The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines.

BACKGROUND: Clinical and real-world effectiveness data for the COVID-19 vaccines have shown that they are the best defense in preventing severe illness and death throughout the pandemic. However, in the US, some groups remain more hesitant than others about receiving COVID-19 vaccines. One important group is long-term care workers (LTCWs), especially because they risk infecting the vulnerable and clinically complex populations they serve. There is a lack of research about how best to increase vaccine confidence, especially in frontline LTCWs and healthcare staff. Our aims are to: (1) compare the impact of two interventions delivered online to enhanced usual practice on LTCW COVID-19 vaccine confidence and other pre-specified secondary outcomes, (2) determine if LTCWs' characteristics and other factors mediate and moderate the interventions' effect on study outcomes, and (3) explore the implementation characteristics, contexts, and processes needed to sustain a wider use of the interventions. METHODS: We will conduct a three-arm randomized controlled effectiveness-implementation hybrid (type 2) trial, with randomization at the participant level. Arm 1 is a dialogue-based webinar intervention facilitated by a LTCW and a medical expert and guided by an evidence-based COVID-19 vaccine decision tool. Arm 2 is a curated social media web application intervention featuring interactive, dynamic content about COVID-19 and relevant vaccines. Arm 3 is enhanced usual practice, which directs participants to online public health information about COVID-19 vaccines. Participants will be recruited via online posts and advertisements, email invitations, and in-person visits to care settings. Trial data will be collected at four time points using online surveys. The primary outcome is COVID-19 vaccine confidence. Secondary outcomes include vaccine uptake, vaccine and booster intent for those unvaccinated, likelihood of recommending vaccination (both initial series and booster), feeling informed about the vaccines, identification of vaccine information and misinformation, and trust in COVID-19 vaccine information provided by different people and organizations. Exploration of intervention implementation will involve interviews with study participants and other stakeholders, an in-depth process evaluation, and testing during a subsequent sustainability phase. DISCUSSION: Study findings will contribute new knowledge about how to increase COVID-19 vaccine confidence and effective informational modalities for LTCWs. TRIAL REGISTRATION: NCT05168800 at ClinicalTrials.gov, registered December 23, 2021.

A Rectal Cancer Surgical Decision Aid Is Not Enough: A Qualitative Study.

BACKGROUND: Rectal cancer patients often face complex surgical treatment decisions, but there are few available tools to aid in decision-making. OBJECTIVE: We aimed to identify content and delivery preferences of rectal cancer patients and colorectal surgeons to guide future surgical decision aid creation. DESIGN: Qualitative study: inductive thematic analysis of semi-structured interviews. SETTING: In-person and phone interviews. PATIENTS: We purposively sampled 15 rectal cancer survivors based on demographics and surgery type. Five caregivers also participated. We purposively selected 10 surgeons based on practice type and years of experience. INTERVENTIONS: Semi-structured interviews. MAIN OUTCOME MEASURES: Major and minor themes for survivors and surgeons with thematic saturation. RESULTS: Interviews were a median of 61 minutes (41-93) for patients and 35 minutes (25-59) for surgeons. Nine survivors were younger than 65 years; 7 were female. Surgeons had been practicing for a mean of 10 years (SD 7.4), with 7 in academic and 3 in private settings. Participating survivors and surgeons wanted a comprehensive educational tool-not just a surgical decision aid. Survivors wanted more information on rectal cancer basics and lifestyle, care timelines, and resources during treatment. Surgeons thought patients mostly desired information about surgical options and bowel function. Both patients and surgeons wanted a tool that was personalized, simple, understandable, visually appealing, interactive, short, and in multiple formats. LIMITATIONS: Results may not be generalizable due to selection bias of participants. CONCLUSION: Rectal cancer survivors, their caregivers, and colorectal surgeons wanted an educational support tool that would address substantial educational needs through the continuum of disease rather than a surgical decision aid focusing on a discrete surgical choice only. See Video Abstract at http://links.lww.com/DCR/C20 . UNA AYUDA PARA LA DECISIN QUIRRGICA DEL CNCER DE RECTO NO ES SUFICIENTE UN ESTUDIO CUALITATIVO: ANTECEDENTES:Los pacientes con cáncer de recto a menudo enfrentan decisiones de tratamiento quirúrgico complejas, pero hay pocas herramientas disponibles para ayudar en la toma de decisiones.OBJETIVO:Nuestro objetivo fue identificar el contenido y las preferencias de entrega de los pacientes con cáncer de recto y los cirujanos colorrectales para guiar la futura creación de ayuda para la toma de decisiones quirúrgicas.DISEÑO:Estudio cualitativo: análisis temático inductivo de entrevistas semiestructuradas.ESCENARIO:Entrevistas en persona y por teléfono.PACIENTES:Tomamos muestras intencionalmente de 15 sobrevivientes de cáncer de recto, según la demografía y el tipo de cirugía. También participaron cinco cuidadores. Seleccionamos intencionalmente a 10 cirujanos según el tipo de práctica y los años de experiencia.INTERVENCIONES:Entrevistas semiestructuradas.PRINCIPALES MEDIDAS DE RESULTADO:Temas principales y secundarios para sobrevivientes y cirujanos con saturación temática.RESULTADOS:Las entrevistas tuvieron una mediana de 61 minutos (41-93) para pacientes y 35 minutos (25-59) para cirujanos. Nueve sobrevivientes tenían menos de 65 años; siete eran mujeres. Los cirujanos habían estado ejerciendo una media de 10 años (DE 7,4), con siete en entornos académicos y 3 en entornos privados. Los sobrevivientes y cirujanos participantes querían una herramienta educativa comprensible, no solo una ayuda para la decisión quirúrgica. Los sobrevivientes querían más información sobre los conceptos básicos y el estilo de vida del cáncer de recto, los plazos de atención y los recursos durante el tratamiento. Los cirujanos pensaron que los pacientes en su mayoría deseaban información sobre las opciones quirúrgicas y la función intestinal. Tanto los pacientes como los cirujanos querían una herramienta que fuera personalizada, simple, comprensible, visualmente atractiva, interactiva, corta y en múltiples formatos.LIMITACIONES:Los resultados pueden no ser generalizables debido al sesgo de selección de los participantes.CONCLUSIÓN:Los sobrevivientes de cáncer rectal, sus cuidadores y los cirujanos colorrectales querían una herramienta de apoyo educativo que cubriera las necesidades educativas sustanciales a lo largo del tratamiento de la enfermedad en lugar de una ayuda para la decisión quirúrgica que se centre solo en una opción quirúrgica discreta. Consulte Video Resumen en http://links.lww.com/DCR/C20 . (Traducción-Dr. Yolanda Colorado ).

Co-Development of a Web Application (COVID-19 Social Site) for Long-Term Care Workers ("Something for Us"): User-Centered Design and Participatory Research Study.

BACKGROUND: Improving confidence in and uptake of COVID-19 vaccines and boosters among long-term care workers (LTCWs) is a crucial public health goal, given their role in the care of elderly people and people at risk. While difficult to reach with workplace communication interventions, most LTCWs regularly use social media and smartphones. Various social media interventions have improved attitudes and uptake for other vaccines and hold promise for the LTCW population. OBJECTIVE: We aimed to develop a curated social web application (interactive website) to increase COVID-19 vaccine confidence (a 3-arm randomized trial is underway). METHODS: Following user-centric design and participatory research approaches, we undertook the following 3 steps: (1) content identification, (2) platform development, and (3) community building. A LTCW and stakeholder advisory group provided iterative input. For content identification (step 1), we identified topics of concern about COVID-19 vaccines via desktop research (published literature, public opinion polls, and social media monitoring), refined by interviewing and polling LTCWs. We also conducted a national online panel survey. We curated and fact-checked posts from popular social media platforms that addressed the identified concerns. During platform development (step 2), we solicited preferences for design and functionality via interviews and user experience testing with LTCWs. We also identified best practices for online community building (step 3). RESULTS: In the interviews (n=9), we identified 3 themes: (1) LTCWs are proud of their work but feel undervalued; (2) LTCWs have varying levels of trust in COVID-19-related information; and (3) LTCWs would welcome a curated COVID-19 resource that is easy to understand and use-"something for us". Through desktop research, LTCW interviews, and our national online panel survey (n=592) we found that participants are interested in information about COVID-19 in general, vaccine benefits, vaccine risks, and vaccine development. Content identification resulted in 434 posts addressing these topic areas, with 209 uploaded to the final web application. Our LTCW poll (n=8) revealed preferences for personal stories and video content. The platform we developed is an accessible WordPress-based social media web application, refined through formal (n=3) and informal user experience testing. Users can sort posts by topic or subtopic and react to or comment on posts. To build an online community, we recruited 3 LTCW "community ambassadors" and instructed them to encourage discussion, acknowledge concerns, and offer factual information on COVID-19 vaccines. We also set "community standards" for the web application. CONCLUSIONS: An iterative, user-centric, participatory approach led to the launch of an accessible social media web application with curated content for COVID-19 vaccines targeting LTCWs in the United States. Through our trial, we will determine if this approach successfully improves vaccine confidence. If so, a similar social media resource could be used to develop curated social media interventions in other populations and with other public health goals.

What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata.

BACKGROUND: Women of lower socioeconomic status (SES) with early-stage breast cancer are more likely to report poorer physician-patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices. METHODS: We conducted a 3-arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon-level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence-based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre-consultation) to T5 (1-year after surgery. RESULTS: Sixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self-reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety. CONCLUSIONS: Paper-based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients. LAY SUMMARY: The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices. Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text-only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education. Conversation aids with pictures and text helped women make better breast cancer surgery choices.

Women Who Are Young, Non-White, and with Lower Socioeconomic Status Report Higher Financial Toxicity up to 1 Year After Breast Cancer Surgery: A Mixed-Effects Regression Analysis.

PURPOSE: We examined self-reported financial toxicity and out-of-pocket expenses among adult women with breast cancer. METHODS: Patients spoke English, Spanish, or Mandarin Chinese, were aged 18+ years, had stage I-IIIA breast cancer, and were eligible for breast-conserving and mastectomy surgery. Participants completed surveys about out-of-pocket costs and financial toxicity at 1 week, 12 weeks, and 1 year postsurgery. RESULTS: Three hundred ninety-five of 448 eligible patients (88.2%) from the parent trial completed surveys. Excluding those reporting zero costs, crude mean ± SD out-of-pocket costs were $1,512 ± $2,074 at 1 week, $2,609 ± $6,369 at 12 weeks, and $3,308 ± $5,000 at 1 year postsurgery. Controlling for surgery, cancer stage, and demographics with surgeon and clinic as random effects, higher out-of-pocket costs were associated with higher financial toxicity 1 week and 12 weeks postsurgery (p < .001). Lower socioeconomic status (SES) was associated with lower out-of-pocket costs at each time point (p = .002-.013). One week postsurgery, participants with lower SES reported financial toxicity scores 1.02 points higher than participants with higher SES (95% confidence interval [CI], 0.08-1.95). Black and non-White/non-Black participants reported financial toxicity scores 1.91 (95% CI, 0.46-3.37) and 2.55 (95% CI, 1.11-3.99) points higher than White participants. Older (65+ years) participants reported financial toxicity scores 2.58 points lower than younger (<65 years) participants (95% CI, -3.41, -1.74). Younger participants reported significantly higher financial toxicity at each time point. DISCUSSION: Younger age, non-White race, and lower SES were associated with higher financial toxicity regardless of costs. Out-of-pocket costs increased over time and were positively associated with financial toxicity. Future work should reduce the impact of cancer care costs among vulnerable groups. IMPLICATIONS FOR PRACTICE: This study was one of the first to examine out-of-pocket costs and financial toxicity up to 1 year after breast cancer surgery. Younger age, Black race, race other than Black or White, and lower socioeconomic status were associated with higher financial toxicity. Findings highlight the importance of addressing patients' financial toxicity in several ways, particularly for groups vulnerable to its effects.

A Mixed-Methods Evaluation of Patient Education Materials for Colorectal Cancer.

BACKGROUND: Patient education materials are created by professional organizations to inform patients about their disease and its treatment. However, it remains unclear if these materials are appropriate for patients. OBJECTIVE: This study aims to broadly evaluate the education materials for patients with colorectal cancer. DESIGN: Patient education materials from the National Comprehensive Cancer Network, the National Cancer Institute, and the American Society of Colon and Rectal Surgeons were assessed quantitatively by using 1) the Flesch-Kincaid readability formula and 2) the Patient Education Material Assessment Tool. The Patient Education Material Assessment Tool scores materials in 2 domains: understandability and actionability. These materials were further evaluated qualitatively via an exploratory focus group with patients and their caregivers (n = 5) and semi-structured interviews with board-certified/eligible colorectal surgeons (n = 10). SETTING: This study was conducted at academic centers and a regional professional society meeting. PARTICIPANTS: The mean patient age was 63. Most surgeons (8/10) practiced in an academic setting, and 4/10 were female. MAIN OUTCOME MEASURES: The primary outcomes measured were reading grade level and domain scores for the Patient Education Material Assessment Tool. Qualitative data were recorded, transcribed, and coded. Themes were generated through data interpretation and data reduction. RESULTS: Materials ranged from 7th to 11th grade reading level. National Comprehensive Cancer Network materials scored highest for understandability (92.2% ± 6.1%, mean ± SD), followed by National Cancer Institute (84.0% ± 6.6%) and American Society of Colon and Rectal Surgeons (82.2% ± 6.3%) materials. Actionability scores varied; the National Comprehensive Cancer Network materials scored 82.5% ± 1.7%, whereas the National Cancer Institute and American Society of Colon and Rectal Surgeons materials scored 23.3% ± 6.7% and 50.0% ± 8.2%. Critical gaps were identified in the content of these materials. Patients wanted more information about self-care, both emotional and physical. Specifically, patients sought details about postoperative bowel function. Whereas surgeons wanted information about the typical hospital course and recovery, all wanted materials to be customizable. LIMITATIONS: A limited number of materials were reviewed, and patient focus groups were exploratory. CONCLUSIONS: Commonly available printed education materials for colorectal cancer are written at a high reading grade level, vary in their usability, and neglect important details about postoperative recovery. See Video Abstract at http://links.lww.com/DCR/B535. EVALUACIN DE MTODOS MIXTOS DE MATERIALES EDUCATIVOS PARA PACIENTES SOBRE CNCER COLORECTAL: ANTECEDENTES:Los materiales educativos para pacientes son creados por organizaciones profesionales para informar a los pacientes sobre su enfermedad y su tratamiento. Sin embargo, no está claro si estos materiales son apropiados para los pacientes.OBJETIVO:Evaluar ampliamente los materiales para el cáncer colorrectal.DISEÑO:Los materiales educativos para pacientes de la Red Nacional Integral del Cáncer (NCCN), el Instituto Nacional del Cáncer (NCI) y la Sociedad Americana de Cirujanos de Colon y Recto (ASCRS) se evaluaron cuantitativamente utilizando (1) la fórmula de legibilidad de Flesch-Kincaid y (2) la herramienta de evaluación de material educativo para pacientes. La Herramienta de evaluación de materiales educativos para pacientes califica los materiales en dos dominios: comprensibilidad y viabilidad. Estos materiales fueron evaluados cualitativamente a través de un grupo de enfoque exploratorio con pacientes y sus cuidadores (n = 5) y entrevistas semiestructuradas con cirujanos colorrectales certificados o elegibles para certificación por el consejo (n = 10).ESCENARIO:Centros académicos y un encuentro regional de una sociedad profesional.PACIENTES:La edad media de los pacientes fue de 63 años. La mayoría de los cirujanos (8/10) practicaban en un entorno académico, y 4/10 eran mujeres.PRINCIPALES MEDIDAS DE RESULTADO:Nivel de grado de lectura y puntajes de dominios para la Herramienta de evaluación de materiales educativos para pacientes. Los datos cualitativos se registraron, transcribieron y codificaron. Los temas se generaron mediante la interpretación y la reducción de datos.RESULTADOS:Los materiales variaron desde el nivel de lectura del 7° al 11° grado. Los materiales de la NCCN obtuvieron la puntuación más alta en comprensibilidad (92.2 ± 6.1%, media ± DE), seguidos por los materiales de NCI (84.0 ± 6.6%) y ASCRS (82.2 ± 6.3%). Los puntajes de viabilidad variaron; Los materiales de NCCN obtuvieron una puntuación de 82.5 ± 1.7%, mientras que los materiales de NCI y ASCRS obtuvieron una puntuación de 23.3 ± 6.7% y 50.0 ± 8.2%, respectivamente. Se identificaron lagunas críticas en el contenido de estos materiales. Los pacientes querían más información sobre el autocuidado, tanto emocional como físico. Específicamente, los pacientes buscaron detalles sobre la función intestinal posoperatoria. Mientras que los cirujanos querían información sobre el curso hospitalario típico y la recuperación, y todos querían que los materiales fueran personalizables.LIMITACIONES:Se revisó una cantidad limitada de materiales y los grupos de enfoque de pacientes fueron exploratorios.CONCLUSIONES:Los materiales educativos impresos comúnmente disponibles para el cáncer colorrectal están escritos a un alto nivel de grado de lectura, varían en su usabilidad y omiten detalles importantes sobre la recuperación postoperatoria. Consulte Video Resumen en http://links.lww.com/DCR/B535.

