Piloting a patient navigation programme for individuals living with dementia, their care partners and members of the care team: protocol for a mixed-methods evaluation.

INTRODUCTION: Internationally, the number of individuals living with dementia continues to rise. Individuals living with dementia, their care partners and their care team face many barriers and challenges to accessing dementia care resources and supports. One solution to address the multifaceted care needs of this population is patient navigation (PN). METHODS AND ANALYSIS: This protocol describes the implementation and evaluation plan for a pilot PN programme in New Brunswick (NB) Canada for individuals living with dementia, their care partners and care providers. This project will include two components: (1) an in-person PN programme called Navigating Dementia NB/ Naviguer la démence NB and (2) two virtual peer-to-peer navigational support groups. The PN programme will be codesigned with stakeholders including researchers, patient partners, clinicians and health system managers. Patient navigators will be housed at six primary care sites across the province and the services will be offered in English and French. We will conduct a mixed-methods evaluation to explore the characteristics and experiences of participants who enrol in the PN programme and the navigational support groups, as well as the facilitators and barriers to implementation. Data collection will include navigation charts, Facebook analytics, as well as postintervention surveys, semistructured interviews and focus groups. All participants will provide written informed consent to take part in the intervention and have their data collected for research and evaluation purposes. Demographic data will be analysed using frequency and central tendency measures, while qualitative data from interviews and focus groups will undergo thematic analysis. Content analysis will be used to analyse posts published to the Facebook groups. The evaluation will assess the programme's effectiveness in the short and medium terms, evaluating its ability to achieve the intended outcomes. ETHICS AND DISSEMINATION: This study has been approved by the research ethics boards at the University of New Brunswick, Université de Moncton, Horizon Health Network and Vitalité Health Network. Knowledge translation activities (eg, presentations at local, national and international conferences; publications for open-access journals; reports and lay summaries) will be undertaken to share the findings from this pilot project with diverse stakeholders, such as decision-makers, health system managers, clinicians and the general public.

Healthcare system navigation difficulties among informal caregivers of older adults: a logistic regression analysis of social capital, caregiving support and utilization factors.

BACKGROUND: Informal caregivers of older adults play a vital role in improving the degree to which older adults access community and healthcare services in a seamless and timely manner. They are fulfilling important navigation and support roles for their older care recipients. However, there is still little knowledge of the most significant facilitators and barriers to effective and efficient system navigation among caregivers. This paper aims to fill these knowledge gaps through investigation of the key factors (i.e., social capital/cohesion, caregiving supports, and utilization factors) affecting navigation difficulties faced by informal caregivers of older adults. METHODS: The Behavioural-Ecological Framework of Healthcare Access and Navigation (BEAN) model is used to frame the study. Using the General Social Survey on Caregiving and Care Receiving 2018, we analyzed 2,733 informal caregivers whose primary care recipients were aged 65 or older. Hierarchical logistic regression was conducted to identify the relationship between system navigation difficulties among informal caregivers and four sequentially ordered blocks of predictors: (1) sociodemographic (2), social capital/cohesion (3), caregiving supports, and (4) healthcare demand. RESULTS: The fully adjusted model showed that the probability of reporting navigation difficulties was lower for caregivers with social capital/cohesion compared to those without social capital/cohesion. In comparison, the probability of reporting navigation difficulties was higher among caregivers with caregiving support and among caregivers whose care receivers use a higher amount of health service use. Several sociodemographic covariates were also identified. CONCLUSION: Our findings support certain aspects of the BEAN model. This study extends our understanding of potential facilitators and barriers that informal caregivers of older adults face while navigating complex community and health systems. There is a need to implement coordinated schemes and health policies especially for older adults with mental/neurological issues to address the challenges of their caregivers given the specific vulnerability identified in this study. The need for further research using different approaches to examine the disproportionate impact of COVID-19 on caregivers' system navigation experience is crucial.

Improving Hypertension and Diabetes Mellitus Control with a Dedicated Patient Navigator.

