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

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.