The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship.

BACKGROUND: There is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health services use between patients receiving a financial navigation intervention versus a comparison group at 12 months follow-up, and to assess patient-level factors associated with dose received of a financial navigation intervention. METHODS: The Cancer Financial Experience (CAFÉ) study is a multi-site randomized controlled trial (RCT) with individual-level randomization. Participants will be offered either brief (one financial navigation cycle, Arm 2) or extended (three financial navigation cycles, Arm 3) financial navigation. The intervention period for both Arms 2 and 3 is 6 months. The comparison group (Arm 1) will receive enhanced usual care. The setting for the CAFÉ study is the medical oncology and radiation oncology clinics at two integrated health systems in the Pacific Northwest. Inclusion criteria includes age 18 or older with a recent cancer diagnosis and visit to a study clinic as identified through administrative data. Outcomes will be assessed at 12-month follow-up. Primary outcomes are self-reported financial distress and health-related quality of life. Secondary outcomes are delayed or foregone care; receipt of medical financial assistance; and account delinquency. A mixed methods exploratory analysis will investigate factors associated with total intervention dose received. DISCUSSION: The CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship. It is theory-informed, clinic-based, aligned with patient preferences, and has been developed following preliminary qualitative studies and stakeholder input. By design, it will provide prospective evidence on the potential benefits of financial navigation on patient-relevant cancer outcomes. The CAFÉ trial's strengths include its broad inclusion criteria, its equity-focused sampling plan, its novel intervention developed in partnership with clinical and operations stakeholders, and mixed methods secondary analyses related to intervention dose offered and dose received. The resulting analytic dataset will allow for rich mixed methods analysis and provide critical information related to implementation of the intervention should it prove effective. TRIAL REGISTRATION: ClinicalTrials.gov NCT05018000 . August 23, 2021.

Social Risk Factors and Desire for Assistance Among Patients Receiving Subsidized Health Care Insurance in a US-Based Integrated Delivery System.

PURPOSE: Because social conditions such as food insecurity and housing instability shape health outcomes, health systems are increasingly screening for and addressing patients' social risks. This study documented the prevalence of social risks and examined the desire for assistance in addressing those risks in a US-based integrated delivery system. METHODS: A survey was administered to Kaiser Permanente members on subsidized exchange health insurance plans (2018-2019). The survey included questions about 4 domains of social risks, desire for help, and attitudes. We conducted a descriptive analysis and estimated multivariate modified Poisson regression models. RESULTS: Of 438 participants, 212 (48%) reported at least 1 social risk factor. Housing instability was the most common (70%) factor reported. Members with social risks reported more discomfort being screened for social risks (14.2% vs 5.4%; P = .002) than those without risks, although 90% of participants believed that health systems should assist in addressing social risks. Among those with 1-2 social risks, however, only 27% desired assistance. Non-Hispanic Black participants who reported a social risk were more than twice as likely to desire assistance compared with non-Hispanic White participants (adjusted relative risk [RR] 2.2; 95% CI, 1.3-3.8). CONCLUSIONS: Athough most survey participants believed health systems have a role in addressing social risks, a minority of those reporting a risk wanted assistance and reported more discomfort being screened for risk factors than those without risks. Health systems should work to increase the comfort of patients in reporting risks, explore how to successfully assist them when desired, and offer resources to address these risks outside the health care sector.VISUAL ABSTRACT.

Leading Innovative Practice: Leadership Attributes in LEAP Practices.

Policy Points An onslaught of policies from the federal government, states, the insurance industry, and professional organizations continually requires primary care practices to make substantial changes; however, ineffective leadership at the practice level can impede the dissemination and scale-up of these policies. The inability of primary care practice leadership to respond to ongoing policy demands has resulted in moral distress and clinician burnout. Investments are needed to develop interventions and educational opportunities that target a broad array of leadership attributes. CONTEXT: Over the past several decades, health care in the United States has undergone substantial and rapid change. At the heart of this change is an assumption that a more robust primary care infrastructure helps achieve the quadruple aim of improved care, better patient experience, reduced cost, and improved work life of health care providers. Practice-level leadership is essential to succeed in this rapidly changing environment. Complex adaptive systems theory offers a lens for understanding important leadership attributes. METHODS: A review of the literature on leadership from a complex adaptive system perspective identified nine leadership attributes hypothesized to support practice change: motivating others to engage in change, managing abuse of power and social influence, assuring psychological safety, enhancing communication and information sharing, generating a learning organization, instilling a collective mind, cultivating teamwork, fostering emergent leaders, and encouraging boundary spanning. Through a secondary qualitative analysis, we applied these attributes to nine practices ranking high on both a practice learning and leadership scale from the Learning from Effective Ambulatory Practice (LEAP) project to see if and how these attributes manifest in high-performing innovative practices. FINDINGS: We found all nine attributes identified from the literature were evident and seemed important during a time of change and innovation. We identified two additional attributes-anticipating the future and developing formal processes-that we found to be important. Complexity science suggests a hypothesized developmental model in which some attributes are foundational and necessary for the emergence of others. CONCLUSIONS: Successful primary care practices exhibit a diversity of strong local leadership attributes. To meet the realities of a rapidly changing health care environment, training of current and future primary care leaders needs to be more comprehensive and move beyond motivating others and developing effective teams.