OBJECTIVES: Hypertension and diabetes mellitus (DM) are the leading causes of cardiovascular, cerebrovascular, and chronic kidney diseases. They affect an estimated 47% and 11% of Americans, respectively. In this study, we assessed whether a dedicated patient navigator embedded within a patient-centered medical home (PCMH) using a structured panel management and patient outreach strategy could improve blood pressure and glycemic control in primary care patients with uncontrolled hypertension and DM. METHODS: We performed a prospective study comparing blood pressure and glycemic control in primary care patients before and after implementation of a patient navigator executing a hypertension and DM-focused panel management plan. RESULTS: From January 2014 to October 2019, inclusion criteria were met 5164 times, which comprised 1958 unique patients within a PCMH. Multivariate regression analysis reveals a significant decrease in uncontrolled systolic blood pressure (SBP) over time, with an actual decrease of roughly 40% of uncontrolled episodes of SBP becoming controlled by 12 months. Multivariate regression analysis reveals a significant decrease in uncontrolled hemoglobin A1c (HbA1c) over time for each plot (P < 0.0001), with an actual decrease of roughly 30% of uncontrolled episodes of HbA1c becoming controlled by 12 months. CONCLUSIONS: This study demonstrated the benefit of a dedicated patient navigator embedded within a PCMH on improving BP and glycemic control in primary care patients with uncontrolled hypertension and DM. Glycemic control was achieved, with 30% of episodes reaching an HbA1c of <8% and BP control achieved for 40% of episodes with SBP <140 mm Hg at 12 months. There were no differences by the social determinants of race and poverty.

Impact of a Comprehensive Financial Navigation Intervention to Reduce Cancer-Related Financial Toxicity.

BACKGROUND: Although the need to reduce the impact of financial toxicity among patients with cancer is widely acknowledged, few interventions have been developed to address this issue. We tested a novel, multiphase, patient-centered financial navigation (FN) intervention at a large academic medical center. METHODS: We developed a financial toxicity screening tool consisting of the Comprehensive Score for Financial Toxicity (COST) measure plus several additional items based on patient feedback. After systematizing the screening process, 50 patients from the North Carolina Basnight Cancer Hospital were enrolled in the FN intervention following a positive screen for financial distress (COST score <23). The FN intervention involved one-on-one consultations with a trained financial navigator and included an initial comprehensive intake appointment to determine patient eligibility for financial assistance and follow-up appointments to discuss paperwork and application(s) status. We assessed preliminary intervention effectiveness (preintervention and postintervention COST scores) and implementation (ie, fidelity, uptake, acceptability). RESULTS: All 50 patients assessed for study eligibility screened positive for financial distress. A total of 46 patients completed both the preintervention and postintervention COST instrument and other measures. Postintervention mean COST scores improved from 6.4 at baseline to 13.3 post-FN (P<.0001), indicating a significant decrease in perceived financial toxicity. Fidelity to the intervention was high and 96% of participants received financial assistance. CONCLUSIONS: A patient-centered FN intervention fully integrated into an existing care coordination model can help to decrease the burden of cancer-related financial toxicity among patients with cancer experiencing financial distress. Further studies are needed to test FN interventions in various oncology settings and among targeted populations.

The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators.

BACKGROUND: Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching and navigation intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm. METHODS: Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching and navigation session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods. DISCUSSION: We will assess whether a decision coaching and patient navigation intervention can feasibly and effectively support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022. PROTOCOL VERSION: Version 1, April 10, 2024.

Tracking modifications to implementation strategies: a case study from SNaP - a hybrid type III randomized controlled trial to scale up integrated systems navigation and psychosocial counseling for PWID with HIV in Vietnam.

INTRODUCTION: Evaluation of implementation strategies is core to implementation trials, but implementation strategies often deviate from the original plan to adjust to the real-world conditions. The optimal approach to track modifications to implementation strategies is unclear, especially in low-resource settings. Using data from an implementation trial for people who inject drugs (PWID) with HIV in Vietnam, we describe the tracking of implementation strategy modifications and present findings of this process. METHODS: SNaP (Systems Navigation and Psychosocial Counseling) is a hybrid type-III effectiveness-implementation randomized controlled trial aiming to scale up the evidence-based intervention, integrated systems navigation and psychosocial counseling, for PWID with HIV in Vietnam. Forty-two HIV testing sites were randomized 1:1 to a standard or tailored arm. While the standard arm (SA) received a uniform package of strategies, implementation strategies for the tailored arm (TA) were tailored to address specific needs of each site. The central research team also met monthly with the TA to document how their tailored strategies were implemented over time. Five components were involved in the tracking process: describing the planned strategies; tracking strategy use; monitoring barriers and solutions; describing modifications; and identifying and describing any additional strategies. RESULTS: Our approach allowed us to closely track the modifications to implementation strategies in the tailored arms every month. TA sites originally identified 27 implementation strategies prior to implementation. During implementation, five strategies were dropped by four sites and two new strategies were added to twelve sites. Modifications of five strategies occurred at four sites to accommodate their changing needs and resources. Difficulties related to the COVID-19 pandemic, low number of participants recruited, high workload at the clinic, lack of resources for HIV testing and high staff turnover were among barriers of implementing the strategies. A few challenges to tracking modifications were noted, including the considerable amount of time and efforts needed as well as the lack of motivation from site staff to track and keep written documentations of modifications. CONCLUSIONS: We demonstrated the feasibility of a systematic approach to tracking implementation strategies for a large-scale implementation trial in a low-resource setting. This process could be further enhanced and replicated in similar settings to balance the rigor and feasibility of implementation strategy tracking. Our findings can serve as additional guidelines for future researchers planning to report and track modifications to implementation strategies in large, complex trials. TRIAL REGISTRATION: clinicaltrials.gov ID: NCT03952520 (first posted 2019-05-16).

