Leah Tuzzio’s research while affiliated with Kaiser Permanente Washington Health Research Institute and other places

Background: Optimal care for persons with multiple chronic conditions (MCC) requires primary and specialty care continuity, access to multiple providers, social risk assessment, and self-management support. The COVID-19 pandemic abruptly changed primary care delivery to increase reliance on telehealth and virtual care. We report on the experiences of individuals with MCC and their family caregivers on managing their health and receiving health care during the initial pandemic. Methods: Semistructured qualitative interviews with 30 patients (19 English speaking, 11 Spanish speaking) plus 9 accompanying care partners, who had 2+ primary care encounters between March 1, 2020, and November 30, 2020, 2+ chronic conditions, and 1 or more self-reported social risks. Questions focused on access to and experiences with care, roles for care partners, and self-management during the first 6 months of the pandemic. Results: Participants experienced substantial changes in care delivery. The most commonly reported changes were a shift to more virtual relative to in-person care and shifting roles for care partners. Changes fostered new perspectives on self-management and an appreciation of personal resilience and self-reliance. Virtual care was an acceptable complement to in-person care, though not a substitute for periodic in-person visits. It was more acceptable for English speakers and with a usual provider. Conclusion: New models of care delivery that recognize patient and family resilience and resourcefulness, emphasize provider continuity, and combine virtual and in-person care may support self-management for individuals with MCC and social needs.

Background: Heterogeneity in healthcare systems’ organizational structures, policies and decisions influences practice implementation and care delivery. While quantitative data harmonization has been used to compare outcomes, few have conducted cross-site qualitative inquiry of healthcare delivery; thus, little is known about how to harmonize qualitative data across multiple settings. Objective: We illustrate a methodological approach for a theory-driven qualitative data harmonization process for the PROSPR II Cervical Research Center, a large multi-site, mixedmethods study evaluating cervical cancer screening across three diverse healthcare settings. Methods: We compared three geographically, socio-demographically, and structurally diverse healthcare systems using a multi-modal qualitative data collection strategy. We grounded our sampling strategy in a cervical cancer screening process model, then tailored it for system-specific differences (e.g., clinic staffing structure and individual roles). Data collection tools included domains corresponding to shared research objectives (e.g., abnormal follow-up) while accommodating local context. Analysis drew on operational domains from the screening process model and constructs from the Consolidated Framework for Implementation Research and Normalization Process Theory. Results: Exemplars demonstrate how data harmonization revealed insights suggesting opportunities to improve clinical processes across healthcare systems. Discussion: This analysis advances the application of qualitative methods in implementation science, where assessing context is key to responding to organizational challenges and shaping implementation strategies across multiple health systems. We demonstrate how systematically collecting, analyzing and harmonizing qualitative data elucidates the impact of process factors and accelerates efforts to identify opportunities for quality improvement interventions.

Objective Prior research suggests shared decision‐making (SDM) could improve patient and health care provider communication about bariatric surgery. The aim of this work was to identify and prioritize barriers to SDM around bariatric surgery to help guide implementation of SDM. Methods Two large US health care systems formed multidisciplinary teams to facilitate the implementation of SDM around bariatric surgery. The teams used a nominal group process approach involving (1) generation of multilevel barriers, (2) round‐robin recording of barriers, (3) facilitated discussion, and (4) selection and ranking of barriers according to importance and feasibility to address. Results One health system identified 13 barriers and prioritized 5 as the most important and feasible to address. The second health system identified 14 barriers and prioritized 6. Both health systems commonly prioritized six barriers: lack of insurance coverage; lack of understanding of insurance coverage; lack of organizational prioritization of SDM; lack of knowledge about bariatric surgery; lack of interdepartmental clarity between primary and specialty care; and limited training on SDM conversations and tools. Conclusions Health systems face numerous barriers to SDM around bariatric surgery, and these can be easily identified and prioritized by multistakeholder teams. Future research should seek to identify effective strategies to address these common barriers.

