Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial.

INTRODUCTION: Socioeconomic disparities for breast cancer surgical care exist. Although the aetiology of the observed socioeconomic disparities is likely multifactorial, patient engagement during the surgical consult is critical. Shared decision-making may reduce health disparities by addressing barriers to patient engagement in decision-making that disproportionately impact socioeconomically disadvantaged patients. In this trial, we test the impact of a decision aid on increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making. METHODS AND ANALYSIS: This multisite randomised trial is conducted through 10 surgical clinics within the National Cancer Institute Community Oncology Research Program (NCORP). We plan a stepped-wedge design with clinics randomised to the time of transition from usual care to the decision aid arm. Study participants are female patients, aged ≥18 years, with newly diagnosed stage 0-III breast cancer who are planning breast surgery. Data collection includes a baseline surgeon survey, baseline patient survey, audio-recording of the surgeon-patient consultation, a follow-up patient survey and medical record data review. Interviews and focus groups are conducted with a subset of patients, surgeons and clinic stakeholders. The effectiveness of the decision aid at increasing patient engagement (primary outcome) is evaluated using generalised linear mixed-effects models. The extent to which the effect of the decision aid intervention on patient engagement is mediated through the mitigation of barriers is tested in joint linear structural equation models. Qualitative interviews explore how barriers impact engagement, especially for socioeconomically disadvantaged women. ETHICS AND DISSEMINATION: This protocol has been approved by the National Cancer Institute Central Institutional Review Board, and Certificate of Confidentiality has been obtained. We plan to disseminate the findings through journal publications and national meetings, including the NCORP network. Our findings will advance the science of medical decision-making with the potential to reduce socioeconomic health disparities. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03766009).

Barriers to breast reconstruction for socioeconomically disadvantaged women.

PURPOSE: Socioeconomic disparities in post-mastectomy breast reconstruction exist. Key informants have suggested that finding providers who accept Medicaid insurance and longer travel time to a plastic surgeon are important barriers. Our objective was to assess the relationship between these factors and reconstruction for socioeconomically disadvantaged women in Wisconsin. METHODS: We identified women < 75 years of age with stage 0-III breast cancer who underwent mastectomy using the Wisconsin Cancer Reporting System. Women in the most disadvantaged state-based tertile of the Area Deprivation Index were included (n = 1809). Geocoding determined turn-by-turn drive time from women's address to the nearest accredited Commission on Cancer or National Accreditation Program for Breast Centers. Multivariable logistic regression determined the relationship between reconstruction, Medicaid, and travel time, controlling for patient factors known to impact reconstruction. Average adjusted predicted probabilities of receiving reconstruction were calculated. RESULTS: Most patients had early-stage breast cancer (51% stage 0/I) and 15.2% had Medicaid. 37% of women underwent reconstruction. Socioeconomically disadvantaged women with Medicaid (OR = 0.62, 95% CI 0.46-0.84) and longer travel times (OR = 0.99, 95% CI 0.99-1.0) were less likely to receive reconstruction. Patients with the lowest predicted probability of reconstruction were those with Medicaid who lived furthest from a plastic surgeon. CONCLUSION: Among socioeconomically disadvantaged women, Medicaid and travel remained associated with lower rates of reconstruction. Further work will explore opportunities to improve access to reconstruction for women with Medicaid. This is particularly challenging as it may require socioeconomically disadvantaged women to travel further to receive care.

Perspectives of Wisconsin Providers on Factors Influencing Receipt of Post-Mastectomy Breast Reconstruction.

