My anesthesia Choice-HF: development and preliminary testing of a tool to facilitate conversations about anesthesia for hip fracture surgery.

BACKGROUND: Patients often desire involvement in anesthesia decisions, yet clinicians rarely explain anesthesia options or elicit preferences. We developed My Anesthesia Choice-Hip Fracture, a conversation aid about anesthesia options for hip fracture surgery and tested its preliminary efficacy and acceptability. METHODS: We developed a 1-page, tabular format, plain-language conversation aid with feedback from anesthesiologists, decision scientists, and community advisors. We conducted an online survey of English-speaking adults aged 50 and older. Participants imagined choosing between spinal and general anesthesia for hip fracture surgery. Before and after viewing the aid, participants answered a series of questions regarding key outcomes, including decisional conflict, knowledge about anesthesia options, and acceptability of the aid. RESULTS: Of 364/409 valid respondents, mean age was 64 (SD 8.9) and 59% were female. The proportion indicating decisional conflict decreased after reviewing the aid (63-34%, P < 0.001). Median knowledge scores increased from 50% correct to 67% correct (P < 0.001). 83% agreed that the aid would help them discuss options and preferences. 76.4% would approve of doctors using it. CONCLUSION: My Anesthesia Choice-Hip Fracture decreased decisional conflict and increased knowledge about anesthesia choices for hip fracture surgery. Respondents assessed it as acceptable for use in clinical settings. PRACTICE IMPLICATIONS: Use of clinical decision aids may increase shared decision-making; further testing is warranted.

Evaluation of the nurse-assisted eHealth intervention 'eHealth@Hospital-2-Home' on self-care by patients with heart failure and colorectal cancer post-hospital discharge: protocol for a randomised controlled trial.

BACKGROUND: Patients with heart failure (HF) and colorectal cancer (CRC) are prone to comorbidity, a high rate of readmission, and complex healthcare needs. Self-care for people with HF and CRC after hospitalisation can be challenging, and patients may leave the hospital unprepared to self-manage their disease at home. eHealth solutions may be a beneficial tool to engage patients in self-care. METHODS: A randomised controlled trial with an embedded evaluation of intervention engagement and cost-effectiveness will be conducted to investigate the effect of eHealth intervention after hospital discharge on the self-efficacy of self-care. Eligible patients with HF or CRC will be recruited before discharge from two Norwegian university hospitals. The intervention group will use a nurse-assisted intervention-eHealth@Hospital-2-Home-for six weeks. The intervention includes remote monitoring of vital signs; patients' self-reports of symptoms, health and well-being; secure messaging between patients and hospital-based nurse navigators; and access to specific HF and CRC health-related information. The control group will receive routine care. Data collection will take place before the intervention (baseline), at the end of the intervention (Post-1), and at six months (Post-2). The primary outcome will be self-efficacy in self-care. The secondary outcomes will include measures of burden of treatment, health-related quality of life and 30- and 90-day readmissions. Sub-study analyses are planned in the HF patient population with primary outcomes of self-care behaviour and secondary outcomes of medication adherence, and readmission at 30 days, 90 days and 6 months. Patients' and nurse navigators' engagement and experiences with the eHealth intervention and cost-effectiveness will be investigated. Data will be analysed according to intention-to-treat principles. Qualitative data will be analysed using thematic analysis. DISCUSSION: This protocol will examine the effects of the eHealth@ Hospital-2-Home intervention on self-care in two prevalent patient groups, HF and CRC. It will allow the exploration of a generic framework for an eHealth intervention after hospital discharge, which could be adapted to other patient groups, upscaled, and implemented into clinical practice. TRIAL REGISTRATION: Clinical trials.gov (ID 301472).

The Costs of Implementing a Conversation Aid for Uterine Fibroids in Multiple Health Care Settings.

