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

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 managed by diet, drinks, drugs (phosphate binder medication), and dialysis (the 4Ds). Adherence to the 4Ds is challenging for patients. DESIGN: A pragmatic cluster randomized controlled trial with repeated measures. METHODS: Participants were adults receiving haemodialysis with high serum phosphate (>1.6 mmol/L for at least 3 months) recruited between August 2017 -May 2018. Cluster randomization was according to haemodialysis treatment shifts. The 'teach-back' intervention was designed to improve phosphate control. Expected outcomes were reduced serum phosphate and increased knowledge of phosphate in end-stage kidney disease, self-efficacy and adherence to diet, drugs, and dialysis. RESULTS: There were no differences between groups at baseline. Both groups had similar mean serum phosphate over time; at three months, 46% of the intervention group achieved reductions that met the target serum phosphate level compared with 33% of the control group. There were significant improvements in knowledge of phosphate in end-stage kidney disease, self-efficacy and adherence to diet, drugs, and dialysis (missing) in the intervention group compared with control group. CONCLUSION: The 4Ds, a bundled self-management intervention, was effective in improving patient confidence and adherence to phosphate control methods. IMPACT: The 4Ds intervention bundles together four essential strategies for preventing and controlling hyperphosphataemia in end-stage kidney disease. TRIAL REGISTRATION: ACTRN12617000703303 Registered 16/05/2017.

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.

Effectiveness of educational or behavioral interventions on adherence to phosphate control in adults receiving hemodialysis: a systematic review.

BACKGROUND: People with end-stage kidney disease (ESKD) develop impaired excretion of phosphate. Hyperphosphatemia develops in ESKD as a result of the kidney's reduced ability to excrete ingested phosphate load and is characterized by high bone turnover and increased musculoskeletal morbidity including bone pain and muscle weakness. Increased serum phosphate levels are also associated with cardiovascular disease and associated mortality. These effects are significant considering that cardiovascular disease is the leading cause of death in ESKD, making phosphate control a crucial treatment goal. OBJECTIVES: To determine the effectiveness of education or behavioral interventions on adherence to phosphate control in adults with ESKD receiving hemodialysis (HD). INCLUSION CRITERIA TYPES OF PARTICIPANTS: Adults aged over 18 years with ESKD undergoing HD, attending dialysis facilities regardless of frequency and duration of treatment sessions per week. Studies with participants receiving hemodiafiltration were excluded. TYPES OF INTERVENTION(S)/PHENOMENA OF INTEREST: All types of educational and behavioral interventions aimed at improving adherence to dietary phosphate restriction, phosphate binder medication and HD. TYPES OF STUDIES: Randomized controlled trials (RCTs), non-RCTs, before and after and cohort studies. OUTCOMES: Outcome measures included serum phosphate levels, patient knowledge and adherence to phosphate control methods, chronic kidney disease (CKD) self-management behavior and perceived self-efficacy for CKD related to phosphate control. SEARCH STRATEGY: A search was conducted in CINAHL, MEDLINE, The Cochrane Library, Embase, Web of Science, PsycINFO and ProQuest Dissertations and Theses Global to find published studies between January 2005 and December 2015. METHODOLOGICAL QUALITY: Risk of bias was assessed by three reviewers prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI). DATA EXTRACTION: Data were extracted using the standardized data extraction tool from JBI-MAStARI. DATA SYNTHESIS: Data were pooled using JBI software. Mean differences (95% confidence interval [CI]) and effect size estimates were calculated for continuous outcomes. Meta-analysis using a random-effects model was performed for serum phosphate levels, and where the findings could not be pooled using meta-analysis, results have been presented in a narrative form. Standard GRADE (Grading of Recommendations Assessment, Development and Evaluation) evidence assessment of outcomes has been reported. RESULTS: A total of 18 studies were included in the review: seven studies focused on dietary phosphate, four studies focused on medications (phosphate binders) and six studies focused on dietary phosphate and medications. Only one study taught patients about diet, medications and HD to control phosphate. Sixteen studies showed significant improvements in phosphate levels. Meta-analysis of eight RCTs favored educational or behavioral interventions over standard care for serum phosphate control, with a weighted mean reduction of -0.23 mmol/l (95% CI -0.37, -0.08) in treatment groups. CONCLUSION: Overall, educational or behavioral interventions increase adherence to phosphate control. Studies in this systematic review revealed improved outcomes on serum phosphate levels, patient knowledge and adherence to phosphate control methods, CKD self-management behavior and perceived self-efficacy for CKD related to phosphate control. However, there is a lack of sufficient data on how some of the studies implemented their interventions, suggesting that further research is required. Successful strategies that improve and optimize long-term adherence to phosphate control still need to be formulated.