BACKGROUND: The objective is to determine perspectives of general surgeons, plastic surgeons, and cancer navigators on factors contributing to breast cancer patients' decision for post-mastectomy reconstruction, especially for women facing financial hardship. METHODS: We mailed Wisconsin general and plastic surgeons who performed >5 breast cancer procedures annually a survey, including a postcard inviting cancer navigators to participate. Descriptive statistics summarize item responses. McNemar's chi-squared tests evaluated surgeons' perspectives of factors influencing reconstruction for all women compared to women facing financial hardship. RESULTS: Respondents include 70 general surgeons, 18 plastic surgeons, and 9 navigators. Respondents perceived preference-related factors as important, including "does not want more surgery" (85% reported it important overall and 77% for financial hardship women) and "reconstructed breast is not important to her" (77% vs. 61%). Surgeons perceived logistical factors were more important for women facing financial hardship, including "capacity to be away from work or home responsibilities for recovery" (30% reported important overall and 60% for financial hardship women), "concerned about out-of-pocket costs" (26% vs. 57%), and "frequent visits to complete reconstruction too burdensome" (27% vs. 49%). CONCLUSION: Our findings demonstrate Wisconsin surgeons and cancer navigators perceive logistical concerns influence reconstruction decisions for women facing financial hardship.

Surgeon Use of Shared Decision-making for Older Adults Considering Major Surgery: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Because major surgery carries significant risks for older adults with comorbid conditions, shared decision-making is recommended to ensure patients receive care consistent with their goals. However, it is unknown how often shared decision-making is used for these patients. Objective: To describe the use of shared decision-making during discussions about major surgery with older adults. Design, Setting, and Participants: This study is a secondary analysis of conversations audio recorded during a randomized clinical trial of a question prompt list. Data were collected from June 1, 2016, to November 31, 2018, from 43 surgeons and 446 patients 60 years or older with at least 1 comorbidity at outpatient surgical clinics at 5 academic centers. Interventions: Patients received a question prompt list brochure that contained questions they could ask a surgeon. Main Outcomes and Measures: The 5-domain Observing Patient Involvement in Decision-making (OPTION5) score (range, 0-100, with higher scores indicating greater shared decision-making) was used to measure shared decision-making. Results: A total of 378 surgical consultations were analyzed (mean [SD] patient age, 71.9 [7.2] years; 206 [55%] male; 312 [83%] White). The mean (SD) OPTION5 score was 34.7 (20.6) and was not affected by the intervention. The mean (SD) score in the group receiving the question prompt list was 36.7 (21.2); in the control group, the mean (SD) score was 32.9 (19.9) (effect estimate, 3.80; 95% CI, -0.30 to 8.00; P = .07). Individual surgeon use of shared decision-making varied greatly, with a lowest median score of 10 (IQR, 10-20) to a high of 65 (IQR, 55-80). Lower-performing surgeons had little variation in OPTION5 scores, whereas high-performing surgeons had wide variation. Use of shared decision-making increased when surgeons appeared reluctant to operate (effect estimate, 7.40; 95% CI, 2.60-12.20; P = .003). Although longer conversations were associated with slightly higher OPTION5 scores (effect estimate, 0.69; 95% CI, 0.52-0.88; P < .001), 57% of high-scoring transcripts were 26 minutes long or less. On multivariable analysis, patient age and gender, patient education, surgeon age, and surgeon gender were not significantly associated with OPTION5 scores. Conclusions and Relevance: These findings suggest that although shared decision-making is important to support the preferences of older adults considering major surgery, surgeon use of shared decision-making is highly variable. Skillful shared decision-making can be done in less than 30 minutes; however, surgeons who engage in high-scoring shared decision-making are more likely to do so when surgical intervention is less obviously beneficial for the patient. Trial Registration: ClinicalTrials.gov Identifier: NCT02623335.

The Association Between Factors Promoting Nonbeneficial Surgery and Moral Distress: A National Survey of Surgeons.