BACKGROUND: Health care organizations considering adopting a conversation aid (CA), a type of patient decision aid innovation, need information about the costs of implementation. OBJECTIVES: The aims of this study were to: (1) calculate the costs of introducing a CA in a study of supported implementation in 5 gynecologic settings that manage individuals diagnosed with uterine fibroids and (2) estimate the potential costs of future clinical implementation efforts in hypothetical settings. RESEARCH DESIGN: We used time-driven activity-based costing to estimate the costs of CA implementation at multiple steps: integration with an electronic health record, preimplementation, implementation, and sustainability. We then estimated costs for 2 disparate hypothetical implementation scenarios. SUBJECTS AND DATA COLLECTION: We conducted semistructured interviews with participants and examined internal documentation. RESULTS: We interviewed 41 individuals, analyzed 51 documents and 100 emails. Overall total implementation costs over ∼36 months of activities varied significantly across the 5 settings, ranging from $14,157 to $69,134. Factors influencing costs included size/complexity of the setting, urban/rural location, practice culture, and capacity to automate patient identification. Initial investments were substantial, comprising mostly personnel time. Settings that embedded CA use into standard workflows and automated identification of appropriate patients had the lowest initial investment and sustainability costs. Our estimates of the costs of sustaining implementation were much lower than initial investments and mostly attributable to CA subscription fees. CONCLUSION: Initiation and implementation of the interventions require significant personnel effort. Ongoing costs to maintain use are much lower and are a small fraction of overall organizational operating costs.

Decision making in metoidioplasty and phalloplasty gender-affirming surgery: a mixed methods study.

BACKGROUND: Gender-affirming surgical procedures, such as metoidioplasty and phalloplasty for those assigned female at birth, are complex and multistaged and involve risks. Individuals considering these procedures experience greater uncertainty or decisional conflict, compounded by difficulty finding trustworthy information. AIM: (1) To explore the factors contributing to decisional uncertainty and the needs of individuals considering metoidioplasty and phalloplasty gender-affirming surgery (MaPGAS) and (2) to inform development of a patient-centered decision aid. METHODS: This cross-sectional study was based on mixed methods. Adult transgender men and nonbinary individuals assigned female at birth at various stages of MaPGAS decision making were recruited from 2 study sites in the United States to participate in semistructured interviews and an online gender health survey, which included measures of gender congruence, decisional conflict, urinary health, and quality of life. Trained qualitative researchers conducted all interviews with questions to explore constructs from the Ottawa decision support framework. OUTCOMES: Outcomes included goals and priorities for MaPGAS, expectations, knowledge, and decisional needs, as well as variations in decisional conflict by surgical preference, surgical status, and sociodemographic variables. RESULTS: We interviewed 26 participants and collected survey data from 39 (24 interviewees, 92%) at various stages of MaPGAS decision making. In surveys and interviews, affirmation of gender identity, standing to urinate, sensation, and the ability to "pass" as male emerged as highly important factors for deciding to undergo MaPGAS. A third of survey respondents reported decisional conflict. Triangulation of data from all sources revealed that conflict emerged most when trying to balance the strong desire to resolve gender dysphoria through surgical transition against the risks and unknowns in urinary and sexual function, appearance, and preservation of sensation post-MaPGAS. Insurance coverage, age, access to surgeons, and health concerns further influenced surgery preferences and timing. CLINICAL IMPLICATIONS: The findings add to the understanding of decisional needs and priorities of those considering MaPGAS while revealing new complexities among knowledge, personal factors, and decisional uncertainty. STRENGTHS AND LIMITATIONS: This mixed methods study was codeveloped by members of the transgender and nonbinary community and yielded important guidance for providers and individuals considering MaPGAS. The results provide rich qualitative insights for MaPGAS decision making in US contexts. Limitations include low diversity and sample size; both are being addressed in work underway. CONCLUSIONS: This study increases understanding of the factors important to MaPGAS decision making, and results are being used to guide development of a patient-centered surgical decision aid and informed survey revision for national distribution.

The impact of adding cost information to a conversation aid to support shared decision making about low-risk prostate cancer treatment: Results of a stepped-wedge cluster randomised trial.

