Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000319976
Ethics application status
Approved
Date submitted
14/09/2010
Date registered
25/03/2011
Date last updated
25/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prescribing Data in General Practice Demonstration Project
Scientific title
Improving prescribing practices and patient outcomes for chronic heart failure and hypertension in the general practice setting: A quality improvement project
Secondary ID [1] 1152 0
Nil
Universal Trial Number (UTN)
Trial acronym
PDGPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic heart failure 252285 0
Hypertension 252286 0
Condition category
Condition code
Cardiovascular 252466 252466 0 0
Other cardiovascular diseases
Cardiovascular 252467 252467 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A general practice quality improvement intervention which includes: provision of evidence-based indicators to general practitioners (GPs) using their practice prescribing data, at each of the two peer group discussions (with general practitioners (GPs).These discussions are facilitated by a trained Division of General Practice facilitator, and last around 60 minutes. They are held at approximately at 1 month and 5 months after the data extraction during a six month topic block. Written resources are prvided for each topic. Professional development incentives are awarded to the GP when two clinical meetings for a topic are completed. This is equivalent to a clinical audit. This also contributes to QPI Practice Incentive Payments. The study will run for approximately 18 months.
Intervention code [1] 241603 0
Behaviour
Intervention code [2] 241604 0
Other interventions
Comparator / control treatment
Practices within each participating Division will be randomised to three arms:
- Arm 1 (Intervention Topic - Hypertension) will also act as topic control group for Arm 2 during the first 6 months of the study
- Arm 2 (Intervention Topic - Chronic Heart Failure) will also act as topic control group for Arm 1 during the first 6 months of the study
- Arm 3 - (Control group) - Usual care - will not receive any intervention in the first six months and will act a true control for Arm 1 and Arm 2
Control group
Active

Outcomes
Primary outcome [1] 253339 0
Proportion of patients with hypertension (HT) receiving pharmacological treatment. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [1] 253339 0
0, 6, 12 and 18 months
Primary outcome [2] 253340 0
Proportion of patients with Chronic Heart Failure (CHF) receiving appropriate treatment (ie using an angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor antagonists.) This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [2] 253340 0
0, 6, 12 and 18 months
Primary outcome [3] 253341 0
Proportion of patients with hypertension achieving target blood pressures. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [3] 253341 0
0, 6, 12 and 18 months
Secondary outcome [1] 262412 0
Proportion of CHF patients who were using ACE inhibitors or angiotensin II-receptors, but were not using a heart-failure specific beta-blocker. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [1] 262412 0
0, 6, 12 and 18 months
Secondary outcome [2] 262413 0
Proportion of CHF patients who were using an ACE inhibitor or angiotensin II-receptors, but at levels below the recommended dose. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [2] 262413 0
0, 6, 12 and 18 months
Secondary outcome [3] 262414 0
Proportion of CHF patients who were using a drug which may exacerbate this disease. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [3] 262414 0
0, 6, 12 and 18 months
Secondary outcome [4] 262415 0
Proportion of hypertension patients using a pro-hypertension drug whose latest blood pressure was greater than or equal to 140/90. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [4] 262415 0
0, 6, 12 and 18 months
Secondary outcome [5] 262416 0
Changes in the proportion of hypertension patients using an antihypertensive drug whose latest blood pressure was greater than or equal to 140/90. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [5] 262416 0
0, 6, 12 and 18 months
Secondary outcome [6] 262417 0
Mean change in blood pressure among hypertension patients who also had one of the following problems: chronic heart failure, diabetes, renal insufficiency, stroke or Transient ischaemic attacks. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [6] 262417 0
0, 6, 12 and 18 months
Secondary outcome [7] 262418 0
Proportion of patients using an ACE inhibitor or an angiotensin II-receptor antagonist and are also using a systemic non steroidal anti-inflammatory drug (NSAID) and a diuretic. This will be assessed using patient records extracted automatically and anonymously from the prescribing systems in each practice.
Timepoint [7] 262418 0
0, 6, 12 and 18 months

