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David T Eton,1,2 Jennifer L Ridgeway,1,2 Mark Linzer,3 Deborah H Boehm,4 Elizabeth A Rogers,5 Kathleen J Yost,1,2 Lila J Finney Rutten,1,2 Jennifer L St Sauver,1,2 Sara Poplau,4 Roger T Anderson6 1Department of Health Sciences Research, 2Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, 3Division of General Internal Medicine, Hennepin County Medical Center, 4Minneapolis Medical Research Foundation, 5Division of General Internal Medicine, University of Minnesota Medical School, Minneapolis, MN, 6Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA Purpose: Having multiple chronic conditions (MCCs) can lead to appreciable treatment and self-management burden. Healthcare provider relational quality (HPRQ) – the communicative and interpersonal skill of the provider – may mitigate treatment burden and promote self-management. The objectives of this study were to 1) identify the associations between HPRQ, treatment burden, and psychosocial outcomes in adults with MCCs, and 2) determine if certain indicators of HPRQ are more strongly associated than others with these outcomes.Patients and methods: This is a cross-sectional survey study of 332 people with MCCs. Patients completed a 7-item measure of HPRQ and measures of treatment and self-management burden, chronic condition distress, self-efficacy, provider satisfaction, medication adherence, and physical and mental health. Associations between HPRQ, treatment burden, and psychosocial outcomes were determined using correlational analyses and independent samples t-tests, which were repeated in item-level analyses to explore which indicators of HPRQ were most strongly associated with the outcomes.Results: Most respondents (69%) were diagnosed with ≥3 chronic conditions. Better HPRQ was found to be associated with less treatment and self-management burden and better psychosocial outcomes (P

David T Eton,1,2 Jennifer L Ridgeway,1,2 Jason S Egginton,1,2 Kristina Tiedje,3 Mark Linzer,4,5 Deborah H Boehm,4 Sara Poplau,6 Djenane Ramalho de Oliveira,7 Laura Odell,8 Victor M Montori,1,9 Carl R May,10 Roger T Anderson11 1Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA; 3Department of Sociology and Anthropology, Université Lumière Lyon 2, Lyon, France; 4Division of General Internal Medicine, Hennepin County Medical Center, Minneapolis, MN, USA; 5University of Minnesota Medical School, University of Minnesota, Minneapolis, MN, USA; 6Minneapolis Medical Research Foundation, Minneapolis, MN, USA; 7Department of Social Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil; 8Pharmacy Services, Mayo Clinic, Rochester, MN, USA; 9Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA; 10Faculty of Health Sciences and NIHR CLAHRC Wessex, University of Southampton, Southampton, UK; 11School of Medicine, University of Virginia, Charlottesville, VA, USA Purpose: The workload of health care and its impact on patient functioning and well-being is known as treatment burden. The purpose of this study was to finalize a conceptual framework of treatment burden that will be used to inform a new patient-reported measure of this construct. Patients and methods: Semi-structured interviews were conducted with 50 chronically ill patients from a large academic medical center (n=32) and an urban safety-net hospital (n=18). We coded themes identifying treatment burden, with the themes harmonized through discussion between multiple coders. Four focus groups, each with five to eight participants with chronic illness, were subsequently held to confirm the thematic structure that emerged from the interviews. Results: Most interviewed patients (98%) were coping with multiple chronic conditions. A preliminary conceptual framework using data from the first 32 interviews was evaluated and was modified using narrative data from 18 additional interviews with a racially and socioeconomically diverse sample of patients. The final framework features three overarching themes with associated subthemes. These themes included: 1) work patients must do to care for their health (eg, taking medications, keeping medical appointments, monitoring health); 2) challenges/stressors that exacerbate perceived burden (eg, financial, interpersonal, provider obstacles); and 3) impacts of burden (eg, role limitations, mental exhaustion). All themes and subthemes were subsequently confirmed in focus groups. Conclusion: The final conceptual framework can be used as a foundation for building a patient self-report measure to systematically study treatment burden for research and analytical purposes, as well as to promote meaningful clinic-based dialogue between patients and providers about the challenges inherent in maintaining complex self-management of health. Keywords: treatment burden, conceptual framework, adherence, questionnaire, self-management, multi-morbidity

Jennifer L Ridgeway,1,2 Jason S Egginton,1,2 Kristina Tiedje,3 Mark Linzer,4,5 Deborah Boehm,4 Sara Poplau,6 Djenane Ramalho de Oliveira,7 Laura Odell,8 Victor M Montori,2,9 David T Eton1,2 1The Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, 2Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 3Department of Anthropology, Université Lumière Lyon 2, Lyon, France; 4Division of General Internal Medicine, Hennepin County Medical Center, 5University of Minnesota Medical School, 6Minneapolis Medical Research Foundation, Minneapolis, MN, USA; 7Department of Social Pharmacy, Universidade Federal de Minas Gerais, Brazil; 8Pharmacy Services, 9Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA Purpose: Patients with multiple chronic conditions (multimorbidity) often require ongoing treatment and complex self-care. This workload and its impact on patient functioning and well-being are, together, known as treatment burden. This study reports on factors that patients with multimorbidity draw on to lessen perceptions of treatment burden. Patients and methods: Interviews (n=50) and focus groups (n=4 groups, five to eight participants per group) were conducted with patients receiving care in a large academic medical center or an urban safety-net hospital. Interview data were analyzed using qualitative framework analysis methods, and themes and subthemes were used to identify factors that mitigate burden. Focus groups were held to confirm these findings and clarify any new issues. This study was part of a larger program to develop a patient-reported measure of treatment burden. Results: Five major themes emerged from the interview data. These included: 1) problem-focused strategies, like routinizing self-care, enlisting support of others, planning for the future, and using technology; 2) emotion-focused coping strategies, like maintaining a positive attitude, focusing on other life priorities, and spirituality/faith; 3) questioning the notion of treatment burden as a function of adapting to self-care and comparing oneself to others; 4) social support (informational, tangible, and emotional assistance); and 5) positive aspects of health care, like coordination of care and beneficial relationships with providers. Additional subthemes arising from focus groups included preserving autonomy/independence and being proactive with providers. Conclusion: Patients attempt to lessen the experience of treatment burden using a variety of personal, social, and health care resources. Assessing these factors in tandem with patient perceptions of treatment burden can provide a more complete picture of how patients fit complex self-care into their daily lives. Keywords: adherence, patient-centered, minimally disruptive medicine, patient preferences

David T Eton,1 Tarig A Elraiyah,2 Kathleen J Yost,3 Jennifer L Ridgeway,1 Anna Johnson,2 Jason S Egginton,1 Rebecca J Mullan,4 Mohammad Hassan Murad,2 Patricia J Erwin,2 Victor M Montori1,2 1Division of Heath Care Policy and Research, Department of Health Sciences Research, 2Knowledge and Evaluation Research Unit, 3Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 4University of Minnesota Medical School, Minneapolis, MN, USA Background: Burden of treatment refers to the workload of health care and its impact on patient functioning and well-being. There are a number of patient-reported measures that assess burden of treatment in single diseases or in specific treatment contexts. A review of such measures could help identify content for a general measure of treatment burden that could be used with patients dealing with multiple chronic conditions. We reviewed the content and psychometric properties of patient-reported measures that assess aspects of treatment burden in three chronic diseases, ie, diabetes, chronic kidney disease, and heart failure. Methods: We searched Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO, and EBSCO CINAHL through November 2011. Abstracts were independently reviewed by two people, with disagreements adjudicated by a third person. Retrieved articles were reviewed to confirm relevance, with patient-reported measures scrutinized to determine consistency with the definition of burden of treatment. Descriptive information and psychometric properties were extracted. Results: A total of 5686 abstracts were identified from the database searches. After abstract review, 359 full-text articles were retrieved, of which 76 met our inclusion criteria. An additional 22 articles were identified from the references of included articles. From the 98 studies, 57 patient-reported measures of treatment burden (full measures or components within measures) were identified. Most were multi-item scales (89%) and assessed treatment burden in diabetes (82%). Only 15 measures were developed using direct patient input and had demonstrable evidence of reliability, scale structure, and multiple forms of validity; six of these demonstrated evidence of sensitivity to change. We identified 12 content domains common across measures and disease types. Conclusion: Available measures of treatment burden in single diseases can inform derivation of a patient-centered measure of the construct in patients with multiple chronic conditions. Patients should take part in developing the measure to ensure salience and relevance. Keywords: patient-reported outcomes, treatment burden, questionnaire, psychometric properties, self-management, patient-centered

