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.

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.

Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials.

INTRODUCTION: Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients. METHODS AND ANALYSIS: Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention. ETHICS AND DISSEMINATION: The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website. TRIAL REGISTRATION NUMBERS: NCT05575128, NCT05685511, NCT05697835, pre-results.

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.

A Qualitative Exploration of Stakeholders' Preferences for Early-Stage Rectal Cancer Treatment.

As treatment options for patients with rectal cancer evolve, patients with early-stage rectal cancer may have a treatment choice between surgery and a trial of nonoperative management. Patients must consider the treatments' clinical tradeoffs alongside their personal goals and preferences. Shared decision-making (SDM) between patients and clinicians can improve decision quality when patients are faced with preference-sensitive care options. We interviewed 28 stakeholders (13 clinicians and 15 patients) to understand their perspectives on early-stage rectal cancer treatment decision-making. Clinicians included surgeons, medical oncologists, and radiation oncologists who treat rectal cancer. Adult patients included those diagnosed with early-stage rectal cancer in the past 5 years, recruited from an institutional database. A semi-structured interview guide was developed based on a well-established decision support framework and reviewed by the research team and stakeholders. Interviews were conducted between January 2022 and January 2023. Transcripts were coded by 2 raters and analyzed using thematic analysis. Both clinicians and patients recognized the importance of SDM to support high-quality decisions about the treatment of early-stage rectal cancer. Barriers to SDM included variable clinician motivation due to lack of training or perception of patients' desires or abilities to engage, as well as time-constrained encounters. A decision aid could help facilitate SDM for early-stage rectal cancer by providing standardized, evidence-based information about treatment options that align with clinicians' and patients' decision needs.

Description of the Content and Quality of Publicly Available Information on the Internet About Inhaled Volatile Anesthesia and Total Intravenous Anesthesia: Descriptive Study.

BACKGROUND: More than 300 million patients undergo surgical procedures requiring anesthesia worldwide annually. There are 2 standard-of-care general anesthesia administration options: inhaled volatile anesthesia (INVA) and total intravenous anesthesia (TIVA). There is limited evidence comparing these methods and their impact on patient experiences and outcomes. Patients often seek this information from sources such as the internet. However, the majority of websites on anesthesia-related topics are not comprehensive, updated, and fully accurate. The quality and availability of web-based patient information about INVA and TIVA have not been sufficiently examined. OBJECTIVE: This study aimed to (1) assess information on the internet about INVA and TIVA for availability, readability, accuracy, and quality and (2) identify high-quality websites that can be recommended to patients to assist in their anesthesia information-seeking and decision-making. METHODS: Web-based searches were conducted using Google from April 2022 to November 2022. Websites were coded using a coding instrument developed based on the International Patient Decision Aids Standards criteria and adapted to be appropriate for assessing websites describing INVA and TIVA. Readability was calculated with the Flesch-Kincaid (F-K) grade level and the simple measure of Gobbledygook (SMOG) readability formula. RESULTS: A total of 67 websites containing 201 individual web pages were included for coding and analysis. Most of the websites provided a basic definition of general anesthesia (unconsciousness, n=57, 85%; analgesia, n=47, 70%). Around half of the websites described common side effects of general anesthesia, while fewer described the rare but serious adverse events, such as intraoperative awareness (n=31, 46%), allergic reactions or anaphylaxis (n=29, 43%), and malignant hyperthermia (n=18, 27%). Of the 67 websites, the median F-K grade level was 11.3 (IQR 9.5-12.8) and the median SMOG score was 13.5 (IQR 12.2-14.4), both far above the American Medical Association (AMA) recommended reading level of sixth grade. A total of 51 (76%) websites distinguished INVA versus TIVA as general anesthesia options. A total of 12 of the 51 (24%) websites explicitly stated that there is a decision to be considered about receiving INVA versus TIVA for general anesthesia. Only 10 (20%) websites made any direct comparisons between INVA and TIVA, discussing their positive and negative features. A total of 12 (24%) websites addressed the concept of shared decision-making in planning anesthesia care, but none specifically asked patients to think about which features of INVA and TIVA matter the most to them. CONCLUSIONS: While the majority of websites described INVA and TIVA, few provided comparisons. There is a need for high-quality patient education and decision support about the choice of INVA versus TIVA to provide accurate and more comprehensive information in a format conducive to patient understanding.

