A Randomized Controlled Trial of the Implementation of BREASTChoice, a Multilevel Breast Reconstruction Decision Support Tool With Personalized Risk Predictiona.

OBJECTIVE: To implement the BREASTChoice decision tool into the electronic health record and evaluate its effectiveness. BACKGROUND: BREASTChoice, is a multilevel decision tool that: 1) educates patients about breast reconstruction; 2) estimates personalized risk of complications; 3) clarifies patient preferences; and 4) informs clinicians about patients' risk and preferences. METHODS: A multisite randomized controlled trial enrolled adult women with stage 0-III breast malignancy undergoing mastectomy. Participants were randomized to BREASTChoice or a control website. A survey assessed knowledge, preferences, decisional conflict, shared decision-making, preferred treatment, and usability. We conducted intent-to-treat (ITT), per-protocol (PP) analyses (those randomized to BREASTChoice who accessed the tool), and stratified analyses. RESULTS: 23/25 eligible clinicians enrolled. 369/761 (48%) contacted patients enrolled and were randomized. Patients' average age was 51 years; 15% were older than 65. BREASTChoice participants had higher knowledge than control participants (ITT: mean 70.6 vs. 67.4, P=0.08; PP: mean 71.4 vs. 67.4, P=0.03), especially when stratified by site (ITT: P=0.04, PP: P=0.01), age (ITT: P=0.04, PP: P=0.02), and race (ITT: P=0.04, PP: P=0.01). BREASTChoice did not improve decisional conflict, match between preferences and treatment, or shared decision-making. In PP analyses, fewer high-risk patients using BREASTChoice chose reconstruction. BREASTChoice had high usability. CONCLUSIONS: BREASTChoice is a novel decision tool incorporating risk prediction, patient education, and clinician engagement. Patients using BREASTChoice had higher knowledge; older adults and those from racially minoritized backgrounds especially benefitted. There was no impact on other decision outcomes. Future studies should overcome implementation barriers and specifically examine decision outcomes among high-risk patients.

A Perioperative Mental Health Intervention for Depressed and Anxious Older Surgical Patients: Results From a Feasibility Study.

OBJECTIVES: The perioperative period is challenging and stressful for older adults. Those with depression and/or anxiety have an increased risk of adverse surgical outcomes. We assessed the feasibility of a perioperative mental health intervention composed of medication optimization and a wellness program following principles of behavioral activation and care coordination for older surgical patients. METHODS: We included orthopedic, oncologic, and cardiac surgical patients aged 60 and older. Feasibility outcomes included study reach, the number of patients who agreed to participate out of the total eligible; and intervention reach, the number of patients who completed the intervention out of patients who agreed to participate. Intervention efficacy was assessed using the Patient Health Questionnaire for Anxiety and Depression (PHQ-ADS). Implementation potential and experiences were collected using patient surveys and qualitative interviews. Complementary caregiver feedback was also collected. RESULTS: Twenty-three out of 28 eligible older adults participated in this study (mean age 68.0 years, 65% women), achieving study reach of 82% and intervention reach of 83%. In qualitative interviews, patients (n = 15) and caregivers (complementary data, n = 5) described overwhelmingly positive experiences with both the intervention components and the interventionist, and reported improvement in managing depression and/or anxiety. Preliminary efficacy analysis indicated improvement in PHQ-ADS scores (F = 12.13, p <0.001). CONCLUSIONS: The study procedures were reported by participants as feasible and the perioperative mental health intervention to reduce anxiety and depression in older surgical patients showed strong implementation potential. Preliminary data suggest its efficacy for improving depression and/or anxiety symptoms. A randomized controlled trial assessing the intervention and implementation effectiveness is currently ongoing.

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.

Shared Decision-Making: Process for Design and Implementation of a Decision Aid for Patients With Craniosynostosis.

