Strategies to promote language inclusion at 17 CTSA hubs.

The prioritization of English language in clinical research is a barrier to translational science. We explored promising practices to advance the inclusion of people who speak languages other than English in research conducted within and supported by NIH Clinical Translational Science Award (CTSA) hubs. Key informant interviews were conducted with representatives (n = 24) from CTSA hubs (n = 17). Purposive sampling was used to identify CTSA hubs focused on language inclusion. Hubs electing to participate were interviewed via Zoom. Thematic analysis was performed to analyze interview transcripts. We report on strategies employed by hubs to advance linguistic inclusion and influence institutional change that were identified. Strategies ranged from translations, development of culturally relevant materials and consultations to policies and procedural changes and workforce initiatives. An existing framework was adapted to conceptualize hub strategies. Language justice is paramount to bringing more effective treatments to all people more quickly. Inclusion will require institutional transformation and CTSA hubs are well positioned to catalyze change.

Health Insurance Navigation Tools Intervention: A Pilot Trial Within the Childhood Cancer Survivor Study.

PURPOSE: Childhood cancer survivors are at increased risk for underinsurance and health insurance-related financial burden. Interventions targeting health insurance literacy (HIL) to improve the ability to understand and use health insurance are needed. METHODS: We codeveloped a four-session health insurance navigation tools (HINT) intervention, delivered synchronously by a patient navigator, and a corresponding booklet. We conducted a randomized pilot trial with survivors from the Childhood Cancer Survivor Study comparing HINT with enhanced usual care (EUC; booklet). We assessed feasibility, acceptability, and preliminary efficacy (HIL, primary outcome; knowledge and confidence with health insurance terms and activity) on a 5-month survey and exit interviews. RESULTS: Among 231 invited, 82 (32.5%) survivors enrolled (53.7% female; median age 39 years, 75.6% had employer-sponsored insurance). Baseline HIL scores were low (mean = 28.5; 16-64; lower scores better); many lacked knowledge of Affordable Care Act (ACA) provisions. 80.5% completed four HINT sessions, and 93.9% completed the follow-up survey. Participants rated HINT's helpfulness a mean of 8.9 (0-10). Exit interviews confirmed HINT's acceptability, specifically its virtual and personalized delivery and helpfulness in building confidence in understanding one's coverage. Compared with EUC, HINT significantly improved HIL (effect size = 0.94. P < .001), ACA provisions knowledge (effect size = 0.73, P = .003), psychological financial hardship (effect size = 0.64, P < .006), and health insurance satisfaction (effect size = 0.55, P = .03). CONCLUSION: Results support the feasibility and acceptability of a virtual health insurance navigation program targeted for childhood survivors to improve HIL. Randomized trials to assess the efficacy and sustainability of health insurance navigation on HIL and financial burden are needed.

Community advisory board members' perspectives on their contributions to a large multistate cluster RCT: a mixed methods study.

Background: Community advisory boards (CABs) are an established approach to ensuring research reflects community priorities. This paper examines two CABs that are part of the HEALing Communities Study which aims to reduce overdose mortality. This analysis aimed to understand CAB members' expectations, experiences, and perspectives on CAB structure, communication, facilitation, and effectiveness during the first year of an almost fully remote CAB implementation. Current literature exploring these perspectives is limited. Methods: We collected qualitative and survey data simultaneously from members (n = 53) of two sites' CABs in the first 9 months of CAB development. The survey assessed trust, communication, and relations; we also conducted 32 semi-structured interviews. We analyzed the survey results descriptively. The qualitative data were analyzed using a deductive codebook based on the RE-AIM PRISM framework. Themes were drawn from the combined qualitative data and triangulated with survey results to further enrich the findings. Results: CAB members expressed strong commitment to overall study goals and valued the representation of occupational sectors. The qualitative data described a dissonance between CAB members' commitment to the mission and unmet expectations for influencing the study within an advisory role. Survey results indicated lower satisfaction with the research teams' ability to create a mutually beneficial process, clear communication, and sharing of power. Conclusion: Building a CAB on a remote platform, within a study utilizing a community engagement strategy, still presents challenges to fully realizing the potential of a CAB. These findings can inform more effective operationalizing of community-engaged research through enhanced CAB engagement.

ACR Appropriateness Criteria® Breast Implant Evaluation: 2023 Update.

