Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000313437
Ethics application status
Not yet submitted
Date submitted
8/06/2007
Date registered
13/06/2007
Date last updated
13/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A collaborative disease management program for managing cholesterol in hospital patients
Scientific title
A protocol-driven collaborative ambulatory care service run by hospital pharmacists for the management of hyperlipidaemia and its role in improving lipid levels and medication adherence
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidaemia 1856 0
Peripheral vascular disease 1857 0
Condition category
Condition code
Blood 1950 1950 0 0
Other blood disorders
Cardiovascular 1951 1951 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The clinic will be run by an experienced clinical pharmacist as per protocols under the supervision of a physician. A competency package will be developed for the pharmacist undertaking the role around Peripheral Vascular Disease and hyperlipidaemia. Intervention group patients will be given appointments to see the trained pharmacist at an out-patient clinic every six weeks. An algorithim with a patient sticker will be signed by the physician ahead of patient’s clinic visit. During the first visit the pharmacist will review the patient’s lipid levels. Patients who are not already on lipid lowering medication will be started on a suitable dose of lipid lowering medication (e.g. Pravastatin 40mg or equivalent). For those who are already on lipid lowering medication, adjustments in the dosing regimen will be done if needed, as per the algorithm and clinic protocols. The pharmacist will review pateint’s medication regimen for drug interactions and adverse reactions. The pharmacist will educate the patient, emphasising the need for adherence to drug therapy and non-pharmacological management such as exercise, dietary control and life style changes. Direct dispensing at the point of care will be used to enhance medication adherence. At the subsequent visit (after six weeks) if lipid levels have not reduced by at least 10%, dose increases will be ordered. This will be a doubling of the dose of statin or its equivalence ( for example, pravastatin 40mg changed to 40mg atorvastatin). Feedback on lipid levels with reinforcement on the importance of adherence to treatment recommendations will be provided to the patient. Review of lipid levels, dosage adjustment and patient feedback will continue to be offered at each of the three subsequent six weekly visits. Minimal input from the physician will be sought for the running of the clinic. However, patients whose management is beyond the competence of the pharmacist (e.g. uncontrolled diabetes, high LDL resistant to two successive dosage changes) will be referred to the physician in charge of the clinic or other relevant health professional (e.g. dietician). Such patients will continue to be part of the intervention arm after the particular referral.
Intervention code [1] 1817 0
Early detection / Screening
Comparator / control treatment
Control group will get routine care. A booklet on lipid management will be provided at baseline. Patients are given an appointment to see the clinic pharmacist at six months. Lipid levels and lipid management at baseline and end of study will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 2768 0
Lipid levels
Timepoint [1] 2768 0
Measured in the two groups at baseline and end of study (6 months)
Primary outcome [2] 2769 0
Patient adherence to treatment
Timepoint [2] 2769 0
Measured in the two groups at baseline and end of study (6 months)
Primary outcome [3] 2770 0
Provider adherence to treatment guidelines
Timepoint [3] 2770 0
Measured in the two groups at baseline and end of study (6 months)
Secondary outcome [1] 4665 0
Patient satisfaction with the service, economic benefits will be compared between the intervention and control group.
Timepoint [1] 4665 0
At the end of study (6months)

Eligibility
Key inclusion criteria
Patients at Barwon Health who are undergoing treatment (medical and/or surgical) for PVD or those with limb artery disease; and2. With uncontrolled lipid profile (Total cholesterol >5.5mmol/L or LDL >3.5mmol/L after overnight fasting)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Minors/ patients who are unable to provide informed consent2. Patients who are already part of another compliance program or study3. Patients unwilling/unable for follow-up for six months.4. Patients having triglyceride levels >4mmol or other spurious lipid values.5. Patients with poor diabetes control, i.e HbA1c >6.5%.6. Patients having any hypersensitivity/ contraindication to lipid lowering drugs 7. Pregnancy

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)
A series of random numbers will be generated and an enevlope containing the number will be picked up by the participant at the time of enrolment into the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers will be generated from the computer (from www.random.org)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2094 0
Charities/Societies/Foundations
Name [1] 2094 0
Society of Hospital Pharmacists of Australia
Country [1] 2094 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Country
Australia
Secondary sponsor category [1] 1900 0
University
Name [1] 1900 0
Monash University
Address [1] 1900 0
Country [1] 1900 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3883 0
HRECs of Barwon Health
Ethics committee address [1] 3883 0
Ethics committee country [1] 3883 0
Australia
Date submitted for ethics approval [1] 3883 0
Approval date [1] 3883 0
Ethics approval number [1] 3883 0
Ethics committee name [2] 3884 0
HRECs of Monash University
Ethics committee address [2] 3884 0
Ethics committee country [2] 3884 0
Australia
Date submitted for ethics approval [2] 3884 0
Approval date [2] 3884 0
Ethics approval number [2] 3884 0

Summary
Brief summary
The project aims at evaluating the role of a collaborative disease management service in the hospital setting. A protocol-driven out-patient service run by hospital pharmacists working under medical supervision will be developed for managing high cholesterol levels in patients with peripheral vascular disease (PVD). Patients with PVD undergoing medical and/or surgical treatment at Barwon Health with uncontrolled cholesterol levels will be recruited randomly into either the study group or the control group. Cholesterol management in the study group will be undertaken by a trained pharmacist with minimal input from the physicians, while control group will receive routine care. Subjects in the study group will be reviewed every 6 weeks by the pharmacist. The pharmacist will review patient’s medicines, adjust doses of cholesterol lowering medications as per set protocols, provide feedback to patients on their cholesterol levels, provide education on cholesterol management and offer periodic reinforcement. The extent to which patients use their cholesterol medicines and the cholesterol levels at six months will be compared in the two groups. The extent to which cholesterol management guidelines are followed and cost effectiveness of the service will also be compared in the two groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27631 0
Address 27631 0
Country 27631 0
Phone 27631 0
Fax 27631 0
Email 27631 0
Contact person for public queries
Name 11006 0
Mr Greg Weeks
Address 11006 0
Director of Pharmacy, The Geelong Hospital, Barwon Health, Ryrie Street, Geelong, VIC 3220
Country 11006 0
Australia
Phone 11006 0
(03) 5226 7638
Fax 11006 0
Email 11006 0
[email protected]
Contact person for scientific queries
Name 1934 0
Dr Johnson George
Address 1934 0
Department of Pharmacy Practice
Monash University
381 Royal Parade
Parkville VIC 3052
Country 1934 0
Australia
Phone 1934 0
03 9903 9178
Fax 1934 0
Email 1934 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

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

Documents added automatically
No additional documents have been identified.