Assessing an Online Patient Decision Aid about Upper Extremity Reconstructive Surgery for Cervical Spinal Cord Injury: Pilot Testing Knowledge, Decisional Conflict, and Acceptability.

Background. While nerve and tendon transfer surgery can restore upper extremity function and independence after midcervical spinal cord injury, few individuals (∼14%) undergo surgery. There is limited information regarding these complex and time-sensitive treatment options. Patient decision aids (PtDAs) convey complex health information and help individuals make informed, preference-consistent choices. The purpose of this study is to evaluate a newly created PtDA for people with spinal cord injury who are considering options to optimize upper extremity function. Methods. The PtDA was developed by our multidisciplinary group based on clinical evidence and the Ottawa Decision Support Framework. A prospective pilot study enrolled adults with midcervical spinal cord injury to evaluate the PtDA. Participants completed surveys about knowledge and decisional conflict before and after viewing the PtDA. Acceptability measures and suggestions for further improvement were also solicited. Results. Forty-two individuals were enrolled and completed study procedures. Participants had a 20% increase in knowledge after using the PtDA (P < 0.001). The number of participants experiencing decisional conflict decreased after viewing the PtDA (33 v. 18, P = 0.001). Acceptability was high. To improve the PtDA, participants suggested adding details about specific surgeries and outcomes. Limitations. Due to the COVID-19 pandemic, we used an entirely virtual study methodology and recruited participants from national networks and organizations. Most participants were older than the general population with a new spinal cord injury and may have different injury causes than typical surgical candidates. Conclusions. A de novo PtDA improved knowledge of treatment options and reduced decisional conflict about reconstructive surgery among people with cervical spinal cord injury. Future work should explore PtDA use for improving knowledge and decisional conflict in the nonresearch, clinical setting. Highlights: People with cervical spinal cord injury prioritize gaining upper extremity function after injury, but few individuals receive information about treatment options.A newly created patient decision aid (PtDA) provides information about recovery after spinal cord injury and the role of traditional tendon and newer nerve transfer surgery to improve upper extremity upper extremity function.The PtDA improved knowledge and decreased decisional conflict in this pilot study.Future work should focus on studying dissemination and implementation of the ptDA into clinical practice.

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).

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.

Financial burden of men with localized prostate cancer: a process paper.

Background: Many individuals undergoing cancer treatment experience substantial financial hardship, often referred to as financial toxicity (FT). Those undergoing prostate cancer treatment may experience FT and its impact can exacerbate disparate health outcomes. Localized prostate cancer treatment options include: radiation, surgery, and/or active surveillance. Quality of life tradeoffs and costs differ between treatment options. In this project, our aim was to quantify direct healthcare costs to support patients and clinicians as they discuss prostate cancer treatment options. We provide the transparent steps to estimate healthcare costs associated with treatment for localized prostate cancer among the privately insured population using a large claims dataset. Methods: To quantify the costs associated with their prostate cancer treatment, we used data from the Truven Health Analytics MarketScan Commercial Claims and Encounters, including MarketScan Medicaid, and peer reviewed literature. Strategies to estimate costs included: (1) identifying the problem, (2) engaging a multidisciplinary team, (3) reviewing the literature and identifying the database, (4) identifying outcomes, (5) defining the cohort, and (6) designing the analytic plan. The costs consist of patient, clinician, and system/facility costs, at 1-year, 3-years, and 5-years following diagnosis. Results: We outline our specific strategies to estimate costs, including: defining complex research questions, defining the study population, defining initial prostate cancer treatment, linking facility and provider level related costs, and developing a shared understanding of definitions on our research team. Discussion and next steps: Analyses are underway. We plan to include these costs in a prostate cancer patient decision aid alongside other clinical tradeoffs.

