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Abstract Background Hip fracture surgery under general or spinal anesthesia is a common procedure for older adults in the United States (US). Although spinal or general anesthesia can be appropriate for many patients, and the choice between anesthesia types is preference-sensitive, shared decision-making is not consistently used by anesthesiologists counseling patients on anesthesia for this procedure. We designed an Option Grid™-style conversation aid, My Anesthesia Choice─Hip Fracture, to promote shared decision making in this interaction. This study will refine the aid and evaluate its implementation and effectiveness in clinical practice. Methods The study will be conducted over 2 phases: qualitative interviews with relevant clinicians and patients to refine the aid, followed by a stepped wedge cluster randomized trial of the intervention at 6 settings in the US. Primary outcomes will include the percentage of eligible patients who receive the intervention (intervention reach) and the change in quality of patient/clinician communication (intervention effectiveness). Secondary outcomes addressing other RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) domains will also be collected. Outcomes will be compared between baseline data and an active implementation period and then compared between the active implementation period and a sustainment period. Implementation strategies are guided by three constructs from the Practical, Robust Implementation and Sustainability Model (PRISM): intervention, recipients, and implementation and sustainability infrastructure. Discussion This is a novel, large-scale trial evaluating and implementing a shared decision-making conversation aid for anesthesia choices. Strong buy-in from site leads and expert advisors will support both the success of implementation and the future dissemination of results and the intervention. Results from this study will inform the broader implementation of this aid for patients with hip fractures and can lead to the development and implementation of similar conversation aids for other anesthesia choices. Trial registration ClinicalTrials.gov, NCT06438640

Abstract 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

Background:. Metoidioplasty and phalloplasty gender-affirming surgery (MaPGAS) is increasingly performed and requires patients to make complex decisions that may lead to decisional uncertainty. This study aimed to evaluate decisional conflict in individuals considering MaPGAS. Methods:. We administered a cross-sectional survey to adult participants assigned female sex at birth and considering MaPGAS, recruited via social media platforms and community health centers. We collected data on demographics, medical and surgical history, MaPGAS type considered, and the Decisional Conflict Scale (DCS). DCS scores range from 0 to 100 (>37.5 indicates greater decisional conflict). Demographic characteristics and DCS scores were compared between subgroups, using descriptive and chi-square statistics. Participants commented on MaPGAS uncertainty, and their comments were evaluated and thematically analyzed. Results:. Responses from 264 participants were analyzed: mean age 29 years; 64% (n = 168) trans men, 80% (n = 210) White, 78% (n = 206) nonrural, 45% (n = 120) privately insured, 56% (n = 148) had 4 or more years of college, 23% (n = 84) considering metoidioplasty, 24% (n = 87) considering phalloplasty, and 26% (n = 93) considering metoidioplasty and phalloplasty. DCS total scores were significantly higher (39.8; P < 0.001) among those considering both MaPGAS options, as were mean ratings on the Uncertainty subscale [64.1 (SD 25.5; P < 0.001)]. Concerns surrounding complications were the top factor contributing to uncertainty and decisional conflict. Conclusions:. In a cross-sectional national sample of individuals seeking MaPGAS, decisional uncertainty was the highest for those considering both MaPGAS options compared with metoidioplasty or phalloplasty alone. This suggests this cohort would benefit from focused decision support.

Objectives Patients’ preferences, values and contexts are important elements of the shared decision-making (SDM) process. We captured those elements into the concept of ‘personal perspective elicitation’ (PPE), which reflects the need to elicit patients’ preferences, values and contexts in patient–clinician conversations. We defined PPE as: ‘the disclosure (either elicited by the clinician or spontaneously expressed by the patient) of information related to the patient’s personal preferences, values and/or contexts potentially relevant to decision-making’. Our goal was to operationalise the concept of PPE through the evaluation of preferences, values and contexts and explore how PPE occurs in clinical encounters.Design Cross-sectional study: observational coding based on a novel coding scheme of audio-recorded outpatient clinical encounters where encounter patient decision aids were applied.Setting We audio-recorded patient–clinician interactions at three Dutch outpatient clinics. PPE was analysed using a novel observational coding scheme, distinguishing preferences, contexts and four Armstrong taxonomy value types (global, decisional, external and situational). We measured SDM using the Observer OPTION5.Participants Twenty patients who suffered from psoriasis or ovarian cysts; four clinicians.Results We included 20 audio-recordings. The mean Observer OPTION5 score was 57.5 (SD:10.1). The audio-recordings gave a rich illustration of preferences, values and contexts that were discussed in the patient–clinician interactions. Examples of identified global values: appearance, beliefs, personality traits. Decisional values were related to the process of decision-making. External values related to asking advice from for example, the clinician or significant others. An identified situational value: a new job ahead. Contexts related to how the illness impacted the life (eg, sexuality, family, sports, work life) of patients.Conclusions The operationalisation of PPE, an important aspect of SDM, explores which preferences, values and contexts were discussed during patient–clinician interactions where an ePDA was used. The coding scheme appeared feasible to apply but needs further refinement.

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

Purpose: The study aim was to test the feasibility of collecting qualitative patient-preferred outcomes or goals and the degree of their attainment as an addition to a standardized process for collecting quantitative composite patient-reported outcome measures (PROMs) from patients undergoing knee joint replacement.. Methods: Patients of a large Midwestern medical group scheduled to have total replacement of their knee joint have been asked to complete a PROMs survey preoperatively and at 3 and 12 months after surgery since 2014. In March 2020, an open-ended question about their most important preferred outcome was added to the existing questionnaire. The responses for all 3 time periods from the first 6 months of this addition were summarized quantitatively and analyzed by 2 reviewers. Results: During that 6-month period, 1481 people completed the main survey while 1463 (98.8%) also completed the open-ended question. At baseline, 90.8% of the 590 baseline respondents identified a preferred outcome. If multiple-choice categories had been used, 82.7% of the responses would have lost some or a large amount of their preferred goals’ meaning. Of the 144 who completed surveys at both baseline and 3 months, 86.1% reported another outcome in addition to pain relief, while 54.2% reported “Complete or Mostly” achieving their self-identified preferred outcome. Conclusions: Most people who have joint replacement surgery and respond to a quantitative PROMs survey are willing to report on their other preferred outcomes as well. Adding an open-ended question to PROMs surveys may increase clinician focus on addressing outcomes important to each patient.