BACKGROUND: Decision aids help patients consider the benefits and drawbacks of care options but rarely include cost information. We assessed the impact of a conversation-based decision aid containing information about low-risk prostate cancer management options and their relative costs. METHODS: We conducted a stepped-wedge cluster randomised trial in outpatient urology practices within a US-based academic medical center. We randomised five clinicians to four intervention sequences and enroled patients newly diagnosed with low-risk prostate cancer. Primary patient-reported outcomes collected postvisit included the frequency of cost conversations and referrals to address costs. Other patient-reported outcomes included: decisional conflict postvisit and at 3 months, decision regret at 3 months, shared decision-making postvisit, financial toxicity postvisit and at 3 months. Clinicians reported their attitudes about shared decision-making pre- and poststudy, and the intervention's feasibility and acceptability. We used hierarchical regression analysis to assess patient outcomes. The clinician was included as a random effect; fixed effects included education, employment, telehealth versus in-person visit, visit date, and enrolment period. RESULTS: Between April 2020 and March 2022, we screened 513 patients, contacted 217 eligible patients, and enroled 117/217 (54%) (51 in usual care, 66 in the intervention group). In adjusted analyses, the intervention was not associated with cost conversations (ß = .82, p = .27), referrals to cost-related resources (ß = -0.36, p = .81), shared decision-making (ß = -0.79, p = .32), decisional conflict postvisit (ß = -0.34, p= .70), or at follow-up (ß = -2.19, p = .16), decision regret at follow-up (ß = -9.76, p = .11), or financial toxicity postvisit (ß = -1.32, p = .63) or at follow-up (ß = -2.41, p = .23). Most clinicians and patients had positive attitudes about the intervention and shared decision-making. In exploratory unadjusted analyses, patients in the intervention group experienced more transient indecision (p < .02) suggesting increased deliberation between visit and follow-up. DISCUSSION: Despite enthusiasm from clinicians, the intervention was not significantly associated with hypothesised outcomes, though we were unable to robustly test outcomes due to recruitment challenges. Recruitment at the start of the COVID-19 pandemic impacted eligibility, sample size/power, study procedures, and increased telehealth visits and financial worry, independent of the intervention. Future work should explore ways to support shared decision-making, cost conversations, and choice deliberation with a larger sample. Such work could involve additional members of the care team, and consider the detail, quality, and timing of addressing these issues. PATIENT OR PUBLIC CONTRIBUTION: Patients and clinicians were engaged as stakeholder advisors meeting monthly throughout the duration of the project to advise on the study design, measures selected, data interpretation, and dissemination of study findings.

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 ).

Is Shared Decision-making Associated with Better Patient-reported Outcomes? A Longitudinal Study of Patients Undergoing Total Joint Arthroplasty.