Processes for evidence summarization for patient decision aids: A Delphi consensus study.

BACKGROUND: Patient decision aids (PDAs) should provide evidence-based information so patients can make informed decisions. Yet, PDA developers do not have an agreed-upon process to select, synthesize and present evidence in PDAs. OBJECTIVE: To reach the consensus on an evidence summarization process for PDAs. DESIGN: A two-round modified Delphi survey. SETTING AND PARTICIPANTS: A group of international experts in PDA development invited developers, scientific networks, patient groups and listservs to complete Delphi surveys. DATA COLLECTION: We emailed participants the study description and a link to the online survey. Participants were asked to rate each potential criterion (omit, possible, desirable, essential) and provide qualitative feedback. ANALYSIS: Criteria in each round were retained if rated by >80% of participants as desirable or essential. If two or more participants suggested rewording, reordering or merging, the steering group considered the suggestion. RESULTS: Following two Delphi survey rounds, the evidence summarization process included defining the decision, reporting the processes and policies of the evidence summarization process, assembling the editorial team and managing (collect, manage, report) their conflicts of interest, conducting a systematic search, selecting and appraising the evidence, presenting the harms and benefits in plain language, and describing the method of seeking external review and the plan for updating the evidence (search, selection and appraisal of new evidence). CONCLUSION: A multidisciplinary stakeholder group reached consensus on an evidence summarization process to guide the creation of high-quality PDAs. PATIENT CONTRIBUTION: A patient partner was part of the steering group and involved in the development of the Delphi survey.

Clinician-Spoken Plain Language in Health Care Encounters: A Qualitative Analysis to Assess Measurable Elements.

PURPOSE: Good communication and use of plain language in health care encounters improve outcomes, including emotional health, symptom resolution, and functional status. Yet there is limited research on how to measure and report spoken plain language, which is the use of familiar, clear language. The authors aimed to describe key, measurable elements of spoken plain language that can be assessed and reported back to clinicians for self-reflection. METHOD: The authors conducted secondary analysis of transcripts from recorded encounters between breast cancer surgeons and patients with early-stage breast cancer. Two coders used a hybrid qualitative analysis with a framework based on U.S. Federal Plain Language Guidelines. To develop major themes, they examined (1) alignment with the Guidelines and (2) code frequencies within and across transcripts. They also noted minor themes. RESULTS: From 74 transcripts featuring 13 surgeons, the authors identified 2 major themes representing measurable elements of spoken plain language: (1) clinicians had a propensity to use both explained and unexplained medical terms, and (2) clinicians delivered information using either short turns (one unit of someone speaking) with 1 topic or long turns with multiple topics. There were 3 minor themes that were not indicative of whether or not clinicians used spoken plain language. First, clinicians regularly used absolute risk communication techniques. Second, question-asking techniques varied and included open-ended, close-ended, and comprehension checks. Third, some clinicians used imagery to describe complex topics. CONCLUSIONS: Clinicians' propensity to use medical terms with and without explanation and parse encounters into shorter or longer turns are measurable elements of spoken plain language. These findings will support further research on the development of a tool that can be used in medical education and other settings. This tool could provide direct and specific feedback to improve the plain language practices of clinicians in training and beyond.