Abstract 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 (β = .82, p = .27), referrals to cost‐related resources (β = −0.36, p = .81), shared decision‐making (β = −0.79, p = .32), decisional conflict postvisit (β = −0.34, p= .70), or at follow‐up (β = −2.19, p = .16), decision regret at follow‐up (β = −9.76, p = .11), or financial toxicity postvisit (β = −1.32, p = .63) or at follow‐up (β = −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

Background: Shared decision making (SDM) is the process by which patients and clinicians exchange information and preferences to come to joint healthcare decisions. Clinical dashboards can support SDM by collecting, distilling, and presenting critical information, such as patient-reported outcomes (PROs), to be shared at points of care and in between appointments. We describe the implementation strategies and outcomes of a multistakeholder collaborative process known as “co-design” to develop a PRO-informed clinical dashboard to support SDM for patients with advanced cancer or chronic kidney disease (CKD). Methods: Across 14 sessions, two multidisciplinary teams comprising patients, care partners, clinicians, and other stakeholders iteratively co-designed an SDM dashboard for either advanced cancer (N = 25) or CKD (N = 24). Eligible patients, care partners, and frontline clinicians were identified by six physician champions. The co-design process included four key steps: (1) define “the problem”, (2) establish context of use, (3) build a consensus on design, and (4) define and test specifications. We also evaluated our success in implementing the co-design strategy using measures of fidelity, acceptability, adoption, feasibility, and effectiveness which were collected throughout the process. Results: Mean (M) scores across implementation measures of the co-design process were high, including observer-rated fidelity and adoption of co-design practices (M = 19.1 on a 7–21 scale, N = 36 ratings across 9 sessions), as well as acceptability based on the perceived degree of SDM that occurred during the co-design process (M = 10.4 on a 0 to 12 adapted collaboRATE scale). Capturing the feasibility and adoption of convening multistakeholder co-design teams, min–max normalized scores (ranging from 0 to 1) of stakeholder representation demonstrated that, on average, 95% of stakeholder types were represented for cancer sessions (M = 0.95) and 85% for CKD sessions (M = 0.85). The co-design process was rated as either “fully” or “partially” effective by 100% of respondents, in creating a dashboard that met its intended objective. Conclusions: A co-design process was successfully implemented to develop SDM clinical dashboards for advanced cancer and CKD care. We discuss key strategies and learnings from this process that may aid others in the development and uptake of patient-centered healthcare innovations.

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

The transition to and acceptance of digital mental health tools has been heralded as a paradigm shift for providing and accessing care. Yet, providers and clients express concerns over privacy, efficacy, and personalization, as well as their ability to assess the thousands of available digital tools. In response to these concerns and calls for support to address them, the authors developed the Technology Specialist program. After a successful feasibility study, the research team launched a pilot study in late 2021 amid continuing COVID-19 protocols, presuming the rapid adoption of technology during the pandemic would facilitate the incorporation of the Technology Specialist. Despite the success of the role, the shifts in care delivery at one community mental health center created and exposed barriers to the implementation and uptake of digital tools. In this paper, the authors describe key access barriers exposed through the implementation of the pilot at the client, provider, and organizational levels. These barriers highlight a shifting digital divide for access to digital mental health among people with serious mental illness. The re-framed method of contextual engagement presented here may help direct research and practice toward collaborative and equitable action strategies for long-term success in community health settings.

Abstract Background Clinical and real-world effectiveness data for the COVID-19 vaccines have shown that they are the best defense in preventing severe illness and death throughout the pandemic. However, in the US, some groups remain more hesitant than others about receiving COVID-19 vaccines. One important group is long-term care workers (LTCWs), especially because they risk infecting the vulnerable and clinically complex populations they serve. There is a lack of research about how best to increase vaccine confidence, especially in frontline LTCWs and healthcare staff. Our aims are to: (1) compare the impact of two interventions delivered online to enhanced usual practice on LTCW COVID-19 vaccine confidence and other pre-specified secondary outcomes, (2) determine if LTCWs’ characteristics and other factors mediate and moderate the interventions’ effect on study outcomes, and (3) explore the implementation characteristics, contexts, and processes needed to sustain a wider use of the interventions. Methods We will conduct a three-arm randomized controlled effectiveness-implementation hybrid (type 2) trial, with randomization at the participant level. Arm 1 is a dialogue-based webinar intervention facilitated by a LTCW and a medical expert and guided by an evidence-based COVID-19 vaccine decision tool. Arm 2 is a curated social media web application intervention featuring interactive, dynamic content about COVID-19 and relevant vaccines. Arm 3 is enhanced usual practice, which directs participants to online public health information about COVID-19 vaccines. Participants will be recruited via online posts and advertisements, email invitations, and in-person visits to care settings. Trial data will be collected at four time points using online surveys. The primary outcome is COVID-19 vaccine confidence. Secondary outcomes include vaccine uptake, vaccine and booster intent for those unvaccinated, likelihood of recommending vaccination (both initial series and booster), feeling informed about the vaccines, identification of vaccine information and misinformation, and trust in COVID-19 vaccine information provided by different people and organizations. Exploration of intervention implementation will involve interviews with study participants and other stakeholders, an in-depth process evaluation, and testing during a subsequent sustainability phase. Discussion Study findings will contribute new knowledge about how to increase COVID-19 vaccine confidence and effective informational modalities for LTCWs. Trial registration NCT05168800 at ClinicalTrials.gov, registered December 23, 2021.

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

Objectives: To report a design-thinking approach to a user-centred agenda-setting tool for use in type 2 diabetes clinics. Methods: The study followed design-thinking phases: emphasizing, defining, and ideating an intervention, followed by iterative user-testing of prototypes. It was conducted at a Danish diabetes center using observations, interviews, workshops, focus groups, and questionnaires. Results: Nurses wanted to put more emphasis on agenda-setting in status visits. During brainstorms the idea of using illustrated cards that listed key agenda topics was proposed and became the goal of this research. Adopting a design-thinking approach provided the basis for developing prototypes for iterative user-testing that led to a version that was acceptable to stakeholders. The resulting tool, Conversation Cards, was a set of cards that listed and illustrated seven key topics that were considered important to consider during diabetes status visits. Conclusion: The goal of the Conversation Card intervention is to support collaborative agenda-setting in diabetes status visits. Further evaluation is needed to determine the utility and acceptability of the tool to nurses and to people with diabetes in routine settings. Innovation: This novel tool is designed to trigger agenda-setting conversations and thereby prioritize individuals' choice of topics to talk about during diabetes status visits.