How, When, and With Whom Should Cost of Care Conversations Occur? Preferences of Two Distinct Cancer Survivor Groups.

PURPOSE: Cost of care (CoC) conversations should occur routinely in oncology practice. However, patient preferences about with whom, when, and how to have these conversations are missing and preferences may vary across patient populations. METHODS: We performed a secondary qualitative analysis of quotes from interviews with 28 cancer survivors from two health care settings (Kaiser Permanente Washington and O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham [UABCCC]). A targeted approach searched for three constructs: (1) Who should have CoC conversations with patients? (2) When should CoC conversations occur? and (3) How should CoC conversations happen? RESULTS: Interviewees were similar in age and education, but UABCCC participants had more racial/ethnic minority representation and financial distress. Within each construct, themes were similar across both groups. As to who should have CoC conversations, we found that (1) providers' main role is medical care, not CoC; and (2) care team staff members are a more appropriate choice to address CoC needs. About the question of when, we found that (3) individuals have strong convictions about when and if they want to discuss CoC; and (4) CoC information and resources need to be available when patients are ready. About the question of how, themes were (5) provide estimates of anticipated out-of-pocket costs and insurance coverage; (6) provide reassurance, sympathy, and concrete solutions; and (7) because of their sensitivity, conduct CoC conversations in a comfortable, private space. CONCLUSION: These findings offer general guidance as to who should conduct CoC conversations and when and how they should occur, with applicability across different patient populations.

Workflow Requirements for Cost-of-Care Conversations in Outpatient Settings Providing Oncology or Primary Care: A Qualitative, Human-Centered Design Study.

Background: Patients prefer to discuss costs in the clinical setting, but physicians and teams may be unprepared to incorporate cost discussions into existing workflows. Objective: To understand and improve clinical workflows related to cost-of-care conversations. Design: Qualitative human-centered design study. Setting: 2 integrated health systems in the U.S. Pacific Northwest: a system-wide oncology service line and a system-wide primary care service line. Participants: Clinicians, clinical team members, operations staff, and patients. Measurements: Ethnographic observations were made at the integrated health systems, assessing barriers to and facilitators of discussing costs with patients. Three unique patient experiences of having financial concerns addressed in the clinic were designed. These experiences were refined after in-person interviews with patients (n = 20). Data were synthesized into a set of clinical workflow requirements. Results: Most patient cost concerns take 1 of 3 pathways: informing clinical care decision making, planning and budgeting concerns, and addressing immediate financial hardship. Workflow requirements include organizational recognition of the need for clinic-based cost-of-care conversations; access to cost and health plan benefit data to support each conversation pathway; clear team member roles and responsibilities for addressing cost-of-care concerns; a patient experience where cost questions are normal and each patient's preferences and privacy are respected; patients know who to go to with cost questions; patients' concerns are documented to minimize repetition to multiple team members; and patients learn their expected out-of-pocket costs before treatment begins. Limitation: Results may have limited generalizability to other health care settings, and the study did not test the effectiveness of the workflows developed. Conclusion: Clinic-based workflows for cost-of-care conversations that optimize patients' care experience require organizational commitment to addressing cost concerns, clear roles and responsibilities, appropriate and complete data access, and a team-based approach. Primary Funding Source: Robert Wood Johnson Foundation.

Addressing guideline and policy changes during pragmatic clinical trials.

While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions.

Design and Implementation of a Physician Coaching Pilot to Promote Value-Based Referrals to Specialty Care.

