Patient Navigation in Medically Underserved Areas study design: A trial with implications for efficacy, effect modification, and full continuum assessment

Abstract

Background The Patient Navigation in Medically Underserved Areas study objectives are to assess if navigation improves: 1) care uptake and time to diagnosis; and 2) outcomes depending on patients’ residential medically underserved area (MUA) status. Secondary objectives include the efficacy of navigation across 1) different points of the care continuum among patients diagnosed with breast cancer; and 2) multiple regular screening episodes among patients who did not obtain breast cancer diagnoses. Design/Methods Our randomized controlled trial was implemented in three community hospitals in South Chicago. Eligible participants were: 1) female, 2) 18+ years old, 3) not pregnant, 4) referred from a primary care provider for a screening or diagnostic mammogram based on an abnormal clinical breast exam. Participants were randomized to 1) control care or 2) receive longitudinal navigation, through treatment if diagnosed with cancer or across multiple years if asymptomatic, by a lay health worker. Participants’ residential areas were identified as: 1) established MUA (before 1998), 2) new MUA (after 1998), 3) eligible/but not designated as MUA, and 4) affluent/ineligible for MUA. Primary outcomes include days to initially recommended care after randomization and days to diagnosis for women with abnormal results. Secondary outcomes concern days to treatment initiation following a diagnosis and receipt of subsequent screening following normal/benign results. Discussion This intervention aims to assess the efficacy of patient navigation on breast cancer care uptake across the continuum. If effective, the program may improve rates of early cancer detection and breast cancer morbidity.

Gendered and racialized social expectations, barriers, and delayed breast cancer diagnosis

“…We used data from the Patient Navigation in Medically Underserved Areas (PNMUA) study which was a patient navigation randomized controlled trial in Chicago, IL. 47,48 Participants were recruited from three hospitals on the South Side of Chicago over a three-year period. Participants were women who were referred for a screening mammogram, with a history of benign/normal screening results.…”

“…For women who received a breast cancer diagnosis, women were navigated throughout the treatment process. 48…”

“…47,48 Participants were recruited from 3 hospitals on the South Side of Chicago over a three-year period. We used data from the Patient Navigation in Medically Underserved Areas (PNMUA) study, which was a patient navigation randomized controlled trial conducted in Chicago, Illinois.…”

Patient Navigation Improves Subsequent Breast Cancer Screening After a Noncancerous Result: Evidence from the Patient Navigation in Medically Underserved Areas Study

“…23 Some differences between hospitals existed: Hospital C had a larger patient population; Hospital B and C were sites of two multisite healthcare systems; and, Hospital C was, at the point of the study, a Breast Imaging Center of Excellence. Eight lay health workers living in surrounding communities where the three hospitals were located were hired and trained as navigators (e.g., breast cancer disparities facts; enabling patients to choose from multiple solutions to address barriers) 24,25 The study was designed to examine the effectiveness of patient navigation on time to diagnostic resolution among adult women referred for a screening or diagnostic mammogram within one of the three hospitals. Overall processes were described in previous work.…”

“…Overall processes were described in previous work. 24 Primary outcomes included adherence to this initial referral and time to a definitive diagnosis (cancer/not cancer). Randomization processes differed across hospitals, due to patient population size.…”