To describe the process of developing a craniosynostosis decision aid.We conducted a mixed-methods exploratory study between August 2019 and March 2020 to develop a decision aid about surgical treatment for single suture craniosynostosis.A single tertiary care academic children's hospital.The decision aid development team consisted of surgeons, research fellows, a clinical nurse practitioner, clinical researchers with expertise in decision science, and a university-affiliated design school. Qualitative interviews (N = 5) were performed with families, clinicians (N = 2), and a helmeting orthotist to provide feedback on decision aid content, format, and usability.After cycles of revisions and iterations, 3 related decision aids were designed and approved by the marketing arm of our institution. Distinct booklets were created to enable focused discussion of treatment options for the 3 major types of single suture craniosynostosis (sagittal, metopic, unicoronal).Three decision aids representing the 3 most common forms of single suture craniosynostosis were developed. Clinicians found the decision aids could help facilitate discussions about families' treatment preferences, goals, and concerns.We developed a customizable decision aid for single suture craniosynostosis treatment options. This tool lays the foundation for shared decision-making by assessing family preferences and providing clear, concise, and credible information regarding surgical treatment. Future research can evaluate this tool's impact on patient-clinician discussions about families' goals and preferences for treatment.

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.

A survey of surgical patients' perspectives and preferences towards general anesthesia techniques and shared-decision making.

BACKGROUND: The decision about which type of general anesthetic to administer is typically made by the clinical team without patient engagement. This study examined patients' preferences, experiences, attitudes, beliefs, perceptions, and perceived social norms about anesthesia and about engaging in the decision regarding general anesthetic choice with their clinician. METHODS: We conducted a survey in the United States, sent to a panel of surgical patients through Qualtrics (Qualtrics, Provo, UT) from March 2022 through May 2022. Questions were developed based on the Theory of Planned Behavior and validated measures were used when available. A patient partner who had experienced both intravenous and inhaled anesthesia contributed to the development and refinement of the questions. RESULTS: A total of 806 patients who received general anesthesia for an elective procedure in the last five years completed the survey. 43% of respondents preferred a patient-led decision making role and 28% preferred to share decision making with their clinical team, yet only 7.8% reported being engaged in full shared decision making about the anesthesia they received. Intraoperative awareness, pain, nausea, vomiting and quickly returning to work and usual household activities were important to respondents. Waking up in the middle of surgery was the most commonly reported concern, despite this experience being reported only 8% of the time. Most patients (65%) who searched for information about general anesthesia noted that it took a lot of effort to find the information, and 53% agreed to feeling frustrated during the search. CONCLUSIONS: Most patients prefer a patient-led or shared decision making process when it comes to their anesthetic care and want to be engaged in the decision. However, only a small percentage of patients reported being fully engaged in the decision. Further studies should inform future shared decision-making tools, informed consent materials, educational materials and framing of anesthetic choices for patients so that they are able to make a choice regarding the anesthetic they receive.

Uncertainty in healthcare and health decision making: Five methodological and conceptual research recommendations from an interdisciplinary team.

Uncertainty is prevalent in various health contexts. It is imperative to understand how health-related uncertainty can impact individuals' healthcare experiences and health decision making. The purpose of the present paper is to provide five overarching recommendations from an interdisciplinary team of experts to address gaps in the literature on health-related uncertainty. We present a case study of health-related uncertainty within the specific context of alcohol use to demonstrate these gaps and provide context for the recommendations. The five recommendations concerning health-related uncertainty include: (1) use common, consistent terminology to discuss uncertainty, (2) clarify measures of individual differences in response to uncertainty, (3) increase research on uncertainty and affect, (4) investigate the impact of the channel through which uncertainty is communicated, and (5) develop theory-driven interventions to improve uncertainty management. We conclude by reviewing health contexts in which health-related uncertainty exists and note how our recommendations complement existing reviews and data.

A multi- and mixed-method adaptation study of a patient-centered perioperative mental health intervention bundle.

