Study design and procedures

JS Justin D. Smith
JM James L. Merle
KW Kimberly A. Webster
SC September Cahue
FP Frank J. Penedo
SG Sofia F. Garcia
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The overall study used a cluster randomized, modified stepped wedge design, using a type 2 hybrid effectiveness-implementation approach spanning 4 years (28). This approach allowed for the evaluation of both the cPRO effectiveness as well as the implementation outcomes associated with the implementation strategies. The design leveraged the healthcare system's three geographic and operational regions (Central, North, West) of 32 total clinical units. Regions were pseudo-randomly assigned to the roll-out sequence with 3-month steps. The Central region was the first cluster at the request of system leadership. West and North were then randomly assigned to the second and third spots in the sequence. For each regional cluster, a multicomponent “package” of implementation strategies was used to increase adoption and reach of cPRO. The package consisted primarily of strategies that were system-wide, which were introduced immediately prior to the crossover in the stepped wedge to evaluate their impact on implementation. cPRO usage data prior to the crossover provided an “implementation as usual” comparison.

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