Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care.

BACKGROUND: Patient navigation is an evidence-based intervention for reducing delays in oncology care among underserved populations. In order to address the financial sustainability of this intervention, information is needed on the cost of implementing patient navigation in diverse healthcare settings. Because patient navigation programs and care settings are highly variable, this paucity of cost data creates difficulties in identifying best practices and decisions about the feasibility of implementing navigation programs within a health care system. One barrier to collecting these cost data is the lack of assessment tools available to support patient navigation programs. These tools must be relevant to the wide variety of navigation activities that exist in health care settings, and be flexible enough to collect cost data important to stakeholders in fee-for-service and value-based care environments. METHODS AND RESULTS: We present a novel approach and methods for assessing the cost of a patient navigation program implemented across six hospital systems to enhance timely entry and uptake of breast cancer care and treatment. These methods and tools were developed in partnership with breast oncology patient navigators and supervisors using principles of stakeholder engagement, with the goal of increasing usability and feasibility in the field. CONCLUSIONS: This methodology can be used to strengthen cost analysis and assessment tools for other navigation programs for improving care and treatment for patients with chronic conditions. TRIAL REGISTRATION: NCT03514433.

Patient navigation to address sociolegal barriers for patients with cancer: A comparative-effectiveness study.

BACKGROUND: Sociolegal barriers to cancer care are defined as health-related social needs like affordable healthy housing, stable utility service, and food security that may be remedied by public policy, law, regulation, or programming. Legal support has not been studied in cancer care. METHODS: The authors conducted a randomized controlled trial of patients who had newly diagnosed cancer at a safety-net medical center in Boston from 2014 through 2017, comparing standard patient navigation versus enhanced navigation partnered with legal advocates to identify and address sociolegal barriers. English-speaking, Spanish-speaking, or Haitian Creole-speaking patients with breast and lung cancer were eligible within 30 days of diagnosis. The primary outcome was timely treatment within 90 days of diagnosis. Secondary outcomes included patient-reported outcomes (distress, cancer-related needs, and satisfaction with navigation) at baseline and at 6 months. RESULTS: In total, 201 patients with breast cancer and 19 with lung cancer enrolled (response rate, 78%). The mean patient age was 55 years, 51% of patients were Black and 22% were Hispanic, 20% spoke Spanish and 8% spoke Haitian Creole, 73% had public health insurance, 77% reported 1 or more perceived sociolegal barrier, and the most common were barriers to housing and employment. Ninety-six percent of participants with breast cancer and 73% of those with lung cancer initiated treatment within 90 days. No significant effect of enhanced navigation was observed on the receipt of timely treatment among participants with breast cancer (odds ratio, 0.88; 95% CI, 0.17-4.52) or among those with lung cancer (odds ratio, 4.00; 95% CI, 0.35-45.4). No differences in patient-reported outcomes were observed between treatment groups. CONCLUSIONS: Navigation enhanced by access to legal consultation and support had no impact on timely treatment, patient distress, or patient needs. Although most patients reported sociolegal barriers, few required intensive legal services that could not be addressed by navigators. LAY SUMMARY: In patients with cancer, the experience of sociolegal barriers to care, such as unstable housing, utility services, or food insecurity, is discussed. Addressing these barriers through legal information and assistance may improve care. This study compares standard patient navigation versus enhanced navigation partnered with legal advocates for patients with breast and lung cancers. Almost all patients in both navigation groups received timely care and also reported the same levels of distress, needs, and satisfaction with navigation. Although 75% of patients in the study had at least 1 sociolegal barrier identified, few required legal advocacy beyond what a navigator who received legal information and coaching could provide.

Communicating to Engage: An Improvisational Theater-Based Communication Training Designed to Support Community-Academic Partnership Development.

