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.

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.

Work- and school-related distress among patients with cancer: Single-site retrospective chart review.

OBJECTIVES: To (1) describe the prevalence of work- or school-related distress among patients with cancer and (2) compare overall distress among those impacted at work or school to overall distress among those not impacted at work or school. DESIGN: Retrospective chart review. PARTICIPANTS: All patients visiting the study site March 2016-December 2020 who completed the NCCN Distress Thermometer and Problem List. METHODS: Descriptive statistics examined work- or school-related distress across patient characteristics and compared mean Distress Thermometer scores between patients with and without work- or school-related distress. FINDINGS: Among 1,760 unique patients, 7.5% reported work- or school-related distress at one or more visits. Rates were highest among patients seen for neurological (14.1%), skin (10.6%), and gastrointestinal (9.2%) cancers. Those reporting work- or school-related distress had higher overall distress scores (mean = 4.76; SD = 2.52) than others (mean = 3.37; SD = 2.92) (g=-0.482; t=-5.327, p < 0.001). CONCLUSIONS: Although the prevalence of work- or school-related distress was low in this sample, the magnitude of this distress emphasizes the importance of having effective resources available for patients with cancer who experience work- or school-related problems. IMPLICATIONS: More research is needed to understand how well distress screening processes identify and support patients with work- or school-related problems.

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.

Coproducing value during the COVID-19 pandemic.

Service users, professionals, and civil society all contribute to public health. Inclusion of all relevant actors in a network community coproduction approach can improve public health crisis responses. Using the Swiss canton of Vaud's COVID-19 response as an example, we describe ways in which a network approach can add value to public health services.

Initial development of a self-assessment approach for coproduction value creation by an international community of practice.

BACKGROUND: Coproduction offers a new way of conceptualizing healthcare as a service that is co-created by people (health professionals and people seeking health services) rather than a product that is generated by providers or health systems and delivered to patients. This offers new possibilities for those introducing and testing changes, and it enables additional ways of creating value. Fjeldstad and colleagues describe the architecture of several kinds of value creating systems: (i) Chain; (ii) Shop; (iii) Network and (iv) Access. An international Value Creating Business Model Community of practice (VCBM CoP) was formed by the International Coproduction of Health Network and explored these types of systems and developed a self-assessment guide for health systems to use to assess value. METHODS: An international community of practice comprising leaders, clinicians, patients and finance specialists representing 12 health systems from four countries (USA, UK, Israel and Sweden) met monthly for 1 year and used a semi-structured process to iteratively refine and adapt Fjeldstad's model for use in healthcare and develop a draft self-assessment guide. The process concluded with initial focus group user experience sessions with six health systems. RESULTS: The community of practice successfully completed a 1-year journey of discovery, development and learning, resulting in two products: (1) a full-version self-assessment guide (detailed) and (2) an abbreviated 'short-form' of the guide. Initial focus-group results suggest that there is initial perceived feasibility, acceptability and utility of the guides and that further development and research is reasonable to pursue. Results suggest significant variation and context specificity in the use of the guide, simple and complex knowledge transfer applications in use, and the need for the development of simple and technology supported versions for use in the future. CONCLUSION: The VCBM CoP has successfully completed a 1-year collaborative learning cycle, resulting in the development of a self-assessment guide that is now ready for additional investigation using formal research methods. The CO-VALUE study has been designed to build on the work of the CoP and includes qualitative and quantitative assessment phases and a concept mapping study.

A starter's guide to learning and teaching how to coproduce healthcare services.