Patient navigator programmes for children and adolescents with chronic diseases.

BACKGROUND: Despite a substantial global improvement in infant and child mortality from communicable diseases since the early 1990s there is now a growing burden of chronic disease in children and adolescents worldwide, mimicking the trend seen in the adult population. Chronic diseases in children and adolescents can affect all aspects of their well-being and function with these burdens and their health-related consequences often carried into adulthood. Up to one third of disability-adjusted life years for children and adolescents globally are a result of chronic disease. This has profound implications for the broader family unit, communities, and health systems in which these children and young people reside. Models of chronic care delivery for children and adolescents with chronic disease have traditionally been adapted from adult models. There is a growing recognition that children and adolescents with chronic diseases have a unique set of healthcare needs. Their needs extend beyond disease education and management appropriate to the developmental stage of the child, to encompass psychological well-being for the entire family and a holistic care approach focusing on the social determinants of health. It is for this reason that patient navigators have been proposed as a potential intervention to help fulfil this critical healthcare gap. Patient navigators are trained medical or non-medical personnel (e.g. lay health workers, community health workers, nurses, or people with lived experience) who provide guidance for the patients (and their primary caregivers) as they move through complex (and often bewildering) medical and social systems. The navigator may deliver education, help to co-ordinate patient care, be an advocate for the patient (and their primary caregivers), or combinations of these. Patient navigators can assist people with a chronic illness (especially those who are vulnerable or from a marginalised population, or both) to better understand their diagnoses, treatment options, and available resources. As there is considerable variation in the purpose, design, and target population of patient navigator programmes, there is a need to systematically review and summarise the existing literature on the effectiveness of navigator programmes in children and young adults with chronic disease. OBJECTIVES: To assess the effectiveness of patient navigator programmes in children and adolescents with chronic diseases. SEARCH METHODS: We searched the Cochrane Library and Epistemonikos up to 20 January 2023 for related systematic reviews using search terms relevant to this review. We searched CENTRAL, MEDLINE, Embase, CINAHL EBSCO, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov for primary studies. SELECTION CRITERIA: We included randomised controlled trials reporting the effect of patient navigator interventions on children and adolescents (aged 18 years or younger) with any chronic disease in hospital or community settings. Two review authors independently assessed the retrieved titles and abstracts, and where necessary, the full text to identify studies that satisfied the inclusion criteria. DATA COLLECTION AND ANALYSIS: Two review authors extracted data using a standard data extraction form. We used a random-effects model to perform a quantitative synthesis of the data. We used the I² statistic to measure heterogeneity amongst the studies in each analysis. We indicated summary estimates as mean differences (MD), where studies used the same scale, or standardised mean differences (SMD), where studies used different scales, with 95% confidence intervals (CI). We used subgroup and univariate meta-regression to assess reasons for between-study differences. We used the Cochrane RoB 1 tool to assess the methodological quality of the included studies. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included 17 studies (2895 randomised participants). All studies compared patient navigators with standard care. Most studies were at unclear or high risk of bias. Meta-analysis was undertaken only for those studies that had the same duration of patient navigator intervention and follow-up/reporting of outcome measures. The evidence is very uncertain about the effects of patient navigator programmes compared with standard care on self-reported quality of life of children with chronic illness (SMD 0.63, 95% CI -0.20 to 1.47; I2 = 96%; 4 studies, 671 participants; very low-certainty evidence); parent proxy-reported quality of life (SMD 0.09, 95% CI -2.21 to 2.40; I2 = 99%; 2 studies, 309 participants; very low-certainty evidence); or parents' or caregivers' quality of life (SMD -1.98, 95% CI -4.13 to 0.17; I2 = 99%; 3 studies, 757 participants; very low-certainty evidence). It is uncertain whether duration of patient navigator intervention accounts for any of the variances in the changes in quality of life. The evidence is very uncertain about the effects of patient navigator programmes compared with standard care on the number of hospital admissions (MD -0.05, 95% CI -0.34 to 0.23; I2 = 99%; 2 studies, 381 participants; very low-certainty evidence) and the number of presentations to the emergency department (MD 0.06, 95% CI -0.23 to 0.34; I2 = 98%; 2 studies, 381 participants; very low-certainty evidence). Furthermore, it is unclear whether patient navigator programmes reduce the number of missed school days as data were sparse (2 studies, 301 participants). Four studies (629 participants) reported data on resource use. However, given the variation in units of analysis used, meta-analysis was not possible (very low-certainty evidence). All studies reported cost savings or quality-adjusted life year improvement (or both) in the patient navigation arm. No studies reported on adverse events (specifically, abuse of any type against the navigator, the patient, or their family members). AUTHORS' CONCLUSIONS: There is insufficient evidence at present to support the use of patient navigator programmes for children and adolescents with chronic diseases. The current evidence is based on limited data with very low-certainty evidence. Further studies are likely to significantly change these results.