Abstract Background Patient decision aids (PDAs) should provide evidence‐based information so patients can make informed decisions. Yet, PDA developers do not have an agreed‐upon process to select, synthesize and present evidence in PDAs. Objective To reach the consensus on an evidence summarization process for PDAs. Design A two‐round modified Delphi survey. Setting and participants A group of international experts in PDA development invited developers, scientific networks, patient groups and listservs to complete Delphi surveys. Data collection We emailed participants the study description and a link to the online survey. Participants were asked to rate each potential criterion (omit, possible, desirable, essential) and provide qualitative feedback. Analysis Criteria in each round were retained if rated by >80% of participants as desirable or essential. If two or more participants suggested rewording, reordering or merging, the steering group considered the suggestion. Results Following two Delphi survey rounds, the evidence summarization process included defining the decision, reporting the processes and policies of the evidence summarization process, assembling the editorial team and managing (collect, manage, report) their conflicts of interest, conducting a systematic search, selecting and appraising the evidence, presenting the harms and benefits in plain language, and describing the method of seeking external review and the plan for updating the evidence (search, selection and appraisal of new evidence). Conclusion A multidisciplinary stakeholder group reached consensus on an evidence summarization process to guide the creation of high‐quality PDAs. Patient contribution A patient partner was part of the steering group and involved in the development of the Delphi survey.

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

BackgroundPatient-reported outcomes—symptoms, treatment side effects, and health-related quality of life—are important to consider in chronic illness care. The increasing availability of health IT to collect patient-reported outcomes and integrate results within the electronic health record provides an unprecedented opportunity to support patients’ symptom monitoring, shared decision-making, and effective use of the health care system. ObjectiveThe objectives of this study are to co-design a dashboard that displays patient-reported outcomes along with other clinical data (eg, laboratory tests, medications, and appointments) within an electronic health record and conduct a longitudinal demonstration trial to evaluate whether the dashboard is associated with improved shared decision-making and disease management outcomes. MethodsCo-design teams comprising study investigators, patients with advanced cancer or chronic kidney disease, their care partners, and their clinicians will collaborate to develop the dashboard. Investigators will work with clinic staff to implement the co-designed dashboard for clinical testing during a demonstration trial. The primary outcome of the demonstration trial is whether the quality of shared decision-making increases from baseline to the 3-month follow-up. Secondary outcomes include longitudinal changes in satisfaction with care, self-efficacy in managing treatments and symptoms, health-related quality of life, and use of costly and potentially avoidable health care services. Implementation outcomes (ie, fidelity, appropriateness, acceptability, feasibility, reach, adoption, and sustainability) during the co-design process and demonstration trial will also be collected and summarized. ResultsThe dashboard co-design process was completed in May 2020, and data collection for the demonstration trial is anticipated to be completed by the end of July 2022. The results will be disseminated in at least one manuscript per study objective. ConclusionsThis protocol combines stakeholder engagement, health care coproduction frameworks, and health IT to develop a clinically feasible model of person-centered care delivery. The results will inform our current understanding of how best to integrate patient-reported outcome measures into clinical workflows to improve outcomes and reduce the burden of chronic disease on patients and health care systems. International Registered Report Identifier (IRRID)DERR1-10.2196/38461

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

Abstract Background Conversation aids can facilitate shared decision-making and improve patient-centered outcomes. However, few examples exist of sustained use of conversation aids in routine care due to numerous barriers at clinical and organizational levels. We explored factors that will promote the sustained use of two early-stage breast cancer conversation aids. We examined differences in opinions between the two conversation aids and across socioeconomic strata. Methods We nested this study within a randomized controlled trial that demonstrated the effectiveness of two early-stage breast cancer surgery conversation aids, one text-based and one picture-based. These conversation aids facilitated more shared decision-making and improved the decision process, among other outcomes, across four health systems with socioeconomically diverse patient populations. We conducted semi-structured interviews with a purposive sample of patient participants across conversation aid assignment and socioeconomic status (SES) and collected observations and field notes. We interviewed trial surgeons and other stakeholders. Two independent coders conducted framework analysis using the NOrmalization MeAsure Development through Normalization Process Theory. We also conducted an inductive analysis. We conducted additional sub-analyses based on conversation aid assignment and patient SES. Results We conducted 73 semi-structured interviews with 43 patients, 16 surgeons, and 14 stakeholders like nurses, cancer center directors, and electronic health record (EHR) experts. Patients and surgeons felt the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid (EHR, email, patient portal, before consultation). Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision-making. Intervention surgeons reported using the conversation aids did not lengthen their typical consultation time. Most intervention surgeons felt using the conversation aids enhanced their usual care after using it a few times, and most patients felt it appeared part of their normal routine. Conclusions Key factors that will guide the future sustained implementation of the conversation aids include adapting to existing clinical workflows, flexibility of use, patient characteristics, and communication preferences. Trial registration ClinicalTrials.gov Identifier: NCT03136367 , registered on May 2, 2017

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

Abstract Background Despite decades of ethical, empirical, and policy support, shared decision-making (SDM) has failed to become standard practice in US cancer care. Organizational and health system characteristics appear to contribute to the difficulties in implementing SDM in routine care. However, little is known about the relevance of the different characteristics in specific healthcare settings. The aim of the study was to explore how organizational and health system characteristics affect SDM implementation in US cancer care. Methods We conducted semi-structured interviews with diverse cancer care stakeholders in the USA. Of the 36 invited, 30 (83%) participants consented to interview. We used conventional content analysis to analyze transcript content. Results The dominant theme in the data obtained was that concerns regarding a lack of revenue generation, or indeed, the likely loss of revenue, were a major barrier preventing implementation of SDM. Many other factors were prominent as well, but the view that SDM might impair organizational or individual profit margins and reduce the income of some health professionals was widespread. On the organizational level, having leadership support for SDM and multidisciplinary teams were viewed as critical to implementation. On the health system level, views diverged on whether embedding tools into electronic health records (EHRs), making SDM a criterion for accreditation and certification, and enacting legislation could promote SDM implementation. Conclusion Cancer care in the USA has currently limited room for SDM and is prone to paying lip service to the idea. Implementation efforts in US cancer care need to go further than interventions that target only the clinician-patient level. On a policy level, SDM could be included in alternative payment models. However, its implementation would need to be thoroughly assessed in order to prevent further misdirected incentivization through box ticking.

Abstract Objective To investigate the association between patients' preferred treatment and eventual treatment. Second, to compare patients with surgical treatment to watchful waiting in order to identify predictive factors for surgery. Methods A single‐centre retrospective study was performed between December 2015 and August 2018. Patients (≥18 years) who used a patient decision aid (PDA) for gallstones or inguinal hernia were included. After their first surgical consultation, patients received access to an online PDA. The patients' preferred treatment after the PDA was compared with their choice of eventual treatment. Multivariable regression analyses were performed for predictive factors for surgery. Results In total, 567 patients with gallstones and 585 patients with an inguinal hernia were included. Of the patients with gallstones, 121 (21%) preferred watchful waiting, 367 (65%) preferred surgery, and 79 (14%) were not sure. The patients' preferred treatment was performed in 85.9%. Frequent pain attacks (OR 2.1, 95% CI 1.1‐3.9, P = .020) and preference for surgery (OR 4.4, 95% CI 1.9‐10.1, P = .001) independently predicted surgery. Of the patients with an inguinal hernia, 77 (13.2%) preferred watchful waiting, 452 (78.8%) preferred surgery, and 56 (9.6%) were not sure. The patients' preferred treatment was performed in 86.0%. The preference for surgery (OR 5.2, 95% CI 2.5‐10.6, P

Abstract Background Developing a stroke health-education mobile app (SHEMA) and examining its effectiveness on improvement of knowledge of stroke risk factors and health-related quality of life (HRQOL) in patients with stroke. Methods We recruited 76 stroke patients and randomly assigned them to either the SHEMA intervention (n = 38) or usual care where a stroke health-education booklet was provided (n = 38). Knowledge of stroke risk factors and HRQOL were assessed using the stroke-knowledge questionnaire and European Quality of Life–Five Dimensions (EQ-5D) questionnaire, respectively. Results Sixty-three patients completed a post-test survey (the SHEMA intervention, n = 30; traditional stroke health-education, n = 33). Our trial found that patients’ mean knowledge score of stroke risk factors was improved after the SHEMA intervention (Mean difference = 2.83; t = 3.44; p = .002), and patients’ knowledge was also improved in the after traditional stroke health-education (Mean difference = 2.79; t = 3.68; p = .001). However, patients after the SHEMA intervention did not have significantly higher changes of the stroke knowledge or HRQOL than those after traditional stroke health-education. Conclusions Both the SHEMA intervention and traditional stroke health-education can improve patients’ knowledge of stroke risk factors, but the SHEMA was not superior to traditional stroke health-education. Trial registration NCT02591511 Verification Date 2015-10-01.

Abstract Background There is limited evidence on how to implement shared decision-making (SDM) interventions in routine practice. We conducted a qualitative study, embedded within a 2 × 2 factorial cluster randomized controlled trial, to assess the acceptability and feasibility of two interventions for facilitating SDM about contraceptive methods in primary care and family planning clinics. The two SDM interventions comprised a patient-targeted intervention (video and prompt card) and a provider-targeted intervention (encounter decision aids and training). Methods Participants were clinical and administrative staff aged 18 years or older who worked in one of the 12 clinics in the intervention arm, had email access, and consented to being audio-recorded. Semi-structured telephone interviews were conducted upon completion of the trial. Audio recordings were transcribed verbatim. Data collection and thematic analysis were informed by the 14 domains of the Theoretical Domains Framework, which are relevant to the successful implementation of provider behaviour change interventions. Results Interviews (n = 29) indicated that the interventions were not systematically implemented in the majority of clinics. Participants felt the interventions were aligned with their role and they had confidence in their skills to use the decision aids. However, the novelty of the interventions, especially a need to modify workflows and change behavior to use them with patients, were implementation challenges. The interventions were not deeply embedded in clinic routines and their use was threatened by lack of understanding of their purpose and effect, and staff absence or turnover. Participants from clinics that had an enthusiastic study champion or team-based organizational culture found these social supports had a positive role in implementing the interventions. Conclusions Variation in capabilities and motivation among clinical and administrative staff, coupled with inconsistent use of the interventions in routine workflow contributed to suboptimal implementation of the interventions. Future trials may benefit by using implementation strategies that embed SDM in the organizational culture of clinical settings.

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

There are numerous opportunities for shared decision-making (SDM) in cystic fibrosis (CF) care, yet little is known about patients’ SDM experiences. This study evaluated SDM across 159 CF care programs (4024 participants) in the United States. Shared decision-making was assessed using the patient-reported collabo RATE measure, which was included in the CF Foundation’s Patient and Family Experience of Care Survey over 18 months. Overall, 69% of respondents reported experiencing SDM. Respondents at pediatric programs were more likely to experience SDM than those at adult programs (72% vs 67%, P < .001). Multivariable logistic regression analyses showed a relationship between SDM and patient age, whereby SDM was less likely to occur with patients aged 18 to 24 years, compared to some younger and older age groups ( P = .02-

Abstract Background Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA. Methods We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics. Discussion This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences. Trial registration Clinicaltrials.gov, NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449

Abstract Background Multimorbidity poses a challenge for decision-making processes and requires that more attention is paid to patient goals, preferences and needs; however, goal setting is not yet widely recognised as a core aspect of the shared decision-making (SDM) approach. This study aims to analyse clinician perceptions of the concept of goal setting within the context of SDM with older patients with multimorbidity. Methods Semi-structured interviews with general practitioners (GPs) and clinical geriatricians (CGs) were analysed using a framework analysis. The integrative model of SDM was used to develop a categorisation matrix, including goal setting as an additional component. Results Sixteen of the 33 clinicians mentioned explicit Goal setting as an integrated component of their definition of SDM, which was comparable to the number of clinicians who listed Patient values and preferences (n = 16), Doctor knowledge and recommendations (n = 19) and Make or explicitly defer a decision (n = 19), elements which are commonly considered to be important aspects of SDM. The other 17 clinicians (6 CGs and 11 GPs) did not mention Goal setting as an explicit component of SDM. Our analysis revealed two potential reasons for this observation. Besides the use of other terminology, part of clinicians viewed collaborative goal setting and SDM as separate but related processes. Conclusions Our study on clinician perspectives highlighted goal setting as component of a SDM approach and could therefore be considered supportive of recent theoretical insights that SDM models that lack an explicit goal-setting component appear to be deficient and overlook an important aspect of engaging patients in decision-making, particularly for patients with complex multimorbidities. We therefore call for the further development of a comprehensive SDM approach for older patients with multimorbidity to include explicit and unequivocal goal setting elements to sufficiently meet the expectations and needs of clinicians and their patients.