OBJECTIVE: To assess the prevalence of moral distress among surgeons and test the association between factors promoting non-beneficial surgery and surgeons' moral distress. SUMMARY BACKGROUND DATA: Moral distress experienced by clinicians can lead to low-quality care and burnout. Older adults increasingly receive invasive treatments at the end of life that may contribute to surgeons' moral distress, particularly when external factors, such as pressure from colleagues, institutional norms, or social demands, push them to offer surgery they consider non-beneficial. METHODS: We mailed surveys to 5200 surgeons randomly selected from the American College of Surgeons membership, which included questions adapted from the revised Moral Distress Scale. We then analyzed the association between factors influencing the decision to offer surgery to seriously ill older adults and surgeons' moral distress. RESULTS: The weighted adjusted response rate was 53% (n = 2161). Respondents whose decision to offer surgery was influenced by their belief that pursuing surgery gives the patient or family time to cope with the patient's condition were more likely to have high moral distress (34% vs 22%, P < 0.001), and this persisted on multivariate analysis (odds ratio 1.44, 95% confidence interval 1.02-2.03). Time required to discuss nonoperative treatments or the consulting intensivists' endorsement of operative intervention, were not associated with high surgeon moral distress. CONCLUSIONS: Surgeons experience moral distress when they feel pressured to perform surgery they believe provides no clear patient benefit. Strategies that empower surgeons to recommend nonsurgical treatments when they believe this is in the patient's best interest may reduce nonbeneficial surgery and surgeon moral distress.

Best case/worst case for the trauma ICU: Development and pilot testing of a communication tool for older adults with traumatic injury.

BACKGROUND: "Best Case/Worst Case" (BC/WC) is a communication tool to support shared decision making in older adults with surgical illness. We aimed to adapt and test BC/WC for use with critically ill older adult trauma patients. METHODS: We conducted focus groups with 48 trauma clinicians in Wisconsin, Texas, and Oregon. We used qualitative content analysis to characterize feedback and adapted the tool to fit this setting. Using rapid sequence iterative design, we developed an implementation tool kit. We pilot tested this intervention at two trauma centers using a pre-post study design with older trauma patients in the intensive care unit (ICU). Main outcome measures included study feasibility, intervention acceptability, quality of communication, and clinician moral distress. RESULTS: BC/WC for trauma patients uses a graphic aid to document major events over time, illustrate plausible scenarios, and convey uncertainty. We enrolled 86 of 116 eligible patients and their surrogates (48 pre/38 postintervention). The median patient age was 72 years (51-95 years) and mean Geriatric Trauma Outcome Score was 126.1 (±30.6). We trained 43 trauma attendings and trauma fellows to use the intervention. Ninety-four percent could perform essential tool elements after training. The median end-of-life communication score (scale 0-10) improved from 4.5 to 6.6 (p = 0.006) after intervention as reported by family and from 4.1 to 6.0 (p = 0.03) as reported by nurses. Moral distress did not change. However, there was improvement (less distress) reported by physicians regarding "witnessing providers giving false hope" from 7.34 to 5.03 (p = 0.022). Surgeons reported the tool put multiple clinicians on the same page and was useful for families, but tedious to incorporate into rounds. CONCLUSION: BC/WC trauma ICU is acceptable to clinicians and may support improved communication in the ICU. Future efficacy testing is threatened by enrollment challenges for severely injured older adults and their family members. LEVEL OF EVIDENCE: Therapeutic, level III.

Opportunities to Improve Shared Decision Making in Dialysis Decisions for Older Adults with Life-Limiting Kidney Disease: A Pilot Study.

Background: Lack of awareness about the life-limiting nature of renal failure is a significant barrier to palliative care for older adults with end-stage renal disease. Objective: To train nephrologists to use the best case/worst case (BC/WC) communication tool to improve shared decision making about dialysis initiation for older patients with limited life expectancy. Design: This is a pre-/postinterventional pilot study. Setting/Subjects: There were 16 nephrologists and 30 patients of age 70 years and older with estimated glomerular filtration rate (eGFR) <20 mL/min per 1.73 m2 in outpatient nephrology clinics, in Madison, WI. Measurements: Performance of tool elements, content of communication about dialysis, shared decision making, acceptability of the intervention, decisions to pursue dialysis, and palliative care referrals were measured. Results: Fifteen of 16 nephrologists achieved competence performing the BC/WC tool with standardized patients, executing at least 14 of 19 items. Nine nephrologists met with 30 patients who consented to audio record their clinic visit. Before training, clinic visits focused on laboratory results and preparation for dialysis. After training, nephrologists noted that declining kidney function was "bad news," presented dialysis and "no dialysis" as treatment options, and elicited patient preferences. Observer-measured shared decision-making (OPTION 5) scores improved from a median of 20/100 (interquartile range [IQR] 15-35) before training to 58/100 (IQR 55-65). Patients whose nephrologist used the BC/WC tool were less likely to make a decision to initiate dialysis and were more likely to be referred to palliative care. Conclusions: Nephrologists can learn to use the BC/WC tool with older patients to improve shared decision making about dialysis, which may increase access to palliative care.