Engaging Long-Term Care Workers in Research: Recruitment Approaches and Participant Characteristics From a Randomized Controlled Trial to Improve COVID-19 Vaccine Confidence.

OBJECTIVE: To describe and compare the recruitment methods employed in a randomized controlled trial targeting long-term care workers, and resulting participant baseline characteristics. DESIGN: We used a multifaceted recruitment process to enroll long-term care workers in our 3-arm randomized controlled trial comparing 2 interventions to enhanced usual practice, for improving COVID-19 vaccine confidence and other outcomes. SETTING AND PARTICIPANTS: Adult long-term care workers living in the United States employed within the last 2 years were invited to join the study. Participants also had to meet specific screening criteria related to their degree of worry about the vaccine and/or their vaccination status. METHODS: We used a participatory approach to engage our long-term care stakeholders in codesigning and executing a combination of recruitment methods, including targeted e-recruitment, paid e-recruitment, and in-person recruitment. Participants were screened, consented, and enrolled online. We implemented a participant verification process to ensure the integrity of our study data, and used a tailored participant management platform to manage enrollment. RESULTS: We enrolled 1930 long-term care workers between May 2022 and January 2023. We met our enrollment target, despite each recruitment method having limitations. Total variable costs of approximately $102,700 were incurred and differed on a per-enrolled participant basis across methods: $25.73 for targeted e-recruitment, $57.12 for paid e-recruitment, and $64.92 for in-person methods. Our sample differed from the national population in age, gender, race/ethnicity, education, and role in long-term care. Differences were also observed between online and in-person recruitment methods. CONCLUSIONS AND IMPLICATIONS: Our results support the feasibility of enrolling a large number of long-term care workers in a randomized controlled trial to increase COVID-19 vaccine confidence. Findings build upon the evidence base for engaging this important population in research, a critical step to improving long-term care resident health and well-being. Results from our trial are anticipated in 2024.

"It helps us say what's important..." Developing Serious Illness Topics: A clinical visit agenda-setting tool.

BACKGROUND: Skillful communication with attention to patient and care partner priorities can help people with serious illnesses. Few patient-facing agenda-setting tools exist to facilitate such communication. OBJECTIVE: To develop a tool to facilitate prioritization of patient and care partner concerns during serious illness visits. PATIENT OR FAMILY INVOLVEMENT: Two family members of seriously ill individuals advised. METHODS: We performed a literature review and developed a prototype agenda-setting tool. We modified the tool based on cognitive interviews with patients, families and clinicians. We piloted the tool with patients, care partners and clinicians to gain an initial impression of its perceived value. RESULTS: Interviews with eight patients, eight care partners and seven clinicians, resulted in refinements to the initial tool, including supplementation with visual cues. In the pilot test, seven clinicians used the tool with 11 patients and 12 family members. Qualitatively, patients and care partners reported the guide helped them consider and assert their priorities. Clinicians reported the tool complemented usual practice. Most participants reported no distress, disruption or confusion. DISCUSSION: Patients, care partners and clinicians appreciated centering patient priorities in serious illness visits using the agenda-setting tool. More thorough evaluation is required. PRACTICAL VALUE: The agenda-setting tool may operationalize elements of good serious illness care.

Psychometric assessment of the consideRATE questions, a new measure of serious illness experience, with an online simulation study.

OBJECTIVE: To assess the psychometric properties of the consideRATE questions, a measure of serious illness experience. METHODS: We recruited people at least 50 years old via paid panels online, with US-Census-based quotas. We randomized participants to a patient experience story at two time points. Participants completed a series of measures, including the consideRATE questions. We assessed convergent (Pearson's correlation), discriminative (one-way ANOVA with Tukey's test for multiple comparisons) and divergent (Pearson's correlation) validity. We also assessed intra-rater reliability (intra-class correlation) and responsiveness to change (t-tests). RESULTS: We included 809 individuals in our analysis. We established convergent validity (r = 0.77; p < 0.001); discriminative validity (bad/neutral stories [mean diff=0.4; p < 0.001]; neutral/ good stories [mean diff=1.3; p < 0.001]) and moderate divergent validity (r = 0.57; p < 0.001). We established sensitivity to change in all stories (bad/good [mean diff=1.52; p < 0.001]; good/bad [mean diff= -1.68; p < 0.001]; neutral/bad [mean diff= -0.57; p < 0.001]; good/neutral [mean diff= -1.11; p < 0.001]; neutral/good [mean diff= 1.1; p < 0.001]) but one (bad/neutral [mean diff= 0.4; p < 0.07]). Intra-rater reliability was demonstrated between time points (r = 0.77; p < 0.001). CONCLUSIONS: the consideRATE questions were reliable and valid in a simulated online test. PRACTICE IMPLICATIONS: the consideRATE questions may be a practical way to measure serious illness experience and the effectiveness of interventions to improve it.