BACKGROUND: Anxiety and depression are common among older adults and can intensify during perioperative periods, but few mental health interventions are designed for older surgical patients' unique needs. As part of the feasibility trial, we developed and adapted a perioperative mental health (PMH) bundle for older patients comprised of behavioral activation (BA) and medication optimization (MO) to ameliorate anxiety and depressive symptoms before, during, and after cardiac, orthopedic, and oncologic surgery. METHODS: We used mixed-methods including workshop studios with patients, caregivers, clinicians, researchers, and interventionists; intervention refinement and reflection meetings; patient case review meetings; intervention session audio-recordings and documentation forms; and patient and caregiver semi-structured interviews. We used the results to refine our PMH bundle. We used multiple analytical approaches to report the nature of adaptations, including hybrid thematic analysis and content analysis informed by the Framework for Reporting Adaptations and Modifications - Expanded. RESULTS: Adaptations were categorized by content (intervention components), context (how the intervention is delivered, based on the study, target population, intervention format, intervention delivery mode, study setting, study personnel), training, and evaluation. Of 51 adaptations, 43.1% involved content, 41.2% involved context, and 15.7% involved training and evaluation. Several key adaptations were noted: (1) Intervention content was tailored to patient preferences and needs (e.g., rewording elements to prevent stigmatization of mental health needs; adjusting BA techniques and documentation forms to improve patient buy-in and motivation). (2) Cohort-specific adaptations were recommended based on differing patient needs. (3) Compassion was identified by patients as the most important element. CONCLUSIONS: We identified evidence-based mental health intervention components from other settings and adapted them to the perioperative setting for older adults. Informed by mixed-methods, we created an innovative and pragmatic patient-centered intervention bundle that is acceptable, feasible, and responsive to the needs of older surgical populations. This approach allowed us to identify implementation strategies to improve the reach, scalability, and sustainability of our bundle, and can guide future patient-centered intervention adaptations. CLINICAL TRIALS REGISTRATION: NCT05110690 (11/08/2021).

Using the sociotechnical model to conduct a focused usability assessment of a breast reconstruction decision tool.

INTRODUCTION: BREASTChoice is a web-based breast reconstruction decision aid. The previous clinical trial-prior to the adaptation of this refined tool in which we explored usability-measured decision quality, quality of life, patient activation, shared decision making, and treatment choice. The current usability study was designed to elicit patients' and clinicians' perspectives on barriers and facilitators for implementing BREASTChoice into the clinical workflow. METHODS: We conducted qualitative interviews with patients and clinicians from two Midwestern medical specialty centers from August 2020 to April 2021. Interviews were first double coded until coders achieved a kappa > 0.8 and percent agreement > 95%, then were coded independently. We used a sociotechnical framework to evaluate BREASTChoice's implementation and sustainability potential according to end-users, human-computer interaction, and contextual factors. RESULTS: Twelve clinicians and ten patients completed interviews. Using the sociotechnical framework we determined the following. People Using the Tool: Patients and clinicians agreed that BREASTChoice could help patients make more informed decisions about their reconstruction and prepare better for their first plastic surgery appointment. Workflow and Communications: They felt that BREASTChoice could improve communication and process if the patient could view the tool at home and/or in the waiting room. Clinicians suggested the information from BREASTChoice about patients' risks and preferences be included in the patient's chart or the clinician electronic health record (EHR) inbox for accessibility during the consultation. Human Computer Interface: Patients and clinicians stated that the tool contains helpful information, does not require much time for the patient to use, and efficiently fills gaps in knowledge. Although patients found the risk profile information helpful, they reported needing time to read and digest. CONCLUSION: BREASTChoice was perceived as highly usable by patients and clinicians and has the potential for sustainability. Future research will implement and test the tool after integrating the stakeholder-suggested changes to its delivery process and content. It is critical to conduct usability assessments such as these prior to decision aid implementation to ensure success of the tool to improve risk communication.

Municipal officials' perspectives on policymaking for addressing obesity and health equity.

Background: Obesity evidence-based policies (EBPs) can make a lasting, positive impact on community health; however, policy development and enactment is complex and dependent on multiple forces. Aims and objectives: This study investigated key factors affecting municipal officials' policymaking for obesity and related health disparities. Methods: Semi-structured interviews were conducted with 20 local officials from a selection of municipalities with high obesity or related health disparities across the United States between December 2020 and April 2021. Findings: Policymakers follow a general decision-making process with limited distinction between health and other policy areas. Factors affecting policymaking included: being informed about other local, state, and federal policy, conducting their own research using trustworthy sources, and seeking constituent and stakeholder perspectives. Key facilitators included the need for timely, relevant local data, and seeing or hearing from those impacted. Key local policymaking barriers included constituent opposition, misinformation, controversial issues with contentious solutions, and limited understanding of the connection between issues and obesity/health. Policymakers had a range of understanding about causes of health disparities, including views of individual choices, environmental influences on behaviors, and structural factors impacting health. To address health disparities, municipal officials described: a variety of roles policymakers can take, limitations based on the scope of government, challenges with intergovernmental collaboration or across government levels, ability of policymakers and government employees to understand the problem, and the challenge of framing health disparities given the social-political context. Discussion and conclusion: Understanding factors affecting the uptake of EBPs can inform local-level interventions that encourage EBP adoption.

