Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial.

ABSTRACT:

Background

As part of the IMPACT Consortium of three effectiveness-implementation trials, the NU IMPACT trial was designed to evaluate implementation and effectiveness outcomes for an electronic health record (EHR)-embedded symptom monitoring and management program for outpatient cancer care. NU IMPACT uses a unique stepped-wedge cluster randomized design, involving six clusters of 26 clinics, for evaluation of implementation outcomes with an embedded patient-level randomized trial to evaluate effectiveness outcomes. Collaborative, consortium-wide efforts to ensure use of the most robust and recent analytic methodologies for stepped-wedge trials motivated updates to the statistical analysis plan for implementation outcomes in the NU IMPACT trial.

Methods

In the updated stati

SUBMITTER: Scholtens DM 

PROVIDER: S-EPMC11283938 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature