The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration.
Laura M DemberEduardo LacsonSteven M BrunelliJesse Y HsuAlfred K CheungJohn T DaugirdasTom GreeneCsaba Pal KovesdyDana C MiskulinRavi I ThadhaniWolfgang C WinkelmayerSusan S EllenbergDenise CifelliRosemary MadiganAmy YoungMichael AngelettiRebecca L WingardChristina KahnAllen R NissensonFranklin W MadduxKevin C AbbottJ Richard LandisPublished in: Journal of the American Society of Nephrology : JASN (2019)
Although a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.
Keyphrases
- end stage renal disease
- study protocol
- phase iii
- clinical trial
- phase ii
- chronic kidney disease
- peritoneal dialysis
- open label
- randomized controlled trial
- double blind
- placebo controlled
- healthcare
- ejection fraction
- newly diagnosed
- palliative care
- electronic health record
- health insurance
- transcranial direct current stimulation
- affordable care act
- quality improvement
- insulin resistance
- skeletal muscle
- metabolic syndrome
- patient reported outcomes
- weight loss
- data analysis