Adapting a Remotely Delivered Patient Navigation Program for Colorectal Cancer Screening in Primary Care: Important Considerations for Rural Contexts.

INTRODUCTION: Colonoscopy is a critical component of colorectal cancer (CRC) screening and patient navigation (PN) improves colonoscopy completion. A lay navigator remotely providing navigation across rural primary care organizations (PCOs) could increase PN access. In preparation for the Colonoscopy Outreach for Rural Communities (CORC) study, we examined partners' perspectives on contextual factors that could influence CORC program implementation, and adaptations to mitigate potential barriers. METHODS: We interviewed 29 individuals from 6 partner PCOs and the community-based organization (CBO) delivering the PN program. An analysis approach informed by Miles, Huberman, and Saldana identified critical themes. Results are reported using the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME). RESULTS: Potential barriers included that rural patients are hard to reach remotely and might mistrust the navigator, and the CBO is unfamiliar with the patient communities and does not have patient care experience or pre-existing communication pathways with the PCOs. Program content and navigator training was adapted to mitigate these challenges. CONCLUSIONS: Our study highlights contextual factors to account for before implementing a remote, centralized patient navigation program serving rural communities. Gathering partner perspectives led to intervention adaptations intended to address potential barriers while leaving the core components of the evidence-based intervention intact.

Patient navigation in reproductive healthcare.

PURPOSE OF REVIEW: This review summarizes evidence about barriers to abortion care pre- Dobbs and post- Dobbs , inequities in abortion access, and approaches to improving access to abortion care with use of patient navigators. RECENT FINDINGS: The Dobbs decision and resulting state-level restrictions exacerbated economic, knowledge, and logistic barriers to abortion care. Abortion funds and emotional support are two main resources to help address these barriers; however, only with coordination can patients and clinics fully benefit from the resources. Patient navigation provides that coordination. Evidence shows it improves reproductive outcomes, is acceptable to patients and providers, and engages community health workers and community-based organizations. SUMMARY: Increasing legal restrictions and barriers to abortion care have motivated advocates to identify effective interventions to facilitate patient-centered and culturally competent care. Navigators have improved postpartum care by increasing attendance, education and helping coordinate overall care. They have improved referrals and access to abortion care in statewide programs.

Maternal navigation: for the common good.

