Table 2.

TiME Trial design

Design Element	Details
Treatment groups	Intervention: dialysis facility adopts approach of prescribing hemodialysis session duration of ≥4.25 h
	Usual Care: no trial-driven approach to hemodialysis session duration
Randomization	Cluster-randomization by dialysis facility
	Stratification by provider organization, facility race distribution, and facility catheter use
Target sample size	6432 patients
	402 clusters
Eligibility criteria – patients	Age ≥18 yr
	Initiation of maintenance hemodialysis within the past 120 d
	Ability to provide consent for dialysis
	Currently treated with in-center hemodialysis
Eligibility criteria – facilities	Agreement by facility leadership and nephrologists to adopt trial intervention
	Capacity to accommodate treatment session durations of ≥4.25 h for incident patients
Duration of intervention	Median 2.5 yr
Source of data	Dialysis provider organization electronic data systems
Primary outcome	Mortality
Major secondary outcomes	Hospitalizations
	Quality of life
Consent approach	Opt-out
Analysis	Primary: intention to treat, patient-level
	Secondary: incorporation of intervention adherence
Oversight	Single IRB of Record
	External Data and Safety Monitoring Board