BACKGROUND: Although shared decision-making (SDM) has knowledge and satisfaction benefits for patients and is promising, we lack data demonstrating that SDM is associated with better patient-reported functional outcomes. Such data would support the integration and prioritization of SDM into all aspects of orthopaedic care. QUESTIONS/PURPOSES: (1) Is a measure of SDM before total joint arthroplasty associated with better patient-reported outcome measures (PROMs) 1 year postoperatively? (2) What is the relationship between the measure of SDM and two measures of patient experience (patient rating of the provider and patient likelihood of recommending the provider) at 1 year postoperatively? METHODS: In this observational longitudinal survey-based study, patients receiving an initial THA or TKA from a large, multispecialty medical group in the Midwestern United States were surveyed after they were scheduled for surgery and again at 12 months after their procedure. The three-item collaboRATE measure of SDM was added to existing patient surveys of PROMs. However, the surgeons and their department had no organized approach to SDM during this time. The surveys also included the Oxford knee or hip score and two validated measures of patient experience (patient rating of the provider and whether a patient would recommend the provider). Of the 2779 eligible primary joint arthroplasties that occurred from April 23, 2018 to May 1, 2019, 48% (1334 procedures; 859 TKAs and 485 THAs) of the patients responded to both the preoperative and 12-month postoperative surveys. Most of the patients who were included in the analytic sample were white (93%; 1255 of 1344), with only 3% (37) using Medicaid benefits at the time of surgery. Differences between responders and nonresponders were present and explored in an analysis. Patient responses were analyzed in regression models to estimate the association between preoperative collaboRATE scores and the Oxford knee or hip scores, and patient experience measures 12 months postoperatively. RESULTS: There was a moderate, positive association between preoperative collaboRATE scores and the Oxford scores at 12 months, after adjustment for potential confounders such as patient age and preoperative functional score (ß = 0.58; 95% CI 0.14-1.02; p = 0.01). Similarly, patients with preoperative collaboRATE scores had marginally higher patient experience scores at 12 months postoperatively (ß = 0.14; 95% CI 0.05-0.24; p = 0.003) and were more likely to recommend their surgeon (OR 1.43; 95% CI 1.11-1.84; p = 0.005). The patient experience measures were also modestly correlated with collaboRATE scores in cross-sectional associations, both preoperatively and at 12 months postoperatively (0.29 ≤ r ≤ 0.54; p < 0.01). CONCLUSION: The association between preoperative collaboRATE scores and Oxford hip or knee scores suggests that SDM could be one tool to encourage better outcomes. Although previous studies have shown that SDM can improve patient experience, the lack of a strong correlation in our study suggests that PROMs and experience measures are separate domains, at least partly. Improving preoperative SDM between the surgeon and patient might help improve surgical outcomes for patients undergoing TKA and THA. LEVEL OF EVIDENCE: Level II, therapeutic study.

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.

Cardiology providers' recommendations for treatments and use of patient decision aids for multivessel coronary artery disease.

BACKGROUND: Rates of recommending percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) vary across clinicians. Whether clinicians agree on preferred treatment options for multivessel coronary artery disease patients has not been well studied. METHODS AND RESULTS: We distributed a survey to 104 clinicians from the Northern New England Cardiovascular Study Group through email and at a regional meeting with 88 (84.6%) responses. The survey described three clinical vignettes of multivessel coronary artery disease patients. For each patient vignette participants selected appropriate treatment options and whether they would use a patient decision aid. The likelihood of choosing PCI only or PCI/CABG over CABG only was modeled using a multinomial regression. Across all vignettes, participants selected CABG only as an appropriate treatment option 24.2% of the time, PCI only 25.4% of the time, and both CABG or PCI as appropriate treatment options 50.4% of the time. Surgeons were less likely to choose PCI over CABG (RR 0.14, 95% CI 0.03, 0.59) or both treatments over CABG only (RR 0.10, 95% CI 0.03, 0.34) relative to cardiologists. Overall, 65% of participants responded they would use a patient decision aid with each vignette. CONCLUSIONS: There is a lack of consensus on the appropriate treatment options across cardiologists and surgeons for patients with multivessel coronary artery disease. Treatment choice is influenced by both patient characteristics and clinician specialty.

Development and piloting of four decision aids for implantable cardioverter-defibrillators in different media formats.

BACKGROUND: Using DAs for preference-sensitive decisions is an evidence-based way to improve patient-centered decisions. Reimbursement mandates have increased the need for DAs in ICD care, although none have been formally evaluated. The objectives were to develop and pilot implantable cardioverter-defibrillator (ICD) decision aids (DAs) for patients considering primary prevention ICDs. METHODS: Development Phase: An expert panel, including patients and physicians, iteratively developed four DAs: a one-page Option GridTM conversation aid, a four-page in-depth paper tool, a 17-minute video, and an interactive website. Trial Phase: At three sites, patients with heart failure who were eligible for primary prevention ICDs were randomly assigned 2:1 to intervention (received DAs) or control (usual care). We conducted a mixed-methods evaluation exploring acceptability and feasibility. RESULTS: Twenty-one eligible patients enrolled (15 intervention). Most intervention participants found the DAs to be unbiased (67%), helpful (89%), and would recommend them to others (100%). The pilot was feasible at all sites; however, using clinic staff to identify eligible patients was more efficient than chart review. Although the main goals were to measure acceptability and feasibility, intervention participants trended towards increased concordance between longevity values and ICD decisions (71% concordant vs. 29%, p = .06). Participants preferred the in-depth paper tool and video DAs. Access to a nurse during the decision-making window encouraged questions and improved participant-perceived confidence. CONCLUSIONS: Participants felt the DAs provided helpful, balanced information that they would recommend to other patients. Further exploration of this larger context of DA use and strategies to promote independent use related to electrophysiology (EP) visits are needed.

