None listed
Conditions
Brief summary
This research project is a pre-post comparative cohort study of a pharmacist led decision support protocol in anaemia management vs. the current physician based treatment system. The cohort will include dialysis dependent stage 5 chronic kidney disease patients within 3 dialysis units of Fraser Coast renal service (FCRS), within Wide Bay Hospital and Health Service South (WBBHS South). The intervention group will be based in Hervey Bay Hospital (HBH), Maryborough Hospital (MBH) and the Fraser Coast home haemodialysis unit. The current patients being treated in the Fraser Coast renal service will act as their own control. Post hoc data will be collected for four previous months of standard physician based treatment. FCRS mostly use Darbepoetin alfa and Iron polymaltose as part of the current anaemia treatment plan. A t-test will be used to statistically compare the clinical parameters in the two arms of treatment. The main outcomes will be the impact of the pharmacist involvement in optimising anaemia management. This will be summarised by looking at the target haemoglobin and iron stores for the patients. Patients are best stabilised with a haemoglobin between 95-115mg/L (9.5-11.5g/DL). Ferritin targets should maintain between 200-500µg/L and transferrin saturation between 20-40%9,10,11,12,17. A t-test will examine the null hypothesis (H0) comparing the 2 treatment arms. Primary outcome will investigate if a pharmacist led decision support protocol in anaemia management will adequately maintain the haemoglobin within the target range. Secondary outcome will measure stability in Ferritin, TSAT%, the appropriate and safe use of iron and erythropoietin stimulating agents (ESA), and the efficiency of medication use. Aim The aim of this study is to evaluate the impact of a pharmacist led decision support protocol in anaemia management in a regional haemodialysis unit, using an anaemia management work unit guideline, under the supervision of the consultant nephrologist. • H0 = The implementation of a pharmacist led decision support protocol in anaemia management service will result in no change in optimising clinical parameters related to iron and Hb compared to the current treatment of a physician based anaemia treatment in dialysis dependent stage 5 kidney disease. • H1 = The implementation of a pharmacist led decision support protocol in anaemia management will show change in optimising clinical parameters related to iron and Hb compared to the current treatment of a physician based anaemia treatment in dialysis dependent stage 5 kidney disease. The primary outcome will investigate whether a pharmacist led decision support protocol in anaemia management will adequately maintain the haemoglobin within the target range. This will be summarised by looking at the target haemoglobin and iron stores for patients on dialysis. Patients are best stabilised with a haemoglobin between 95-115mg/L (9.5-11.5g/DL).
Interventions
This research project is a comparative cohort study of a pharmacist led decision support protocol in anaemia management vs. the current physician based treatment system
Intervention treatment is protocol driven dose adjustment for iron and ESA dose's.
Patients will be dosed with the following medications:
Darbepoetin alfa 10mcg to 200mcg Weekly IV/SC
methoxy polyethylene glycol epoetin beta 30 to 360mcg IV/SC Monthly
Iron Polymaltose 100mg Weekly IV
Iron Sucrose 100mg Weekly IV
Ferric Carboxyma
This research project is a comparative cohort study of a pharmacist led decision support protocol in anaemia management vs. the current physician based treatment system Intervention treatment is protocol driven dose adjustment for iron and ESA dose's. Patients will be dosed with the following medications: Darbepoetin alfa 10mcg to 200mcg Weekly IV/SC methoxy polyethylene glycol epoetin beta 30 to 360mcg IV/SC Monthly Iron Polymaltose 100mg Weekly IV Iron Sucrose 100mg Weekly IV Ferric Carboxymaltose 100mg IV weekly Only ONE type of iron preparation and ONE type of ESA preparation will be used in each patient. The first choice will be iron polymaltose and darbepoetin alfa. patients will only be chaged from iron polymaltose to iron sucrose or ferric carboxymaltose if there was an adverse drug reaction to the iron polymaltose. Methoxy polyethylene glycol epoetin beta will only be used as second line treatment is darbepoetin is considered inappropriate by the nephrologist or as continuation of care for those patients currently being treated with Micera. The intervention will occur on the dialysis floor in the Hervey Bay Hospital. The trial interventions will occur ONCE a month for 4 months (total of 4 interventions per patient). The mode of delivery will be myself on the computer viewing the monthly bloods. The recommendations will be handed to the RMO on the dialysis unit and the medication changes will be charted on the national inpatient medication chart. Dose changes will be made on the recommendation set out on the intervention protocol. For Iron: please see below for the simplified flow chart, and please see the protocol attached to the original ANZCTR registration record for detailed explanation. If ferritin is <200µg/L or TSAT <20% Start or recommence iron administration If ferritin is 200-500µg/L and TSAT is 20-40% No change, continue current status. If ferritin is >500µg/L or TSAT >40% Stop iron administration If there is conflict between TSAT % and ferritin levels, consult the CNC or Doctor. For ESA’s: please see the protocol attached to the original ANZCTR registration record for detailed explanation of dose adjustments for ESA’s Please refer to Darbepoetin dose adjustment tables in the study protocol attached. Mircera™ methoxy polyethylene glycol-epoetin beta If Hb increase by <10g/L per month, increase by ~25%, rounded to the nearest convenient formulation. If Hb target not reached the next month, Increase by another 25%, rounded to the nearest convenient formulation Please refer to methoxy polyethylene glycol-epoetin beta dose adjustment tables in the study protocol attached. The intervention will be carried out by myself the Pharmacist. I am a senior pharmacist working in the Renal Unit in Hervey Bay. My Qualifications include Batch. of Pharmaceutical Science (2008) and a Masters of Pharmacy (2009) from Griffith University, and a Graduate Diploma in Clinical Pharmacy from Queens University Belfast, Ireland (2015).
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria Subjects will need to fulfil the following selection criteria. • Patients must be 18 years old or greater • Must be diagnosed with End Stage Chronic Kidney Disease (Stage 5) by a Nephrologist o Study population – CKD dialysis dependent Stage 5 on haemodialysis or home haemodialysis • Must be established on dialysis.
Exclusion criteria
Exclusion Criteria • Non-English-speaking personal and those who have been declared medically incompetent to make health care decisions. • Pregnant or lactating woman. • Patient who have a known allergy to any ESA’s or intravenous Iron preparations. • The nephrologist does not feel that the patient is suitable for the program. • The patient is currently on an ESA dose greater that the recommended maximum of 150mcg of darbepoetin per week or Mircera dose of 360mcg monthly. • The patient is currently receiving treatment for malignancy with chemotherapy.
Outcome results
None listed