Abstract Background Guidelines recommend shared decision making (SDM) for determining whether to use statins to prevent cardiovascular events in at-risk patients. We sought to develop a toolkit to facilitate the cross-organizational spread and scale of a SDM intervention called the Statin Choice Conversation Aid (SCCA) by (i) assessing the work stakeholders must do to implement the tool; and (ii) orienting the resulting toolkit’s components to communicate and mitigate this work. Methods We conducted multi-level and mixed methods (survey, interview, observation, focus group) characterizations of the contexts of 3 health systems (n = 86, 84, and 26 primary care clinicians) as they pertained to the impending implementation of the SCCA. We merged the data within implementation outcome domains of feasibility, appropriateness, and acceptability. Using Normalization Process Theory, we then characterized and categorized the work stakeholders did to implement the tool. We used clinician surveys and IP address-based tracking to calculate SCCA usage over time and judged how stakeholder effort was allocated to influence outcomes at 6 and 18 months. After assessing the types and impact of the work, we developed a multi-component toolkit. Results At baseline, the three contexts differed regarding feasibility, acceptability, and appropriateness of implementation. The work of adopting the tool was allocated across many strategies in complex and interdependent ways to optimize these domains. The two systems that allocated the work strategically had higher uptake (5.2 and 2.9 vs. 1.1 uses per clinician per month at 6 months; 3.8 and 2.1 vs. 0.4 at 18 months, respectively) than the system that did not. The resulting toolkit included context self-assessments intended to guide stakeholders in considering the early work of SCCA implementation; and webinars, EMR integration guides, video demonstrations, and an implementation team manual aimed at supporting this work. Conclusions We developed a multi-component toolkit for facilitating the scale-up and spread of a tool to promote SDM across clinical settings. The theory-based approach we employed aimed to distinguish systems primed for adoption and support the work they must do to achieve implementation. Our approach may have value in orienting the development of multi-component toolkits and other strategies aimed at facilitating the efficient scale up of interventions. Trial registration ClinicalTrials.gov NCT02375815.

The objective of this study was to assess the psychometric properties of IntegRATE—a 4-item patient-reported measure of integration in health care delivery—under controlled conditions. Adults who reported having received health care in the previous year were exposed to a fictional health care scenario featuring good, mixed, or poor integration on 1 or 2 occasions. They were then asked to imagine themselves as a patient in the scenario and complete IntegRATE and other measures. The data collected were analyzed to assess the discriminative, concurrent, and divergent validity of IntegRATE and its test–retest reliability and responsiveness using both “sum score” and “top score” scoring approaches. Six-hundred people participated in the study with 190 taking part on 2 occasions. The IntegRATE sum score demonstrated discriminative validity, concurrent validity, divergent validity, and responsiveness and partially demonstrated test–retest reliability. The IntegRATE top score demonstrated concurrent validity, divergent validity, and responsiveness and partially demonstrated discriminative validity and test–retest reliability. We conclude that the IntegRATE sum score exhibits encouraging psychometric properties and performs more optimally than the IntegRATE top score.

BackgroundFew studies have examined the best way to convey the probability of serious events occurring in the future (i.e., risk of stroke or death) to persons with low numeracy or graph literacy proficiency. To address this gap, we developed and user-tested a bar graph and compared it to icon arrays to assess its impact on understanding and preference for viewing risk information.ObjectivesTo determine the: (i) formats' impact on participants' understanding of risk information; (ii) formats' impact on understanding and format preference across numeracy and graph literacy subgroups; (iii) rationale supporting participants' preference for each graphical display format.MethodsAn online sample (evenly made up of participants with high and low objective numeracy and graph literacy) was randomized to view either the icon array or the bar graph. Each format conveyed the risk of major stroke and death five years after choosing surgery, a stent, or medication to treat carotid artery stenosis. Participants answered questions to assess their understanding of the risk information. Lastly, both formats were presented in parallel, and participants were asked to identify their preferred format to view risk information and explain their preference.ResultsOf the 407 participants, 197 were assigned the icon array and 210 the bar graph. Understanding of risk information and format preference did not differ significantly between the two trial arms, irrespective of numeracy and graph literacy proficiency. High numeracy and graph literacy proficiency was associated with high understanding (pConclusionWe found no evidence to demonstrate the superiority of one format over another on understanding. The majority of participants preferred viewing the risk information using the bar graph format.

Shared decision-making (SDM) between clinicians and patients is a key component of patient experience, but measurement efforts have been hampered by a lack of valid and reliable measures that are feasible for routine use. In this study, we aim to investigate collabo RATE’s reliability, calculate required sample sizes for reliable measurement, and compare Consumer Assessment of Healthcare Providers and Systems (CAHPS) patient experience survey items to collabo RATE. Collabo RATE’s provider group-level reliability reached acceptable reliability at 190 patient reports, while the CAHPS SDM measure demonstrated similar reliability at a sample size of 124. The CAHPS communication measure reached acceptable reliability with 55 patient reports. A strong correlation was observed between collabo RATE and CAHPS communication measures ( r = 0.83). As a reliable measure of SDM, collabo RATE may be useful for both building payment models that support shared clinical decision-making and encouraging data transparency with regard to provider group performance.

Objective: Definitions of shared decision-making (SDM) have largely neglected to consider goal setting as an explicit component. Applying SDM to people with multiple long-term conditions requires attention to goal setting. We propose an integrated model, which shows how goal setting, at 3 levels, can be integrated into the 3-talk SDM model. Method: The model was developed by integrating 2 published models. Results: An integrated, goal-based SDM model is proposed and applied to a patient with multiple, complex, long-term clinical conditions to illustrate the use of a visualization tool called a Goal Board. A Goal Board prioritizes collaborative goals and aligns goals with interventional options. Conclusion: The model provides an approach to achieve person-centered decision-making by not only eliciting and prioritizing goals but also by aligning prioritized goals and interventions. Practice Implications: Further research is required to evaluate the utility of the proposed model.

Patient characteristics have been linked to prevalence and quality of shared decision-making (SDM) behaviors across diverse studies of varied size and focus. We aim to evaluate the extent to which patient characteristics are associated with patient-rated SDM scores as measured by collabo RATE and whether or not collabo RATE varies at the provider group level. We used the 2017 California Patient Assessment Survey data set, which included adult patients of 153 California-based medical groups receiving services between January and October 2016. Mixed-effects logistic regression evaluated relationships between collabo RATE scores and patient characteristics. We analyzed 31 265 total survey responses. Among included covariates, patients’ health status, race, primary language, and mode of survey response were significantly associated with collabo RATE scores. Case-mix adjustment is common in healthcare quality measurement and can be useful in pay-for-performance systems. For those use cases, we recommend adjusting collabo RATE scores by patients’ age, health status, gender, race, and language spoken at home, and survey response mode. However, when case-mix adjustment is not required, we suggest highlighting observed disparities across diverse patient populations to improve attention to inequities in patient experience.

ObjectivesGraphic display formats are often used to enhance health information. Yet limited attention has been paid to graph literacy in people of lower education and lower socioeconomic status (SES). This study aimed to: 1) examine the relationship between graph literacy, numeracy, health literacy and sociodemographic characteristics in a Medicaid-eligible population 2) determine the impact of graph literacy on comprehension and preference for different visual formats.MethodsWe conducted a cross-sectional online survey among people in the US on Medicaid, and of presumed lower education and SES.ResultsThe mean graph literacy score among 436 participants was 1.47 (SD 1.05, range: 0 to 4). Only graph literacy was significantly associated with overall comprehension (p < .001). Mean comprehension scores were highest for the table format (1.91), closely followed by bar graph (1.85) and icon array (1.80). Information comprehension was aligned with preference scores.ConclusionsGraph literacy in a Medicaid-eligible population was lower than previous estimates in the US. Tables were better understood, with icon arrays yielding the lowest score. Preferences aligned with comprehension.Practice implicationsIt may be necessary to reconsider the use of graphic display formats when designing information for people with lower educational levels. Further research is needed.