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.

The role of co-production in Learning Health Systems.

BACKGROUND: Co-production of health is defined as 'the interdependent work of users and professionals who are creating, designing, producing, delivering, assessing, and evaluating the relationships and actions that contribute to the health of individuals and populations'. It can assume many forms and include multiple stakeholders in pursuit of continuous improvement, as in Learning Health Systems (LHSs). There is increasing interest in how the LHS concept allows integration of different knowledge domains to support and achieve better health. Even if definitions of LHSs include engaging users and their family as active participants in aspects of enabling better health for individuals and populations, LHS descriptions emphasize technological solutions, such as the use of information systems. Fewer LHS texts address how interpersonal interactions contribute to the design and improvement of healthcare services. OBJECTIVE: We examined the literature on LHS to clarify the role and contributions of co-production in LHS conceptualizations and applications. METHOD: First, we undertook a scoping review of LHS conceptualizations. Second, we compared those conceptualizations to the characteristics of LHSs first described by the US Institute of Medicine. Third, we examined the LHS conceptualizations to assess how they bring four types of value co-creation in public services into play: co-production, co-design, co-construction and co-innovation. These were used to describe core ideas, as principles, to guide development. RESULT: Among 17 identified LHS conceptualizations, 3 qualified as most comprehensive regarding fidelity to LHS characteristics and their use in multiple settings: (i) the Cincinnati Collaborative LHS Model, (ii) the Dartmouth Coproduction LHS Model and (iii) the Michigan Learning Cycle Model. These conceptualizations exhibit all four types of value co-creation, provide examples of how LHSs can harness co-production and are used to identify principles that can enhance value co-creation: (i) use a shared aim, (ii) navigate towards improved outcomes, (iii) tailor feedback with and for users, (iv) distribute leadership, (v) facilitate interactions, (vi) co-design services and (vii) support self-organization. CONCLUSIONS: The LHS conceptualizations have common features and harness co-production to generate value for individual patients as well as for health systems. They facilitate learning and improvement by integrating supportive technologies into the sociotechnical systems that make up healthcare. Further research on LHS applications in real-world complex settings is needed to unpack how LHSs are grown through coproduction and other types of value co-creation.

Integrating Option Grid Patient Decision Aids in the Epic Electronic Health Record: Case Study at 5 Health Systems.