This document discusses the appropriate initial imaging in both asymptomatic and symptomatic patients with breast implants. For asymptomatic patients with saline implants, no imaging is recommended. If concern for rupture exists, ultrasound is usually appropriate though saline rupture is often clinically evident. The FDA recently recommended patients have an initial ultrasound or MRI examination 5 to 6 years after initial silicone implant surgery and then every 2 to 3 years thereafter. In a patient with unexplained axillary adenopathy with current or prior silicone breast implants, ultrasound and/or mammography are usually appropriate, depending on age. In a patient with concern for silicone implant rupture, ultrasound or MRI without contrast is usually appropriate. In the setting of a patient with breast implants and possible implant-associated anaplastic large cell lymphoma, ultrasound is usually appropriate as the initial imaging. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

Strategies for Recruiting a Diverse Postpartum Survey Sample.

BACKGROUND: Data from diverse populations are needed to inform interventions for maternal health equity. However, research recruitment of postpartum individuals is challenging, especially in minoritized and structurally marginalized populations. MATERIALS AND METHODS: We developed a recruitment strategy for a cross-sectional survey among postpartum individuals at an urban safety-net hospital in New England, inclusive of those with a language preference other than English (LPOE) and those not attending scheduled postpartum visits. Recruitment was primarily conducted before, during, and after clinic visits in obstetrics or pediatrics. Surveys could be completed in-person, over the phone, or online. All study materials were trilingual (English, Spanish, Haitian Creole). After reaching our recruitment goal of 120 individuals, we analyzed our recruitment efforts to identify key recruitment strategies. RESULTS: From April to June 2022, 245 individuals were invited to participate, and 120 (49%) completed the survey, of whom 119 contributed recruitment data to the present analysis. Most participants (83.1%) self-identified as Black or Hispanic, and 30.2% had an LPOE. Compared with the overall sample, participants with an LPOE were more likely to have been recruited in-person (73% versus 78%), while those not attending postpartum visits required more outreach attempts (mean 2.3 versus 2.6). We identified 4 key strategies contributing to recruitment success: multilingual materials, frequent assessment and adjustment of our recruitment approach, pediatrics-based recruitment, and multiple timings and modes of outreach. CONCLUSIONS: Using a multi-stage, multilingual, and multi-method recruitment strategy including pediatrics-based outreach, we recruited a diverse postpartum sample with > 80% individuals of color and > 30% with an LPOE. Our experience can inform more inclusive postpartum research.

Sociodemographic Variations in Women's Reports of Discussions With Clinicians About Breast Density.

Importance: Breast density notifications advise women to discuss breast density with their clinicians, yet little is known about such discussions. Objectives: To examine the content of women's reports of breast density discussions with clinicians and identify variations by women's sociodemographic characteristics (age, income, state legislation status, race and ethnicity, and literacy level). Design, Setting, and Participants: This US nationwide, population-based, random-digit dial telephone survey study was conducted from July 1, 2019, to April 30, 2020, among 2306 women aged 40 to 76 years with no history of breast cancer who underwent mammography in the prior 2 years and had heard the term dense breasts or breast density. Results were analyzed from a subsample of 770 women reporting a conversation about breast density with their clinician after their last mammographic screening. Statistical analysis was conducted in April and July 2023. Main Outcomes and Measures: Survey questions inquired whether women's clinicians had asked about breast cancer risk or their worries or concerns about breast density, had discussed mammography results or other options for breast cancer screening or their future risk of breast cancer, as well as the extent to which the clinician answered questions about breast density. Results: Of the 770 women (358 [47%] aged 50-64 years; 47 Asian [6%], 125 Hispanic [16%], 204 non-Hispanic Black [27%], 317 non-Hispanic White [41%], and 77 other race and ethnicity [10%]) whose results were analyzed, most reported that their clinicians asked questions about breast cancer risk (88% [670 of 766]), discussed mammography results (94% [724 of 768]), and answered patient questions about breast density (81% [614 of 761]); fewer women reported that clinicians had asked about worries or concerns about breast density (69% [524 of 764]), future risk of breast cancer (64% [489 of 764]), or other options for breast cancer screening (61% [459 of 756]). Women's reports of conversations varied significantly by race and ethnicity; non-Hispanic Black women reported being asked questions about breast cancer risk more often than non-Hispanic White women (odds ratio [OR], 2.08 [95% CI, 1.05-4.10]; P = .04). Asian women less often reported being asked about their worries or concerns (OR, 0.42 [95% CI, 0.20-0.86]; P = .02), and Hispanic and Asian women less often reported having their questions about breast density answered completely or mostly (Asian: OR, 0.28 [95% CI, 0.13-0.62]; P = .002; Hispanic: OR, 0.48 [95% CI, 0.27-0.87]; P = .02). Women with low literacy were less likely than women with high literacy to report being asked about worries or concerns about breast density (OR, 0.64 [95% CI, 0.43-0.96]; P = .03), that mammography results were discussed with them (OR, 0.32 [95% CI, 0.16-0.63]; P = .001), or that their questions about breast density were answered completely or mostly (OR, 0.51 [95% CI, 0.32-0.81]; P = .004). Conclusions and Relevance: In this survey study, although most women reported that their clinicians counselled them about breast density, the unaddressed worries or concerns and unanswered questions, especially among Hispanic and Asian women and those with low literacy, highlighted areas where discussions could be improved.