Introduction: When implementing interventions in primary care, tailoring implementation strategies to practice barriers can be effective, but additional work is needed to understand how to best select these strategies. This study sought to identify clinicians' contributions to the process of tailoring implementation strategies to barriers in clinical settings. Methods: We conducted a modified nominal group exercise involving 8 implementation scientists and 26 primary care clinicians in the WWAMI region Practice and Research Network. Each group identified implementation strategies it felt would best address barriers to using a cardiovascular disease (CVD) risk calculator previously identified across 44 primary care clinics from the Healthy Hearts Northwest pragmatic trial (2015 to 2018). These barriers had been mapped beforehand to the Consolidated Framework for Implementation Research (CFIR) domains. We examined similarities and differences in the strategies that 30% or more of each group identified (agreed-on strategies) for each barrier and for barriers in each CFIR domain. We used the results to demonstrate how strategies might be tailored to individual clinics. Results: Clinicians selected 23 implementation strategies to address 1 or more of the 13 barriers; implementation scientists selected 35. The 2 groups agreed on at least 1 strategy for barriers in each CFIR domain: Inner Setting, Outer Setting, Intervention Characteristics, Characteristics of Individuals, and Process. Conducting local needs assessment and assessing for readiness/identifying barriers and facilitators were the 2 most common implementation strategies chosen only by clinicians. Conclusions: Clinician stakeholders identified implementation strategies that augmented those chosen by implementation scientists, suggesting that codesign of implementation processes between implementation scientists and clinicians may strengthen the process of tailoring strategies to overcome implementation barriers.

The authors examine the origin, benefits, and challenges of pragmatic clinical trials to assess the ultimate value of this research design.

e13527 Background: As efforts to reduce financial hardship within oncology settings increase, development of multidisciplinary approaches based on principles of care coordination – effective communication, shared goals, role clarity, handoff – are essential. Cancer Financial Experiences (CAFÉ) is a randomized controlled trial [NCT05018000] of a financial navigation intervention in two regions of Kaiser Permanente. Our objective was to develop workflows for CAFÉ Financial Navigators (CNs) to provide navigation to trial participants by engaging a multidisciplinary team. Methods: Workflows are based on our conceptual framework of unique care pathways to address financial concerns among cancer patients: resolving acute financial needs; planning for out of pocket (OOP) costs; and making cost-informed care decisions. Influenced by user-centered design, we collected multi-stakeholder perspectives through interviews with approximately 39 staff from 15 departments between 2019-2021 including clinicians (e.g. physicians, nurses, social workers), health care staff (e.g. case managers, patient navigators) and operations/business staff (e.g. business operations analysts, financial counselors). Topics included the current state; existing organizational and informal relationships between operations units; and opportunities for improvement relative to current evidence on patient needs for cancer-related financial navigation. Results: We identified several opportunities to create or enhance workflows to provide financial navigation for oncology patients. We also identified organizational barriers that require further work (e.g., providing detailed oncology-specific fee estimates for treatment and OOP costs). Workflows centered the CN as a primary contact for patients to facilitate engagement with services and ensure effective, consistent connections between patients and care delivery and operations units. We developed (1) cost coordination maps outlining the healthcare team member points of contact within departments and sequence of contacts, for addressing each financial pathway and (2) resource directories that detail the unique financial needs, contact information and role for CNs. We maintained these strategic relationships throughout the trial to serve participants and support sustainability. Conclusions: Our multi-stakeholder strategy aligns clinical and healthcare operations workflows to optimize patient experience and outcomes to reduce financial hardship from cancer. Our work suggests research teams can facilitate process improvement within care delivery settings. However, barriers to certain financial navigation processes remain, reflecting future research needs. An oncology-specific financial navigation model supported by multidisciplinary workflows is key to addressing financial hardship from cancer.

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.

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.