Introduction. We aimed to conduct a multinational cross-sectional online survey of medical students’ attitudes toward, knowledge of, and experience with shared decision making (SDM). Methods. We conducted the survey from September 2016 until May 2017 using the following: 1) a convenience sample of students from four medical schools each in Canada, the United States, and the Netherlands ( n = 12), and 2) all medical schools in the United Kingdom through the British Medical School Council ( n = 32). We also distributed the survey through social media. Results. A total of 765 students read the information sheet and 619 completed the survey. Average age was 24, 69% were female. Mean SDM knowledge score was 83.6% (range = 18.8% to 100%; 95% confidence interval [CI] = 82.8% to 84.5%). US students had the highest knowledge scores (86.2%, 95% CI = 84.8% to 87.6%). The mean risk communication score was 57.4% (range = 0% to 100%; 95% CI = 57.4% to 60.1%). Knowledge did not vary with age, race, gender, school, or school year. Attitudes were positive, except 46% believed SDM could only be done with higher educated patients, and 80.9% disagreed that physician payment should be linked to SDM performance (increased with years in training, P < 0.05). Attitudes did not vary due to any tested variable. Students indicated they were more likely than experienced clinicians to practice SDM (72.1% v. 48.8%). A total of 74.7% reported prior SDM training and 82.8% were interested in learning more about SDM. Discussion. SDM knowledge is high among medical students in all four countries. Risk communication is less well understood. Attitudes indicate that further research is needed to understand how medical schools deliver and integrate SDM training into existing curricula.

Abstract Background In advanced stages of Parkinson’s disease (PD), patients and neurologists regularly face complex treatment decisions. Shared decision-making (SDM) can support the process where evidence, the clinician’s expertise and the patient’s preferences jointly contribute to reach an optimal decision. Here, we describe the rationale of our feasibility study protocol. The aim of the study is to test the feasibility of the SDM intervention by (1) analysing the acceptability of the intervention by users (i.e. professionals and patients), (2) assessing the level of implementation, (3) testing efficacy on a small scale and (4) evaluating the study procedures. Methods Using an uncontrolled before-after mixed methods design, patients in the pre-intervention group will receive information and decisional support as usual. Patients in the post-intervention group will receive the SDM intervention, consisting of an Option Grid™ patient decision aid and a website with supplementary information plus a value clarification tool for both patients and professionals. An Option Grid is a one-page, evidence-based summary of available options, listing the frequently asked questions that patients consider when making treatment decisions. A value clarification tool helps patients identify which option he/she prefers based on attributes in the treatment decision context. Neurologists and PD nurse specialists will receive a 1-h instruction on SDM and how to use the SDM intervention. Through purposive sampling, neurologists and PD nurse specialists will be recruited from both specialised neurology clinics and community-based hospitals. Included professionals will invite consecutive patients who are eligible for the advanced therapies. Data will be collected using questionnaires, interviews and audio observations of the consultations and by tracking users’ logging behaviour of the website. Data will be analysed using a mixed methods design. Discussion The mixed methods design will create a deeper understanding of how the SDM intervention affects the interactions between professionals (a neurologist and/or a PD nurse specialist) and the patient, when an advanced treatment is chosen. The results of the study will inform the design of an RCT to test the effectiveness of the SDM intervention. Trial registration NTR6649, retrospectively registered 28 August 2017.

Abstract Background People with psychosis struggle with decisions about their use of antipsychotics. They often want to reduce the dose or stop, while facing uncertainty regarding the effects these decisions will have on their treatment and recovery. They may also fear raising this issue with clinicians. The purpose of this study was to develop and test a shared decision making (SDM) tool to support patients and clinicians in making decisions about antipsychotics. Methods A diverse editorial research team developed an Encounter Decision Aid (EDA) for patients and clinicians to use as part of the psychiatric consultation. The EDA was tested using 24 semistructured interviews with participants representing six stakeholder groups: patients with first-episode psychosis, patients with long-term psychosis, family members, psychiatrists, mental health counselors, and administrators. We used inductive and deductive coding of interview transcripts to identify points to revise within three domains: general impression and purpose of the EDA; suggested changes to the content, wording, and appearance; and usability and potential contribution to the psychiatric consultation. Results An EDA was developed in an iterative process that yielded evidence-based answers to five frequently asked questions about antipsychotic medications. Patients with long-term psychosis and mental health counselors suggested more changes and revisions than patients with first-episode psychosis and psychiatrists. Family members suggested more revisions to the answers about potential risks of stopping or adjusting antipsychotics than other respondents. Conclusions The EDA was perceived as potentially useful and feasible in psychiatric routine care, especially if presented during the consultation.

Abstract Background Shared decision-making (SDM) is poorly implemented in routine care, despite being promoted by health policies. No reviews have solely focused on an in-depth synthesis of the literature around organizational- and system-level characteristics (i.e., characteristics of healthcare organizations and of healthcare systems) that may affect SDM implementation. A synthesis would allow exploration of interventions to address these characteristics. The study aim was to compile a comprehensive overview of organizational- and system-level characteristics that are likely to influence the implementation of SDM, and to describe strategies to address those characteristics described in the literature. Methods We conducted a scoping review using the Arksey and O’Malley framework. The search strategy included an electronic search and a secondary search including gray literature. We included publications reporting on projects that promoted implementation of SDM or other decision support interventions in routine healthcare. We screened titles and abstracts, and assessed full texts for eligibility. We used qualitative thematic analysis to identify organizational- and system-level characteristics. Results After screening 7745 records and assessing 354 full texts for eligibility, 48 publications on 32 distinct implementation projects were included. Most projects (N = 22) were conducted in the USA. Several organizational-level characteristics were described as influencing the implementation of SDM, including organizational leadership, culture, resources, and priorities, as well as teams and workflows. Described system-level characteristics included policies, clinical guidelines, incentives, culture, education, and licensing. We identified potential strategies to influence the described characteristics, e.g., examples how to facilitate distribution of decision aids in a healthcare institution. Conclusions Although infrequently studied, organizational- and system-level characteristics appear to play a role in the failure to implement SDM in routine care. A wide range of characteristics described as supporting and inhibiting implementation were identified. Future studies should assess the impact of these characteristics on SDM implementation more thoroughly, quantify likely interactions, and assess how characteristics might operate across types of systems and areas of healthcare. Organizations that wish to support the adoption of SDM should carefully consider the role of organizational- and system-level characteristics. Implementation and organizational theory could provide useful guidance for how to address facilitators and barriers to change.