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.

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.

Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial.

INTRODUCTION: Millions of patients receive general anaesthesia for surgery annually. Crucial gaps in evidence exist regarding which technique, propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA), yields superior patient experience, safety and outcomes. The aim of this pilot study is to assess the feasibility of conducting a large comparative effectiveness trial assessing patient experiences and outcomes after receiving propofol TIVA or INVA. METHODS AND ANALYSIS: This protocol was cocreated by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 300-patient, two-centre, randomised, feasibility pilot trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to propofol TIVA or INVA, stratified by centre and procedural complexity. The feasibility endpoints include: (1) proportion of patients approached who agree to participate; (2) proportion of patients who receive their assigned randomised treatment; (3) completeness of outcomes data collection and (4) feasibility of data management procedures. Proportions and 95% CIs will be calculated to assess whether prespecified thresholds are met for the feasibility parameters. If the lower bounds of the 95% CI are above the thresholds of 10% for the proportion of patients agreeing to participate among those approached and 80% for compliance with treatment allocation for each randomised treatment group, this will suggest that our planned pragmatic 12 500-patient comparative effectiveness trial can likely be conducted successfully. Other feasibility outcomes and adverse events will be described. ETHICS AND DISSEMINATION: This study is approved by the ethics board at Washington University (IRB# 202205053), serving as the single Institutional Review Board for both participating sites. Recruitment began in September 2022. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media. TRIAL REGISTRATION NUMBER: NCT05346588.

A Patient-Centered Perioperative Mental Health Intervention Bundle: A Multi- and Mixed-Method Adaptation Study.

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. 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.

Clinician Perspectives on Barriers and Enablers to Implementing an Inpatient Oncology Early Warning System: A Mixed-Methods Study.

PURPOSE: To elicit end-user and stakeholder perceptions regarding design and implementation of an inpatient clinical deterioration early warning system (EWS) for oncology patients to better fit routine clinical practices and enhance clinical impact. METHODS: In an explanatory-sequential mixed-methods study, we evaluated a stakeholder-informed oncology early warning system (OncEWS) using surveys and semistructured interviews. Stakeholders were physicians, advanced practice providers (APPs), and nurses. For qualitative data, we used grounded theory and thematic content analysis via the constant comparative method to identify determinants of OncEWS implementation. RESULTS: Survey respondents generally agreed that an oncology-focused EWS could add value beyond clinical judgment, with nurses endorsing this notion significantly more strongly than other clinicians (nurse: median 5 on a 6-point scale [6 = strongly agree], interquartile range 4-5; doctors/advanced practice providers: 4 [4-5]; P = .005). However, some respondents would not trust an EWS to identify risk accurately (n = 36 [42%] somewhat or very concerned), while others were concerned that institutional culture would not embrace such an EWS (n = 17 [28%]).Interviews highlighted important aspects of the EWS and the local context that might facilitate implementation, including (1) a model tailored to the subtleties of oncology patients, (2) transparent model information, and (3) nursing-centric workflows. Interviewees raised the importance of sepsis as a common and high-risk deterioration syndrome. CONCLUSION: Stakeholders prioritized maximizing the degree to which the OncEWS is understandable, informative, actionable, and workflow-complementary, and perceived these factors to be key for translation into clinical benefit.

Developing an Educational and Decision Support Tool for Stage I Lung Cancer Using Decision Science.

BACKGROUND: Guidelines recommend shared decision-making about treatment options for high-risk, operable stage I lung cancer. Patient decision aids can facilitate shared decision-making; however, their development, implementation, and evaluation in routine clinical practice presents numerous challenges and opportunities. METHODS: The purpose of this review is to reflect on the process of tool development; identify the challenges associated with meeting the needs of patients, clinicians from multiple disciplines, and institutional workflow during implementation; and propose recommendations for future clinicians who wish to develop, refine, or implement similar tools into routine care. RESULTS: In this review, we: (1) discuss guidelines for decision aid development; (2) describe how we applied those to create an education and decision support tool for patients with clinical stage I lung cancer deciding between radiation therapy and surgical resection; and (3) highlight challenges in implementing and evaluating the tool. CONCLUSIONS: We provide recommendations for those seeking to develop, refine, or implement similar tools into routine care.