Talking numbers: how women and providers use risk scores during and after risk counseling - a qualitative investigation from the NRG Oncology/NSABP DMP-1 study.

OBJECTIVES: Little research exists on how risk scores are used in counselling. We examined (a) how Breast Cancer Risk Assessment Tool (BCRAT) scores are presented during counselling; (b) how women react and (c) discuss them afterwards. DESIGN: Consultations were video-recorded and participants were interviewed after the consultation as part of the NRG Oncology/National Surgical Adjuvant Breast and Bowel Project Decision-Making Project 1 (NSABP DMP-1). SETTING: Two NSABP DMP-1 breast cancer care centres in the USA: one large comprehensive cancer centre serving a high-risk population and an academic safety-net medical centre in an urban setting. PARTICIPANTS: Thirty women evaluated for breast cancer risk and their counselling providers were included. METHODS: Participants who were identified as at increased risk of breast cancer were recruited to participate in qualitative study with a video-recorded consultation and subsequent semi-structured interview that included giving feedback and input after viewing their own consultation. Consultation videos were summarised jointly and inductively as a team.tThe interview material was searched deductively for text segments that contained the inductively derived themes related to risk assessment. Subgroup analysis according to demographic variables such as age and Gail score were conducted, investigating reactions to risk scores and contrasting and comparing them with the pertinent video analysis data. From this, four descriptive categories of reactions to risk scores emerged. The descriptive categories were clearly defined after 19 interviews; all 30 interviews fit principally into one of the four descriptive categories. RESULTS: Risk scores were individualised and given meaning by providers through: (a) presenting thresholds, (b) making comparisons and (c) emphasising or minimising the calculated risk. The risk score information elicited little reaction from participants during consultations, though some added to, agreed with or qualified the provider's information. During interviews, participants reacted to the numbers in four primary ways: (a) engaging easily with numbers; (b) expressing greater anxiety after discussing the risk score; (c) accepting the risk score and (d) not talking about the risk score. CONCLUSIONS: Our study highlights the necessity that patients' experiences must be understood and put into relation to risk assessment information to become a meaningful treatment decision-making tool, for instance by categorising patients' information engagement into types. TRIAL REGISTRATION NUMBER: NCT01399359.

Women's Reactions to Breast Density Information Vary by Sociodemographic Characteristics.

BACKGROUND: Breast density information aims to increase awareness of breast density and its risks and to foster more informed future breast screening decisions among women with dense breasts. We explored associations between such information and outcomes including anxiety, confusion, or feeling informed, and whether they varied by race/ethnicity or literacy, or differentially affected future mammography plans. METHODS: A national telephone survey of a diverse sample of women previously informed of personal breast density (N = 1,322) assessed reactions to receipt of breast density information and future mammography plans. RESULTS: Most women (86%) felt informed after receiving personal breast density information; however, some felt anxious (15%) or confused (11%). Reactions varied significantly by sociodemographics; non-Hispanic Black, Asian, and Hispanic women and women with low literacy were nearly two to three times more likely to report anxiety than non-Hispanic White women (all ps < .05). Asian women and those with low literacy less often felt informed and more often felt confused. Non-Hispanic Black and Asian women were nearly twice as likely to report that knowing their breast density made them more likely to have future mammograms. Women with low literacy were more likely to change mammography plans, with some being more likely and others less likely to plan to have future mammograms. Greater anxiety and confusion were associated with higher likelihood of planning future mammograms; those feeling informed were less likely to plan future mammography. CONCLUSIONS: Differential reactions to breast density information are concerning if associated with disparate future screening plans. Future breast density education efforts should ensure that such information is readily accessible and understandable to all women in order to lead to desired effects.

Prepregnancy Cardiovascular Disease Risk Factors and Adverse Pregnancy Outcomes in a Safety-Net Hospital.