PROBLEM: The potential for community-engaged research to address health inequity requires deliberate effort to create trusting and equitable community-academic partnerships. A lack of evidence-based opportunities for cultivating such partnerships remains a barrier. APPROACH: In 2017 and 2018, the authors designed, facilitated, and evaluated a mixed stakeholder training, Communicating to Engage, at 2 urban academic medical centers involved in the All of Us research program, Boston Medical Center and Mass General Brigham. The goal was to bring together researchers and community members to develop communication skills through improvisational theater-based co-learning. The curriculum was inspired by several evidence-based learning frameworks including community-based participatory research principles and improvisational theater techniques. A self-administered survey completed before and after the training session measured participants' communication skills using the Self-Perceived Communication Competence Scale (SPCCS) and comfort with specific communication styles as outlined in the program's training objectives. Paired t tests were used to measure changes in scaled responses among combined participants and separately among self-identified community members and researchers. OUTCOMES: Sixty-nine total participants across 6 workshops completed training evaluations. Overall, pre-post survey analysis demonstrated significant mean score improvement for both the SPCCS and comfort with specific communication styles. In stratified analysis, both community members (n = 26) and researchers (n = 38) reported significant improvement in scores related to comfort with specific communication styles. Only researchers, but not community members, had significant improvement in SPCCS scores. NEXT STEPS: The Communicating to Engage program brought community and researcher stakeholders together and demonstrated improvement in self-perceived communication styles, yet researcher participants benefited more than community participants. Future innovation is necessary to further target community stakeholder communication training needs. Mixed stakeholder improvisational theater-based learning provides deliberate opportunities to build new community-academic partnerships that may enhance health equity initiatives.

Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative.

BACKGROUND: Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2-3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings. METHODS: Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost. CONCLUSION: TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.

Health Literacy, Language, and Cancer-Related Needs in the First 6 Months After a Breast Cancer Diagnosis.

PURPOSE: Low health literacy (HL) and language negatively affect cancer screening and prevention behaviors; less is known about how they affect the patient's experience during cancer treatment. This study explores associations among HL, spoken language, and dimensions of cancer-related needs within 6 months of receiving a breast cancer diagnosis. METHODS: Women speaking English, Spanish, or Haitian Creole, enrolled in a patient navigation study at diagnosis, completed a survey in their primary spoken language at baseline and 6 months to characterize their cancer-related needs. HL was measured using the Brief Health Literacy Screening Tool. Outcomes included the Cancer Needs Distress Inventory (CaNDI; n = 38 items) and the Communication and Attitudinal Self-Efficacy scale (CASE-Cancer) for cancer (n = 12 items). Linear regressions measured the impact of HL and language on total CaNDI and CASE-Cancer scale for cancer scores and subscales, adjusted for demographics. RESULTS: At baseline, 262 women participated and 228 (87%) followed up at 6 months. Of these, 38% had adequate HL, 33% had marginal HL, and 29% had inadequate HL. Women with inadequate or marginal HL had higher median baseline CaNDI scores (P = .02) and lower self-efficacy scores (P = .008), relative to those with adequate HL. Haitian-Creole speakers had significantly lower CANDI scores at baseline (P = .03). Adjusting for demographics, differences in CaNDI scores at baseline remained significant for those with lower HL and Haitian-Creole speakers. At 6 months, differences in self-efficacy persisted for Haitian-Creole speakers. CONCLUSION: Findings suggest that interventions oriented to mitigating HL and language barriers might reduce distress at the time of diagnosis and improve self-efficacy over the course of treatment.

The impact of health insurance reform on insurance instability.

We investigated the impact of the 2006 Massachusetts health care reform on insurance coverage and stability among minority and underserved women. We examined 36 months of insurance claims among 1,946 women who had abnormal cancer screening at six community health centers pre-(2004-2005) and post-(2007-2008) insurance reform. We examined frequency of switches in insurance coverage as measures of longitudinal insurance instability. On the date of their abnormal cancer screening test, 36% of subjects were publicly insured and 31% were uninsured. Post-reform, the percent ever uninsured declined from 39% to 29% (p .001) and those consistently uninsured declined from 23% to 16%. To assess if insurance instability changed between the pre- and post-reform periods, we conducted Poisson regression models, adjusted for patient demographics and length of time in care. These revealed no significant differences from the pre- to post-reform period in annual rates of insurance switches, incident rate ratio 0.98 (95%- CI 0.88-1.09). Our analysis is limited by changes in the populations in the pre- and post-reform period and inability to capture care outside of the health system network. Insurance reform increased stability as measured by decreasing uninsured rates without increasing insurance switches.