Development of a Parent-Reported Outcome Measure for Febrile Infants ≤60 Days Old.

OBJECTIVE: We aimed to develop a parent-reported outcome measure for febrile infants 60 days or younger evaluated in the emergency department. METHODS: We conducted a 3-part study: (1) individual, semistructured interviews with parents of febrile infants 60 days or younger to generate potential items for the measure; (2) expert review with pediatric emergency medicine physicians and member checking with parents, who rated each item's clarity and relevance using 4-point scales; and (3) cognitive interviews with a new sample of parents, who gave feedback and rated the measure's ease of use on a 4-point scale. The measure was iteratively revised during each part of the development process. RESULTS: In part 1, we interviewed 24 parents of 21 infants. Interviews revealed several themes: parents' experiences with medical care, communication, and decision making; parents' emotions, particularly worry, fear, and stress; the infant's outcomes valued by parents; and the impact of the infant's illness on the family. From these themes, we identified 22 potential items for inclusion in the measure. In part 2, 10 items were revised for clarity based on feedback from physicians and parents, primarily under the domains of parents' emotions and the infant's outcomes. In part 3, we further revised the measure for clarity and added an item. The final measure included 23 items and was rated as excellent in its ease of use. CONCLUSIONS: The 23-item parent-reported outcome measure includes the experiences and outcomes important to parents. Further studies are needed to evaluate the measure's psychometric properties.

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.

Shared decision making in pediatric dermatology: context, opportunities, and practical examples.

PURPOSE OF REVIEW: Shared decision making (SDM) is an important part of patient-centered care. However, it is neither widely practiced nor researched in pediatric dermatology. In this article, we provide practical examples of how to engage in SDM in pediatric dermatology, and identify future areas of research. RECENT FINDINGS: Children and parents/guardians desire SDM in clinical encounters. The process is applicable to discussions of medical as well as surgical care. Additionally, SDM can help prepare children for the transition from pediatric to adult/general providers. Clinicians often want more guidance on its implementation, and there is a dearth of research on SDM or decision tools specific to pediatric dermatology. SUMMARY: SDM is underused and understudied in pediatric dermatology. This article highlights how to engage in SDM and presents opportunities for research and implementation in pediatric dermatology.

A Randomized Controlled Trial Evaluating the BREASTChoice Tool for Personalized Decision Support About Breast Reconstruction After Mastectomy.

OBJECTIVE: To evaluate a web-based breast reconstruction decision aid, BREASTChoice. SUMMARY AND BACKGROUND DATA: Although postmastectomy breast reconstruction can restore quality of life and body image, its morbidity remains substantial. Many patients lack adequate knowledge to make informed choices. Decisions are often discordant with patients' preferences. METHODS: Adult women with stages 0-III breast cancer considering postmastectomy breast reconstruction with no previous reconstruction were randomized to BREASTChoice or enhanced usual care (EUC). RESULTS: Three hundred seventy-six patients were screened; 120 of 172 (69.8%) eligible patients enrolled. Mean age = 50.7 years (range 25-77). Most were Non-Hispanic White (86.3%) and had a college degree (64.3%). Controlling for health literacy and provider seen, BREASTChoice users had higher knowledge than those in EUC (84.6% vs. 58.2% questions correct; P < 0.001). Those using BREASTChoice were more likely to know that reconstruction typically requires more than 1 surgery, delayed reconstruction lowers one's risk, and implants may need replacement over time (all ps < 0.002). BREASTChoice compared to EUC participants also felt more confident understanding reconstruction information (P = 0.009). There were no differences between groups in decisional conflict, decision process quality, shared decision-making, quality of life, or preferences (all ps > 0.05). There were no differences in consultation length between BREASTChoice and EUC groups (mean = 29.7 vs. 30.0 minutes; P > 0.05). BREASTChoice had high usability (mean score = 6.3/7). Participants completed BREASTChoice in about 27 minutes. CONCLUSIONS: BREASTChoice can improve breast reconstruction decision quality by improving patients' knowledge and providing them with personalized risk estimates. More research is needed to facilitate point-of-care decision support and examine BREASTChoice's impact on patients' decisions over time.

Improving Cancer Patients' Insurance Choices (I Can PIC): A Randomized Trial of a Personalized Health Insurance Decision Aid.