Effectiveness of a Question Prompt List Intervention for Older Patients Considering Major Surgery: A Multisite Randomized Clinical Trial.

Importance: Poor preoperative communication can have serious consequences, including unwanted treatment and postoperative conflict. Objective: To compare the effectiveness of a question prompt list (QPL) intervention vs usual care on patient engagement and well-being among older patients considering major surgery. Design, Setting, and Participants: This randomized clinical trial used a stepped-wedge design to randomly assign patients to a QPL intervention (n = 223) or usual care (n = 223) based on the timing of their visit with 1 of 40 surgeons at 5 US study sites. Patients were 60 years or older with at least 1 comorbidity and an oncologic or vascular (cardiac, neurosurgical, or peripheral vascular) problem that could be treated with major surgery. Family members were also enrolled (n = 263). The study dates were June 2016 to November 2018. Data analysis was by intent-to-treat. Interventions: A brochure of 11 questions to ask a surgeon developed by patient and family stakeholders plus an endorsement letter from the surgeon were sent to patients before their outpatient visit. Main Outcomes and Measures: Primary patient engagement outcomes included the number and type of questions asked during the surgical visit and patient-reported Perceived Efficacy in Patient-Physician Interactions scale assessed after the surgical visit. Primary well-being outcomes included (1) the difference between patient's Measure Yourself Concerns and Well-being (MYCaW) scores reported after surgery and scores reported after the surgical visit and (2) treatment-associated regret at 6 to 8 weeks after surgery. Results: Of 1319 patients eligible for participation, 223 were randomized to the QPL intervention and 223 to usual care. Among 446 patients, the mean (SD) age was 71.8 (7.1) years, and 249 (55.8%) were male. On intent-to-treat analysis, there was no significant difference between the QPL intervention and usual care for all patient-reported primary outcomes. The difference in MYCaW scores for family members was greater in usual care (effect estimate, 1.51; 95% CI, 0.28-2.74; P = .008). When the QPL intervention group was restricted to patients with clear evidence they reviewed the QPL, a nonsignificant increase in the effect size was observed for questions about options (odds ratio, 1.88; 95% CI, 0.81-4.35; P = .16), expectations (odds ratio, 1.59; 95% CI, 0.67-3.80; P = .29), and risks (odds ratio, 2.41; 95% CI, 1.04-5.59; P = .04) (nominal α = .01). Conclusions and Relevance: The results of this study were null related to primary patient engagement and well-being outcomes. Changing patient-physician communication may be difficult without addressing clinician communication directly. Trial Registration: ClinicalTrials.gov identifier: NCT02623335.

A Randomized Controlled Trial Evaluating the Impact of Pre-Consultation Information on Patients' Perception of Information Conveyed and Satisfaction with the Decision-Making Process.