David T Eton,1 Djenane Ramalho de Oliveira,2,3 Jason S Egginton,1 Jennifer L Ridgeway,1 Laura Odell,4 Carl R May,5 Victor M Montori1,61Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2College of Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; 3Medication Therapy Management Program, Fairview Pharmacy Services LLC, Minneapolis, MN, USA; 4Pharmacy Services, Mayo Clinic, Rochester, MN, USA; 5Faculty of Health Sciences, University of Southampton, Southampton, UK; 6Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USABackground: Burden of treatment refers to the workload of health care as well as its impact on patient functioning and well-being. We set out to build a conceptual framework of issues descriptive of burden of treatment from the perspective of the complex patient, as a first step in the development of a new patient-reported measure.Methods: We conducted semistructured interviews with patients seeking medication therapy management services at a large, academic medical center. All patients had a complex regimen of self-care (including polypharmacy), and were coping with one or more chronic health conditions. We used framework analysis to identify and code themes and subthemes. A conceptual framework of burden of treatment was outlined from emergent themes and subthemes.Results: Thirty-two patients (20 female, 12 male, age 26–85 years) were interviewed. Three broad themes of burden of treatment emerged including: the work patients must do to care for their health; problem-focused strategies and tools to facilitate the work of self-care; and factors that exacerbate the burden felt. The latter theme encompasses six subthemes including challenges with taking medication, emotional problems with others, role and activity limitations, financial challenges, confusion about medical information, and health care delivery obstacles.Conclusion: We identified several key domains and issues of burden of treatment amenable to future measurement and organized them into a conceptual framework. Further development work on this conceptual framework will inform the derivation of a patient-reported measure of burden of treatment.Keywords: conceptual framework, patient-centered, medication therapy management, adherence, questionnaire, minimally disruptive medicine

Background: Technology has revolutionized not only direct patient care but also diagnostic care processes. This study evaluates the transition from glass-slide microscopy to digital pathology (DP) at a multisite academic institution, using mixed methods to understand user perceptions of digitization and key productivity metrics of practice change., Methods: Participants included dermatopathologists, pathology reporting specialists, and clinicians. Electronic surveys and individual or group interviews included questions related to technology comfort, trust in DP, and rationale for DP adoption. Case volumes and turnaround times were abstracted from the electronic health record from Qtr 4 2020 to Qtr 1 2023 (inclusive). Data were analyzed descriptively, while interviews were analyzed using methods of content analysis., Results: Thirty-four staff completed surveys and 22 participated in an interview. Case volumes and diagnostic turnaround time did not differ across the institution during or after implementation timelines (p = 0.084; p = 0.133, respectively). 82.5% (28/34) of staff agreed that DP improved the sign-out experience, with accessibility, ergonomics, and annotation features described as key factors. Clinicians reported positive perspectives of DP impact on patient safety and interdisciplinary collaboration., Conclusions: Our study demonstrates that DP has a high acceptance rate, does not adversely impact productivity, and may improve patient safety and care collaboration., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Transgender and gender diverse (TGD) people experience disparities in cancer care, including more late-stage diagnoses, worse cancer-related outcomes, and an increased number of unaddressed and more severe symptoms related to cancer and cancer-directed therapy. This article outlines plans to address the unique needs of TGD people through a TGD-focused oncology clinic. Such a clinic could be structured by upholding the following tenets: (1) champion a supportive, gender-affirming environment that seeks to continuously improve, (2) include a transdisciplinary team of specialists who are dedicated to TGD cancer care, and (3) initiate and embrace TGD-patient-centric research on health outcomes and health care delivery., Competing Interests: The authors report no competing interests., (© 2024 The Authors.)

Rationale: Endotracheal intubation is the third most common bedside procedure in U.S. hospitals. In over 40% of intubations, preventable complications attributable to human factors occur. A better understanding of team dynamics during intubation may improve patient safety. Objectives: To explore team dynamics and safety-related actions during emergent endotracheal intubations in the emergency department and intensive care unit and to engage members of the care team in reflection for process improvement through a novel video-based team debriefing technique. Methods: Video-reflexive ethnography involves in situ video recording and reflexive discussions with practitioners to scrutinize behaviors and to identify opportunities for improvement. In this study, real-time intubations were recorded in the emergency department and intensive care unit at Mayo Clinic Rochester, and facilitated video-reflexive sessions were conducted with the multidisciplinary procedural teams. Themes about team dynamics and safety-related action were identified inductively from transcriptions of recorded sessions. Results: Between December 2022 and January 2023, eight video-reflexive sessions were conducted with a total of 78 participants. Multidisciplinary members included nurses ( n  = 23), respiratory therapists ( n  = 16), pharmacists ( n  = 7), advanced practitioners ( n  = 5), and physicians ( n  = 26). In video-reflexive discussions, major safety gaps were identified and several solutions were proposed related to the use of a multidisciplinary intubation checklist, standardized communication and team positioning, developing a culture of safety, and routinely debriefing after the procedure. Conclusions: The findings of this study may inform the development of a team supervision model for emergent endotracheal intubations. This approach could integrate key components such as a multidisciplinary intubation checklist, standardized communication and team positioning, a culture of safety, and debriefing as part of the procedure itself.

Introduction: Shared decision-making (SDM) is a method of care by which patients and clinicians work together to co-create a plan of care. Electronic health record (EHR) integration of SDM tools may increase adoption of SDM. We conducted a "lightweight" integration of a freely available electronic SDM tool, CV Prevention Choice, within the EHRs of three healthcare systems. Here, we report how the healthcare systems collaborated to achieve integration., Methods: This work was conducted as part of a stepped wedge randomized pragmatic trial. CV Prevention Choice was developed using guidelines for HTML5-based web applications. Healthcare systems integrated the tool in their EHR using documentation the study team developed and refined with lessons learned after each system integrated the electronic SDM tool into their EHR. CV Prevention Choice integration populates the tool with individual patient data locally without sending protected health information between the EHR and the web. Data abstraction and secure transfer systems were developed to manage data collection to assess tool implementation and effectiveness outcomes., Results: Time to integrate CV Prevention Choice in the EHR was 12.1 weeks for the first system, 10.4 weeks for the second, and 9.7 weeks for the third. One system required two 1-hour meetings with study team members and two healthcare systems required a single 1-hour meeting. Healthcare system information technology teams collaborated by sharing information and offering improvements to documentation. Challenges included tracking CV Prevention Choice use for reporting and capture of combination medications. Data abstraction required refinements to address differences in how each healthcare system captured data elements., Conclusion: Targeted documentation on tool features and resource mapping supported collaboration of IT teams across healthcare systems, enabling them to integrate a web-based SDM tool with little additional research team effort or oversight. Their collaboration helped overcome difficulties integrating the web application and address challenges to data harmonization for trial outcome analyses., Competing Interests: The authors declare no conflicts of interest., (© 2024 Mayo Clinic. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)

