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A collaborative disease management program for managing cholesterol in hospital patients

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000313437
Enrollment
80
Registered
2007-06-13
Start date
2007-07-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 vi

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.

Sponsors

Barwon Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026