BACKGROUND: Patient participation in treatment decision-making is a health care priority. This study hypothesized that providing a decision aid before surgical consultation would better prepare patients for decision-making. The objective was to examine the impact of a decision aid versus high-quality websites on patients' perceptions of information conveyed during surgical consultation and satisfaction with the decision process. METHODS: Patients with stages 0 to 3 breast cancer were randomized. Surveys assessed perceptions of information conveyed, being asked surgical preference, and satisfaction with the decision process. Multivariable logistic regression assessed associations between outcomes and randomization arm, patient factors, and surgeon. Change in Pseudo-R2 assessed the comparative effect of these factors on perceptions of the information conveyed. RESULTS: The median patient age was 59 years. Most of the patients (98%) were white, and 62% were college educated (n = 201). The findings showed no association between randomization arm and perceptions of information conveyed, being asked surgical preference, or satisfaction with the decision process. Most of the patients reported discussing both breast-conserving therapy and mastectomy (69%) and being asked their surgical preference (65%). The surgeon seen was more important than the randomization arm or the patient factors in predicting patients' perceptions of information conveyed (explained 64-69% of the variation), and 63% of the patients were satisfied with the decision process. CONCLUSION: Use of a decision aid compared with high-quality websites did not increase patients' perceptions of information conveyed or satisfaction with the decision process. Although the surgeon seen influenced aspects of the patient experience, the surgeon was not associated with satisfaction. Understanding the factors driving low satisfaction is critical because this is increasingly used as a marker of health care quality.

Using Implementation Science to Adapt a Training Program to Assist Surgeons with High-Stakes Communication.

OBJECTIVE: Surgeons often conduct difficult conversations with patients near the end of life, yet surgical education provides little formalized communication training. We developed a communication tool, Best Case/Worst Case, and trained surgeons using a one-on-one resource intensive format that was effective but difficult to scale for widespread dissemination. We aimed to generate an implementation package to teach surgeons using fewer resources without sacrificing fidelity. DESIGN, SETTING, AND PARTICIPANTS: We used the Replicating Effectiveness Programs framework to guide our implementation strategy and tested our intervention with 39 surgical residents at 4 institutions from September 2016 to June 2017. The implementation package consisted of: (1) instructional video, (2) checklist to assess competence, (3) learner manual, and (4) instructor manual. We focused on 3 implementation outcomes: feasibility, fidelity, and acceptability to participants. RESULTS: Attendance rates ranged from 16% to 75%. Site leaders had little difficulty identifying suitable instructors; however, resident recruitment proved challenging. Sixty-nine percent of residents completed the post-training assessment and the mean score was 12.8 (range 8-15) using the 15-point checklist. Across sites, 69% strongly agreed that Best Case/Worst Case is better than how they usually approach high-stakes conversations and 100% felt prepared to use the tool after training. Instructors reported that the training provided residents with the necessary skills to perform the fundamental elements of Best Case/Worst Case. CONCLUSIONS: Using implementation science we demonstrated that a resource intensive communication training intervention can be successfully modified for group-learning and wide-scale dissemination. However, we identified barriers to implementation, including challenges with feasibility and programmatic buy-in that inform not only resident education but also communication skills training more broadly.

A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options.

BACKGROUND: Previous research suggests that providing information to women newly diagnosed with breast cancer, during the gap between cancer diagnosis and their first surgeon consultation, may support decision making. Our objective was to compare patients' knowledge after the pre-consultation delivery of standard websites vs a web-based decision aid (DA). STUDY DESIGN: We randomized women with stage 0 to III breast cancer, within an academic and community breast clinic, to be emailed a link to selected standard websites (National Cancer Institute, American Cancer Society, Breastcancer.org,) vs the Health Dialog DA (Clinicaltrials.govNCT03116035). Patients seeking second opinions, diagnosed by excisional biopsy, or without an email address, were ineligible. Pre-consultation knowledge was assessed using the Breast Cancer Surgery Decision Quality Instrument. We compared differences in knowledge using t-test. RESULTS: Median patient age was 59 years, 99% were white, and 65% had a college degree or higher, with no differences in demographics between study arms. Knowledge was higher in patients who received the DA (median 80% vs 66% correct, p = 0.01). Decision-aid patients were more likely to know that waiting a few weeks to make a treatment decision would not affect survival (72% vs 54%, p < 0.01). Patients in both arms found the information helpful (median score 8 of 10). CONCLUSIONS: Although patients found receipt of any pre-consultation information helpful, the DA resulted in improved knowledge over standard websites and effectively conveyed that there is time to make a breast cancer surgery decision. Decreasing the urgency patients feel may improve the quality of patient-surgeon interactions and lead to more informed decision-making.