Translational and implementation sciences aim to prioritize and guide efforts to create greater efficiency and speed of scientific innovation across the translational science continuum to improve patient and population health. Key principles and practices rooted in translational and implementation science may be incorporated into clinical trials research, particularly pragmatic trials, to improve the relevance and impact of scientific innovation. This thematic review intends to raise awareness on the value of translational and implementation science in clinical research and to encourage its use in designing and implementing clinical trials across the translational research continuum. Herein, we describe the gap in translating research findings into clinical practice, introduce translational and implementation science, and describe the principles and practices from implementation science that can be used in clinical trial research across the translational continuum to inform clinical practice, to improve population health impact, and to address health care inequities., (Copyright © 2023 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Background: Electronic health record-linked portals may improve health-care quality for patients with cancer. Barriers to portal access and use undermine interventions that rely on portals to reduce cancer care disparities. This study examined portal access and persistence of portal use and associations with patient and structural factors before the implementation of 3 portal-based interventions within the Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium., Methods: Portal use data were extracted from electronic health records for the 12 months preceding intervention implementation. Sociodemographic factors, mode of accessing portals (web vs mobile), and number of clinical encounters before intervention implementation were also extracted. Rurality was derived using rural-urban commuting area codes. Broadband access was estimated using the 2015-2019 American Community Survey. Multiple logistic regression models tested the associations of these factors with portal access (ever accessed or never accessed) and persistence of portal use (accessed the portal ≤20 weeks vs ≥21 weeks in the 35-week study period)., Results: Of 28 942 eligible patients, 10 061 (35%) never accessed the portal. Male sex, membership in a racial and ethnic minority group, rural dwelling, not working, and limited broadband access were associated with lower odds of portal access. Younger age and more clinical encounters were associated with higher odds of portal access. Of those with portal access, 25% were persistent users. Using multiple modalities for portal access, being middle-aged, and having more clinical encounters were associated with persistent portal use., Conclusion: Patient and structural factors affect portal access and use and may exacerbate disparities in electronic health record-based cancer symptom surveillance and management., (© The Author(s) 2023. Published by Oxford University Press.)

Background: The aim of this study was to develop a web-based tool for patients with multiple chronic conditions (MCC) to communicate concerns about treatment burden to their healthcare providers., Methods: Patients and providers from primary-care clinics participated. We conducted focus groups to identify content for a prototype clinical tool to screen for treatment burden by reviewing domains and items from a previously validated measure, the Patient Experience with Treatment and Self-management (PETS). Following review of the prototype, a quasi-experimental pilot study determined acceptability of using the tool in clinical practice. The study protocol was modified to accommodate limitations due to the Covid-19 pandemic., Results: Fifteen patients with MCC and 18 providers participated in focus groups to review existing PETS content. The pilot tool (named PETS-Now) consisted of eight domains (Living Healthy, Health Costs, Monitoring Health, Medicine, Personal Relationships, Getting Healthcare, Health Information, and Medical Equipment) with each domain represented by a checklist of potential concerns. Administrative burden was minimized by limiting patients to selection of one domain. To test acceptability, 17 primary-care providers first saw 92 patients under standard care (control) conditions followed by another 90 patients using the PETS-Now tool (intervention). Each treatment burden domain was selected at least once by patients in the intervention. No significant differences were observed in overall care quality between patients in the control and intervention conditions with mean care quality rated high in both groups (9.3 and 9.2, respectively, out of 10). There were no differences in provider impressions of patient encounters under the two conditions with providers reporting that patient concerns were addressed in 95% of the visits in both conditions. Most intervention group patients (94%) found that the PETS-Now was easy to use and helped focus the conversation with the provider on their biggest concern (98%). Most providers (81%) felt they had learned something new about the patient from the PETS-Now., Conclusion: The PETS-Now holds promise for quickly screening and monitoring treatment burden in people with MCC and may provide information for care planning. While acceptable to patients and clinicians, integration of information into the electronic medical record should be prioritized., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: Understanding factors that shape breast cancer risk perceptions is essential for implementing risk-based approaches to breast cancer detection and prevention. This study aimed to assess multilevel factors, including prior screening behavior, shaping underserved, Hispanic women's perceived risk for breast cancer., Methods: Secondary analysis of survey data from Hispanic women (N = 1325, 92% Spanish speaking, 64% < 50) enrolled in a large randomized controlled trial. Analyses were performed in two cohorts to account for the role of age on screening guideline recommendations (< 50 and 50 +). For each cohort, we examined differences in three common measures of perceived risk of breast cancer (percent lifetime, ordinal lifetime, comparative) by participant factors with chi-square or Kruskal-Wallis tests, as appropriate. Multivariate analyses examined the association between mammography history with percent perceived lifetime risk (outcome > 10 vs ≤ 10%)., Results: Overall, 75% reported a lifetime risk between 0 and 10%, 96% rated their ordinal risk as "not high," and 50% rated their comparative risk as "much lower." Women < 50 with a family history of breast cancer reported significantly higher levels of perceived risk across all three measures. Among women 50 + , those reporting lower levels of perceived risk were significantly more likely to be Spanish speaking. No significant association was observed between mammography history and percent lifetime risk of breast cancer., Conclusion: Factors shaping breast cancer risk perceptions differ by age. Prior screening may play less of role in constructing risk perceptions. Research is needed to develop culturally and linguistically appropriate strategies to improve implementation of risk-based screening., (© 2024. The Author(s).)

Background: Pragmatic trials may need to adapt interventions to enhance local fit, and adaptation tracking is critical to evaluation. This study describes the tracking approach for a multisite, stepped-wedge hybrid pragmatic trial testing implementation and effectiveness of a cancer symptom management intervention., Methods: Study activities were documented in a spreadsheet by date and category. Intervention adaptations were tracked across multiple workgroups in a database structured around the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) domains, e.g., reasons for change. Implementation strategies were tracked longitudinally and by cluster in a database using the Longitudinal Implementation Strategy Tracking System (LISTS) method. A logic model was created at the end of the study to describe core intervention components and implementation strategies with dates of adaptations., Results: Between January 2019 and January 2023, 187 study activities were documented. Most intervention activities took place early, but there were important intervention refinements during the course of the trial, including the expansion of interventionist roles to add two new disciplines. Eleven intervention adaptations were documented. Most were unplanned and aimed at improving fit or increasing engagement. Thirty-three implementation strategies were documented, the largest number of which were related to educating stakeholders. Most (but not all) component and strategy additions were consistent with the mechanisms of change as hypothesized at trial launch., Conclusions: A multifaceted approach to adaptation tracking, combined with a logic model, supported identification of meaningful changes for use in evaluation, but further work is needed to minimize burden and ensure robust and practical systems that inform both evaluation and timely decision-making., Trial: Registration: ClinicalTrials.gov, NCT03892967. Registered on March 25, 2019. https://www.clinicaltrials.gov/., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 Mayo Foundation for Medical Education and Research.)

Competing Interests: The authors have no conflicts of interest to declare.

Background: Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time., Methods: The development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer Moonshot SM ). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User's Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study., Results: Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies., Conclusions: The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types., (© 2023. The Author(s).)

Purpose: Symptoms can negatively impact quality of life for patients with a history of cancer. Digital, electronic health record (EHR)-integrated approaches to routine symptom monitoring accompanied by evidence-based interventions for symptom management have been explored as a scalable way to improve symptom management, particularly between clinic visits. However, little research has evaluated barriers and facilitators to implementing these approaches in real-world settings, particularly during the pre-implementation phase. Pre-implementation assessment is critical for informing the selection and sequencing of implementation strategies and intervention adaptation. Thus, this study sought to understand pre-implementation perceptions of a remote cancer symptom monitoring and management intervention that uses electronic patient-reported outcome measures for symptom assessment., Methods: We interviewed 20 clinical and administrative stakeholders from 4 geographic regions within an academic medical center and its affiliated health system during the months prior to initiation of a stepped-wedge, cluster randomized pragmatic trial. Transcripts were coded using the Consolidated Framework for Implementation Research [CFIR] 2.0. Two study team members reviewed coded transcripts to understand how determinants were relevant in the pre-implementation phase of the trial and prepared analytic memos to identify themes., Results: Findings are summarized in four themes: (1) ability of the intervention to meet patient needs [recipient characteristics], (2) designing with care team needs in mind [innovation design and adaptability], (3) fit of the intervention with existing practice workflows [compatibility], and (4) engaging care teams early [engaging deliverers]., Conclusion: Attention to these aspects when planning intervention protocols can promote intervention compatibility with patients, providers, and practices thereby increasing implementation success., (© 2023. The Author(s).)