BACKGROUND: There has been insufficient attention paid to the role of learning in co-production-both how service users and professional service providers learn to co-produce effectively and how the lessons of co-production are captured at a service level. OBJECTIVE: We aimed to develop and test a curriculum to support healthcare professionals' interest in learning how to co-produce health and healthcare services with patients. METHODS: We developed a co-production curriculum that was tested iteratively in multiple in-person and virtual teaching sessions and short courses. We conducted a formative evaluation of the co-production curriculum and teaching tools to tailor the curriculum. RESULTS: Several theories underpin our approach to learning and teaching how to co-produce healthcare services. The co-production curriculum is grounded in systems theory and shares elements of educational theories, namely, the postmodern curriculum matrix, the actor network theory and situated learning in communities of practice. Learning participants valued the sense of community, the experiential learning environment, and the practical methods to support their exploration of co-production. CONCLUSION: This paper summarizes the educational theories that underpin our efforts to develop and implement the curriculum, reports on a formative assessment conducted with learners, and makes recommendations for creating an environment for learning how health professionals can co-produce health and healthcare with patients.

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.

Using CollaboRATE, a brief patient-reported measure of shared decision making: Results from three clinical settings in the United States.

INTRODUCTION: CollaboRATE is a brief patient survey focused on shared decision making. This paper aims to (i) provide insight on facilitators and challenges to implementing a real-time patient survey and (ii) evaluate CollaboRATE scores and response rates across multiple clinical settings with varied patient populations. METHOD: All adult patients at three United States primary care practices were eligible to complete CollaboRATE post-visit. To inform key learnings, we aggregated all mentions of unanticipated decisions, problems and administration errors from field notes and email communications. Mixed-effects logistic regression evaluated the impact of site, clinician, patient age and patient gender on the CollaboRATE score. RESULTS: While CollaboRATE score increased only slightly with increasing patient age (OR 1.018, 95% CI 1.014-1.021), female patient gender was associated with significantly higher CollaboRATE scores (OR 1.224, 95% CI 1.073-1.397). Clinician also predicts CollaboRATE score (random effect variance 0.146). Site-specific factors such as clinical workflow and checkout procedures play a key role in successful in-clinic implementation and are significantly related to CollaboRATE scores, with Site 3 scoring significantly higher than Site 1 (OR 1.759, 95% CI 1.216 to 2.545) or Site 2 (z=-2.71, 95% CI -1.114 to -0.178). DISCUSSION: This study demonstrates that CollaboRATE can be used in diverse primary care settings. A clinic's workflow plays a crucial role in implementation. Patient experience measurement risks becoming a burden to both patients and administrators. Episodic use of short measurement tools could reduce this burden.

Patient-Centered Organizational Statements: Merely Rhetoric? A Survey of Health Care Leaders.

Health care organizations have embraced the concept of patient-centered care, but there is concern that the mere inclusion of those words in mission and value statements does not equate to implementation at the health care delivery level. Despite initiatives to align the patient-clinician encounter with broader patient-centered values, there have been mixed results, often creating a gap between practice and the organization's stated position. This preliminary study aims to assess the extent to which patient-centered values are reflected in actual patient care. The survey was sent electronically to Dartmouth's Masters in Health Care Delivery Science alumni, leaders in health care management. A majority of 49 survey respondents acknowledged the importance of patient-centered values to their organizations. However, 90% of respondents identified a gap between patient-centered values and day-to-day patient care. Thematic analysis of respondent comments showed a misalignment of organizational incentives with patient-centered care, a lack of leadership priority given to patient-centered values, and a failure to clearly define patient-centered values. Quantitative and qualitative data indicated that patient-centered statements represented rhetoric rather than the reality of patient care. Consistently achieving patient-centered care will require leaders to adopt a systematic approach to move beyond rhetoric.

Strategies to support cancer survivors at work: content analysis of cancer survivor, healthcare provider, and employer perspectives.