Barriers to Goal-concordant Care for Older Patients With Acute Surgical Illness: Communication Patterns Extrinsic to Decision Aids.

OBJECTIVE: We sought to characterize patterns of communication extrinsic to a decision aid that may impede goal-concordant care. BACKGROUND: Decision aids are designed to facilitate difficult clinical decisions by providing better treatment information. However, these interventions may not be sufficient to effectively reveal patient values and promote preference-aligned decisions for seriously ill, older adults. METHODS: We conducted a secondary analysis of 31 decision-making conversations between surgeons and frail, older inpatients with acute surgical problems at a single tertiary care hospital. Conversations occurred before and after surgeons were trained to use a decision aid. We used directed qualitative content analysis to characterize patterns within 3 communication elements: disclosure of prognosis, elicitation of patient preferences, and integration of preferences into a treatment recommendation. RESULTS: First, surgeons missed an opportunity to break bad news. By focusing on the acute surgical problem and need to make a treatment decision, surgeons failed to expose the life-limiting nature of the patient's illness. Second, surgeons asked patients to express preference for a specific treatment without gaining knowledge about the patient's priorities or exploring how patients might value specific health states or disabilities. Third, many surgeons struggled to integrate patients' goals and values to make a treatment recommendation. Instead, they presented options and noted, "It's your decision." CONCLUSIONS: A decision aid alone may be insufficient to facilitate a decision that is truly shared. Attention to elements beyond provision of treatment information has the potential to improve communication and promote goal-concordant care for seriously ill older patients.

Feasibility of Providing Web-Based Information to Breast Cancer Patients Prior to a Surgical Consult.

Patients facing decisions for breast cancer surgery commonly search the internet. Directing patients to high-quality websites prior to the surgeon consultation may be one way of supporting patients' informational needs. The objective was to test an approach for delivering web-based information to breast cancer patients. The implementation strategy was developed using the Replicating Effective Programs framework. Pilot testing measured the proportion that accepted the web-based information. A pre-consultation survey assessed whether the information was reviewed and the acceptability to stakeholders. Reasons for declining guided refinement to the implementation package. Eighty-two percent (309/377) accepted the web-based information. Of the 309 that accepted, 244 completed the pre-consultation survey. Participants were a median 59 years, white (98%), and highly educated (>50% with a college degree). Most patients who completed the questionnaire reported reviewing the website (85%), and nearly all found it helpful. Surgeons thought implementation increased visit efficiency (5/6) and would result in patients making more informed decisions (6/6). The most common reasons patients declined information were limited internet comfort or access (n = 36), emotional distress (n = 14), and preference to receive information directly from the surgeon (n = 7). Routine delivery of web-based information to breast cancer patients prior to the surgeon consultation is feasible. High stakeholder acceptability combined with the low implementation burden means that these findings have immediate relevance for improving care quality.

Socioeconomic Factors Associated with Post-Mastectomy Immediate Reconstruction in a Contemporary Cohort of Breast Cancer Survivors.

BACKGROUND: Post-mastectomy reconstruction is a critical component of high-quality breast cancer care. Prior studies demonstrate socioeconomic disparity in receipt of reconstruction. Our objective was to evaluate trends in receipt of immediate reconstruction and examine socioeconomic factors associated with reconstruction in a contemporary cohort. METHODS: Using the National Cancer Database, we identified women <75 years of age with stage 0-1 breast cancer treated with mastectomy (n = 297,121). Trends in immediate reconstruction rates (2004-2013) for the overall cohort and stratified by socioeconomic factors were examined using Join-point regression analysis, and annual percentage change (APC) was calculated. We then restricted our sample to a contemporary cohort (2010-2013, n = 145,577). Multivariable logistic regression identified socioeconomic factors associated with immediate reconstruction. Average adjusted predicted probabilities of receiving reconstruction were calculated. RESULTS: Immediate reconstruction rates increased from 27 to 48%. Although absolute rates of reconstruction for each stratification group increased, similar APCs across strata led to persistent gaps in receipt of reconstruction. On multivariable logistic regression using our contemporary cohort, race, income, education, and insurance type were all strongly associated with immediate reconstruction. Patients with the lowest predicted probability of receiving reconstruction were patients with Medicaid who lived in areas with the lowest rates of high-school graduation (Black 42.4% [95% CI 40.5-44.3], White 45.7% [95% CI 43.9-47.4]). CONCLUSIONS: Although reconstruction rates have increased dramatically over the past decade, lower rates persist for disadvantaged patients. Understanding how socioeconomic factors influence receipt of reconstruction, and identifying modifiable factors, are critical next steps towards identifying interventions to reduce disparities in breast cancer surgical care.

Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions.

INTRODUCTION: Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations. METHODS AND ANALYSIS: This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received. ETHICS AND DISSEMINATION: Approvals have been granted by the Institutional Review Board at the University of Wisconsin and at each participating site, and a Certificate of Confidentiality has been obtained. Results will be reported in peer-reviewed publications and presented at national meetings. TRIAL REGISTRATION NUMBER: NCT02623335.

A Framework to Improve Surgeon Communication in High-Stakes Surgical Decisions: Best Case/Worst Case.

Importance: Although many older adults prefer to avoid burdensome interventions with limited ability to preserve their functional status, aggressive treatments, including surgery, are common near the end of life. Shared decision making is critical to achieve value-concordant treatment decisions and minimize unwanted care. However, communication in the acute inpatient setting is challenging. Objective: To evaluate the proof of concept of an intervention to teach surgeons to use the Best Case/Worst Case framework as a strategy to change surgeon communication and promote shared decision making during high-stakes surgical decisions. Design, Setting, and Participants: Our prospective pre-post study was conducted from June 2014 to August 2015, and data were analyzed using a mixed methods approach. The data were drawn from decision-making conversations between 32 older inpatients with an acute nonemergent surgical problem, 30 family members, and 25 surgeons at 1 tertiary care hospital in Madison, Wisconsin. Interventions: A 2-hour training session to teach each study-enrolled surgeon to use the Best Case/Worst Case communication framework. Main Outcomes and Measures: We scored conversation transcripts using OPTION 5, an observer measure of shared decision making, and used qualitative content analysis to characterize patterns in conversation structure, description of outcomes, and deliberation over treatment alternatives. Results: The study participants were patients aged 68 to 95 years (n = 32), 44% of whom had 5 or more comorbid conditions; family members of patients (n = 30); and surgeons (n = 17). The median OPTION 5 score improved from 41 preintervention (interquartile range, 26-66) to 74 after Best Case/Worst Case training (interquartile range, 60-81). Before training, surgeons described the patient's problem in conjunction with an operative solution, directed deliberation over options, listed discrete procedural risks, and did not integrate preferences into a treatment recommendation. After training, surgeons using Best Case/Worst Case clearly presented a choice between treatments, described a range of postoperative trajectories including functional decline, and involved patients and families in deliberation. Conclusions and Relevance: Using the Best Case/Worst Case framework changed surgeon communication by shifting the focus of decision-making conversations from an isolated surgical problem to a discussion about treatment alternatives and outcomes. This intervention can help surgeons structure challenging conversations to promote shared decision making in the acute setting.

"Best Case/Worst Case": Training Surgeons to Use a Novel Communication Tool for High-Risk Acute Surgical Problems.