Background: Migraine is a common and major cause of disability, poor quality of life, and high health care use. Access to evidence-based migraine care is limited and projected to worsen. Novel mobile health app-based tools may effectively deliver migraine patient education to support self-management, facilitate remote monitoring and treatment, and improve access to care. The risk that such an intervention may increase the care team workload is a potential implementation barrier., Objective: This study aims to describe a novel electronic health record-integrated mobile app-based Migraine Interactive Care Plan (MICP) and evaluate its feasibility, usability, and impact on care teams in a community neurology practice., Methods: Consecutive enrollees between September 1, 2020, and February 16, 2022, were assessed in a single-arm observational study of usability, defined by 74.3% (127/171) completing ≥1 assigned task. Task response rates, rate and type of care team escalations, and patient-reported outcomes were summarized. Patients were prospectively recruited and randomly assigned to routine care with or without the MICP from September 1, 2020, to September 1, 2021. Feasibility was defined by equal to or fewer downstream face-to-face visits, telephone contacts, and electronic messages in the MICP cohort. The Wilcoxon rank-sum test was used to compare continuous variables, and the chi-square test was used for categorical variables for those with at least 3 months of follow-up., Results: A total of 171 patients were enrolled, and of these, 127 (74.3%) patients completed ≥1 MICP-assigned task. Mean escalations per patient per month was 0.9 (SD 0.37; range 0-1.7). Patient-confirmed understanding of the educational materials ranged from 26.6% (45/169) to 56.2% (95/169). Initial mean headache days per week was 4.54 (SD 2.06) days and declined to 2.86 (SD 1.87) days at week 26. The percentage of patients reporting favorable satisfaction increased from a baseline of 35% (20/57) to 83% (15/18; response rate of 42/136, 30.9% to 28/68, 41%) over the first 6 months. A total of 121 patients with MICP were compared with 62 patients in the control group. No differences were observed in the rate of telephone contacts or electronic messages. Fewer face-to-face visits were observed in the MICP cohort (13/121, 10.7%) compared with controls (26/62, 42%; P<.001)., Conclusions: We describe the successful implementation of an electronic health record-integrated mobile app-based care plan for migraine in a community neurology practice. We observed fewer downstream face-to-face visits without increasing telephone calls, medication refills, or electronic messages. Our findings suggest that the MICP has the potential to improve patient access without increasing care team workload and the need for patient input from diverse populations to improve and sustain patient engagement. Additional studies are needed to assess its impact in primary care., (©Nathan P Young, Jennifer L Ridgeway, Tufia C Haddad, Sarah B Harper, Lindsey M Philpot, Laura A Christopherson, Samantha M McColley, Sarah A Phillips, Julie K Brown, Kelly S Zimmerman, Jon O Ebbert. Originally published in JMIR Formative Research (https://formative.jmir.org), 05.10.2023.)

Background: Social determinants of health lead to better cancer care. This multi-site, single-institution study sought to capture data on social determinants of health data in Asian Americans with hepatocellular carcinoma; this group constitutes 60% of patients with this malignancy and are often undertreated or not treated at all., Methods: This study took advantage of an institutional initiative designed to capture and integrate social determinants of health data into the electronic medical record for all patients. Medical records of Asian Americans with hepatocellular cancer were reviewed to acquire data on housing instability, lack of transportation, financial concerns, and social isolation; a score of 1 indicated poor social determinants of health., Results: Of 112 adult Asian American patients with hepatocellular cancer, 22 (20%) were Southeast Asian, and 74 (67%) described English proficiency/preference. Total noncompletion per domain (no question answered within that domain) was observed in 90 patients (80%) for housing instability; 90 (80%) for lack of transportation; 92 (82%) for financial hardship; and 90 (80%) for social isolation. A score of 1 (highest risk) was observed in 1 patient (0.9%) for housing instability; 1 (0.9%) lack of transportation; no patient for financial hardship; and 1 (0.9%) for social isolation. Of note, institution-wide benchmark total noncompletion rates were 0.3%, 0.3%, 47%, and 39% for these respective domains., Conclusion: High total noncompletion rates make social determinants of health data challenging to interpret and underscore the need for evidence-based guidelines on how best to capture such data in underserved patients., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: We recently reported on a randomized trial of home-based pulmonary rehabilitation (PR) for chronic obstructive pulmonary disease (COPD) that showed improvement in all domains of quality of life, accelerometry-measured physical activity, and self-management. In this current study, we used a theoretical framework to help us gain an in-depth understanding of how patients experience complex, multi-component programs to help uncover factors related to behavior change and to inform program scale-up in other populations., Study Design and Methods: The parent trial was conducted with COPD patients receiving care at an academic medical center and a community health system in the upper Midwest. The 12-week PR intervention included 3 daily video-guided exercises, activity monitors, and weekly telephonic health coaching. Trial participants were eligible to participate in an individual phone interview about their experience if they completed the intervention within the prior 12 months.. Analysis of verbatim transcripts followed an inductive thematic approach followed by deductive categorization and interpretation using a theoretical model: the Capability, Opportunity, Motivation-Behavior (COM-B) model developed for linking intervention functions to aspects of behavioral change., Results: Among 32 eligible program participants,32 were approached, and 15 completed interviews between October 19, 2021, and January 13, 2022. The COM-B model and recommendations for program improvement were observed in the primary findings., Discussion: Participants' feedback highlighted how the health coaching bolstered skills and confidence among individuals with the poorest function at program enrollment and how improved physical function and mood led to motivation. It also highlighted the roles of technology and telephonic support in a home-based program. Suggestions for improvement included providing exercise variations., (JCOPDF © 2023.)

