Table 1 Function QUERI STRIDE SW-CRT design decisions and their impact on the study

Time period length

3 months

Shorter length and larger number of time periods increased power

Longer time period length would have given sites longer window to launch program

Number of sites per sequence

2

Allowed study team to provide significant implementation support to each site; study conducted faster than if only 1 site/time period

Power implications; maximum power with one cluster per sequence

Recruitment and randomization strategy

Recruited and randomized clusters to sequences in 2 separate blocks

Reduced maximum possible time from enrollment to program launch time; ability to start study before all sites recruited; potentially fewer dropouts; ability for earlier sites to serve as mentors for later sites

Not able to collect patient-reported data from block 2 sites in time periods before enrollment

Potential confounding of treatment with block

Full statistical implications of blocked randomization for SW-CRT have not been studied.

Calendar time versus time since randomization may be an issue for blocks

Complete vs. incomplete design and type

Incomplete design—outcome data during implementation interval not used for evaluation

Avoided including data when program is partially implemented

Power implications; loss of data from time periods not included in evaluation