CONTEXT: Older adults often have surgery in the months preceding death, which can initiate postoperative treatments inconsistent with end-of-life values. "Best Case/Worst Case" (BC/WC) is a communication tool designed to promote goal-concordant care during discussions about high-risk surgery. OBJECTIVE: The objective of this study was to evaluate a structured training program designed to teach surgeons how to use BC/WC. METHODS: Twenty-five surgeons from one tertiary care hospital completed a two-hour training session followed by individual coaching. We audio-recorded surgeons using BC/WC with standardized patients and 20 hospitalized patients. Hospitalized patients and their families participated in an open-ended interview 30 to 120 days after enrollment. We used a checklist of 11 BC/WC elements to measure tool fidelity and surgeons completed the Practitioner Opinion Survey to measure acceptability of the tool. We used qualitative analysis to evaluate variability in tool content and to characterize patient and family perceptions of the tool. RESULTS: Surgeons completed a median of 10 of 11 BC/WC elements with both standardized and hospitalized patients (range 5-11). We found moderate variability in presentation of treatment options and description of outcomes. Three months after training, 79% of surgeons reported BC/WC is better than their usual approach and 71% endorsed active use of BC/WC in clinical practice. Patients and families found that BC/WC established expectations, provided clarity, and facilitated deliberation. CONCLUSIONS: Surgeons can learn to use BC/WC with older patients considering acute high-risk surgical interventions. Surgeons, patients, and family members endorse BC/WC as a strategy to support complex decision making.

Variation in the Types of Providers Participating in Breast Cancer Follow-Up Care: A SEER-Medicare Analysis.

BACKGROUND: The current guidelines do not delineate the types of providers that should participate in early breast cancer follow-up care (within 3 years after completion of treatment). This study aimed to describe the types of providers participating in early follow-up care of older breast cancer survivors and to identify factors associated with receipt of follow-up care from different types of providers. METHODS: Stages 1-3 breast cancer survivors treated from 2000 to 2007 were identified in the Surveillance, Epidemiology and End results Medicare database (n = 44,306). Oncologist (including medical, radiation, and surgical) follow-up and primary care visits were defined using Medicare specialty provider codes and linked American Medical Association (AMA) Masterfile. The types of providers involved in follow-up care were summarized. Stepped regression models identified factors associated with receipt of medical oncology follow-up care and factors associated with receipt of medical oncology care alone versus combination oncology follow-up care. RESULTS: Oncology follow-up care was provided for 80 % of the patients: 80 % with a medical oncologist, 46 % with a surgeon, and 39 % with a radiation oncologist after radiation treatment. The patients with larger tumor size, positive axillary nodes, estrogen receptor (ER)-positive status, and chemotherapy treatment were more likely to have medical oncology follow-up care than older patients with higher Charlson comorbidity scores who were not receiving axillary care. The only factor associated with increased likelihood of follow-up care with a combination of oncology providers was regular primary care visits (>2 visits/year). CONCLUSIONS: Substantial variation exists in the types of providers that participate in breast cancer follow-up care. Improved guidance for the types of providers involved and delineation of providers' responsibilities during follow-up care could lead to improved efficiency and quality of care.

Oncologists' perceived barriers to an expanded role for primary care in breast cancer survivorship care.

Concern exists about the sustainability of traditional, oncologist-led models of breast cancer survivorship care. However, many oncologists are hesitant about deferring survivorship care to primary care providers (PCPs). Our objective was to examine oncologists' perceptions of the role PCPs play in breast cancer survivorship and the rationale underlying these perceptions. One-on-one interviews with medical, radiation, and surgical oncologists in Wisconsin were conducted (n = 35) and transcribed. Data analysis was performed using an inductive approach to content analysis. Oncologist-perceived barriers included: PCP's level of experience with cancer care; Lack of PCP comfort in providing survivorship care; Existing demands on PCPs' time; Patient preference for oncology-led survivorship care. Oncologists described familiarity and trust in individual PCPs as factors that could mitigate barriers and lead to increased PCP involvement in survivorship care. Although a number of perceived barriers to PCP participation in survivorship were identified by Wisconsin oncologists, our findings support the direction of ongoing initiatives to facilitate PCP involvement. Our findings also suggest that early PCP involvement in survivorship may increase PCP comfort and patients' trust in PCPs in this role. The identified barrier most challenging to address may be the limited capacity of the current primary care system to manage follow-up for breast cancer survivors.