The US faces a maternal health crisis as overall maternal mortality rates continue to worsen. HHS, in its Healthy People 2030 report, indicates that women in the US are more likely to die from childbirth than are women in other developed countries. The cost of the maternal health crisis and its associated morbidities is estimated to be $32.3 billion from conception to 5 years postpartum, with $18.7 billion in medical costs and $13.6 billion in nonmedical costs. Under the current health care reimbursement system, health care providers alone have little short-term incentive to bear the cost for solutions or prevention strategies that could change the social and cultural factors affecting maternal outcomes. This article provides an overview of the crisis, along with its economic and societal costs, and the role of prenatal care and premature birth in this escalating problem. The article then proposes maternal navigation for pregnant patients who chronically miss prenatal care appointments as one way to reduce premature births and associated health care costs. Through intentional and focused investment in maternal navigation by payers and providers together, health outcomes can be improved and disparities can be reduced. As a result, payer and provider costs are reduced and the interests of all parties are advanced. A connected system of support that improves health outcomes and reduces health care costs for the most at-risk patients is an essential response to a crisis that affects not only the individual but also society.

Codesigning a Community Health Navigator program to assist patients to transition from hospital to community.

Background This study aimed to identify the potential roles for Community Health Navigators (CHNs) in addressing problems faced by patients on discharge from hospital to the community, and attitudes and factors which may influence their adoption. Methods Twenty-six qualitative interviews and an online codesign workshop were conducted with patients, nurses, general practice staff, health service managers, community health workers, general practitioners, medical specialists, and pharmacists in the Sydney Local Health District. Qualitative themes from the interviews and workshop transcripts were analysed inductively and subsequently grouped according to a socio-ecological model. Results CHNs could assist patients to navigate non-clinical problems experienced by patients on discharge through assessing needs, establishing trust, providing social and emotional support that is culturally and linguistically appropriate, engaging family and carers, supporting medication adherence, and helping to arrange and attend follow up health and other appointments. Important factors for the success of the CHNs in the performance and sustainability of their roles were the need to establish effective communication and trust with other healthcare team members, be accepted by patients, have access to information about referral and support services, receive formal recognition of their training and experience, and be supported by appropriate supervision. Conclusions This study was unique in exploring the potential role of CHNs in addressing problems faced by patients on discharge from Australian hospitals and the factors influencing their adoption. It informed training and supervision needs and further research to evaluate CHNs' effectiveness and the acceptance of their role within the healthcare team.

Evaluating the tailored implementation of a multisite care navigation service for mental health in rural and remote Australia (The Bridging Study): protocol for a community-engaged hybrid effectiveness-implementation study.

BACKGROUND: A dramatic decline in mental health of people worldwide in the early COVID-19 pandemic years has not recovered. In rural and remote Australia, access to appropriate and timely mental health services has been identified as a major barrier to people seeking help for mental ill-health. From 2020 to 2021 a care navigation model, Navicare, was co-designed with rural and remote communities in the Greater Whitsunday Region of Central Queensland in Australia. The Exploration, Preparation, Implementation and Sustainment (EPIS) framework was used to design and guide multiple aspects of a multisite study, The Bridging Study, to evaluate the implementation of Navicare in Australia. METHODS: A community-engaged hybrid effectiveness-implementation study design will focus on the tailored implementation of Navicare at three new sites as well as monitoring implementation at an existing site established since 2021. Study outcomes assessed will include sustained access as the co-primary outcome (measured using access to Navicare mental health referral services) and Proctor's Implementation Outcomes of feasibility, acceptability, appropriateness, adoption, fidelity, implementation cost, and sustainability. Data collection for the implementation evaluation will include service usage data, community consultations, interviews, and workshops; analysed using mixed methods and guided by EPIS and other implementation frameworks. Pre-post effectiveness and cost-consequence study components are embedded in the implementation and sustainment phases, with comparison to pre-implementation data and value assessed for each EPIS phase using hospital, service, and resource allocation data. A scaling up strategy will be co-developed using a national roundtable forum in the final year of the study. Qualitative exploration of other aspects of the study (e.g., mechanisms of action and stakeholder engagement) will be conducted. DISCUSSION: Our study will use tailoring to local sites and a community-engaged approach to drive implementation of a mental health care navigation service in rural and remote Australia, with expected benefits to mental healthcare access. This approach is consistent with policy recommendations nationally and internationally as building blocks for rural health including the World Health Organization Framework for Action on Strengthening Health Systems to Improve Health Outcomes. TRIAL REGISTRATION: Prospectively registered on April 2, 2024, on the Australian New Zealand Clinical Trials Registry, no. ACTRN12624000382572. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386665&isReview=true .

Genetics Navigator: protocol for a mixed methods randomized controlled trial evaluating a digital platform to deliver genomic services in Canadian pediatric and adult populations.