Background: Many adverse pregnancy outcomes (APOs) are associated with elevated cardiovascular disease (CVD) risk. However, APO data in the context of pre-existing CVD risk factors, and from diverse populations, are limited. We assessed the occurrence of APOs among individuals with and without prepregnancy CVD risk factors, overall and by race/ethnicity. Methods: We conducted a retrospective study using electronic medical record data from a large urban safety-net hospital. Individuals with prenatal care and delivery between 2016 and 2018 at the hospital were included, and data from prenatal intake through the delivery hospitalization were captured. The exposure, prepregnancy CVD risk factors (hypertension, diabetes, tobacco use, and obesity), and the outcome, APOs (hypertensive disorders of pregnancy, gestational diabetes, preterm delivery, low birth weight, and stillbirth), were identified from electronic medical records. Results: We identified 3760 unique delivering individuals, of whom 55.1% self-identified as Black non-Hispanic and 17% as Hispanic. Prepregnancy CVD risk factor prevalence was 45.6%, most commonly obesity (26.6%). APO prevalence was 35.6%, most commonly a hypertensive disorder of pregnancy (20.1%). Overall, 45.7% of APOs occurred in the absence of recognized prepregnancy CVD risk factors, representing 16.3% of the total sample. Among individuals without prepregnancy CVD risk factors, APO prevalence was 30.0% and did not vary by race/ethnicity. Conclusions: In this racially and ethnically diverse hospital-based sample, APOs were present in one in three parous individuals without prepregnancy CVD risk factors-a group with potentially elevated CVD risk who might otherwise be missed by traditional CVD risk factor screening.

Perceptions of Breast Cancer Risks Among Women Receiving Mammograph Screening.

Importance: Breast density is an independent risk factor for breast cancer. Despite the proliferation of mandated written notifications about breast density following mammography, there is little understanding of how women perceive the relative breast cancer risk associated with breast density. Objective: To assess women's perception of breast density compared with other breast cancer risks and explore their understanding of risk reduction. Design, Setting, and Participants: This mixed-methods qualitative study used telephone surveys and semistructured interviews to investigate perceptions about breast cancer risk among a nationally representative, population-based sample of women. Eligible study participants were aged 40 to 76 years, reported having recently undergone mammography, had no history of prior breast cancer, and had heard of breast density. Survey participants who had been informed of their personal breast density were invited for a qualitative interview. Survey administration spanned July 1, 2019, to April 30, 2020, with 2306 women completing the survey. Qualitative interviews were conducted from February 1 to May 30, 2020. Main Outcomes and Measures: Respondents compared the breast cancer risk associated with breast density with 5 other risk factors. Participants qualitatively described what they thought contributed to breast cancer risk and ways to reduce risk. Results: Of the 2306 women who completed the survey, 1858 (166 [9%] Asian, 503 [27%] Black, 268 [14%] Hispanic, 792 [43%] White, and 128 [7%] other race or ethnicity; 358 [19%] aged 40-49 years, 906 [49%] aged 50-64 years, and 594 [32%] aged ≥65 years) completed the revised risk perception questions and were included in the analysis. Half of respondents thought breast density to be a greater risk than not having children (957 [52%]), having more than 1 alcoholic drink per day (975 [53%]), or having a prior breast biopsy (867 [48%]). Most respondents felt breast density was a lesser risk than having a first-degree relative with breast cancer (1706 [93%]) or being overweight or obese (1188 [65%]). Of the 61 women who were interviewed, 6 (10%) described breast density as contributing to breast cancer risk, and 43 (70%) emphasized family history as a breast cancer risk factor. Of the interviewed women, 17 (28%) stated they did not know whether it was possible to reduce their breast cancer risk. Conclusions and Relevance: In this qualitative study of women of breast cancer screening age, family history was perceived as the primary breast cancer risk factor. Most interviewees did not identify breast density as a risk factor and did not feel confident about actions to mitigate breast cancer risk. Comprehensive education about breast cancer risks and prevention strategies is needed.

A discussion among deans on advancing community engaged research.