BACKGROUND: Many cancer survivors struggle to choose a health insurance plan that meets their needs because of high costs, limited health insurance literacy, and lack of decision support. We developed a web-based decision aid, Improving Cancer Patients' Insurance Choices (I Can PIC), and evaluated it in a randomized trial. MATERIALS AND METHODS: Eligible individuals (18-64 years, diagnosed with cancer for ≤5 years, English-speaking, not Medicaid or Medicare eligible) were randomized to I Can PIC or an attention control health insurance worksheet. Primary outcomes included health insurance knowledge, decisional conflict, and decision self-efficacy after completing I Can PIC or the control. Secondary outcomes included knowledge, decisional conflict, decision self-efficacy, health insurance literacy, financial toxicity, and delayed care at a 3-6-month follow-up. RESULTS: A total of 263 of 335 eligible participants (79%) consented and were randomized; 206 (73%) completed the initial survey (106 in I Can PIC; 100 in the control), and 180 (87%) completed a 3-6 month follow-up. After viewing I Can PIC or the control, health insurance knowledge and a health insurance literacy item assessing confidence understanding health insurance were higher in the I Can PIC group. At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed. There were no significant differences between groups in other outcomes. Results did not change when controlling for health literacy and employment. Both groups reported having limited health insurance options. CONCLUSION: I Can PIC can improve cancer survivors' health insurance knowledge and confidence using health insurance. System-level interventions are needed to lower financial toxicity and help patients manage care costs. IMPLICATIONS FOR PRACTICE: Inadequate health insurance compromises cancer treatment and impacts overall and cancer-specific mortality. Uninsured or underinsured survivors report fewer recommended cancer screenings and may delay or avoid needed follow-up cancer care because of costs. Even those with adequate insurance report difficulty managing care costs. Health insurance decision support and resources to help manage care costs are thus paramount to cancer survivors' health and care management. We developed a web-based decision aid, Improving Cancer Patients' Insurance Choices (I Can PIC), and evaluated it in a randomized trial. I Can PIC provides health insurance information, supports patients through managing care costs, offers a list of financial and emotional support resources, and provides a personalized cost estimate of annual health care expenses across plan types.

A Qualitative Study of Perioperative Depression and Anxiety in Older Adults.

OBJECTIVE: We had three aims 1) understand barriers to perioperative management of anxiety and depression in older surgical patients; 2) identify preferences and requirements for interventions to manage their anxiety and depression; and 3) explore the feasibility of implementing such interventions in perioperative care. DESIGN: A qualitative study using semistructured interviews was conducted. SETTING: Participants were recruited at a large academic medical center. PARTICIPANTS: We interviewed older surgical patients and clinicians to characterize their perspectives on management of anxiety and depression symptoms, with emphasis on patient needs, barriers, and potential interventions to address these needs. MEASUREMENTS: We used the Consolidated Framework for Intervention Research to guide the development of interview questions related to intervention implementation feasibility. Thematic analysis was used to analyze interview responses. RESULTS: Forty semistructured interviews were conducted. Key barriers for perioperative management of depression and anxiety included fear of surgery, acute pain, postoperative neurocognitive disorders, limited understanding of what to expect regarding surgery and recovery, and overwhelmingly complex medication management. Patients and clinicians suggested that a bundled mental health management intervention targeted for older surgical patient population comprised of behavioral and pharmacologic strategies can help mitigate anxiety and depression symptoms during the perioperative period. Clinicians emphasized the need for a collaborative engagement strategy that includes multiple stakeholders in the design, planning, and implementation of such an intevention. CONCLUSION: New care models need to be developed to integrate mental health care into the current perioperative care practice.

Evaluating Adaptation of a Cancer Clinical Trial Decision Aid for Rural Cancer Patients: A Mixed-Methods Approach.

