None listed
Conditions
Brief summary
Glucocorticoids (GCs, also known as steroids or prednisolone) are often used to treat rheumatic diseases such as Rheumatoid Arthritis (RA), Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA), While they can relieve symptoms, they are also associated with many side effects including reduced life expectancy, infection, weight gain, hypertension, diabetes, osteoporosis, cataracts, mood disturbance, thin skin, and easy bruising. In recognition of this, Australian Living Guidelines for RA recommend against the long-term use of GCs. However, studies have shown that once GCs are started, they are often difficult to stop even when the joint disease of RA appears to be well-controlled. Reducing and stopping GCs is often difficult to achieve in the clinic setting, where there are insufficient resources to provide comprehensive education and support. There are no proven methods to improve implementation of these recommendations. The aim of this study is to develop a pharmacist-led GC intervention to assist with GC reduction and cessation and minimise the side effects associated with GC use in patients with rheumatic diseases compared to “usual care”. Rheumatologists will refer people with RA, PMR and GCA who require gradual reduction of GC dose and/or cessation. Patients will either receive the new pharmacist-led intervention or receive “usual care” in an existing routine clinic plus a written schedule for reducing the GC dose from the pharmacist. Patients in the new intervention arm will receive 4-weekly telehealth appointments or phone calls when the pharmacist will collect patient reported data on dose, side effects, and barriers to dose reduction. All participants will have face-to-face visits at baseline, 6 months, and 12 months, when additional information including height, weight, BMI, blood pressure, disease activity and relapse will be collected. The aim will be to see if the pharmacist-led intervention increases the likelihood of achieving the target GC dose at 6 months and reduces the overall GC dose, relapses/flares, side effects, ED presentations and hospitalisations.
Interventions
Patients randomised to the intervention group will receive Telehealth or phone reviews with the study pharmacist every 4 weeks for 16 weeks. At these appointments the pharmacist will provide support for patients as they taper their GCs as per a written schedule provided at the baseline visit. This tapering schedule will be individualised for each patient, according to their current and target dose. The schedule will be created by the pharmacist in conjunction with the treating rheumatologist, an
Patients randomised to the intervention group will receive Telehealth or phone reviews with the study pharmacist every 4 weeks for 16 weeks. At these appointments the pharmacist will provide support for patients as they taper their GCs as per a written schedule provided at the baseline visit. This tapering schedule will be individualised for each patient, according to their current and target dose. The schedule will be created by the pharmacist in conjunction with the treating rheumatologist, and will be based on usual clinical practice. Where available and clinically appropriate, tapering guidelines may be followed (for example, GiACTA for GCA and EUROLUPUS for SLE). The printed schedule will require patients to check off each dose reduction, with space provided for them to record alterations to dose (ie missed doses, increased doses, missed taper etc). The pharmacist will also record any patient reported adverse effects or barriers to tapering including relapse or flare. These visits will be in addition to usual care with their rheumatologist, which will involve outpatient clinic reviews scheduled as frequently as clinically required, which will vary depending on diagnosis, clinical response and individual patient needs. Patients may also contact the rheumatology department between visits for phone advice from rheumatology nurses or doctors regarding flares and medication queries.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age >=18 years 2. Clinical diagnosis of RA, SLE, Myositis, PMR or GCA made by a rheumatologist 3. New or longstanding GC use requiring tapering to lower dose or cessation over the next 6 months
Exclusion criteria
1. Unable to provide informed consent 2. Non-rheumatological indication for GC use
Outcome results
None listed