PURPOSE: To (1) describe the challenges identified by cancer survivors, healthcare providers, and employers related to work maintenance and optimization during and after cancer treatment and (2) identify strategies that can address those challenges. METHODS: We conducted content analysis of semi-structured interview data collected from cancer survivors, healthcare providers, and employers regarding workplace challenges that cancer survivors face and strategies to address them. Challenges and strategies were summarized according to whether they related to the cancer survivor, the work demands, or the work environment. RESULTS: Forty-five total participants identified challenges and strategies primarily related to the cancer survivor's signs and symptoms of treatment. Healthcare providers (n = 17) focused primarily on challenges and strategies related to the cancer survivor, while employers (n = 5) focused on the work environment-especially policies and procedures that facilitate time off work and the importance of bidirectional communication between cancer survivors and employers. Cancer survivors (n = 23) identified challenges and suggestions in all three categories, though they uniquely focused on challenges relating to work demands and adjustments to those demands that would facilitate employment maintenance. CONCLUSIONS: Efforts to address the many challenges that cancer survivors experience at work should include the views of cancer survivors, healthcare providers, and employers reflecting their respective domains of expertise in work demands, cancer survivors' medical care, and the work environment. IMPLICATIONS FOR CANCER SURVIVORS: Survivors and healthcare providers are able to address many side effects that can create work challenges, but improved collaboration between survivors and employers may identify ways to modify work demands and environments to maximize employment maintenance.

17O solid-state NMR as a sensitive probe of hydrogen bonding in crystalline and amorphous solid forms of diflunisal.

(17)O solid-state NMR (SSNMR) can provide insight into hydrogen bonding interactions in pharmaceutical polymorphs, cocrystals, and amorphous dispersions. When combined with straightforward (17)O synthetic labeling, the use of (17)O SSNMR allows for direct study of key interactions such as hydrogen bonding in these systems. In this work, novel applications of (17)O SSNMR are demonstrated in the analysis of a polymorph of diflunisal, a cocrystal of diflunisal with pyrazinamide, and amorphous dispersions of diflunisal in two polymers. The observation of the (17)O nucleus is shown to be a highly specific and useful alternative to more conventional studies of the (1)H, (13)C, and (19)F nuclei in these systems and offers unique insight into hydrogen bonding interactions. Quantum chemical calculations are used to assess the (17)O SSNMR measurements for the polymorph of diflunisal for which a crystal structure has been previously determined. Empirical hydrogen bonding trends are then examined in the cocrystal and amorphous solid forms using (17)O NMR parameters. A novel application of (1)H-(17)O cross-polarization heteronuclear correlation (CP-HETCOR) experiments is also demonstrated for the cocrystal and two dispersions. This experiment offers specific information about proton environments in proximity to the labeled oxygen sites. The use of (17)O SSNMR techniques extends the utility of SSNMR in applications to cocrystals and amorphous dispersions.

Discussing Cost and Value in Patient Decision Aids and Shared Decision Making: A Call to Action.

Direct and indirect costs of care influence patients' health choices and the ability to implement those choices. Despite the significant impact of care costs on patients' health and daily lives, patient decision aid (PtDA) and shared decision-making (SDM) guidelines almost never mention a discussion of costs of treatment options as part of minimum standards or quality criteria. Given the growing study of the impact of costs in health decisions and the rising costs of care more broadly, in fall 2021 we organized a symposium at the Society for Medical Decision Making's annual meeting. The focus was on the role of cost information in PtDAs and SDM. Panelists gave an overview of work in this space at this virtual meeting, and attendees engaged in rich discussion with the panelists about the state of the problem as well as ideas and challenges in incorporating cost-related issues into routine care. This article summarizes and extends our discussion based on the literature in this area and calls for action. We recommend that PtDA and SDM guidelines routinely include a discussion of direct and indirect care costs and that researchers measure the frequency, quality, and response to this information.

Exploring Acceptability of Employment Interventions to Support People Living With Cancer: Qualitative Study of Cancer Survivors, Health Care Providers, and Employers.