Rural-residing cancer patients often do not participate in clinical trials. Many patients misunderstand cancer clinical trials and their rights as participant. The purpose of this study is to modify a previously developed cancer clinical trials decision aid (DA), incorporating the unique needs of rural populations, and test its impact on knowledge and decision outcomes. The study was conducted in two phases. Phase I recruited 15 rural-residing cancer survivors in a qualitative usability study. Participants navigated the original DA and provided feedback regarding usability and implementation in rural settings. Phase II recruited 31 newly diagnosed rural-residing cancer patients. Patients completed a survey before and after using the revised DA, R-CHOICES. Primary outcomes included decisional conflict, decision self-efficacy, knowledge, communication self-efficacy, and attitudes towards and willingness to consider joining a trial. In phase I, the DA was viewed positively by rural-residing cancer survivors. Participants provided important feedback about factors rural-residing patients consider when thinking about trial participation. In phase II, after using R-CHOICES, participants had higher certainty about their choice (mean post-test = 3.10 vs. pre-test = 2.67; P = 0.025) and higher trial knowledge (mean percentage correct at post-test = 73.58 vs. pre-test = 57.77; P < 0.001). There was no significant change in decision self-efficacy, communication self-efficacy, and attitudes towards or willingness to join trials. The R-CHOICES improved rural-residing patients' knowledge of cancer clinical trials and reduced conflict about making a trial decision. More research is needed on ways to further support decisions about trial participation among this population.

Interventions for increasing the use of shared decision making by healthcare professionals.

BACKGROUND: Shared decision making (SDM) is a process by which a healthcare choice is made by the patient, significant others, or both with one or more healthcare professionals. However, it has not yet been widely adopted in practice. This is the second update of this Cochrane review. OBJECTIVES: To determine the effectiveness of interventions for increasing the use of SDM by healthcare professionals. We considered interventions targeting patients, interventions targeting healthcare professionals, and interventions targeting both. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and five other databases on 15 June 2017. We also searched two clinical trials registries and proceedings of relevant conferences. We checked reference lists and contacted study authors to identify additional studies. SELECTION CRITERIA: Randomized and non-randomized trials, controlled before-after studies and interrupted time series studies evaluating interventions for increasing the use of SDM in which the primary outcomes were evaluated using observer-based or patient-reported measures. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane.We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included 87 studies (45,641 patients and 3113 healthcare professionals) conducted mainly in the USA, Germany, Canada and the Netherlands. Risk of bias was high or unclear for protection against contamination, low for differences in the baseline characteristics of patients, and unclear for other domains.Forty-four studies evaluated interventions targeting patients. They included decision aids, patient activation, question prompt lists and training for patients among others and were administered alone (single intervention) or in combination (multifaceted intervention). The certainty of the evidence was very low. It is uncertain if interventions targeting patients when compared with usual care increase SDM whether measured by observation (standardized mean difference (SMD) 0.54, 95% confidence interval (CI) -0.13 to 1.22; 4 studies; N = 424) or reported by patients (SMD 0.32, 95% CI 0.16 to 0.48; 9 studies; N = 1386; risk difference (RD) -0.09, 95% CI -0.19 to 0.01; 6 studies; N = 754), reduce decision regret (SMD -0.10, 95% CI -0.39 to 0.19; 1 study; N = 212), improve physical (SMD 0.00, 95% CI -0.36 to 0.36; 1 study; N = 116) or mental health-related quality of life (QOL) (SMD 0.10, 95% CI -0.26 to 0.46; 1 study; N = 116), affect consultation length (SMD 0.10, 95% CI -0.39 to 0.58; 2 studies; N = 224) or cost (SMD 0.82, 95% CI 0.42 to 1.22; 1 study; N = 105).It is uncertain if interventions targeting patients when compared with interventions of the same type increase SDM whether measured by observation (SMD 0.88, 95% CI 0.39 to 1.37; 3 studies; N = 271) or reported by patients (SMD 0.03, 95% CI -0.18 to 0.24; 11 studies; N = 1906); (RD 0.03, 95% CI -0.02 to 0.08; 10 studies; N = 2272); affect consultation length (SMD -0.65, 95% CI -1.29 to -0.00; 1 study; N = 39) or costs. No data were reported for decision regret, physical or mental health-related QOL.Fifteen studies evaluated interventions targeting healthcare professionals. They included educational meetings, educational material, educational outreach visits and reminders among others. The certainty of evidence is very low. It is uncertain if these interventions when compared with usual care increase SDM whether measured by observation (SMD 0.70, 95% CI 0.21 to 1.19; 6 studies; N = 479) or reported by patients (SMD 0.03, 95% CI -0.15 to 0.20; 5 studies; N = 5772); (RD 0.01, 95%C: -0.03 to 0.06; 2 studies; N = 6303); reduce decision regret (SMD 0.29, 95% CI 0.07 to 0.51; 1 study; N = 326), affect consultation length (SMD 0.51, 95% CI 0.21 to 0.81; 1 study, N = 175), cost (no data available) or physical health-related QOL (SMD 0.16, 95% CI -0.05 to 0.36; 1 study; N = 359). Mental health-related QOL may slightly improve (SMD 0.28, 95% CI 0.07 to 0.49; 1 study, N = 359; low-certainty evidence).It is uncertain if interventions targeting healthcare professionals compared to interventions of the same type increase SDM whether measured by observation (SMD -0.30, 95% CI -1.19 to 0.59; 1 study; N = 20) or reported by patients (SMD 0.24, 95% CI -0.10 to 0.58; 2 studies; N = 1459) as the certainty of the evidence is very low. There was insufficient information to determine the effect on decision regret, physical or mental health-related QOL, consultation length or costs.Twenty-eight studies targeted both patients and healthcare professionals. The interventions used a combination of patient-mediated and healthcare professional directed interventions. Based on low certainty evidence, it is uncertain whether these interventions, when compared with usual care, increase SDM whether measured by observation (SMD 1.10, 95% CI 0.42 to 1.79; 6 studies; N = 1270) or reported by patients (SMD 0.13, 95% CI -0.02 to 0.28; 7 studies; N = 1479); (RD -0.01, 95% CI -0.20 to 0.19; 2 studies; N = 266); improve physical (SMD 0.08, -0.37 to 0.54; 1 study; N = 75) or mental health-related QOL (SMD 0.01, -0.44 to 0.46; 1 study; N = 75), affect consultation length (SMD 3.72, 95% CI 3.44 to 4.01; 1 study; N = 36) or costs (no data available) and may make little or no difference to decision regret (SMD 0.13, 95% CI -0.08 to 0.33; 1 study; low-certainty evidence).It is uncertain whether interventions targeting both patients and healthcare professionals compared to interventions of the same type increase SDM whether measured by observation (SMD -0.29, 95% CI -1.17 to 0.60; 1 study; N = 20); (RD -0.04, 95% CI -0.13 to 0.04; 1 study; N = 134) or reported by patients (SMD 0.00, 95% CI -0.32 to 0.32; 1 study; N = 150 ) as the certainty of the evidence was very low. There was insuffient information to determine the effects on decision regret, physical or mental health-related quality of life, or consultation length or costs. AUTHORS' CONCLUSIONS: It is uncertain whether any interventions for increasing the use of SDM by healthcare professionals are effective because the certainty of the evidence is low or very low.

