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Cited by 29Health Policy Implementation ScienceGlobal Cancer Incidence and ScreeningWomen's cancer prevention and management

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

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Highfield, L., Rajan, S.S., Valerio, M.A., Walton, G., Fernandez, M.E., Bartholomew, L.K.·2015·Implementation Science
DOI 10.1186/s13012-015-0334-xPMC PMC4604615
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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.

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  • The stepped-wedge design is a quasi-experimental design commonly used to evaluate organization-wide interventions.

    “The stepped-wedge is a quasi-experimental design commonly used to evaluate organization-wide interventions”

    From Improving relationship quality in group care settings: The impact of implementing the CARE model (2020) · cites this paper as Highfield et al., 2015

    Methods > Trial design describes this study as a non-randomized stepped-wedge evaluation in which clinics implement the intervention at staggered times. That supports the design as an example for evaluating a clinic-level intervention, but the paper does not establish that stepped-wedge designs are commonly used for organization-wide interventions or that they are necessarily quasi-experimental; it also discusses randomized stepped-wedge trials. (LLM, conf=0.82)

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Cited by

Sorted by citations

Authors
Highfield, L., Rajan, S. S., Valerio, M. A., Walton, G., Fernandez, M. E., & Bartholomew, L. K.
Affiliations
The University of Texas Health Science Center at Houston (US)
Corresponding author
Highfield, L.
ORCID
Venue
Implementation Science
Publisher
Springer Science and Business Media LLC
Published
2015-10-14
Volume
10
Issue
1
Pages
143-143
ISSN
1748-5908 (ISSN-L)
DOI
10.1186/s13012-015-0334-x
PMC
PMC4604615
OpenAlex
W1891876852
Cited by
29
References
5
Citations by year
2026: 2 · 2024: 3 · 2023: 2 · 2022: 4 · 2021: 8 · 2020: 4 · 2019: 3 · 2018: 2 · 2016: 1
FWCI
1.70
Type
journal article
Language
en
Open access
Licence
Locations
  • Implementation Science (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
Agency for Healthcare Research and Quality (1R18HS023255-01)
Topics
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
Keywords
mammography, breast cancer screening, appointment adherence, patient navigation, underserved women, racial and socioeconomic disparities, federally qualified health centers, implementation strategies, stepped wedge design, Consolidated Framework for Implementation Research, budget impact
MeSH terms
Adult, Appointments and Schedules, Breast Neoplasms, Female, Humans, Mammography, Medical Assistance, Middle Aged, Patient Compliance, Referral and Consultation, Research Design, Socioeconomic Factors, Texas, Time Factors, Vulnerable Populations, Early Detection of Cancer, Safety-net Providers

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