Purpose: Pulmonary rehabilitation is a behavioral modification intervention shown to improve exercise tolerance and patient-reported quality of life in patients with fibrotic interstitial lung disease. Home-based rehabilitation may provide easier access for those who struggle to complete center-based rehabilitation programs due to increased symptom burden or frailty., Methods: We present the quantitative and qualitative findings of a pilot study of 21 patients with fibrotic interstitial lung disease who participated in a 12-wk home-based pulmonary rehabilitation program with activity monitoring and health coaching., Results: Pre- and post-intervention patient-reported outcome questionnaires suggested improvements in dyspnea and respiratory-related quality of life but were underpowered to meet statistical significance. Half had increases in mean daily step counts while a quarter declined because of disease progression. Qualitative analysis of semistructured participant interviews suggested a significant baseline disease burden with related secondary impacts, including anxiety regarding disease progression and prognosis. Many who participated had no specific program expectations or self-determined goals but still found the program impactful, particularly on their abilities to adapt and cope with the disease., Conclusion: Our study suggests feasibility in a diverse set of patients with varying severity and diagnostic subtypes. We also provide quantitative and qualitative aspects of program impact on patient well-being and highlight the complex interaction between measured physical and self-reported outcomes and disease experience., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: The purpose of this study is to evaluate potential gender-based differences in interpreting the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and to explore if there are aspects of health-related quality of life (HRQOL) not captured by the KCCQ-23 that are important to assess in men and/or women with heart failure (HF)., Methods: Patients ≥ 22 years of age with clinician-diagnosed HF and left ventricular ejection fraction ≤ 40% were recruited from two academic medical centers to participate in semi-structured concept elicitation and cognitive debriefing interviews. Enrollment was stratified by patient-identified gender (half women/half men). All interviews were conducted over the phone/web and audio recorded. Interviews were transcribed and descriptive qualitative content analysis was used to summarize findings overall and by gender., Results: Twenty-five adults (56% women) diagnosed with HF participated. The average age was 67 years (range: 25-88). Women attributed a wider variety of symptoms to HF than men. Some participants had difficulty differentiating whether their experiences were due to HF, side effects of their medications, or age. We found very little evidence that participants interpreted KCCQ-23 items differently based on gender., Conclusions: Overall, our findings indicate that interpretation of the KCCQ-23 items were similar in men and women. However, some modifications to items may improve clarity of interpretation for a wide range of patients., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: New patient-centered models of care are needed to individualize care and reduce high-cost care, including emergency department (ED) visits and hospitalizations for low- and intermediate-acuity conditions that could be managed outside the hospital setting. Community paramedics (CPs) have advanced training in low- and high-acuity care and are equipped to manage a wide range of health conditions, deliver patient education, and address social determinants of health in the home setting. The objective of this trial is to evaluate the effectiveness and implementation of the Care Anywhere with Community Paramedics (CACP) program with respect to shortening and preventing acute care utilization., Methods: This is a pragmatic, hybrid type 1, two-group, parallel-arm, 1:1 randomized clinical trial of CACP versus usual care that includes formative evaluation methods and assessment of implementation outcomes. It is being conducted in two sites in the US Midwest, which include small metropolitan areas and rural areas. Eligible patients are ≥ 18 years old; referred from an outpatient, ED, or hospital setting; clinically appropriate for ambulatory care with CP support; and residing within CP service areas of the referral sites. Aim 1 uses formative data collection with key clinical stakeholders and rapid qualitative analysis to identify potential facilitators/barriers to implementation and refine workflows in the 3-month period before trial enrollment commences (i.e., pre-implementation). Aim 2 uses mixed methods to evaluate CACP effectiveness, compared to usual care, by the number of days spent alive outside of the ED or hospital during the first 30 days following randomization (primary outcome), as well as self-reported quality of life and treatment burden, emergency medical services use, ED visits, hospitalizations, skilled nursing facility utilization, and adverse events (secondary outcomes). Implementation outcomes will be measured using the RE-AIM framework and include an assessment of perceived sustainability and metrics on equity in implementation. Aim 3 uses qualitative methods to understand patient, CP, and health care team perceptions of the intervention and recommendations for further refinement. In an effort to conduct a rigorous evaluation but also speed translation to practice, the planned duration of the trial is 15 months from the study launch to the end of enrollment., Discussion: This study will provide robust and timely evidence for the effectiveness of the CACP program, which may pave the way for large-scale implementation. Implementation outcomes will inform any needed refinements and best practices for scale-up and sustainability., Trial Registration: ClinicalTrials.gov NCT05232799. Registered on 10 February 2022., (© 2023. The Author(s).)

Pragmatic trials aim to generate timely evidence while ensuring feasibility, minimizing practice burden, and maintaining real-world conditions. We conducted rapid-cycle qualitative research in the preimplementation period of a trial evaluating a community paramedic program to shorten and prevent hospitalizations. Between December 2021 and March 2022, interviews ( n = 30) and presentations/discussions ( n = 17) were conducted with clinical and administrative stakeholders. Two investigators analyzed interview and presentation data to identify potential trial challenges, and team reflections were used to develop responsive strategies. Solutions were implemented prior to the commencement of trial enrollment and were aimed at bolstering feasibility and building ongoing practice feedback loops., Competing Interests: In the last 36 months, Dr McCoy has received support from NIDDK, PCORI, and AARP®. She also serves as a consultant to Emmi® (Wolters Kluwer) on developing patient education materials related to prediabetes and diabetes. All other authors declare no conflicts., (© The Author(s) 2023.)

Objectives: To examine the current state of unique device identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world evidence (RWE) generation for medical devices., Design: Mixed methods, including a structured survey and semistructured interviews., Setting: Eight health systems participating in the National Evaluation System for health Technology research network within the USA., Participants: Individuals identified as being involved in or knowledgeable about UDI implementation or medical device identification from supply chain, information technology and high-volume procedural area(s) in their health system., Main Outcomes Measures: Interview topics were related to UDI implementation, including barriers and facilitators; UDI use; benefits of UDI adoption; and vision for UDI implementation. Data were analysed using directed content analysis, drawing on prior conceptual models of UDI implementation and the Exploration, Preparation, Implementation, Sustainment framework. A brief survey of health system characteristics and scope of UDI implementation was also conducted., Results: Thirty-five individuals completed interviews. Three of eight health systems reported having implemented UDI. Themes identified about barriers and facilitators to UDI implementation included knowledge of the UDI and its benefits among decision-makers; organisational systems, culture and networks that support technology and workflow changes; and external factors such as policy mandates and technology. A final theme focused on the availability of UDIs for RWE; lack of availability significantly hindered RWE studies on medical devices., Conclusions: UDI adoption within health systems requires knowledge of and impetus to achieve operational and clinical benefits. These are necessary to support UDI availability for medical device safety and effectiveness studies and RWE generation., Competing Interests: Competing interests: SSD receives research support from the Medical Device Innovation Consortium (MDIC) as part of the National Evaluation System for health Technology Coordinating Center (NESTcc), Greenwall Foundation, National Institute for Health Care Management, Arnold Ventures and Department of Veterans Affairs. JSR currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the MDIC as part of the NESTcc, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) programme (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International; in addition, JSR is an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. JPD has received research support from Medtronic and Johnson & Johnson. His non-dependent son is an employee of Boston Scientific. NAW has received research support from the MDIC as part of the NESTcc, Patient-Centered Outcomes Research Institute, U.S. Food and Drug Administration, Johnson & Johnson, and Medtronic; serves on advisory committees for the AIM North America UDI Advisory Committee, Association for Health Care Resource reports consulting for Arizona State University’s Center for Healthcare Delivery and Policy, Mass General Brigham; and had purchased stock options in Vitreos Health. The remaining author has nothing to disclose., (This manuscript's contents are solely the responsibility of the authors and do not necessarily represent the official views nor the endorsements of the Department of Health and Human Services or the FDA.)

Objective: We gained insights into women's experiences and knowledge about the occurrence of vaginal bleeding during perimenopause requiring evaluation., Methods: Qualitative inquiry was chosen to explore topics in greater depth to understand individuals' experiences. Interviews with individuals were chosen due to the sensitive nature of gynecologic symptoms and management. Interviews were completed following gynecologic care to explore individuals' experiences with the evaluation and management of vaginal bleeding during perimenopause., Results: Twelve individuals were interviewed between December 2019 and March 2020. Patient uncertainty about the medical significance of developing vaginal bleeding during perimenopause was associated with self-appraisal and gathering information from multiple sources. This experience of seeking evaluation and treatment resulted in varying degrees of trust concerning information received within or outside the clinic. Regarding new technologies that could replace the current invasive tests performed for diagnosis (i.e. ultrasound, hysteroscopy and biopsy), most women preferred the smartphone app and tampon home collection option., Conclusions: The experience of irregular or heavy vaginal bleeding during perimenopause is fraught with ambiguity, feelings of uncertainty about how to make sense of symptoms and inevitably begins with a period of self-appraisal.

Patients at high risk for cardiovascular disease (CVD) tend to receive less intensive preventive care. Clinical practice guidelines recommend shared decision making (SDM) to improve the quality of primary CVD prevention. There are tools for use during the clinical encounter that promote SDM, but, to our knowledge, there are no SDM encounter tools that support conversations about available lifestyle and pharmacological options that can lead to preventive care that is congruent with patient goals and CVD risk. Using the best available evidence and human-centered design (iterative design in the context of ultimate use with users), our team developed a SDM encounter tool, CV Prevention Choice. Each subsequent version during the iterative development process was evaluated in terms of content, usefulness, and usability by testing it in real preventive encounters. The final version of the tool includes a calculator that estimates the patient's risk of a major atherosclerotic CVD event in the next 10 years. Lifestyle and medication options are presented, alongside their pros, cons, costs, and other burdens. The risk reduction achieved by the selected prevention program is then displayed to support collaborative deliberation and decision making. A U.S. multicenter trial is estimating the effectiveness of CV Prevention Choice in achieving risk-concordant CV prevention while identifying the best strategies for increasing the adoption of the SDM encounter tool and its routine use in practice., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 Mayo Foundation for Medical Education and Research.)