What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata.

BACKGROUND: Breast cancer is the most commonly diagnosed malignancy in women. Mastectomy and breast-conserving surgery (BCS) have equivalent survival for early stage breast cancer. However, each surgery has different benefits and harms that women may value differently. Women of lower socioeconomic status (SES) diagnosed with early stage breast cancer are more likely to experience poorer doctor-patient communication, lower satisfaction with surgery and decision-making, and higher decision regret compared to women of higher SES. They often play a more passive role in decision-making and are less likely to undergo BCS. Our aim is to understand how best to support women of lower SES in making decisions about early stage breast cancer treatments and to reduce disparities in decision quality across socioeconomic strata. METHODS: We will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES and clinician-level randomization. At four large cancer centers in the United States, 1100 patients (half higher SES and half lower SES) will be randomized to: (1) Option Grid, (2) Picture Option Grid, or (3) usual care. Interviews, field-notes, and observations will be used to explore strategies that promote the interventions' sustained use and dissemination. Community-Based Participatory Research will be used throughout. We will include women aged at least 18 years of age with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak English, Spanish, or Mandarin Chinese. Our primary outcome measure is the 16-item validated Decision Quality Instrument. We will use a regression framework, mediation analyses, and multiple informants analysis. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. DISCUSSION: Currently, women of lower SES are more likely to make treatment decisions based on incomplete or uninformed preferences, potentially leading to poorer decision quality, quality of life, and decision regret. This study hopes to identify solutions that effectively improve patient-centered care across socioeconomic strata and reduce disparities in decision and care quality. TRIAL REGISTRATION: NCT03136367 at ClinicalTrials.gov Protocol version: Manuscript based on study protocol version 2.2, 7 November 2017.