Testing a new stepwise strategy for the management of renal anaemia
Testing a new stepwise strategy for the management of renal anaemia in primary care: An exploratory cluster randomised trial
Simon de Lusignan
Anaemia is common in people with chronic kidney disease (CKD), and is associated with poor health outcomes. In the United Kingdom, CKD is largely managed in primary care, and although anaemia is a cardiovascular risk factor, few people with anaemia and CKD currently have active management of their anaemia. Many trials have studied anaemia management in CKD, but these have been conducted in specialist renal units, a trial is needed of other interventions to manage anaemia in primary care.
This study aims to develop and evaluate a step-wise model of intervention for treating anaemia in people with CKD in primary care.
Subjects and Setting
The research team will recruit 20 GP practices in London and Southeast England. Patients with CKD and anaemia, who are not under the care of a renal physician are the subject of this study.
The study adopts the Medical Research Council’s framework for the development and evaluation of complex interventions in health care services. It has two distinct phases:
Phase 1: Diagnostic analysis and define the step-wise intervention (Year 1)
Using qualitative research methods, the study will explore the reasons for any variation from NICE guidance and whether the proposed step-wise intervention is both feasible and acceptable.
Phase 2: Cluster randomised trial (Years 2 and 3)
Conduct a two-armed randomised study to evaluate the effectiveness of step-wise intervention:
1. Step-wise intervention
2. Usual practice
Primary outcome measures:
• Proportion of people with CKD who remain anaemic one year after the study
• comparing change in haemoglobin levels and % of patients with Hb<10g/dL in the two groups
Secondary outcome measures:
• Health-Related Quality of Life
• Symptoms of anaemia
• Major cardiovascular events, surrogate markers of cardiovascular risk and confounding factors
• Renal function
• Adverse events and death
• Cost effectiveness of the interventions
London - City & East Research Ethics Committee
Date of REC Opinion
26 Aug 2014
Further Information Favourable Opinion