The impact of insurance coverage during insurance reform on diagnostic resolution of cancer screening abnormalities.

We examined the impact of Massachusetts insurance reform on the care of women at six community health centers with abnormal breast and cervical cancer screening to investigate whether stability of insurance coverage was associated with more timely diagnostic resolution. We conducted Cox proportional hazards models to predict time from cancer screening to diagnostic resolution, examining the impact of 1) insurance status at time of screening abnormality, 2) number of insurance switches over a three-year period, and 3) insurance history over a three-year period. We identified 1,165 women with breast and 781 with cervical cancer screening abnormalities. In the breast cohort, Medicaid insurance at baseline, continuous public insurance, and losing insurance predicted delayed resolution. We did not find these effects in the cervical cohort. These data provide evidence that stability of health insurance coverage with insurance reform nationally may improve timely care after abnormal cancer screening in historically underserved women.

Social service barriers delay care among women with abnormal cancer screening.

BACKGROUND: Inequity in cancer outcomes for minorities and vulnerable populations has been linked to delays in cancer care that arise from barriers to accessing care. Social service barriers represent those obstacles related to meeting life's most basic needs, like housing and income, which are often supported by public policy, regulation and services. OBJECTIVE: To examine the association between social service barriers and timely diagnostic resolution after a cancer screening abnormality. DESIGN: Secondary analysis of the intervention arm of Boston Patient Navigation Research Program (2007-2008) conducted across six urban community health centers. Subjects with no barriers, other barriers, and social service barriers were compared on their time to diagnostic resolution. SUBJECTS: Women ≥ 18 years of age with a breast or cervical cancer screening abnormality. MAIN MEASURES: Social service barriers included: income supports, housing and utilities, education and employment, and personal/family stability and safety. Time to event analyses compared across five groups: those with no barriers, one barrier (other), one barrier (social service), two or more barriers (all other), and two or more barriers (at least one social service). KEY RESULTS: 1,481 navigated women; 31 % Hispanic, 27 % Black, 32 % White; 37 % non-English speakers and 28 % had private health insurance. Eighty-eight women (6 %) had social service barriers. Compared to those without social service barriers, those with were more likely to be Hispanic, younger, have public/no health insurance, and have multiple barriers. Those with two or more barriers (at least one social service barrier), had the longest time to resolution compared to the other four groups (aHR resolution < 60 days = 0.27, ≥ 60 days = 0.37). CONCLUSION: Vulnerable women with multiple barriers, when at least one is a social service barrier, have delays in care despite navigation. The impact of patient navigation may never be fully realized if social service barriers persist without being identified or addressed.

Boston Patient Navigation Research Program: the impact of navigation on time to diagnostic resolution after abnormal cancer screening.

BACKGROUND: There is a need for controlled studies to assess the impact of patient navigation in vulnerable cancer populations. METHODS: Boston Patient Navigation Research Program conducted a quasi-experimental patient navigation intervention across six federally qualified inner-city community health centers, three assigned to a breast cancer navigation intervention and three assigned to a cervical cancer navigation intervention; each group then served as the control for the other. Eligible women had an abnormal breast or cervical cancer screening test conducted at one of the participating health centers during a baseline (2004-2005) or intervention period (2007-2008). Kaplan-Meier survival curves and proportional hazards regression examined the effect of patient navigation on time to definitive diagnosis, adjusting for covariates, clustering by clinic and differences between the baseline and intervention period. RESULTS: We enrolled 997 subjects in the baseline period and 3,041 subjects during the intervention period, of whom 1,497 were in the navigated arm, and 1,544 in the control arm. There was a significant decrease in time to diagnosis for subjects in the navigated group compared with controls among those with a cervical screening abnormality [aHR 1.46; 95% confidence interval (CI), 1.1-1.9]; and among those with a breast cancer screening abnormality that resolved after 60 days (aHR 1.40; 95% CI, 1.1-1.9), with no differences before 60 days. CONCLUSIONS: This study documents a benefit of patient navigation on time to diagnosis among a racially/ethnically diverse inner city population. IMPACT: Patient navigation may address cancer health disparities by reducing time to diagnosis following an abnormal cancer-screening event.