A bundled phosphate control intervention (4Ds) for adults with end-stage kidney disease receiving haemodialysis: A cluster randomized controlled trial protocol

J Adv Nurs. 2018 Oct;74(10):2431-2441. doi: 10.1111/jan.13774. Epub 2018 Jul 12.

Abstract

Aim: To evaluate the effectiveness of a bundled self-management intervention (Taking control of your phosphate with the 4Ds) to improve phosphate control among adults receiving haemodialysis.

Background: Hyperphosphataemia occurs in end-stage kidney disease and is associated with increased morbidity and mortality. While hyperphosphataemia can be managed through four methods (food, drinks, drugs and dialysis) adherence to these methods is challenging for patients. Studies also tend to focus on one method of phosphate control rather than bundling all methods together into a theoretically driven intervention.

Design: A multisite cluster randomized controlled trial with repeated measures.

Methods: Adults receiving haemodialysis with high serum phosphate levels (>1.6 millimoles per litre for at least 3 months) will be cluster randomized to standard care or intervention according to haemodialysis treatment shift. Informed by social cognitive theory, the intervention focuses on improving self-efficacy and incorporates the "teach-back" method of patient education. The intervention brings together essential phosphate control strategies of diet, drinks, drugs (phosphate binders) and dialysis prescription in a 12-week self-management education programme. The primary outcome is serum phosphate level. Secondary outcomes are knowledge of and adherence to phosphate control strategies and self-efficacy for managing kidney disease.

Discussion: Efforts to improve phosphate control have been undertaken although the optimal approach remains unclear. This study will make an important contribution to building an evidence base of phosphate control nursing intervention that can be delivered during routine haemodialysis.

Trial registration: Australian and New Zealand Clinical Trials Registry Number ACTRN12617000703303.

Keywords: adherence; behaviour; chronic kidney disease; education; end-stage kidney disease; haemodialysis; knowledge; nursing; phosphate; self-management.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Australia
  • Clinical Protocols
  • Humans
  • Hyperphosphatemia* / complications
  • Hyperphosphatemia* / prevention & control
  • Kidney Failure, Chronic* / blood
  • Kidney Failure, Chronic* / complications
  • Kidney Failure, Chronic* / therapy
  • Multicenter Studies as Topic
  • New Zealand
  • Outcome Assessment, Health Care
  • Patient Compliance
  • Patient Education as Topic* / methods
  • Phosphates* / blood
  • Randomized Controlled Trials as Topic
  • Renal Dialysis*
  • Self Efficacy
  • Self-Management* / methods
  • Teach-Back Communication

Substances

  • Phosphates