INTRODUCTION: Genetic testing is used across medical disciplines leading to unprecedented demand for genetic services. This has resulted in excessive waitlists and unsustainable pressure on the standard model of genetic healthcare. Alternative models are needed; e-health tools represent scalable and evidence-based solution. We aim to evaluate the effectiveness of the Genetics Navigator, an interactive patient-centred digital platform that supports the collection of medical and family history, provision of pregenetic and postgenetic counselling and return of genetic testing results across paediatric and adult settings. METHODS AND ANALYSIS: We will evaluate the effectiveness of the Genetics Navigator combined with usual care by a genetics clinician (physician or counsellor) to usual care alone in a randomised controlled trial. One hundred and thirty participants (adults patients or parents of paediatric patients) eligible for genetic testing through standard of care will be recruited across Ontario genetics clinics. Participants randomised into the intervention arm will use the Genetics Navigator for pretest and post-test genetic counselling and results disclosure in conjunction with their clinician. Participants randomised into the control arm will receive usual care, that is, clinician-delivered pretest and post-test genetic counselling, and results disclosure. The primary outcome is participant distress 2 weeks after test results disclosure. Secondary outcomes include knowledge, decisional conflict, anxiety, empowerment, quality of life, satisfaction, acceptability, digital health literacy and health resource use. Quantitative data will be analysed using statistical hypothesis tests and regression models. A subset of participants will be interviewed to explore user experience; data will be analysed using interpretive description. A cost-effectiveness analysis will examine the incremental cost of the Navigator compared with usual care per unit reduction in distress or unit improvement in quality of life from public payer and societal perspectives. ETHICS AND DISSEMINATION: This study was approved by Clinical Trials Ontario. Results will be shared through stakeholder workshops, national and international conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06455384.

The Development of a Digital Patient Navigation Tool to Increase Colorectal Cancer Screening Among Federally Qualified Health Center Patients: Acceptability and Usability Testing.

BACKGROUND: Federally Qualified Health Centers (FQHCs) are an essential place for historically underserved patients to access health care, including screening for colorectal cancer (CRC), one of the leading causes of cancer death in the United States. Novel interventions aimed at increasing CRC screening completion rates at FQHCs are crucial. OBJECTIVE: This study conducts user testing of a digital patient navigation tool, called eNav, designed to support FQHC patients in preparing for, requesting, and completing CRC screening tests. METHODS: We recruited English- and Spanish-speaking patients (N=20) at an FQHC in New York City to user-test the eNav website (2 user tests; n=10 participants per user test). In each user test, participants engaged in a "think aloud" exercise and a qualitative interview to summarize and review their feedback. They also completed a baseline questionnaire gathering data about demographics, technology and internet use, medical history, and health literacy, and completed surveys to assess the website's acceptability and usability. Based on participant feedback from the first user test, we modified the eNav website for a second round of testing. Then, feedback from the second user test was used to modify and finalize the eNav website. RESULTS: Survey results supported the overall usability and acceptability of the website. The average System Usability Scale score for our first user test was 75.25; for the second, it was 75.28. The average Acceptability E-scale score for our first user test was 28.3; for the second, it was 29.2. These scores meet suggested benchmarks for usability and acceptability. During qualitative think-aloud exercises, in both user tests, many participants favorably perceived the website as motivating, interesting, informative, and user-friendly. Respondents also gave suggestions on how to improve the website's content, usability, accessibility, and appeal. We found that some participants did not have the digital devices or internet access needed to interact with the eNav website at home. CONCLUSIONS: Based on participant feedback on the eNav website and reported limitations to digital access across both user tests, we made modifications to the content and design of the website. We also designed alternative methods of engagement with eNav to increase the tool's usability, accessibility, and impact for patients with diverse needs, including those with limited access to devices or the internet at home. Next, we will test the eNav intervention in a randomized controlled trial to evaluate the efficacy of the eNav website for improving CRC screening uptake among patients treated at FQHCs.

Patient and navigator experiences with the opioid use disorder treatment system in Philadelphia, PA.