Personalized, Electronic Health Record-Integrated Decision Aid for Stroke Prevention in Atrial Fibrillation: A Small Cluster Randomized Trial and Qualitative Analysis of Efficacy and Acceptability.

BACKGROUND: Shared decision-making in cardiology is increasingly recommended to improve patient-centeredness of care. Decision aids can improve patient knowledge and decisional quality but are infrequently used in real-world practice. This mixed-methods study tests the efficacy and acceptability of a decision aid integrated into the electronic health record (Integrated Decision Aid [IDeA]) and delivered by clinicians for patients with atrial fibrillation considering options to reduce stroke risk. We aimed to determine whether the IDeA improves patient knowledge, reduces decisional conflict, and is seen as acceptable by clinicians and patients. METHODS: A small cluster randomized trial included 6 cardiovascular clinicians and 66 patients randomized either to the IDeA (HealthDecision) or usual care (clinician discretion) during a clinical encounter when stroke prevention treatment options were discussed. The primary outcome was patient knowledge of personalized stroke risk. Exploratory outcomes included decisional conflict, values concordance, trust, the presence of a shared decision-making process, and patient knowledge related to time spent using the IDeA. Additionally, we conducted semistructured interviews with clinicians and patients who used the IDeA were conducted to assess acceptability and predictions of future use. RESULTS: The IDeA significantly increased patients' knowledge of their stroke risk (odds ratio, 3.88 [95% CI, 1.39-10.78]; P<0.01]). Patients had less uncertainty about their final decision (P=0.04). There were no significant differences in values concordance, trust in clinician or shared decision-making. Despite training, each clinician used the IDeA differently. Qualitative analysis revealed patients prefer using the IDeA earlier in their diagnosis. Clinicians were satisfied with the IDeA, yet varied in the contexts in which they planned to use it in the future. CONCLUSIONS: Using an Integrated Decision Aid, or IDeA, increases patient knowledge and lessens uncertainty for decision-making around stroke prevention in atrial fibrillation. Qualitative data provide insight into potential implementation strategies in real-world practice.

An absence of equipoise: Examining surgeons' decision talk during encounters with women considering breast cancer surgery.

Shared decision-making is recommended for decisions with multiple reasonable options, yet clinicians often subtly or explicitly guide choices. Using purposive sampling, we performed a secondary analysis of 142 audio-recorded encounters between 13 surgeons and women eligible for breast-conserving surgery with radiation or mastectomy. We trained 9 surgeons in shared decision-making and provided them one of two conversation aids; 4 surgeons practiced as usual. Based on a published taxonomy of treatment recommendations (pronouncements, suggestions, proposals, offers, assertions), we examined how surgeons framed choices with patients. Many surgeons made assertions providing information and advice (usual care 71% vs. intervention 66%; p = 0.54). Some made strong pronouncements (usual care 51% vs. intervention 36%; p = .09). Few made proposals and offers, leaving the door open for deliberation (proposals usual care 21% vs. intervention 26%; p = 0.51; offers usual care 40% vs. intervention 40%; p = 0.98). Surgeons were significantly more likely to describe options as comparable when using a conversation aid, mentioning this in all intervention group encounters (usual care 64% vs. intervention 100%; p<0.001). Conversation aids can facilitate offers of comparable options, but other conversational actions can inhibit aspects of shared decision-making.

'Because Everybody is so Different': a qualitative analysis of the lived experiences and information needs of rectal cancer survivors.

OBJECTIVE: To (1) characterise (A) the lived experiences and (B) information needs of patients with rectal cancer; and (2) compare to the perceived lived experiences and information needs of colorectal surgeons. DESIGN: We conducted 1-hour semistructured qualitative interviews, dual independent transcript coding and thematic analysis. SETTING/PARTICIPANTS: Interviews included rectal cancer survivors (stages I-III), some accompanied by caregivers, at Dartmouth-Hitchcock Medical Center and experienced colorectal surgeons. RESULTS: We performed 25 interviews involving 30 participants, including 15 patients with 5 caregivers, plus 10 physicians. Two major themes emerged. First, patients reported major impacts on their lives following rectal cancer, including on their everyday lives and leisure activities; identity, self-confidence and intimacy; mental health, especially anxiety. These impacts were mediated by their medical experiences, lifestyle and attitudes. Second, the diversity of effects on patients' lives means that care, counselling and information needs should be personalised for a better medical experience and outcomes. Surgeons did not report knowledge of the full range of patient experiences and reported limited counselling in key areas, particularly concerning intimacy and mental health. CONCLUSION: Rectal cancer diagnosis, treatment and survivorship dramatically affect all people, regardless of which surgical treatment they undergo. Effects are varied and necessitate customised care, counselling and information, which surgeons are not currently providing. Because rectal cancer affects every part of patients' lives, they need holistic support and information. Patients would benefit from substantial support after treatment as they establish a new normal.

User-Centered Design of the consideRATE Questions, a Measure of People's Experiences When They Are Seriously Ill.

