Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2015 Oct 14:10:143.
doi: 10.1186/s13012-015-0334-x.

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

L Highfield  1 , S S Rajan  2 , M A Valerio  2   3 , G Walton  4 , M E Fernandez  3 , L K Bartholomew  3
Affiliations
Clinical Trial

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

L Highfield et al. Implement Sci. .

Abstract

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.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Stepped wedge trial design
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Bradley CJ, Given CW, Roberts C. Disparities in cancer diagnosis and survival. Cancer. 2001;91:178–88. doi: 10.1002/1097-0142(20010101)91:1<178::AID-CNCR23>3.0.CO;2-S. - DOI - PubMed
    1. Gordon NH, Crowe JP, Brumberg DJ, Berger NA. Socioeconomic factors and race in breast cancer recurrence and survival. Am J Epidemiol. 1992;135:609–18. - PubMed
    1. Byers TE, Wolf HJ, Bauer KR, Bolick-Aldrich S, Chen VW, Finch JL, et al. The impact of socioeconomic status on survival after cancer in the United States: findings from the National Program of Cancer Registries Patterns of Care Study. Cancer. 2008;113:582–91. doi: 10.1002/cncr.23567. - DOI - PubMed
    1. Farley TA, Flannery JT. Late-stage diagnosis of breast cancer in women of lower socioeconomic status: public health implications. Am J Public Health. 1989;79:1508–12. doi: 10.2105/AJPH.79.11.1508. - DOI - PMC - PubMed
    1. Ayanian JZ, Kohler BA, Abe T, Epstein AM. The relation between health insurance coverage and clinical outcomes among women with breast cancer. N Engl J Med. 1993;329:326–31. doi: 10.1056/NEJM199307293290507. - DOI - PubMed

Publication types

MeSH terms

Associated data