The benefits of community-engaged research (CEnR) have been documented in the literature. However, the adoption of community engaged (CE) and participatory approaches among health researchers remains limited. The Boston University (BU) Clinical Translational Science Institute's community engagement program initiated a discussion among five BU Deans to explore their approaches to support the practice of CEnR among faculty in their schools. The discussion was recorded and the transcript analyzed to identify and explore themes that emerged. Most strategies discussed by the Deans were not focused on changing institutional systems to advance CEnR. Instead, the analyses showed that institutional CE efforts highlighted by the Deans were focused on "responsibility centered on one person" or "research mentors." Approaches to developing a culture of CEnR that centers responsibility for promoting it on a few people in a university may place significant burden on leadership and researchers and is not an effective way to promote culture change. Systems change is needed to support CEnR, improve accountability, and realize successful partnerships between academic institutions and communities. The dialogue among Deans focused on the topic of CEnR provided an effective method to catalyze discussion and over time may help to strengthen a culture of CEnR research.

Community engagement and financial arrangements: Navigating institutional change.

Despite their documented benefits, the widespread adoption of community-engaged and participatory approaches among health researchers remains limited. Institutional practices and policies influence the uptake of community engagement and participatory approaches. We examine the role of financial arrangements between university researchers and community partners, by exploring efforts to bridge the gap between research administration and researchers at two research-intensive institutions. The type of financial arrangement a researcher has with a community partner plays an important role in setting the stage for the structure of the partnership as it relates to shared decision-making and ownership of the research. Continued efforts to clarify and streamline subcontracting processes are needed as is infrastructure to support community partners and researchers as they navigate financial arrangements if progress is to be made.

Integrating community engagement with implementation science to advance the measurement of translational science.

This special communication provides an approach for applying implementation science frameworks to a Clinical and Translational Science Institutes (CTSIs) community engagement (CE) program that measures the use of implementation strategies and outcomes that promote the uptake of CE in research. Using an iterative multi-disciplinary group process, we executed a four-phased approach to developing an evaluation plan: 1) creating an evaluation model adapted from Proctor's conceptual model of implementation research; 2) mapping implementation strategies to CTSI CE program interventions that support change in research practice; 3) identifying and operationalizing measures for each strategy; and 4) conducting an evaluation. Phase 2 employed 73 implementation strategies across 9 domains generated by the Expert Recommendations for Implementing Change project. The nine domains were used to classify each CE program implementation strategy. In Phase 3, the group used the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to define measures for each individual strategy. Phase 4 demonstrates the application of this framework and measures Year 1 outcomes for the strategy providing interactive assistance, which we implemented using a centralized consultation model. This approach can support the CTSA program in operationalizing CE program measurement to demonstrate which activities and strategies may lead to benefits derived by the program, institution, and community.

Protocol for community-driven selection of strategies to implement evidence-based practices to reduce opioid overdoses in the HEALing Communities Study: a trial to evaluate a community-engaged intervention in Kentucky, Massachusetts, New York and Ohio.

INTRODUCTION: Opioid-involved overdose deaths continue to surge in many communities, despite numerous evidence-based practices (EBPs) that exist to prevent them. The HEALing Communities Study (HCS) was launched to develop and test an intervention (ie, Communities That HEAL (CTH)) that supports communities in expanding uptake of EBPs to reduce opioid-involved overdose deaths. This paper describes a protocol for a process foundational to the CTH intervention through which community coalitions select strategies to implement EBPs locally. METHODS AND ANALYSIS: The CTH is being implemented in 67 communities (randomised to receive the intervention) in four states in partnership with coalitions (one per community). Coalitions must select at least five strategies, including one to implement each of the following EBPs: (a) overdose education and naloxone distribution; expanded (b) access to medications for opioid use disorder (MOUD), (c) linkage to MOUD, (d) retention in MOUD and (e) safer opioid prescribing/dispensing. Facilitated by decision aid tools, the community action planning process includes (1) data-driven goal setting, (2) discussion and prioritisation of EBP strategies, (3) selection of EBP strategies and (4) identification of next steps. Following review of epidemiologic data and information on existing local services, coalitions set goals and discuss, score and/or rank EBP strategies based on feasibility, appropriateness within the community context and potential impact on reducing opioid-involved overdose deaths with a focus on three key sectors (healthcare, behavioural health and criminal justice) and high-risk/vulnerable populations. Coalitions then select EBP strategies through consensus or majority vote and, subsequently, suggest or choose agencies with which to partner for implementation. ETHICS AND DISSEMINATION: The HCS protocol was approved by a central Institutional Review Board (Advarra). Results of the action planning process will be disseminated in academic conferences and peer-reviewed journals, online and print media, and in meetings with community stakeholders. TRIAL REGISTRATION NUMBER: NCT04111939.

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.

Evaluating the sustainability of patient navigation programs in oncology by length of existence, funding, and payment model participation.