CONTEXT: No brief patient-reported experience measure focuses on the most significant concerns of seriously ill individuals. OBJECTIVES: The objective of the study was to develop the consideRATE questions. METHODS: This user-centered design study had three phases. We reviewed the literature and consulted stakeholders, including caregivers, clinicians, and researchers, to identify the elements of care most important to patients (Phase 1). We refined items based on cognitive interviews with patients, families, and clinicians (Phase 2). We piloted the measure with patients and families (Phase 3). RESULTS: Phase 1 resulted in seven questions addressing the following elements: 1) care team attention to patients' physical symptoms, 2) emotional symptoms, 3) environment of care, 4) respect for patients' priorities, 5) communication about future plans, 6) communication about financial and similar affairs, and 7) communication about illness trajectory. Phase 2 participants included eight patients, eight family members, and seven clinicians. We added an open-text comment option. We did not identify any other issues that were important enough to participants to include. Response choices ranged from one (very bad) to four (very good), with a not applicable option (does not apply). Phase 3 involved 15 patients and 16 family members and demonstrated the acceptability of the consideRATE questions. Most reported that the questions were not distressing, disruptive, or confusing. Completion time averaged 2.4 minutes (range 1-5). CONCLUSION: Our brief patient-reported serious illness experience measure is based on what matters most to patients, families, and clinicians. It was acceptable to patients and families in a regional sample. It has promise for use in clinical settings.

Implementation and sustainability factors of two early-stage breast cancer conversation aids in diverse practices.

BACKGROUND: Conversation aids can facilitate shared decision-making and improve patient-centered outcomes. However, few examples exist of sustained use of conversation aids in routine care due to numerous barriers at clinical and organizational levels. We explored factors that will promote the sustained use of two early-stage breast cancer conversation aids. We examined differences in opinions between the two conversation aids and across socioeconomic strata. METHODS: We nested this study within a randomized controlled trial that demonstrated the effectiveness of two early-stage breast cancer surgery conversation aids, one text-based and one picture-based. These conversation aids facilitated more shared decision-making and improved the decision process, among other outcomes, across four health systems with socioeconomically diverse patient populations. We conducted semi-structured interviews with a purposive sample of patient participants across conversation aid assignment and socioeconomic status (SES) and collected observations and field notes. We interviewed trial surgeons and other stakeholders. Two independent coders conducted framework analysis using the NOrmalization MeAsure Development through Normalization Process Theory. We also conducted an inductive analysis. We conducted additional sub-analyses based on conversation aid assignment and patient SES. RESULTS: We conducted 73 semi-structured interviews with 43 patients, 16 surgeons, and 14 stakeholders like nurses, cancer center directors, and electronic health record (EHR) experts. Patients and surgeons felt the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid (EHR, email, patient portal, before consultation). Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision-making. Intervention surgeons reported using the conversation aids did not lengthen their typical consultation time. Most intervention surgeons felt using the conversation aids enhanced their usual care after using it a few times, and most patients felt it appeared part of their normal routine. CONCLUSIONS: Key factors that will guide the future sustained implementation of the conversation aids include adapting to existing clinical workflows, flexibility of use, patient characteristics, and communication preferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03136367 , registered on May 2, 2017.

Using pictures to convey health information: A systematic review and meta-analysis of the effects on patient and consumer health behaviors and outcomes.

OBJECTIVE: Assess the effect of pictorial health information on patients' and consumers' health behaviors and outcomes, evaluate these effects in lower health literacy populations, and examine the attributes of the interventions. METHODS: We included randomized controlled trials (RCTs) that assessed the effect of pictorial health information on patient and consumer health behaviors and outcomes. We conducted a meta-analysis of RCTs that assessed knowledge/understanding, recall, or adherence, and a subgroup analysis of those outcomes on lower health literacy populations. We narratively reviewed characteristics of pictorial health interventions that significantly improved outcomes for lower health literacy populations. RESULTS: From 4160 records, we included 54 RCTs (42 in meta-analysis). Pictorial health information moderately improved knowledge/understanding and recall overall, but largely increased knowledge/understanding for lower health literacy populations (n = 13), all with substantial heterogeneity. Icons with few words may be most helpful in conveying health information. CONCLUSION: Our results support including pictures in health communication to improve patient knowledge. Our results should be interpreted with caution considering the significant heterogeneity of the meta-analysis outcomes. PRACTICE IMPLICATIONS: Future research should assess which types and characteristics of pictures that best convey health information and are most useful and the implementation and sustainability in healthcare contexts. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018084743.

Encounter Decision Aids Can Prompt Breast Cancer Surgery Cost Discussions: Analysis of Recorded Consultations.

