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

Implementation Science

L.K. Bartholomew³  M.E. Fernandez³  G. Walton¹  M.A. Valerio³  S.S. Rajan²  L. Highfield² 

[1] Breast Health Collaborative of Texas, Houston, TX, USA;Department of Management, Policy and Community Health Practice, University of Texas School of Public Health, Houston, TX, USA;Department of Health Promotion and Behavioral Sciences, University of Texas School of Public Health, Houston, TX, USA

关键词: Budget impact analysis;    Non-randomized controlled trial;    Mammogram adherence;    Patient navigation;    Evidence-based interventions;    Underserved women;    Breast cancer screening;   

Others  :  1229119
DOI  :  10.1186/s13012-015-0334-x

 received in 2015-09-29, accepted in 2015-10-06,  发布年份 2015

【 摘 要 】

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.

Trial registration

Clinical trials registration number: NCT02296177

【 授权许可】

   
2015 Highfield et al.

【 图 表 】

Fig. 1.

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