INTRODUCTION: Referral rates to specialty care from primary care physicians vary widely. To address this variability, we developed and pilot tested a peer-to-peer coaching program for primary care physicians. OBJECTIVES: To assess the feasibility and acceptability of the coaching program, which gave physicians access to their individual-level referral data, strategies, and a forum to discuss referral decisions. METHODS: The team designed the program using physician input and a synthesis of the literature on the determinants of referral. We conducted a single-arm observational pilot with eight physicians which made up four dyads, and conducted a qualitative evaluation. RESULTS: Primary reasons for making referrals were clinical uncertainty and patient request. Physicians perceived doctor-to-doctor dialogue enabled mutual learning and a pathway to return joy to the practice of primary care medicine. The program helped physicians become aware of their own referral data, reasons for making referrals, and new strategies to use in their practice. Time constraints caused by large workloads were cited as a barrier both to participating in the pilot and to practicing in ways that optimize referrals. Physicians reported that the program could be sustained and spread if time for mentoring conversations was provided and/or nonfinancial incentives or compensation was offered. CONCLUSION: This physician mentoring program aimed at reducing specialty referral rates is feasible and acceptable in primary care settings. Increasing the appropriateness of referrals has the potential to provide patient-centered care, reduce costs for the system, and improve physician satisfaction.

Treatment Prices at the Point of Care in a Clinical Oncology Service: Pilot Project.

PURPOSE: Patients with cancer increasingly wish to discuss cancer care costs with clinicians. We aimed to improve clinician access to treatment prices. METHODS: We developed a pilot tool and accompanying workflow for four oncology clinics in an integrated care system. The online tool included 50 printable worksheets for cancer treatment protocols and was accessible directly from the electronic health record. Each sheet included codes and prices for all drugs and services for one treatment cycle in patient-friendly language. The worksheets did not provide patient-level cost-shares. We evaluated the resource's launch, initial use, and acceptability through a convenience survey of initial users. RESULTS: The project was successfully launched. Initial Web traffic to price sheets exceeded the number of treatments ordered during the launch period. One third of survey respondents reported use of the cost sheets at least once a week. The most useful features were improved access to cost information, treatment protocol-based layout, and ability to meet patient needs. The resource was rated as generally high value to patients, staff, and the organization. Suggested improvements included provision of patient-level cost sharing (63%) followed by expansion of the project to include more protocols (33%). These improvements are in progress. CONCLUSION: The pilot was feasible, built capacity to locate price data, and did not adversely affect staff workload. It addressed a clear need and demonstrated high potential overall value, especially with its protocol-based format. The resource's lack of personalized estimates of out-of-pocket charges was the biggest gap reported.

Patient and oncologist discussions about cancer care costs.

PURPOSE: Patient out-of-pocket costs are higher for cancer care than for any other health-care sector. Oncologist-patient discussions of costs are not well understood. We conducted an exploratory interview study to examine the frequency, patterns, attitudes, and preferences of both patients and providers on discussion of treatment costs. METHODS: We conducted semi-structured telephone interviews with oncology clinicians and people receiving chemotherapy at a large nonprofit health system. Multiple investigators conducted thematic analysis using modified content analysis, grounded theory, and interaction analysis methods. RESULTS: Patient themes included the relevance of cost to their experience, preference for the doctor to be the starting point of cost discussions, but relative infrequency of discussions with doctors or other care team member. Provider themes were an emphasis on clinical benefit above costs, conviction that cost-related decisions should rest with patients, and lack of access to treatment costs. Interest in discussing costs and barriers accessing cost information were common themes from both patients and providers. CONCLUSIONS: Doctors and patients want to discuss treatment costs but lack access to them. These data support growing evidence for a provider role in discussions of cost during cancer treatment planning.

Predictors of 1-year change in patient activation in older adults with diabetes mellitus and heart disease.

OBJECTIVES: To identify patterns and predictors of 1-year change in patient activation in chronically ill older adults. DESIGN: Prospective cohort study. SETTING: Integrated healthcare delivery system. PARTICIPANTS: Members of an integrated delivery system from 2007 to 2009 in western Washington state aged 65 and older with diabetes mellitus or heart disease; participants responded to baseline and 1-year follow-up mailed surveys about their health and health care (N = 2,341). MEASUREMENTS: Patient activation was measured using the 13-item Patient Activation Measure (PAM) at baseline and follow-up. Automated diagnoses and procedure data were extracted from databases. Multinomial logistic regression, stratified according to baseline activation stage, was used to estimate the odds ratios for increasing or decreasing activation stage associated with participant characteristics and serious adverse health events. RESULTS: Fifty-two percent of participants changed activation stage between baseline and follow-up. Of people who changed stage, 54% increased, and 46% decreased. Older age and worse baseline self-reported health were independent predictors of activation change in multivariate models. Changes in health status or serious adverse health events such as the occurrence of hospitalizations, new major diagnoses, or procedures were not related to changes in activation in this age group. CONCLUSION: Patient activation, as measured using the PAM, changes over time in elderly adults with chronic diseases. Clinicians and researchers who use the PAM for patient care or as an outcome measure in research studies should be aware of its fluctuation over time in chronically ill older persons.