Eligibility
Key inclusion criteria
To be eligible for inclusion in the study GPs should:
- Agree to participate in the study
- Participate in activities to improve the data quality of their GP prescribing system ie small group discussions and patient audit and feedback
- Make their data available for the evaluation

Patient data will be included of they have hypertension or chronic heart failure or are taking the relevant medications
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If GPs are unwilling to participate in small group discussions
If GPs are unwilling to make their data available for the evaluation

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)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study is a pragmatic randomised controlled trial of a quality improvement intervention involving volunteer GP small groups/practices who will be randomised by group/practice into the following intervention and control arms:
Practices within in each participating Division will be randomised to three arms:
- Arm 1 (Intervention Topic - Hypertension) will act as topic control group for Arm 2 during the first 6 months of the study
- Arm 2 (Intervention Topic - Chronic Heart Failure) will act as topic control group for Arm 1 during the first 6 months of the study
- Arm 3 - (Control group) - will not receive any intervention in the first six months and will act a true control for Arm 1 and Arm 2
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2262 0
2077
Recruitment postcode(s) [2] 2263 0
2110
Recruitment postcode(s) [3] 2264 0
2113
Recruitment postcode(s) [4] 2265 0
2119
Recruitment postcode(s) [5] 2266 0
2120
Recruitment postcode(s) [6] 2267 0
2145
Recruitment postcode(s) [7] 2268 0
2146
Recruitment postcode(s) [8] 2269 0
2148
Recruitment postcode(s) [9] 2270 0
2227
Recruitment postcode(s) [10] 2271 0
2289
Recruitment postcode(s) [11] 2272 0
2290
Recruitment postcode(s) [12] 2273 0
2303
Recruitment postcode(s) [13] 2274 0
2537
Recruitment postcode(s) [14] 2275 0
2549
Recruitment postcode(s) [15] 2276 0
2550
Recruitment postcode(s) [16] 2277 0
2587
Recruitment postcode(s) [17] 2278 0
2653
Recruitment postcode(s) [18] 2279 0
2720
Recruitment postcode(s) [19] 2280 0
2767
Recruitment postcode(s) [20] 2281 0
3078
Recruitment postcode(s) [21] 2282 0
3083
Recruitment postcode(s) [22] 2283 0
3087
Recruitment postcode(s) [23] 2284 0
3095
Recruitment postcode(s) [24] 2285 0
3171
Recruitment postcode(s) [25] 2286 0
3186
Recruitment postcode(s) [26] 2287 0
3199
Recruitment postcode(s) [27] 2288 0
3337
Recruitment postcode(s) [28] 2289 0
3429
Recruitment postcode(s) [29] 2290 0
3658
Recruitment postcode(s) [30] 2291 0
3910
Recruitment postcode(s) [31] 2292 0
3931
Recruitment postcode(s) [32] 2293 0
4075
Recruitment postcode(s) [33] 2294 0
4109
Recruitment postcode(s) [34] 2295 0
4113
Recruitment postcode(s) [35] 2296 0
4116
Recruitment postcode(s) [36] 2297 0
4121
Recruitment postcode(s) [37] 2298 0
4122
Recruitment postcode(s) [38] 2299 0
4123
Recruitment postcode(s) [39] 2300 0
4343
Recruitment postcode(s) [40] 2301 0
4350
Recruitment postcode(s) [41] 2302 0
4352
Recruitment postcode(s) [42] 2303 0
4810
Recruitment postcode(s) [43] 2304 0
4810
Recruitment postcode(s) [44] 2305 0
4817
Recruitment postcode(s) [45] 2306 0
5045
Recruitment postcode(s) [46] 2307 0
5052
Recruitment postcode(s) [47] 2308 0
5162
Recruitment postcode(s) [48] 2309 0
6102
Recruitment postcode(s) [49] 2310 0
6103
Recruitment postcode(s) [50] 2311 0
6122
Recruitment postcode(s) [51] 2312 0
6155