BACKGROUND: Employment contributes to cancer survivors' quality of life, but this population faces a variety of challenges when working during and after treatment. Factors associated with work outcomes among cancer survivors include disease and treatment status, work environment, and social support. While effective employment interventions have been developed in other clinical contexts, existing interventions have demonstrated inconsistent effectiveness in supporting cancer survivors at work. We conducted this study as a preliminary step toward program development for employment support among survivors at a rural comprehensive cancer center. OBJECTIVE: We aimed (1) to identify supports and resources that stakeholders (cancer survivors, health care providers, and employers) suggest may help cancer survivors to maintain employment and (2) to describe stakeholders' views on the advantages and disadvantages of intervention delivery models that incorporate those supports and resources. METHODS: We conducted a descriptive study collecting qualitative data from individual interviews and focus groups. Participants included adult cancer survivors, health care providers, and employers living or working in the Vermont-New Hampshire catchment area of the Dartmouth Cancer Center in Lebanon, New Hampshire. We grouped interview participants' recommended supports and resources into 4 intervention delivery models, which ranged on a continuum from less to more intensive to deliver. We then asked focus group participants to discuss the advantages and disadvantages of each of the 4 delivery models. RESULTS: Interview participants (n=45) included 23 cancer survivors, 17 health care providers, and 5 employers. Focus group participants (n=12) included 6 cancer survivors, 4 health care providers, and 2 employers. The four delivery models were (1) provision of educational materials, (2) individual consultation with cancer survivors, (3) joint consultation with both cancer survivors and their employers, and (4) peer support or advisory groups. Each participant type acknowledged the value of providing educational materials, which could be crafted to improve accommodation-related interactions between survivors and employers. Participants saw usefulness in individual consultation but expressed concern about the costs of program delivery and potential mismatches between consultant recommendations and the limits of what employers can provide. For joint consultation, employers liked being part of the solution and the possibility of enhanced communication. Potential drawbacks included additional logistical burden and its perceived generalizability to all types of workers and workplaces. Survivors and health care providers viewed the efficiency and potency of peer support as benefits of a peer advisory group but acknowledged the sensitivity of financial topics as a possible disadvantage of addressing work challenges in a group setting. CONCLUSIONS: The 3 participant groups identified both common and unique advantages and disadvantages of the 4 delivery models, reflecting varied barriers and facilitators to their potential implementation in practice. Theory-driven strategies to address implementation barriers should play a central role in further intervention development.

Implementing shared decision making for early-stage breast cancer treatment using a coproduction learning collaborative: the SHAIR Collaborative protocol.

BACKGROUND: Shared decision making (SDM) in breast cancer care improves outcomes, but it is not routinely implemented. Results from the What Matters Most trial demonstrated that early-stage breast cancer surgery conversation aids, when used by surgeons after brief training, improved SDM and patient-reported outcomes. Trial surgeons and patients both encouraged using the conversation aids in routine care. We will develop and evaluate an online learning collaborative, called the SHared decision making Adoption Implementation Resource (SHAIR) Collaborative, to promote early-stage breast cancer surgery SDM by implementing the conversation aids into routine preoperative care. Learning collaboratives are known to be effective for quality improvement in clinical care, but no breast cancer learning collaborative currently exists. Our specific aims are to (1) provide the SHAIR Collaborative resources to clinical sites to use with eligible patients, (2) examine the relationship between the use of the SHAIR Collaborative resources and patient reach, and (3) promote the emergence of a sustained learning collaborative in this clinical field, building on a partnership with the American Society of Breast Surgeons (ASBrS). METHODS: We will conduct a two-phased implementation project: phase 1 pilot at five sites and phase 2 scale up at up to an additional 32 clinical sites across North America. The SHAIR Collaborative online platform will offer free access to conversation aids, training videos, electronic health record and patient portal integration guidance, a feedback dashboard, webinars, support center, and forum. We will use RE-AIM for data collection and evaluation. Our primary outcome is patient reach. Secondary data will include (1) patient-reported data from an optional, anonymous online survey, (2) number of active sites and interviews with site champions, (3) Normalization MeAsure Development questionnaire data from phase 1 sites, adaptations data utilizing the Framework for Reporting Adaptations and Modifications-Extended/-Implementation Strategies, and tracking implementation facilitating factors, and (4) progress on sustainability strategy and plans with ASBrS. DISCUSSION: The SHAIR Collaborative will reach early-stage breast cancer patients across North America, evaluate patient-reported outcomes, engage up to 37 active sites, and potentially inform engagement factors affecting implementation success and may be sustained by ASBrS.

"The Last Thing You Have to Worry About": A Thematic Analysis of Employment Challenges Faced by Cancer Survivors.