BACKGROUND: In 2022, 1413 people in Philadelphia died of an unintentional drug overdose. Addressing the complex challenges within the opioid use disorder (OUD) treatment system requires a comprehensive grasp of multiple system-level siloes from the perspective of patients who are accessing services and certified recovery specialists. Identifying facilitators and barriers to treatment entry and retention are critical. METHODS: We conducted 13 focus groups with 70 people with a history of opioid use in Philadelphia, Pennsylvania. The study recruited participants from non-profit organizations, OUD treatment programs, and street intercept. Certified Recovery Specialists (CRS), people with experience in residential, outpatient, methadone, and buprenorphine programs in Philadelphia, identity-specific groups with Black women, Black men, and Latino men, pregnant and parenting people, and people accessing harm reduction services participated in focus groups. Focus group guides varied by group, but the overarching focus remained on understanding participants' experiences in navigating the OUD treatment system. The research team summarized and edited CRS focus groups and coded all other focus groups for thematic analysis. RESULTS: Most focus group participants (mean age = 45.1 years; 52.9 % men, 40 % Black) had a history with multiple treatment types and reported experiences with different modalities. Salient themes that emerged from analysis included frustrations with the assessment process; reflections on facilitators and barriers by treatment type (residential, methadone, and buprenorphine); and recommendations across treatment modalities. Assessment centers, rather than being easy points of treatment entry, were identified as a major barrier to OUD treatment initiation; issues discussed included length of assessment, limited operating hours, and inadequate withdrawal management. DISCUSSION: The data from the present study were used to develop recommendations for policymakers and other stakeholders of OUD treatment programs to improve care across the spectrum of services. Expansion of residential programs that can support patients with complex comorbid conditions and wounds is needed to prevent delays for patients deemed ineligible for lower levels of care. Housing and income were identified as significant deterrents to initiating drug treatment and greater resources are needed. Greater investment in the OUD workforce is needed, especially expanding staff with lived experience. Findings can enhance OUD treatment programs elsewhere.

The "Latines Lideres En Salud (LaLiSa)" study: Rationale and design.

BACKGROUND: Latines suffer from breast cancer (BC), due to elevated biological and social determinants of health (SDOH) risks. This study compares the effects of different strategies on uptake of cancer genetic services, specifically hereditary cancer risk assessment, genetic counseling, and genetic testing, and risk-based BC care. DESIGN/METHODS: In Chicago, Illinois, Aim 1 participants are recruited from a federally qualified health center (FQHC) and community venues. For Aim 1, eligible participants: (1) are female; (2) are Latine; (3) are 30+ years old; (4) have personal or family history of BC or cancers with shared hereditary mutations; (5) have at least one SDOH risk; and (6) have not received any cancer genetic services. Participants are randomly assigned to different study arms. Both arms include phone-based sessions, FQHC-based navigation for SDOH, and low- or no-cost cancer genetic services. The educate sessions focus on risk assessment and prevention. The empower sessions focus on risk assessment and equip participants with the skills to share information about FQHC-based cancer genetic services. For Aim 2, eligible participants are: (1) female; (2) network members of Aim 1 participants; and (3) eligible for BC screening based on guidelines recommended by the American Cancer Society (ACS). Primary outcomes include uptake of any cancer genetic services. Analyses will also explore intervention differences by neighborhood context. DISCUSSION: This is one of the first trials focused on Latines' participation in cancer genetic services and risk-based BC care within the context of SDOH - which has major implications for equity in precision cancer prevention.

NAVKIDS2: a lesson in matching outcome measures to interventions.

Patient navigator programs may improve outcomes among individuals with chronic kidney disease by reducing barriers to evidence-based care. The NAVKIDS2 trial evaluated a patient navigation program among 162 children with chronic kidney disease from marginalized populations. The intervention was not associated with quantitative changes in self-reported health, but qualitative data indicated substantial benefit in alleviating caregiver strain and facilitating care coordination. Future studies should identify quantitative measures that capture the benefits experienced by patients in care coordination, empowerment, and self-management.

Process Evaluation of a Pilot Food Insecurity Resource Navigation Program Integrated Within Pediatric Primary Care: Utilizing RE-AIM to Inform Program Scale-up.