Abstract 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.

Abstract Background In order to conduct studies on shared decision-making (SDM) and to implement SDM in routine practice, psychometrically tested measures are needed. The development of the short 5-item version of the OPTION scale (Observer OPTION5) allows to assess SDM from an observer perspective. Observer OPTION5 is so far only available in English and Dutch. The aim of this study was to translate the Observer OPTION5 rating scale into German and to test its psychometric properties. Methods The German Observer OPTION5 was tested in a secondary data analysis of audio-recordings of patient-physician-consultations (N = 79) in German primary care practices. Demographic data were analysed using descriptive statistics. To assess inter- and intra-rater reliability, intraclass correlation coefficients (ICCs) were calculated. For assessing concurrent validity, a correlation (Spearman’s Rho) of the sum score of Observer OPTION5 and Observer OPTION12 was calculated. Results The consultations dealt with decisions regarding type 2 diabetes (N = 31), chronic back pain (N = 23), depression (N = 20), and other diseases (N = 5). Analysis of inter-rater reliability yielded an ICC of 0.82 for the sum score; across the five single items ICCs ranged between 0.45 and 0.77. For the intra-rater reliability an ICC of 0.83 was observed for the total score; across the five single items ICCs ranged between 0.45 and 0.86. The Observer OPTION5 had a mean total score of 11.84 (SD = 11.92) and the Observer OPTION12 had a mean total score of 10.3 (SD = 7.9), both on a potential range of 0 to 100. The correlation between the total scores of Observer OPTION5 and Observer OPTION12 was r = 0.47 (p = 0.01). Conclusions The results regarding inter- and intra-rater reliability were excellent on the total score level. Observer OPTION5 showed moderate concurrent validity using Observer OPTON12. The results are generally comparable to the results of the original English version of Observer OPTION5. The German version of Observer OPTION5 can be used in research and evaluation of clinical practice. Nevertheless, further testing is adviced.

Abstract Background Implementing patient decision aids in clinic workflow has proven to be a challenge for healthcare organizations and physicians. Our aim was to determine the organizational strategies, motivations, and facilitating factors to the routine implementation of Option Grid™ encounter decision aids at two independent settings. Method Case studies conducted by semi-structured interview, using the Normalization Process Theory (NPT) as a framework for thematic analysis. Twenty three interviews with physicians, nurses, hospital staff and stakeholders were conducted at: 1) CapitalCare Medical Group in Albany, New York; 2) HealthPartners Clinics in Minneapolis, Minnesota. Results ‘Coherent’ motivations were guided by financial incentives at CapitalCare, and by a ‘champion’ physician at HealthPartners. Nurses worked ‘collectively’ at both settings and played an important role at sites where successful implementation occurred. Some physicians did not understand the perceived utility of Option Grid™, which led to varying degrees of implementation success across sites. The appraisal work (reflexive monitoring) identified benefits, particularly in terms of information provision. Physicians at both settings, however, were concerned with time pressures and the suitability of the tool for patients with low levels of health literacy. Conclusion Although both practice settings illustrated the mechanisms of normalization postulated by the theory, the extent to which Option Grid™ was routinely embedded in clinic workflow varied between sites, and between clinicians. Implementation of new interventions will require attention to an identified rationale (coherence), and to the collective action, cognitive participation, and assessment of value by organizational members of the organization.

Introduction. Breast cancer is the second most common malignancy in women. The Decision Quality Instrument (DQI) measures the extent to which patients are informed and involved in breast surgery decisions and receive treatment that aligns with their preferences. There are limited data on the performance of the DQI in women of lower socioeconomic status (SES). Our aims were to 1) examine (and if necessary adapt) the readability, usability, and acceptability of the DQI and 2) explore whether it captures factors important to breast cancer surgery decisions among women of lower SES (relevance). Methods. We conducted semistructured cognitive interviews with women of lower SES (based on insurance status, income, and education) who had completed early-stage breast cancer treatments at three cancer centers. We used a two-step thematic analysis with dual independent coding. The study team (including Patient Partners and a Community Advisory Board) reviewed and refined suggested changes. The revised DQI was presented in two focus groups of breast cancer survivors. Results. We conducted 39 interviews. Participants found most parts of the DQI to be helpful and easy to understand. We made the following suggested changes: 1) added a glossary of key terms, 2) added two answer choices and an open text question in the goals and concerns subscale, 3) reworded the treatment intention question, and 4) revised the knowledge subscale instructions since several women disliked the wording and were unsure of what was expected. Discussion. The readability, usability, acceptability, and relevance of a measure that was primarily developed and validated in women of higher SES required adaptation for optimal use by women of lower SES. Further research will test these adaptations in lower SES populations.

Given the need for access to patient-facing materials in multiple languages, this study aimed to develop and pilot test an accurate and understandable translation of CollaboRATE, a three-item patient-reported measure of shared decision-making, for Spanish-speaking patients in the United States (US).We followed the Translate, Review, Adjudicate, Pre-test, Document (TRAPD) survey translation protocol. Cognitive interviews were conducted with Spanish-speaking adults within an urban Massachusetts internal medicine clinic. For the pilot test, all patients with weekday appointments between May 1 and May 29, 2015 were invited to complete CollaboRATE in either English or Spanish upon exit. We calculated the proportion of respondents giving the best score possible on CollaboRATE and compared scores across key patient subgroups.Four rounds of cognitive interviews with 26 people were completed between January and April 2015. Extensive, iterative refinements to survey items between interview rounds led to final items that were generally understood by participants with diverse educational backgrounds. Pilot data collection achieved an overall response rate of 73 percent, with 606 (49%) patients completing Spanish CollaboRATE questionnaires and 624 (51%) patients completing English CollaboRATE questionnaires. The proportion of respondents giving the best score possible on CollaboRATE was the same (86%) for both the English and Spanish versions of the instrument.Our translation method, guided by emerging best practices in survey and health measurement translation, encompassed multiple levels of review. By conducting four rounds of cognitive interviews with iterative item refinement between each round, we arrived at a Spanish language version of CollaboRATE that was understandable to a majority of cognitive interview participants and was completed by more than 600 pilot questionnaire respondents.

