Title: Testing a new stepwise strategy for the management of renal anaemia in primary care: An exploratory cluster randomised trial
Funder: Department of Health (England)

Abstract: Background: Anaemia is common in chronic kidney disease and associated with poor health outcomes. Chronic Kidney Disease (CKD) is a condition largely managed in primary care.(Gomez et al., 2006). CKD is divided into stages 1 to 5; 1 is the least severe and stage 5 is renal failure. By convention stages 3 to 5 CKD, are be defined by an estmated glomerular filtration rate (eGFR) of Many trials have studied anaemia management in CKD (Macdougall, 2003),(Szczech et al., 2010),(Mix et al., 2005), but these have been conducted in Renal Units/secondary care, and therefore on a highly selected population. The interventions have focused on erythropoietin stimulating agents (ESA) therapy, whereas anaemia management in primary care needs to have a more ‘holistic’ approach. The outcomes from these trials have raised concerns about fully correcting anaemia with ESA therapy, and therefore other strategies need to be explored. We have found that over three-quarters of people with CKD and anaemia are taking medications which either exacerbate anaemia (e.g. Non Steroidal Anti-inflammatory medications (NSAID)). Oral iron is widely prescribed in primary care but where used has not reversed the anaemia. New interventions are needed to treat anaemia in people with CKD in primary care. Aims (including research question): The aim of this study is to develop and evaluate a complex intervention for treating anaemia in people with CKD in primary care: to treat anaemia and improve quality of life outcomes. Plan of investigation: Development of a complex intervention using MRC methodology, to be subsequently tested in a definitive cluster randomised controlled trial: Phase 1: Diagnostic analysis: We will use focus groups (Crinson et al., 2010) to develop an understanding of current practice. We will ascertain doctor and patient factors that are contributing? We will explore in-depth in four practices the reasons for variance from NICE guidance and whether the proposed step-wise method is acceptable. Phase 2: Pilot cluster randomised trial: We will conduct a two arm study: (1) New step-wise intervention to manage anaemia in primary care, with an initial focus on medicines management, vs. (2) Usual practice. Phase 3: Definitive CRT (Not part of this work) : We will design and conduct the definitive trial. Expected outcomes : We will develop a stepwise management protocol for anaemia in CKD patients in Primary Care. This pilot study should report the effect size of implementing stepped anaemia management in CKD and inform the design of a definitive trial, the results of which may influence future guidelines on anaemia management. Anaemia treatment should reduce the rate of cardiovascular comorbidities in CKD patients and improve quality of life outcomes. More effective treatment in primary care should be cost-effective and may decrease referrals to specialist services.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: BLOOD;RENAL AND UROGENITAL