Accuracy and complexities of using automated clinical data for capturing chemotherapy administrations: implications for future research.

BACKGROUND: Chemotherapy data are important to almost any study on cancer prognosis and outcomes. However, chemotherapy data obtained from tumor registries may be incomplete, and abstracting chemotherapy directly from medical records can be expensive and time consuming. METHODS: We evaluated the accuracy of using automated clinical data to capture chemotherapy administrations in a cohort of 757 ovarian cancer patients enrolled in 7 health plans in the HMO Cancer Research Network. We calculated sensitivity and specificity with 95% confidence intervals of chemotherapy administrations extracted from 3 automated clinical data sources (Health Care Procedure Coding System, National Drug Codes, and International Classification of Diseases) compared with tumor registry data and medical chart data. RESULTS: Sensitivity of all 3 data sources varied across health plans from 79.4% to 95.2% when compared with tumor registries, and 75.0% to 100.0% when compared with medical charts. The sensitivities using a combination of 3 data sources were 88.6% (95% confidence intervals: 85.7-91.1) compared with tumor registries and 89.5% (78.5-96.0) compared with medical records; specificities were 91.5% (86.4-95.2) and 90.0% (55.5-99.7), respectively. There was no difference in accuracy between women aged < 65 and > or = 65 years. Using one set of codes alone (eg, Health Care Procedure Coding System alone) was insufficient for capturing chemotherapy data at most health plans. CONCLUSIONS: While automated data systems are not without limitations, clinical codes used in combination are useful in capturing chemotherapy more comprehensively than tumor registry and without the need for costly medical record abstraction. Key Words: validation of automated clinical data, chemotherapy, medical chart, tumor registry, ovarian cancer.

Cost-effectiveness of nurse-led disease management for heart failure in an ethnically diverse urban community.

BACKGROUND: Randomized, controlled trials have shown that nurse-led disease management for patients with heart failure can reduce hospitalizations. Less is known about the cost-effectiveness of these interventions. OBJECTIVE: To estimate the cost-effectiveness of a nurse-led disease management intervention over 12 months, implemented in a randomized, controlled effectiveness trial. DESIGN: Cost-effectiveness analysis conducted alongside a randomized trial. DATA SOURCES: Medical costs from administrative records, and self-reported quality of life and nonmedical costs from patient surveys. PARTICIPANTS: Patients with systolic dysfunction recruited from ambulatory clinics in Harlem, New York. TIME HORIZON: 12 months. PERSPECTIVE: Societal and payer. INTERVENTION: 12-month program that involved 1 face-to-face encounter with a nurse and regular telephone follow-up. OUTCOME MEASURES: Quality of life as measured by the Health Utilities Index Mark 3 and EuroQol-5D and cost-effectiveness as measured by the incremental cost-effectiveness ratio (ICER). RESULTS OF BASE-CASE ANALYSIS: Costs and quality of life were higher in the nurse-managed group than the usual care group. The ICERs over 12 months were $17,543 per EuroQol-5D-based quality-adjusted life-year (QALY) and $15,169 per Health Utilities Index Mark 3-based QALY (in 2001 U.S. dollars). RESULTS OF SENSITIVITY ANALYSIS: From a payer perspective, the ICER ranged from $3673 to $4495 per QALY. Applying national prices in place of New York City prices yielded a societal ICER of $13,460 to $15,556 per QALY. Cost-effectiveness acceptability curves suggest that the intervention was most likely cost-effective for patients with less severe (New York Heart Association classes I to II) heart failure. LIMITATION: The trial was conducted in an ethnically diverse, inner-city neighborhood; thus, results may not be generalizable to other communities. CONCLUSION: Over 12 months, the nurse-led disease management program was a reasonably cost-effective way to reduce the burden of heart failure in this community.

Disparities in indigenous health: a cross-country comparison between New Zealand and the United States.

OBJECTIVES: We compared the health statuses of the indigenous populations of New Zealand and the United States with those of the numerically dominant populations of these countries. METHODS: Health indicators compared included health outcome measures, preventive care measures, modifiable risk factor prevalence, and treatment measures. RESULTS: In the case of nearly every health status indicator assessed, disparities (both absolute and relative) were more pronounced for Maoris than for American Indians/Alaska Natives. Both indigenous populations suffered from disparities across a range of health indicators. However, no disparities were observed for American Indians/Alaska Natives in regard to immunization coverage. CONCLUSIONS: Ethnic health disparities appear to be more pronounced in New Zealand than in the United States. These disparities are not necessarily intractable. Although differences in national health sector responses exist, New Zealand may be well placed in the future to evaluate the effectiveness of new strategies to reduce these disparities given the extent and quality of Maori-specific health information available.