Table 1.
Measures | Data Source | Variable Type | Point of Data Collection/Abstraction | |||
---|---|---|---|---|---|---|
Pre-/At Initial Care | Diagnostic Care | Treatment | End of study1 | |||
Study arm (navigated; control) | Study logs2 | Primary Predictor | X | |||
Time to mammography appointment (days from randomization to appointment) | MR3 | X | ||||
Time to diagnosis after abnormal result (days from abnormal result to definitive diagnosis) | X | |||||
MUA designation (eligible/designate d before 1998; eligible/designated after 1998; eligible/not designated; ineligible) | HRSA[33]4 | Effect Modifier | X | |||
Adherence to screening, diagnostic care, and treatment guidelines (composite score)5 | MR3 | Secondary Outcome | X | |||
Receipt of multiple mammograms every 1–2 years (yes/no) | MR3 | X | ||||
Hospital Site | Study logs2 | Potential Covariates | X | |||
Number of navigator contacts | Study logs2 | X | ||||
Number and types of barriers[5] | Study logs2 | X | ||||
Census tract factors (e.g. poverty; ethnic composition) | ACS[32 ]6 | X | ||||
Demographics (e.g., age, marital status, ethnicity, income, education)[34] | Survey; MR3 | X | X | |||
Healthcare access (insurance, PCP)[34] | X | X | ||||
Cancer history (e.g., family, personal) | X | X | ||||
Healthcare history (e.g., lifetime mammography/Pap test use)[34] | Survey | X | ||||
Healthcare distrust[35] | X | |||||
Shared decision making preferences7 | X | X | X | |||
Patient-provider communication about breast cancer (e.g., provider recommendations, adherence to recommendation)7 | X | X | X | |||
Fatalism[36] | X | X | ||||
Healthcare self-efficacy[37] | X | X | ||||
Patient satisfaction[5] | X | X |
Full medical record abstraction for all individuals who were randomized to the trial across all three participating hospitals occurred at the end of the study.
Study logs were maintained and managed by navigators under the auspices a staff member with years of management in patient navigation programs.
Medical records from the three participating sites.
Health Resources and Services Administration data for 2011.
This composite variable will be the sum of multiple guidelines and conventions regarding breast cancer care, including uptake of a mammogram every 1–2 years after entry into the study, if 50–74 years old[29–30]; receipt of a diagnosis within 60 days of an abnormal screen or symptomatic presentation[38]; initiation of treatment within 60 days of a definitive cancer diagnosis[38]; and treatment adherence according to the National Comprehensive Cancer Network’s guidelines[39]. Women aged <50 or >75 years old, the range will be 0–3. For women aged 50–74 years old, the range will be 0–4.
American Community Survey data 2007–2011.
Items developed and pilot-tested during this trial.