Integrating a Patient Decision Aid into the Electronic Health Record: A Case Report on the Implementation of BREASTChoice at 2 Sites.

Patient decision aids can support shared decision making and improve decision quality. However, decision aids are not widely used in clinical practice due to multiple barriers. Integrating patient decision aids into the electronic health record (EHR) can increase their use by making them more clinically relevant, personalized, and actionable. In this article, we describe the procedures and considerations for integrating a patient decision aid into the EHR, based on the example of BREASTChoice, a decision aid for breast reconstruction after mastectomy. BREASTChoice's unique features include 1) personalized risk prediction using clinical data from the EHR, 2) clinician- and patient-facing components, and 3) an interactive format. Integrating a decision aid with patient- and clinician-facing components plus interactive sections presents unique deployment issues. Based on this experience, we outline 5 key implementation recommendations: 1) engage all relevant stakeholders, including patients, clinicians, and informatics experts; 2) explicitly and continually map all persons and processes; 3) actively seek out pertinent institutional policies and procedures; 4) plan for integration to take longer than development of a stand-alone decision aid or one with static components; and 5) transfer knowledge about the software programming from one institution to another but expect local and context-specific changes. Integration of patient decision aids into the EHR is feasible and scalable but requires preparation for specific challenges and a flexible mindset focused on implementation. Highlights: Integrating an interactive decision aid with patient- and clinician-facing components into the electronic health record could advance shared decision making but presents unique implementation challenges.We successfully integrated a decision aid for breast reconstruction after mastectomy called BREASTChoice into the electronic health record.Based on this experience, we offer these implementation recommendations: 1) engage relevant stakeholders, 2) explicitly and continually map persons and processes, 3) seek out institutional policies and procedures, 4) plan for it to take longer than for a stand-alone decision aid, and 5) transfer software programming from one site to another but expect local changes.

A case study of adapting a health insurance decision intervention from trial into routine cancer care.

OBJECTIVE: This study adapted Improving Cancer Patients' Insurance Choices (I Can PIC), an intervention to help cancer patients navigate health insurance decisions and care costs. The original intervention improved knowledge and confidence making insurance decisions, however, users felt limited by choices provided in insurance markets. Using decision trees and frameworks to guide adaptations, we modified I Can PIC to focus on using rather than choosing health insurance. The COVID-19 pandemic introduced unforeseen obstacles, prompting changes to study protocols. As a result, we allowed users outside of the study to use I Can PIC (> 1050 guest users) to optimize public benefit. This paper describes the steps took to conduct the study, evaluating both the effectiveness of I Can PIC and the implementation process to improve its impact. RESULTS: Although I Can PIC users had higher knowledge and health insurance literacy compared to the control group, results were not statistically significant. This outcome may be associated with systems-level challenges as well as the number and demographic characteristics of participants. The publicly available tool can be a resource for those navigating insurance and care costs, and researchers can use this flexible approach to intervention delivery and testing as future health emergencies arise.

Unexpected Outcomes of Measuring Decision Regret: Using a Breast Cancer Decision-Making Case Example.

Shared decision making can help patients feel supported and empowered when deciding between healthcare options. Decision regret can be a meaningful measure of the quality of that encounter. However, in a patient-engaged research study examining shared decision making for breast cancer surgery, decision regret was a difficult construct to assess, and asking questions about decision regret caused the patient to experience that emotion upon reflection. In this article, we consider the complexity of decision regret, and discuss the difficulty of measuring that emotion through existing instruments. We call for clarity in definitions of decision regret and offer suggestions for developing a set of questions that can capture regret in a more meaningful way.