Funding & Sponsors
Funding source category [1] 256081 0
Other
Name [1] 256081 0
National Prescribing Service through Department of Health & Ageing
Country [1] 256081 0
Australia
Primary sponsor type
Government body
Name
National Prescribing Service Limited
Address
Level 7, 418a Elizabeth St Surry Hills NSW 2010
PO Box 1147 Strawberry Hills NSW 2012
Country
Australia
Secondary sponsor category [1] 251427 0
Other
Name [1] 251427 0
Australian General Practice Network
Address [1] 251427 0
Ground Floor, Minter Ellison Building, 25 National Circuit, Forrest ACT 2601
Postal Address: PO Box 4308, Manuka ACT 2603
Country [1] 251427 0
Australia
Other collaborator category [1] 972 0
Individual
Name [1] 972 0
Professor Jane Gunn
Address [1] 972 0
200 Berkeley Street
Carlton
VICTORIA 3053
Country [1] 972 0
Australia
Other collaborator category [2] 973 0
Individual
Name [2] 973 0
Professor Jon Emery
Address [2] 973 0
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Country [2] 973 0
Australia
Other collaborator category [3] 974 0
Individual
Name [3] 974 0
Professor Nigel Stocks
Address [3] 974 0
The University of Adelaide
North Terrace Campus
Adelaide SA 5005
AUSTRALIA
Country [3] 974 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258178 0
Royal Australian College of General Practitioners (RACGP) National Research and Evaluation Ethics Committee
Ethics committee address [1] 258178 0
RACGP Ethics Committee
College House
1, Palmerston Crescent
South Melbourne, Victoria 3205
Ethics committee country [1] 258178 0
Australia
Date submitted for ethics approval [1] 258178 0
Approval date [1] 258178 0
21/08/2009
Ethics approval number [1] 258178 0
NREEC 08/007

Summary
Brief summary
This National Prescribing Service (NPS) project aims to improve GPs’ management of these patients through feedback on their own prescribing practices and small group discussions with peers and a trained group facilitator. Participating GPs can examine their prescribing practices using a “data extraction and reporting tool” provided by the researchers that interacts with the software GPs already use to manage patient records and write prescriptions. About twenty Divisions of General Practice will be recruited through expressions of interest and the chosen divisions will in turn recruit approximately 9 practices within their division to participate in the research. Participating practices will be randomly allocated to one of three groups of which two groups will be the intervention group and one group will be the control group. Practices assigned to the intervention group will receive the quality improvement intervention (data extraction tool and small group discussion) with each group undertaking the clinical topics hypertension and chronic heart failure ion the reverse order to the other. The control group will not receive any intervention for the first six months and will therefore act as a “true control” for the other two groups. Participating GP practices will receive continuing education credits and an average of $500 reimbursement for time spent on data cleaning. Non–identifiable patient and GP data before and after the intervention will be extracted and analysed by NPS.
Trial website
http://www.nps.org.au/research_and_evaluation/research/current_research/prescribing_data_in_general_practice
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30549 0
Address 30549 0
Country 30549 0
Phone 30549 0
Fax 30549 0
Email 30549 0
Contact person for public queries
Name 13796 0
Magnolia Cardona-Morrell
Address 13796 0
National Prescribing Service Limited, Level 7, 418A Elizabeth St Surry Hills NSW 2010.
Country 13796 0
Australia
Phone 13796 0
+612 82178603
Fax 13796 0
+612 92117578
Email 13796 0
[email protected]
Contact person for scientific queries
Name 4724 0
Magnolia Cardona-Morrell
Address 4724 0
National Prescribing Service Limited, Level 7, 418A Elizabeth St Surry Hills NSW 2010.
Country 4724 0
Australia
Phone 4724 0
+612 82178603
Fax 4724 0
+612 92117578
Email 4724 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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No documents have been uploaded by study researchers.

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