How is BP being recorded? How is BP being interpreted by the GP and patient? How is BP being managed – lifestyle interventions, medication, as an isolated risk factor or in the context of absolute cardiovascular risk?

We also want to explore the barriers and facilitators to the management of blood pressure in Australian general practice: What factors influence the clinical decision-making of the GP?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37038 0
Prof Mark Nelson
Address 37038 0
Private Bag 23,
Hobart, Tas, 7000
Country 37038 0
Australia
Phone 37038 0
61 (0)3 6226 4734
Fax 37038 0
Email 37038 0
Mark.Nelson@utas.edu.au
Contact person for public queries
Name 37039 0
Dr Faline Howes
Address 37039 0
Private Bag 23,
Hobart, Tas, 7000
Country 37039 0
Australia
Phone 37039 0
61 (0)3 6226 4731
Fax 37039 0
Email 37039 0
Faline.Howes@utas.edu.au
Contact person for scientific queries
Name 37040 0
Dr Faline Howes
Address 37040 0
Private Bag 23,
Hobart, Tas, 7000
Country 37040 0
Australia
Phone 37040 0
61 (0)3 6226 4731
Fax 37040 0
Email 37040 0
Faline.Howes@utas.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.