BACKGROUND: Some researchers argue that the successful implementation of patient decision aids (PDAs) into clinical workflows depends on their integration into electronic health records (EHRs). Anecdotally, we know that EHR integration is a complex and time-consuming task; yet, the process has not been examined in detail. As part of an implementation project, we examined the work involved in integrating an encounter PDA for symptomatic uterine fibroids into Epic EHR systems. OBJECTIVE: This study aims to identify the steps and time required to integrate a PDA into the Epic EHR system and examine facilitators and barriers to the integration effort. METHODS: We conducted a case study at 5 academic medical centers in the United States. A clinical champion at each institution liaised with their Epic EHR team to initiate the integration of the uterine fibroid Option Grid PDAs into clinician-facing menus. We scheduled regular meetings with the Epic software analysts and an expert Epic technologist to discuss how best to integrate the tools into Epic for use by clinicians with patients. The meetings were then recorded and transcribed. Two researchers independently coded the transcripts and field notes before categorizing the codes and conducting a thematic analysis to identify the facilitators and barriers to EHR integration. The steps were reviewed and edited by an Epic technologist to ensure their accuracy. RESULTS: Integrating the uterine fibroid Option Grid PDA into clinician-facing menus required an 18-month timeline and a 6-step process, as follows: task priority negotiation with Epic software teams, security risk assessment, technical review, Epic configuration; troubleshooting, and launch. The key facilitators of the process were the clinical champions who advocated for integration at the institutional level and the presence of an experienced technologist who guided Epic software analysts during the build. Another facilitator was the use of an emerging industry standard app platform (Health Level 7 Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources) as a means of integrating the Option Grid into existing systems. This standard platform enabled clinicians to access the tools by using single sign-on credentials and prevented protected health information from leaving the EHR. Key barriers were the lack of control over the Option Grid product developed by EBSCO (Elton B Stephens Company) Health; the periodic Epic upgrades that can result in a pause on new software configurations; and the unforeseen software problems with Option Grid (ie, inability to print the PDA), which delayed the launch of the PDA. CONCLUSIONS: The integration of PDAs into the Epic EHR system requires a 6-step process and an 18-month timeline. The process required support and prioritization from a clinical champion, guidance from an experienced technologist, and a willing EHR software developer team.

An Audio Personal Health Library of Clinic Visit Recordings for Patients and Their Caregivers (HealthPAL): User-Centered Design Approach.

BACKGROUND: Providing digital recordings of clinic visits to patients has emerged as a strategy to promote patient and family engagement in care. With advances in natural language processing, an opportunity exists to maximize the value of visit recordings for patients by automatically tagging key visit information (eg, medications, tests, and imaging) and linkages to trustworthy web-based resources curated in an audio-based personal health library. OBJECTIVE: This study aims to report on the user-centered development of HealthPAL, an audio personal health library. METHODS: Our user-centered design and usability evaluation approach incorporated iterative rounds of video-recorded sessions from 2016 to 2019. We recruited participants from a range of community settings to represent older patient and caregiver perspectives. In the first round, we used paper prototypes and focused on feature envisionment. We moved to low-fidelity and high-fidelity versions of the HealthPAL in later rounds, which focused on functionality and use; all sessions included a debriefing interview. Participants listened to a deidentified, standardized primary care visit recording before completing a series of tasks (eg, finding where a medication was discussed in the recording). In the final round, we recorded the patients' primary care clinic visits for use in the session. Findings from each round informed the agile software development process. Task completion and critical incidents were recorded in each round, and the System Usability Scale was completed by participants using the digital prototype in later rounds. RESULTS: We completed 5 rounds of usability sessions with 40 participants, of whom 25 (63%) were women with a median age of 68 years (range 23-89). Feedback from sessions resulted in color-coding and highlighting of information tags, a more prominent play button, clearer structure to move between one's own recordings and others' recordings, the ability to filter recording content by the topic discussed and descriptions, 10-second forward and rewind controls, and a help link and search bar. Perceived usability increased over the rounds, with a median System Usability Scale of 78.2 (range 20-100) in the final round. Participants were overwhelmingly positive about the concept of accessing a curated audio recording of a clinic visit. Some participants reported concerns about privacy and the computer-based skills necessary to access recordings. CONCLUSIONS: To our knowledge, HealthPAL is the first patient-centered app designed to allow patients and their caregivers to access easy-to-navigate recordings of clinic visits, with key concepts tagged and hyperlinks to further information provided. The HealthPAL user interface has been rigorously co-designed with older adult patients and their caregivers and is now ready for further field testing. The successful development and use of HealthPAL may help improve the ability of patients to manage their own care, especially older adult patients who have to navigate complex treatment plans.

Evaluation of a shared decision-making strategy with online decision aids in surgical and orthopaedic practice: study protocol for the E-valuAID, a multicentre study with a stepped-wedge design.