Background: Efforts have been made to measure integration in health care delivery, but few existing instruments have adopted a patient perspective, and none is sufficiently generic and brief for administration at scale. We sought to develop a brief and generic patient-reported measure of integration in health care delivery. Methods: Drawing on both existing conceptualisations of integrated care and research on patients’ perspectives, we chose to focus on four distinct domains of integration: information sharing,consistent advice, mutual respect and role clarity. We formulated candidate items and conducted cognitive interviews with end users to further develop and refine the items. We then pilot-tested the measure. Results: Four rounds of cognitive interviews were conducted (n = 14) and resulted in a four-item measure that was both relevant and understandable to end users. The pilot administration of the measure (n = 15) further confirmed the relevance and interpretability of items and demonstrated that the measure could be completed in less than one minute. Conclusions: This new measure, IntegRATE, represents a patient-reported measure of integration in health care delivery that is conducive to use in both routine performance monitoring and research. The psychometric properties of the measure will be assessed in the next stage of development.

BackgroundPatient empowerment has gained considerable importance but uncertainty remains about the best way to define and measure it. The validity of empirical findings depends on the quality of measures used. This systematic review aims to provide an overview of studies assessing psychometric properties of questionnaires purporting to capture patient empowerment, evaluate the methodological quality of these studies and assess the psychometric properties of measures identified.MethodsElectronic searches in five databases were combined with reference tracking of included articles. Peer-reviewed articles reporting psychometric testing of empowerment measures for adult patients in French, German, English, Portuguese and Spanish were included. Study characteristics, constructs operationalised and psychometric properties were extracted. The quality of study design, methods and reporting was assessed using the COSMIN checklist. The quality of psychometric properties was assessed using Terwee's 2007 criteria.Findings30 studies on 19 measures were included. Six measures are generic, while 13 were developed for a specific condition (N=4) or specialty (N=9). Most studies tested measures in English (N=17) or Swedish (N=6). Sample sizes of included studies varied from N=35 to N=8261. A range of patient empowerment constructs was operationalised in included measures. These were classified into four domains: patient states, experiences and capacities; patient actions and behaviours; patient self-determination within the healthcare relationship and patient skills development. Quality assessment revealed several flaws in methodological study quality with COSMIN scores mainly fair or poor. The overall quality of psychometric properties of included measures was intermediate to positive. Certain psychometric properties were not tested for most measures.DiscussionFindings provide a basis from which to develop consensus on a core set of patient empowerment constructs and for further work to develop a (set of) appropriately validated measure(s) to capture this. The methodological quality of psychometric studies could be improved by adhering to published quality criteria.

The phenomenon of patients covertly recording clinical encounters has generated controversial media reports. This study aims to examine the phenomenon and analyze the underlying issues.We conducted a qualitative analysis of online posts, articles, blogs, and forums (texts) discussing patients covertly recording clinical encounters. Using Google and Google Blog search engines, we identified and analyzed 62 eligible texts published in multiple countries between 2006 and 2013. Thematic analysis revealed four key themes: 1) a new behavior that elicits strong reactions, both positive and negative, 2) an erosion of trust, 3) shifting patient-clinician roles and relationships, and 4) the existence of confused and conflicting responses. When patients covertly record clinical encounters - a behavior made possible by various digital recording technologies - strong reactions are evoked among a range of stakeholders. The behavior represents one consequence of an erosion of trust between patients and clinicians, and when discovered, leads to further deterioration of trust. Confused and conflicting responses to the phenomenon by patients and clinicians highlight the need for policy guidance.This study describes strong reactions, both positive and negative, to the phenomenon of patients covertly recording clinical encounters. The availability of smartphones capable of digital recording, and shifting attitudes to patient-clinician relationships, seems to have led to this behavior, mostly viewed as a threat by clinicians but as a welcome and helpful innovation by some patients, possibly indicating a perception of subordination and a lack of empowerment. Further examination of this tension and its implications is needed.

Multidisciplinary team meetings and shared decision-making are potential means of delivering patient-centred care. Not much is known about how those two paradigms fit together in cancer care. This study aimed to investigate how decisions are made in multidisciplinary team meetings and whether patient perspectives are incorporated in these decisions.A qualitative study was conducted using non-participant observation at multidisciplinary team meetings (also called tumor boards) at the University Cancer Center Hamburg-Eppendorf, Germany. Two researchers recorded structured field notes from a total of N = 15 multidisciplinary team meetings. Data were analyzed using content analysis and descriptive statistics.Physicians mainly exchanged medical information and based their decision-making on this information. Individual patient characteristics or their treatment preferences were rarely considered or discussed. In the few cases where patient preferences were raised as a topic, this information did not seem to be taken into account in decision-making processes about treatment recommendations.The processes in multidisciplinary team meetings we observed did not exhibit shared decision-making. Patient perspectives were absent. If multidisciplinary team meetings wish to become more patient-centred they will have to modify their processes and find a way to include patient preferences into the decision-making process.

Interactive decision support applications might help patients to make difficult decisions about their health care. They lie in the context of traditional decision aids, which are known to have effects on a number of patient outcomes, including knowledge and decisional conflict. The problem of restricted uptake with decision aids may be addressed by interactive applications, particularly if associated with health information websites. We suggest that there may be an impact on the doctor–patient relationship and that this presents a number of opportunities. However, there are ethical challenges such as information bias and commercialisation.

BackgroundIncreasing patient engagement in healthcare has become a health policy priority. However, there has been concern that promoting supported shared decision-making could increase health inequalities.ObjectiveTo evaluate the impact of SDM interventions on disadvantaged groups and health inequalities.DesignSystematic review and meta-analysis of randomised controlled trials and observational studies.Data sourcesCINAHL, the Cochrane Register of Controlled Trials, the Cochrane Database of Systematic Reviews, EMBASE, HMIC, MEDLINE, the NHS Economic Evaluation Database, Open SIGLE, PsycINFO and Web of Knowledge were searched from inception until June 2012.Study eligibility criteriaWe included all studies, without language restriction, that met the following two criteria: (1) assess the effect of shared decision-making interventions on disadvantaged groups and/or health inequalities, (2) include at least 50% of people from disadvantaged groups, except if a separate analysis was conducted for this group.ResultsWe included 19 studies and pooled 10 in a meta-analysis. The meta-analyses showed a moderate positive effect of shared decision-making interventions on disadvantaged patients. The narrative synthesis suggested that, overall, SDM interventions increased knowledge, informed choice, participation in decision-making, decision self-efficacy, preference for collaborative decision making and reduced decisional conflict among disadvantaged patients. Further, 7 out of 19 studies compared the intervention's effect between high and low literacy groups. Overall, SDM interventions seemed to benefit disadvantaged groups (e.g. lower literacy) more than those with higher literacy, education and socioeconomic status. Interventions that were tailored to disadvantaged groups' needs appeared most effective.ConclusionResults indicate that shared decision-making interventions significantly improve outcomes for disadvantaged patients. According to the narrative synthesis, SDM interventions may be more beneficial to disadvantaged groups than higher literacy/socioeconomic status patients. However, given the small sample sizes and variety in the intervention types, study design and quality, those findings should be interpreted with caution.