The evidence base for interventions that support the employment goals of cancer survivors is growing but inconclusive. As the first step in initiating a community-engaged program of research aimed at developing and testing interventions to support the employment goals of cancer survivors, 23 cancer survivors, 17 healthcare providers, and 5 employers participated in individual interviews to elicit perceptions regarding local challenges and resources related to work maintenance and optimization within the context of cancer treatment. Interviews were recorded and transcribed verbatim. A thematic analysis was conducted to identify cross-cutting experiences that were voiced by all three types of participants. Three themes were found in the data: (1) the onus for identifying and articulating work-related issues is upon the cancer survivor; (2) the main support offered to cancer survivors involved time away from work and flexibility with scheduling work and treatment activities; and (3) participants voiced a lack of information regarding one or more aspects related to supporting employment goals of cancer survivors. Supportive resources designed for cancer survivors, employers, and/or healthcare providers are needed to help cancer survivors optimize their employment situations.

Assessing Shared Decision-Making in Cystic Fibrosis Care Using collaboRATE: A Cross-Sectional Study of 159 Programs.

There are numerous opportunities for shared decision-making (SDM) in cystic fibrosis (CF) care, yet little is known about patients' SDM experiences. This study evaluated SDM across 159 CF care programs (4024 participants) in the United States. Shared decision-making was assessed using the patient-reported collaboRATE measure, which was included in the CF Foundation's Patient and Family Experience of Care Survey over 18 months. Overall, 69% of respondents reported experiencing SDM. Respondents at pediatric programs were more likely to experience SDM than those at adult programs (72% vs 67%, P < .001). Multivariable logistic regression analyses showed a relationship between SDM and patient age, whereby SDM was less likely to occur with patients aged 18 to 24 years, compared to some younger and older age groups (P = .02-<.001). Shared decision-making was more likely to occur at pediatric programs when patients had better general health (P = .02-<.01), and at pediatric and adult programs when patients had better mental health (P = .02-<.001). Disparities in SDM experiences highlight a need to improve decision-making processes in CF care. Interventions tailored for improving SDM among specific patient populations may be particularly advantageous.

Cost talk: protocol for a stepped-wedge cluster randomized trial of an intervention helping patients and urologic surgeons discuss costs of care for slow-growing prostate cancer during shared decision-making.

BACKGROUND: Costs of care are important to patients making cancer treatment decisions, but clinicians often do not feel prepared to discuss treatment costs. We aim to (1) assess the impact of a conversation-based decision aid (Option Grid) containing cost information about slow-growing prostate cancer management options, combined with urologic surgeon training, on the frequency and quality of patient-urologic surgeon cost conversations, and (2) examine the impact of the decision aid and surgeon training on decision quality. METHODS: We will conduct a stepped-wedge cluster randomized trial in outpatient urology practices affiliated with a large academic medical center in the USA. We will randomize five urologic surgeons to four intervention sequences and enroll their patients with a first-time diagnosis of slow-growing prostate cancer independently at each period. Primary outcomes include frequency of cost conversations, initiator of cost conversations, and whether or not a referral is made to address costs. These outcomes will be collected by patient report (post-visit survey) and by observation (audio-recorded clinic visits) with consent. Other outcomes include the following: patient-reported decisional conflict post-visit and at 3-month follow-up, decision regret at 3-month follow-up, shared decision-making post-visit, communication post-visit, and financial toxicity post-visit and at 3-month follow-up; clinician-reported attitudes about shared decision-making before and after the study, and feasibility of sustained intervention use. We will use hierarchical regression analysis to assess patient-level outcomes, including urologic surgeon as a random effect to account for clustering of patient participants. DISCUSSION: This study evaluates a two-part intervention to improve cost discussions between urologic surgeons and patients when deciding how to manage slow-growing prostate cancer. Establishing the effectiveness of the strategy under study will allow for its replication in other clinical decision contexts. TRIAL REGISTRATION: ClinicalTrials.gov NCT04397016 . Registered on 21 May 2020.

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.