Background. Patients frequently worry about care costs, but clinicians seldom address the topic. Cost information is not typically included in patient decision aids (DAs). We examined whether including cost information in an encounter DA, with clinician training, influenced cost conversations. Method. As part of a larger trial, 14 surgeons from 4 cancer centers were randomized to 1 of 3 interventions: (1) Picture Option Grid DA that included a prompt to discuss relative treatment costs, hereafter called "cost prompt group"; (2) a text-only Option Grid DA that did not include cost information; (3) usual care. Groups 2 and 3 hereafter are referred to as "non-cost prompt groups." Adult (18+) female patients, with stages I-IIIA breast cancer, eligible for both breast-conserving surgery and mastectomy were included. We gave surgeons feedback about adherence to the study protocol at 3, 6, and 12-months. We adapted a checklist to code the content of the audio-recorded clinical encounters. Results. 424/622 (68%) patients consented; 311 (73%) were eligible and successfully recorded (143 in the cost prompt group, 168 in the non-cost prompt groups). Costs were discussed in 132/311 (42.4%) encounters, and occurred more often in the cost prompt versus non-cost prompt groups (66.7% versus 33.3%; p<.001). Surgeons initiated the cost discussion in 86.4% of encounters in the cost prompt group vs. 34.1% in the non-cost prompt groups (p<0.001). In the non-cost prompt groups, insurance or employment questions led patients to ask about costs. Cost discussions lasted about 34 seconds when present and had sparse comparative details. Conclusions. Encounter DAs containing cost information trigger cost discussions. Additional support should help clinicians improve the quality of cost discussions and address financial distress.

Text-only and picture conversation aids both supported shared decision making for breast cancer surgery: Analysis from a cluster randomized trial.

OBJECTIVES: To determine if two encounter conversation aids for early-stage breast cancer surgery increased observed and patient-reported shared decision making (SDM) compared with usual care and if observed and patient-reported SDM were associated. METHODS: Surgeons in a cluster randomized trial at four cancer centers were randomized to use an Option Grid, Picture Option Grid, or usual care. We used bivariate statistics, linear regression, and multilevel models to evaluate the influence of trial arm, patient socioeconomic status and health literacy on observed SDM (via OPTION-5) and patient-reported SDM (via collaboRATE). RESULTS: From 311 recordings, OPTION-5 scores were 73/100 for Option Grid (n = 40), 56.3/100 for Picture Option Grid (n = 144), and 41.0/100 for usual care (n = 127; p < 0.0001). Top collaboRATE scores were 81.6 % for Option Grid, 80.0 % for Picture Option Grid, and 56.4 % for usual care (p < 0.001). Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis. Patients of lower socioeconomic status had lower OPTION-5 scores before accounting for clustering. CONCLUSIONS: Both conversation aids led to meaningfully higher observed and patient-reported SDM. Observed and patient-reported SDM were not strongly correlated. PRACTICE IMPLICATIONS: Healthcare providers could implement these conversation aids in real-world settings.

The Learning Curve for Shared Decision-making in Symptomatic Aortic Stenosis.

Importance: Shared decision-making (SDM) is widely advocated for patients with valvular heart disease yet is not integrated into the heart team model for patients with symptomatic aortic stenosis. Decision aids (DAs) have been shown to improve patient-centered outcomes and may facilitate SDM. Objective: To determine whether the repeated use of a DA by heart teams is associated with greater SDM, along with improved patient-centered outcomes and clinician attitudes about DAs. Design, Setting, and Participants: This mixed-methods study included a nonrandomized pre-post intervention and clinician interviews. It was conducted between April 30, 2015, and December 7, 2017, with quantitative analysis performed between January 12, 2017, and May 26, 2017, within 2 academic medical centers in northern New England among 35 patients with symptomatic aortic stenosis who were at high to prohibitive risk for surgery. The qualitative analysis was performed between August 6, 2018, and May 7, 2019. The Severe Aortic Stenosis Decision Aid was delivered by 6 clinicians, with patients choosing between transcatheter aortic valve replacement and medical management. Main Outcomes and Measures: Clinician SDM performance was measured using the Observer OPTION5 scale with dual-independent coding of audiotaped clinic visits. Previsit and postvisit surveys measured the patient's knowledge, satisfaction, and decisional conflict. Audiotaped clinician interviews were coded, and qualitative thematic analysis was performed. Results: Six male clinicians and 35 patients (19 of 34 women [55.9%; 1 survey was missing]; mean [SD] age, 85.8 [7.8] years) participated in the study. Shared decision-making increased stepwise with repeated use of the DA (mean [SD] Observer OPTION5 scores: usual care, 17.9 [7.6]; first use of a DA, 60.5 [30.9]; fifth use of a DA, 79.0 [8.4]; P < .001 for comparison between usual care and fifth use of DA). Multiple uses of the DA were associated with increased patient knowledge (mean difference, 18.0%; 95% CI, 1.2%-34.8%; P = .04) and satisfaction (mean difference, 6.7%; 95% CI, 2.5%-10.8%; P = .01) but not decisional conflict (mean [SD]: usual care, 96.0% [9.4%]; first use of DA, 93.8% [12.5%]; fifth use of DA, 95.0% [11.2%]; P = .60). Qualitative analysis of clinicians' interviews revealed that clinicians perceived that they used an SDM approach without DAs and that the DA was not well understood by elderly patients. There was infrequent values clarification or discussion of stroke risk. Conclusion and Relevance: In a mixed-methods pilot study, use of a DA for severe aortic stenosis by heart team clinicians was associated with improved SDM and patient-centered outcomes. However, in qualitative interviews, heart team clinicians did not perceive a significant benefit of the DA, and therefore sustained implementation is unlikely. This pilot study of SDM clarifies new research directions for heart teams.