BACKGROUND: Inguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness. METHODS: The E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician's knowledge and preference and the patient's preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months. DISCUSSION: The E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective. TRIAL REGISTRATION: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318 .

Assessing Patients' Perceptions of Clinician Communication: Acceptability of Brief Point-of-Care Surveys in Primary Care.

BACKGROUND: Improving patient-centered (PC) communication is a priority in many healthcare organizations. Most PC communication metrics are distal to the care encounter and lack clear attribution, thereby reducing relevance for leaders and clinicians. OBJECTIVE: We assessed the acceptability of measuring PC communication at the point-of-care. DESIGN: A brief patient survey was conducted immediately post-primary care appointments at one Veterans Affairs Medical Center. Audit-feedback reports were created for clinicians and discussed in qualitative interviews. PARTICIPANTS: A total of 485 patients completed the survey. Thirteen interviews were conducted with clinicians and hospital leaders. MAIN MEASURE(S): Measures included collaboRATE (a 3-item tool measuring PC communication), a question about how well needs were met, and overall visit satisfaction. Data were analyzed using descriptive statistics to characterize the mean and distribution of collaboRATE scores and determine the proportion of patients giving clinicians a "top score" on each item. Associations among responses were examined. Interviews focused on the value of measuring PC communication and were analyzed using a framework approach. KEY RESULTS: The proportion of patients giving PC communication "top scores" ranged from 41 to 92% for 16 clinicians who had ≥ 25 completed surveys. Among patients who gave "top scores" for PC communication, the odds of reporting that needs were "completely met" were 10.8 times higher (p < .001) and the odds of reporting being "very satisfied" with their care were 13.3 times higher (p < .001) compared with patients who did not give "top scores." Interviewees found clinician-specific feedback useful; concerns included prioritizing this data when other measures are used to evaluate clinicians' performance. Difficulties improving PC communication given organizational structures were noted. Recommendations for interventions included peer-to-peer education and mentoring by top-scoring clinicians. CONCLUSIONS: Assessing provider communication at the point-of-care is acceptable and useful to clinicians. Challenges remain to properly incentivize and support the use of this data for improving PC communication.

The association between patients' preferred treatment after the use of a patient decision aid and their choice of eventual treatment.

OBJECTIVE: To investigate the association between patients' preferred treatment and eventual treatment. Second, to compare patients with surgical treatment to watchful waiting in order to identify predictive factors for surgery. METHODS: A single-centre retrospective study was performed between December 2015 and August 2018. Patients (≥18 years) who used a patient decision aid (PDA) for gallstones or inguinal hernia were included. After their first surgical consultation, patients received access to an online PDA. The patients' preferred treatment after the PDA was compared with their choice of eventual treatment. Multivariable regression analyses were performed for predictive factors for surgery. RESULTS: In total, 567 patients with gallstones and 585 patients with an inguinal hernia were included. Of the patients with gallstones, 121 (21%) preferred watchful waiting, 367 (65%) preferred surgery, and 79 (14%) were not sure. The patients' preferred treatment was performed in 85.9%. Frequent pain attacks (OR 2.1, 95% CI 1.1-3.9, P = .020) and preference for surgery (OR 4.4, 95% CI 1.9-10.1, P = .001) independently predicted surgery. Of the patients with an inguinal hernia, 77 (13.2%) preferred watchful waiting, 452 (78.8%) preferred surgery, and 56 (9.6%) were not sure. The patients' preferred treatment was performed in 86.0%. The preference for surgery (OR 5.2, 95% CI 2.5-10.6, P < .001) independently predicted surgery and worry about complications predicted avoidance of surgery (OR 0.5, 95% CI 0.2-1.0, P = .037). CONCLUSION: This study, reflecting current clinical care, shows that patients' preferred treatment after using a PDA matches their eventual treatment choice in 86% of patients with gallstones or an inguinal hernia. In these patients, symptoms and patients' preference for surgery independently predicts eventual choice of surgery.