OBJECTIVE: The purpose of this study was to examine the implementation and effectiveness of a novel pediatric food navigation program through a structured, comprehensive evaluation using the RE-AIM framework. DESIGN AND PARTICIPANTS: Data were collected from October 2021 through August 2022 for 166 pediatric patients and their families who were screened as food insecure or high-risk for food insecurity and were referred to this pilot food resource navigation program (FRNP). A total of 88 patients' guardians consented to participate in this FRNP, receiving initial service connection. Participants were contacted via telephone by trained navigators within this health system to assess food security status across three time points (baseline, follow-up 1 [1- <3 months], and follow-up 2 [3-6 months]) and facilitate connection to appropriate community-based resources related to food assistance. RESULTS: In this sample, we had an overrepresentation of Hispanic patients and an underrepresentation of Non-Hispanic Black and White patients relative to the available clinic population. Patients participating in the navigation program showed incremental shifts toward food security from baseline to two follow-up points. Integration within primary care was supported by physician champions across participating clinics and alignment with systemwide, updated universal screening guidelines to support projected increases in families requiring connecting to assistance programs. Through this evaluation, a comprehensive list of community-based food resource programs related to food assistance was integrated into electronic documentation for navigators to alleviate navigator burden and sustain the effect of this FRNP's implementation. CONCLUSIONS: These findings may be used to inform expansion of current programming efforts within this FRNP and to clarify process evaluations of broader health system-based programming. Further research, building on the findings of this pilot study, is needed to examine the longitudinal, causal effect of FRNPs in pediatric food security and long-term health outcomes for replication across health systems nationwide.

Improving uptake of colorectal cancer screening by complex patients at an academic primary care practice: a feasibility study.

BACKGROUND: Regular screening reduces mortality from colorectal cancer (CRC). The Canton of Vaud, Switzerland, has a regional screening programme offering faecal immunochemical tests (FITs) or colonoscopy. Participation in the screening programme has been low, particularly among complex patients. Patient navigation has strong evidence for increasing the CRC screening rate. DESIGN AND OBJECTIVE: This feasibility study tested patient navigation performed by medical assistants for complex patients at an academic primary care practice. BASELINE MEASUREMENTS: A review of 328 patients' medical charts revealed that 51% were up-to-date with screening (16% within the programme), 24% were ineligible, 5% had a documented refusal and 20% were not up-to-date, of whom 58 (18%) were complex patients. INTERVENTION FEBRUARY 2023 TO MAY 2023: We tried to help complex patients participate in the screening programme using either in-person or telephone patient navigation. Each intervention was piloted by a physician-researcher and then performed by a medical assistant. Based on the reach, effectiveness, adoption, implementation, maintenance framework, we collected: Intervention participation and refusal, screening acceptance and completion and both patients and medical assistant acceptability (ie, qualitative interviews). RESULTS: Only 4/58 (7%) patients participated in the in-person patient navigation test phase due to scheduling problems. All four patients accepted a prescription and 2/4 (50%) completed their test. We piloted a telephone intervention to bypass scheduling issues but all patients refused a telephone discussion with the medical assistant. At two months after the last intervention, the proportion of patients up-to-date increased from 51% to 56%. CONCLUSION: Our overall approach was resource-intensive and had little impact on the overall participation rate. It was likely not sustainable. New approaches and reimbursement for a specific patient navigator role are needed to increase CRC screening of complex patients.

Implementation of a financial navigation program in gynecologic oncology.

BACKGROUND: "Financial Toxicity" (FT) is the financial burden imposed on patients due to disease and its treatment. Approximately 50% of gynecologic oncology patients experience FT. This study describes the implementation and outcomes of a novel financial navigation program (FNP) in gynecologic oncology. METHODS: Patients presenting for initial consultation with a gynecologic oncologist from July 2022 to September 2023 were included. A FNP was launched inclusive of hiring a financial navigator (FN) in July 2022, and implementing FT screening in October 2022. We prospectively captured patient referrals to the FN, collecting clinical, demographic, financial and social needs information, along with FN interventions and institutional support service referrals. Referrals to the FN and support services were quantified before and after screening implementation. RESULTS: There were 1029 patients with 21.6% seen before and 78.4% after screening initiation. Median age was 58 (IQR 46-68). The majority were non-Hispanic white (60%) with private insurance (61%). A total of 10.5% patients were referred to the FN. Transportation (32%), financial assistance (20.5%) and emotional support (15.4%) were the most common needs identified. A higher proportion of patients referred to the FN identified as Black, had government-funded insurance or diagnoses of uterine or cervical cancers (p < 0.05). Post-screening referrals to FN increased (5% vs. 12.9%, p < 0.001), while referrals to other support services decreased (9.5% vs. 2.9%, p < 0.001). CONCLUSIONS: Implementation of the FNP was feasible, though presence of both a FN and FT screening maximized its effectiveness. Further investigation is needed to understand screening barriers and evaluate longer-term impact.