Background: The symptom burden associated with cancer and its treatment can negatively affect patients' quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention., Methods: In a pragmatic, cluster-randomized, stepped-wedge trial conducted as part of the National Cancer Institute IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least 1 severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to "opt-in" to receive a call, but the protocol was later modified so they had to "opt-out" if they did not want a call. We assessed the impact of opt-in vs opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided., Results: Of the 1204 symptom assessments (from 864 patients) on which at least 1 severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, P = .01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, P < .001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, P = .002) were associated with statistically significantly greater willingness to receive a call., Conclusions: Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed., (© The Author(s) 2021. Published by Oxford University Press.)

Background: The objective of this randomized trial was to evaluate the short-term effect of bilingual written and interpersonal education regarding mammographic breast density (MBD)., Methods: Latinas aged 40 to 74 years who were presenting for screening mammography were recruited and randomized 1:1:1 to receive a letter with their mammogram and MBD results (usual care [UC]), a letter plus a brochure (enhanced care [ENH]), or a letter plus a brochure and telephonic promotora education (interpersonal care [INT]). Surveys were administered at enrollment (T 0 ) and 2 weeks to 6 months after intervention delivery (T 1 ). Differences were assessed with χ 2 , Kruskal-Wallis, and McNemar tests and pairwise comparisons as appropriate. INT metrics and audio recordings were analyzed with descriptive statistics and qualitative content analysis., Results: Between October 2016 and October 2019, 943 of 1108 Latina participants (85%) completed both surveys. At T 1 , INT participants were more likely (P < .001) to report seeing their MBD results in the letter (70.2%) than UC (53.1%) or ENH participants (55.1%). The percentage of INT women who reported speaking with a provider about MBD (29.0%) was significantly greater (P < .001) than the percentage of UC (14.7%) or ENH participants (15.6%). All groups saw significant (P < .001) but nondifferential improvements in their knowledge of MBD as a masking and risk factor. In the INT group, the promotora delivered education to 77.1% of the 446 participants randomized to INT and answered questions at 28.3% of the encounters for an average of $4.70 per participant., Conclusions: Among Latinas in a low-resource setting, MBD knowledge may increase with written or interpersonal education, but with modest investment, interpersonal education may better improve MBD awareness and prompt patient-provider discussions., (© 2021 American Cancer Society.)

Purpose: To assess the feasibility of an app-based, electronic health record (EHR)-integrated, interactive care plan (ICP) for breast cancer (BC) survivors., Methods: A single-arm pilot study was conducted with female BC survivors. ICP tasks included quarterly quality of life (QOL) questionnaire; monthly assessments of fatigue, insomnia, sexual dysfunction, hot flashes, and recurrence symptoms; and daily activity reminders. Embedded decision trees escalated recurrence symptoms to providers. On-demand education was available for self-management of treatment-related toxicities. The primary objective was to assess patients' engagement with ICP tasks against feasibility thresholds of 75% completion rate. Secondary objectives were evaluation of the system's functionality to track and escalate symptoms appropriately, and care team impact measured by volume of escalation messages generated. We report preliminary results 6 months after the last patient enrolled., Results: Twenty-three patients enrolled August to November 2020. Mean age was 50.1 years. All patients engaged with at least one ICP task. The monthly average task completion rates were 62% for the QOL questionnaire, 59% for symptom assessments, and 37% for activity reminders. Task completion rate decreased over time. Eleven of 253 symptoms and QOL questionnaires (4.3%) generated messages for care escalation., Conclusion: Implementation of an app-based, EHR-integrated ICP in BC survivors was feasible and created minimal provider burden; however, patient engagement was below the feasibility threshold suggesting that changes may enhance broad implementation and adoption., Implications for Cancer Survivors: An ICP may facilitate remote monitoring, symptom control, and recurrence surveillance for cancer survivors as strategies to enhance patient engagement are applied., (© 2021. The Author(s).)

Purpose: To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making., Methods: In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives., Results: We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them., Conclusions: Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit., Clinical Trial Registration: ClinicalTrial.gov: NCT01502891., (© 2021. The Author(s).)

Background: Dissemination of research findings to participants and communities, particularly among traditionally marginalized groups, is a systemic challenge. In community-based participatory research (CBPR), long-term partnerships may foster a link between recruitment to research studies, dissemination of results, and recruitment to future studies., Objectives: To analyze the recruitment to dissemination continuum of a CBPR study and its potential impact on partnership processes and future research., Methods: We conducted a qualitative study with four focus groups with community members and academic partners who participated in the recruitment and the dissemination of research findings from a study of Hispanic and Somali social networks in Rochester, Minnesota. Thematic analysis and coding of focus group transcripts was conducted by investigators. The CBPR conceptual model for this partnership guided the analysis., Results: Trust, relationship building, and capacity building were key features for successful participant recruitment and research dissemination strategies. Strategies, resources, and relationships used or developed during the recruitment phase of research were directly applied to planning a dissemination event. Participants and members of their communities said they were more likely to participate in future research studies as a result of attending a dissemination event., Conclusions: This study demonstrated the ways in which recruitment of marginalized populations to research studies and dissemination of study results can manifest as a continuum. This continuum is nurtured by trust, longitudinal relationships, and robust partnership dynamics. These factors fit well within an existing CBPR conceptual model.

Purpose: Latinas in low-resource settings face additional barriers to understanding mammographic breast density (MBD) implications. The authors compared MBD awareness and knowledge in Latinas from a safety-net clinic in Arizona with a national sample., Methods: Latinas 40 to 74 years of age were recruited within a safety-net clinic during screening mammography appointments from 2016 to 2019 (AZ cohort) and from a nationally representative online panel in 2017 (NS cohort). Surveys completed in either English or Spanish assessed awareness and knowledge of MBD. Chi-square tests and logistic regression were used for comparisons., Results: The NS cohort (n = 152) was older, more educated, more likely to have undergone prior mammography, and more likely to prefer English compared with the AZ cohort (n = 1,327) (P ≤ .03 for all) The NS cohort was more likely to be aware of MBD (32.6% versus 20.7%). Of those aware, the NS cohort was more likely to understand MBD's effect on masking (67.8% versus 37.0%) and breast cancer risk (72.2% versus 32.6%) compared with the AZ cohort (P ≤ .001 for all). Adjusting for age, education, screening history, and language, MBD awareness was similar between the two cohorts (adjusted odds ratio [ORadj], 0.95; P = .83), but knowledge of MBD as a masking factor (ORadj, 2.8; P = .03) and risk factor (ORadj, 7.2; P < .001) remained higher in the NS cohort compared with the AZ cohort., Conclusions: Differences in MBD awareness, but not knowledge, between Latinas in a low-resource setting compared with a national sample could be explained by age, education, screening history, and language preference, underscoring the need for tailored approaches to MBD education among Latinas., (Copyright © 2021 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Fidelity monitoring is the degree to which a clinical trial intervention is implemented as intended by a research protocol. Consistent implementation of research protocols supported with extant fidelity monitoring plans contribute rigor and validity of study results. Fidelity monitoring plans should be comprehensive yet practical to accommodate the realities of conducting research, particularly a pragmatic clinical trial, in dynamic settings with heterogeneous patient populations. The purposes of this paper are to describe the (1) iterative development and implementation of protocols for intervention fidelity monitoring, (2) pilot testing of the fidelity monitoring plan, (3) the identification of interventionist training deficiencies, and (4) opportunities to enhance protocol rigor for a cancer symptom management intervention delivered through the electronic health record patient portal and telephone as part of a complex, multi-component pragmatic clinical trial to uncover training deficits and bolster protocol integrity. The intervention focuses on prominent symptoms reported among medical oncology patients including sleep disturbance, pain, anxiety, depression, low energy (fatigue) and physical function. In this pragmatic trial, the role of interventionist is a registered nurse symptom care manager (RN SCM). A three-part fidelity monitoring plan with checklists audit: Part-1 RN SCM role training activities in research components, clinical training components, and protocol simulation training; Part-2 RN SCM adherence to the intervention core components delivered over the telephone; and Part-3 maintenance of adherence to core intervention components. The goal is ≥ 80% adherence to components of each of the three checklists. An initial pilot test of the fidelity monitoring plan was conducted to evaluate the checklists and the RN SCM adherence to core protocol components. RN SCM skills and training deficits were identified during the pilot phase, as were opportunities to improve protocol integrity. Overall, approximately 50% of the audited RN SCM telephone calls had ≥80% fidelity to the core components. There remains on-going need for RN SCM training and skill building in action planning. The content presented in this paper is intended to begin to fill the gap of fidelity monitoring plans for complex interventions tested in pragmatic clinical trials and delivered remotely in an effort to strengthen protocol integrity., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 The Authors.)