BACKGROUND: For this study, the authors examined whether specific programmatic factors were associated with the sustainability of patient navigation programs. METHODS: This cross-sectional survey explored navigation programmatic factors associated with 3 measures of sustainability: 1) length of program existence, 2) reliance on sustainable funding, and 3) participation in alternative payment models. In total, 750 patient navigators or program administrators affiliated with oncology navigation programs in clinical-based and community-based settings completed the survey between April and July 2019. RESULTS: Associations were observed between both accreditation and work setting and measures of program sustainability. Accredited programs and larger, more resourced clinical institutions were particularly likely to exhibit multiple measures of sustainability. The results also identified significant gaps at the programmatic level in data collection and reporting among navigation programs, but no association was observed between programmatic data collection/reporting and sustainability. CONCLUSIONS: Navigation is not currently a reimbursable service and has historically been viewed as value-added in oncology settings. Therefore, factors associated with sustainability are critical to understand how to build a framework for successful navigation programs within the current system and also to develop the case for potential reimbursement in the future.

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.

Development of a workflow process mapping protocol to inform the implementation of regional patient navigation programs in breast oncology.

BACKGROUND: Implementing city-wide patient navigation processes that support patients across the continuum of cancer care is impeded by a lack of standardized tools to integrate workflows and reduce gaps in care. The authors present an actionable workflow process mapping protocol for navigation process planning and improvement based on methods developed for the Translating Research Into Practice study. METHODS: Key stakeholders at each study site were identified through existing community partnerships, and data on each site's navigation processes were collected using mixed methods through a series of team meetings. The authors used Health Quality Ontario's Quality Improvement Guide, service design principles, and key stakeholder input to map the collected data onto a template structured according to the case-management model. RESULTS: Data collection and process mapping exercises resulted in a 10-step protocol that includes: 1) workflow mapping procedures to guide data collection on the series of activities performed by health care personnel that comprise a patient's navigation experience, 2) a site survey to assess program characteristics, 3) a semistructured interview guide to assess care coordination workflows, 4) a site-level swim lane workflow process mapping template, and 5) a regional high-level process mapping template to aggregate data from multiple site-level process maps. CONCLUSIONS: This iterative, participatory approach to data collection and process mapping can be used by improvement teams to streamline care coordination, ultimately improving the design and delivery of an evidence-based navigation model that spans multiple treatment modalities and multiple health systems in a metropolitan area. This protocol is presented as an actionable toolkit so the work may be replicated to support other quality-improvement initiatives and efforts to design truly patient-centered breast cancer treatment experiences. LAY SUMMARY: Evidence-based patient navigation in breast cancer care requires the integration of services through each phase of cancer treatment. The Translating Research Into Practice study aims to implement patient navigation for patients with breast cancer who are at risk for delays and are seeking care across 6 health systems in Boston, Massachusetts. The authors designed a 10-step protocol outlining procedures and tools that support a systematic assessment for health systems that want to implement breast cancer patient navigation services for patients who are at risk for treatment delays.

Barriers and opportunities to measuring oncology patient navigation impact: Results from the National Navigation Roundtable survey.

BACKGROUND: Patient navigation improves cancer care delivery for those most at risk for poor outcomes. Lack of sustainable funding threatens the full integration of navigation services into health care delivery systems. Standardized navigation metrics that document impact and identify best practices are necessary to support sustainability. METHODS: The National Navigation Roundtable administered a web-based, cross-sectional survey to oncology patient navigation programs to identify barriers and facilitators to the use of navigation metrics. The 38-item survey asked about data-collection practices and specific navigation metrics used by the program. Exploratory and descriptive statistics were used to identify factors associated with data collection and reporting. RESULTS: Seven hundred fifty respondents from across the country represented navigation programs across the continuum of care. Although 538 respondents (72%) reported participating in routine data collection, only one-half of them used data for reporting purposes. For the 374 programs that used electronic health records, only 40% had discrete, reportable navigation fields, and 25% had an identifier for navigated patients. Program funding was identified as the only characteristic associated with data collection, whereas the type of data collected was associated with work setting, participation in alternative payment models, and where on the continuum navigation services are provided. Respondents participating in an oncology accreditation program were more likely to collect specific outcome metrics across the continuum and to use those data for reporting purposes. The most common barriers to data collection were time (55%) and lack of support for complex data systems and/or platforms (50%). CONCLUSIONS: Inconsistent data collection and reporting of oncology navigation programs remain a threat to sustainability. Aligning data collection with oncology accreditation, funding, and reimbursement is a viable path forward.