A non-randomized controlled stepped wedge trial to evaluate the effectiveness of a multi-level mammography intervention in improving appointment adherence in underserved women.

Background: Considerable racial and socio-economic disparities exist in breast cancer. In spite of the existence of numerous evidence-based interventions (EBIs) aimed at reducing breast cancer screening barriers among the underserved, there is a lack of uptake or sub-optimal uptake of EBIs in community and clinical settings. This study evaluates a theoretically based, systematically designed implementation strategy to support adoption and implementation of a patient navigation-based intervention, called Peace of Mind Program (PMP), aimed at improving breast cancer screening among underserved women.

Methods/design: The PMP will be offered to federally qualified health centers and charity clinics in the Greater Houston area using a non-randomized stepped wedge design. Due to practical constraints of implementing and adopting in the real-world, randomization of start times and blinding will not be used. Any potential confounding or bias will be controlled in the analysis. Outcomes such as appointment adherence, patient referral to diagnostics, time to diagnostic referral, patient referral to treatment, time to treatment referral, and budget impact of the intervention will be assessed. Assessment of constructs from the consolidated framework for implementation research (CFIR) will be assessed during implementation and at the end of the study (sustainment) from each participating clinic. Data will be analyzed using descriptive statistics (chi-square tests) and generalized estimating equations (GEE).

Discussion: While parallel group randomized controlled trials (RCT) are considered the gold standard for evaluating EBI efficacy, withholding an effective EBI in practice can be both unethical and/or impractical. The stepped wedge design addresses this issue by enabling all clinics to eventually receive the EBI during the study and allowing each clinic to serve as its own control, while maintaining strong internal validity. We expect that the PMP will prove to be a feasible and successful strategy for reducing appointment no-shows in underserved women.

Clinical Trials Registration Number: NCT02296177.