Introduction: Latino populations, particularly those living in rural areas, experience a disproportionately high prevalence and poorer outcomes of type 2 diabetes mellitus (T2DM). The purpose of this study was to test the acceptability and perceived effectiveness of a group-based, facilitated digital storytelling intervention for T2DM self-management among rural Latino patients., Method: Twenty Latino adults with T2DM participated in facilitated storytelling discussions at two primary clinics. Participants viewed a 12-minute T2DM self-management digital storytelling intervention, followed by a facilitated group discussion. Surveys, observations, and focus groups were used to assess for acceptability and perceived effectiveness of the intervention through descriptive and qualitative analysis, informed by narrative and social cognitive theory., Results: All participants found the intervention interesting and useful and reported improvement in confidence, motivation, and behavioral intentions for T2DM self-management. Themes mapped closely with narrative theory models, further suggestive of the behavior change potential., Discussion: Facilitated discussions may add value to viewing of digital stories and represent a scalable approach to provide culturally congruent health care for Latino patients with diabetes in rural settings. Within the paradigm of group-based diabetes educational programs, this lends itself well to critical transcultural nursing care.

Background: Health care professionals working in intensive care units report a high degree of burnout, but this topic has not been extensively studied from an interdisciplinary perspective., Objective: To characterize experiences of burnout among members of interprofessional intensive care unit teams and identify possible contributing factors., Methods: This qualitative study involved interviews of registered nurses, respiratory therapists, physicians, pharmacists, and a personal care assistant working in multiple intensive care units of a single academic medical center to assess work stressors., Results: Team composition was a factor in burnout, particularly when nonphysician team members felt that their opinions were not valued despite the institution's emphasis on a multidisciplinary team-based model of care. This was especially true when roles were not well defined at the outset of a code situation. Members of nearly all disciplines stated that there was not enough time in a day to complete all the required tasks., Conclusions: Multiple factors contribute to work-related stress and burnout across different professions in the intensive care unit. Improved communication and increased receptivity to diverse opinions among members of the multidisciplinary team may help reduce stress., (©2021 American Association of Critical-Care Nurses.)

Background: Despite overall declines in cancer mortality in the USA over the past three decades, many patients in community settings fail to receive evidence-based cancer care. Networks that link academic medical centers (AMCs) and community providers may reduce disparities by creating access to specialized expertise and care, but research on network effectiveness is mixed. The objective of this study was to identify factors related to whether and how an exemplar AMC network served to provide advice and referral access in community settings., Methods: An embedded in-depth single case study design was employed to study a network in the Midwest USA that connects a leading cancer specialty AMC with community practices. The embedded case units were a subset of 20 patients with young-onset colorectal cancer or risk-related conditions and the providers involved in their care. The electronic health record (EHR) was reviewed from January 1, 1990, to February 28, 2018. Social network analysis identified care, advice, and referral relationships. Within-case process tracing provided detailed accounts of whether and how the network provided access to expert, evidence-based care or advice in order to identify factors related to network effectiveness., Results: The network created access to evidence-based advice or care in some but not all case units, and there was variability in whether and how community providers engaged the network, including the path for referrals to the AMC and the way in which advice about an evidence-based approach to care was communicated from AMC specialists to community providers. Factors related to instances when the network functioned as intended included opportunities for both rich and lean communication between community providers and specialists, coordinated referrals, and efficient and adequately utilized documentation systems., Conclusions: Network existence alone is insufficient to open up access to evidence-based expertise or care for patients in community settings. In-depth understanding of how this network operated provides insight into factors that support or inhibit the potential of networks to minimize disparities in access to evidence-based community cancer care, including both personal and organizational factors., (© 2021. The Author(s).)

Patients with limited English proficiency (LEP) have disproportionately lower rates of cancer screening than English-proficient patients. Given the multifactorial nature of screening disparities, strategies to improve screening rates must address barriers within and outside of the clinic setting. The objectives of this study were to understand local barriers from multiple stakeholder perspectives, to identify potential multilevel intervention approaches, and to mobilize community-engaged intervention decision making and planning. This participatory formative evaluation approach employed needs assessment and user engagement in order to enhance intervention usefulness and relevance. The study took place in several stages and involved clinic and community partners in a small metropolitan area of the Midwest USA. Interviews were conducted with LEP patients (n = 9) who had not completed three recommended screenings (breast, cervical, and colorectal), primary care providers (n = 5), medical interpreter (n = 5), and community members (n = 3). These highlighted multilevel barriers including limited patient understanding of preventive health, time and cost constraints, and variable roles of language interpreters. The literature was also reviewed to identify interventions used with similar populations. Findings from this review suggest that interventions are largely focused on single population groups or address single screening barriers. Finally, a community-academic summit (n = 48 participants) was held to review results and develop recommendations for community and clinic interventions. Findings from this study indicate that it is possible to engage a diverse group of stakeholders in strategies that are responsive to health care providers and patients, including LEP patients from heterogeneous backgrounds., (© 2020. American Association for Cancer Education.)

Novel endometrial cancer (EC) early-detection approaches may reduce racial disparities in mortality. We conducted six community-based focus groups with White and Black women ( N = 57 participants) in February-March 2020 to explore acceptability of a home-based tampon sampling approach for EC. Participants also completed a survey. Data were analyzed using qualitative content analysis. Awareness of EC and risk factors was low. Acceptability regarding home sampling was high, but participants expressed concerns about instruction complexity and potential risks. Black women reported lower comfort with tampons. Increasing EC awareness, self-efficacy, and familiarization with tampons would advance prospects for at-home sample collection for EC testing., Competing Interests: The authors have no conflicts of interest to declare., (© The Association for Clinical and Translational Science 2021.)

Background: The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use., Methods: This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM)., Discussion: By the project's end, we expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care., Trial Registration: ClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.

Background: The purpose of this study was to evaluate the extent to which a longitudinal student-run clinic (SRC) is meeting its stated learning objectives, including providing critical community services and developing physicians who more fully appreciate the social factors affecting their patients' health., Methods: This was a mixed methods program evaluation of an SRC at Mayo Clinic Alix School of Medicine (MCASOM). A survey was conducted of medical students who had participated in the clinic and seven interviews and three focus groups were conducted with SRC patients, students, faculty, staff, and board members. Transcripts were coded for systematic themes and sub-themes. Major themes were reported. Survey and interview data were integrated by comparing findings and discussing areas of convergence or divergence in order to more fully understand program success and potential areas for improvement., Results: Greater than 85% of student survey respondents (N = 90) agreed or strongly agreed that the SRC met each of its objectives: to provide a vital community service, to explore social determinants of health (SDH), to understand barriers to healthcare access and to practice patience-centered examination. Qualitative data revealed that the SRC contextualized authentic patient care experiences early in students' medical school careers, but the depth of learning was variable between students. Furthermore, exposure to SDH through the program did not necessarily translate to student understanding of the impact of these social factors on patient's health nor did it clearly influence students' future practice goals., Conclusions: The MCASOM SRC experience met core learning objectives, but opportunities to improve long-term impact on students were identified. Participation in the SRC enabled students to engage in patient care early in training that is representative of future practices. SRCs are an avenue by which students can gain exposure to real-world applications of SDH and barriers to healthcare access, but additional focus on faculty development and intentional reflection may be needed to translate this exposure to actionable student understanding of social factors that impact patient care.

Patient-reported outcomes in fibrotic interstitial lung disease may be additionally predicted by novel assessments of self-management ability and affect https://bit.ly/3iwP5M2., Competing Interests: Conflict of interest: T. Moua has nothing to disclose. Conflict of interest: A. Kubbara has nothing to disclose. Conflict of interest: P. Novotny has nothing to disclose. Conflict of interest: J.L. Ridgeway has nothing to disclose. Conflict of interest: A.H. Limper has nothing to disclose. Conflict of interest: J.H. Ryu has nothing to disclose. Conflict of interest: M.M. Clark has nothing to disclose. Conflict of interest: R. Benzo has nothing to disclose., (©The authors 2021.)

The success of vaccination programs is contingent upon irrefutable scientific safety data combined with high rates of public acceptance and population coverage. Vaccine hesitancy, characterized by lack of confidence in vaccination and/or complacency about vaccination that may lead to delay or refusal of vaccination despite the availability of services, threatens to undermine the success of coronavirus disease 2019 (COVID-19) vaccination programs. The rapid pace of vaccine development, misinformation in popular and social media, the polarized sociopolitical environment, and the inherent complexities of large-scale vaccination efforts may undermine vaccination confidence and increase complacency about COVID-19 vaccination. Although the experience of recent lethal surges of COVID-19 infections has underscored the value of COVID-19 vaccines, ensuring population uptake of COVID-19 vaccination will require application of multilevel, evidence-based strategies to influence behavior change and address vaccine hesitancy. Recent survey research evaluating public attitudes in the United States toward the COVID-19 vaccine reveals substantial vaccine hesitancy. Building upon efforts at the policy and community level to ensure population access to COVID-19 vaccination, a strong health care system response is critical to address vaccine hesitancy. Drawing on the evidence base in social, behavioral, communication, and implementation science, we review, summarize, and encourage use of interpersonal, individual-level, and organizational interventions within clinical organizations to address this critical gap and improve population adoption of COVID-19 vaccination., (Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Objective: This study sought to understand the patients' perspective of what contributes to an absence of discussions of sexual orientation (SO), gender identity (GI), and sexual health in cancer care., Methods: Patients were recruited from oncology, gynecology, and a gender transition clinic to participate in semistructured interviews, which were analyzed with qualitative methods., Results: A total of 25 patients were interviewed, shedding light on 2 themes. The first was that these conversations are important but infrequent. One patient explained, "…. we know people who have had sex changes…[they] would have appreciated that question." In response to whether sexual health was ever brought up, one patient responded, "No doctor ever has." Patients described unaddressed issues: "There have been times, you know, we've wondered if it was okay to make love." The second theme consisted of 4 pragmatic, patient-provided points to facilitate discussions: (1) implementation of a scale of 1 to 10 (with 10 being comfortable) to first gauge patients' comfort in talking about SO, GI, and sexual health; (2) having the health-care provider explore the topic again over-time; (3) making sure the health-care provider is comfortable, as such comfort appears to enhance the patient's comfort ("I have a doctor here, a female doctor, who just matter of fact will ask if I get erections and so on because of the medication she's giving me);" and (4) eliminating euphemisms (one patient stated, "I don't know what you mean by 'sexual health'.")., Conclusion: Oncology health-care providers have a unique opportunity and responsibility to address SO, GI, and sexual health.

Background: Faculty supervision of invasive bedside procedures (IBPs) in the ICU may enhance procedural education and ensure patient safety. However, there is limited research on teaching effectiveness in the ICU, and there are no best teaching practices regarding the supervision of IBPs., Research Question: We conducted a multi-institutional qualitative study of pulmonary and critical care medicine faculty and fellows to better understand characteristics of effective IBP teachers., Study Design and Methods: Separate focus groups (FGs) were conducted with fellows and faculty at four large academic institutions that were geographically distributed across the United States. FGs were facilitated by a trained investigator, audio-recorded, and transcribed verbatim for analysis. Themes were identified inductively and compared with constructs from social and situated learning theories. Data were analyzed between and across professional groups. Qualitative research software (NVivo; QSR International) was used to facilitate data organization and create an audit trail of the analysis. A multidisciplinary research team was engaged to minimize interpretive bias., Results: Thirty-three faculty and 30 fellows participated. Inductive analysis revealed three categories of themes among successful IBP teachers: traits, behaviors, and context. Traits included calm demeanor, trust, procedural competence, and effective communication. Behaviors included leading preprocedure huddles to assess learners' experiences and define expectations; debriefing to provide feedback; and allowing appropriate autonomy. Context included learning climate, levels of distraction, patient acuity, and institutional culture., Interpretation: We identified specific traits and behaviors of effective IBP teachers that intersect with the practice environment, which highlights the challenge of teaching IBPs. Notably, FG participants emphasized interpersonal, more than technical, aspects of successful IBP teachers. These findings should inform future curricula on teaching IBPs in the ICU, standardize IBP teaching for pulmonary and critical care medicine fellows, and reduce patient injury from procedural complications., (Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

The lack of data on perspectives of racial and ethnic minority populations regarding family disclosure of individual research results (IRR) hinders the development of return of IRR policies and practices that are meaningful and culturally appropriate in diverse populations. This research aims to uncover preferences regarding family disclosure of IRR and identify factors that may shape the preferences in three minority populations. Nine focus groups with 68 adult African American, Hispanic/Latinx, and American Indian/Alaska Native individuals were conducted. Data were analyzed using thematic analysis. Participants were willing to share IRR with relatives who elected to know and preferred a participant-driven (vs. researcher-driven) decision-making process. Privacy of personal information was deemed important, as were anticipated familial benefits from genetic information, except when improper use of the information was suspected. Factors influencing family disclosure decisions included the family's biological and emotional closeness, and participants' perceived mental preparedness of the relative. Family disclosure of IRR among racial and ethnic minority individuals is a complex decision-making process wherein issues of individual privacy are entangled with family dynamic and familial benefit considerations. These data suggest that policies surrounding family disclosure of IRR should carefully consider participant preferences and adopt a participant-driven approach.

Although endometrial cancer is often diagnosed at an early curable stage, the incidence and mortality from endometrial cancer is rising and minority women are particularly at risk. We hypothesize that delays in clinical presentation contribute to racial disparities in endometrial cancer mortality and treatment-related morbidity. Improved methods for endometrial cancer risk assessment and distinguishing abnormal uterine bleeding and postmenopausal bleeding from physiologic variation are needed. Accordingly, we propose a multipronged strategy that combines innovative patient education with novel early detection strategies to reduce health impacts of endometrial cancer and its precursors, especially among Black women. Futuristic approaches using gamification, smartphone apps, artificial intelligence, and health promotion outside of the physical clinic hold promise in preventing endometrial cancer and reducing morbidity and mortality related to the disease, but they also raise a number of questions that will need to be addressed by future research., (©2020 American Association for Cancer Research.)