Explorative observational study of Dutch patient-clinician interactions: operationalisation of personal perspective elicitation as part of shared decision-making in real-life audio-recorded consultations.

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.

Exploring Decisional Conflict Experienced by Individuals Considering Metoidioplasty and Phalloplasty Gender-affirming Surgery.

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.

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.

Engaging Long-Term Care Workers in Research: Recruitment Approaches and Participant Characteristics From a Randomized Controlled Trial to Improve COVID-19 Vaccine Confidence.

OBJECTIVE: To describe and compare the recruitment methods employed in a randomized controlled trial targeting long-term care workers, and resulting participant baseline characteristics. DESIGN: We used a multifaceted recruitment process to enroll long-term care workers in our 3-arm randomized controlled trial comparing 2 interventions to enhanced usual practice, for improving COVID-19 vaccine confidence and other outcomes. SETTING AND PARTICIPANTS: Adult long-term care workers living in the United States employed within the last 2 years were invited to join the study. Participants also had to meet specific screening criteria related to their degree of worry about the vaccine and/or their vaccination status. METHODS: We used a participatory approach to engage our long-term care stakeholders in codesigning and executing a combination of recruitment methods, including targeted e-recruitment, paid e-recruitment, and in-person recruitment. Participants were screened, consented, and enrolled online. We implemented a participant verification process to ensure the integrity of our study data, and used a tailored participant management platform to manage enrollment. RESULTS: We enrolled 1930 long-term care workers between May 2022 and January 2023. We met our enrollment target, despite each recruitment method having limitations. Total variable costs of approximately $102,700 were incurred and differed on a per-enrolled participant basis across methods: $25.73 for targeted e-recruitment, $57.12 for paid e-recruitment, and $64.92 for in-person methods. Our sample differed from the national population in age, gender, race/ethnicity, education, and role in long-term care. Differences were also observed between online and in-person recruitment methods. CONCLUSIONS AND IMPLICATIONS: Our results support the feasibility of enrolling a large number of long-term care workers in a randomized controlled trial to increase COVID-19 vaccine confidence. Findings build upon the evidence base for engaging this important population in research, a critical step to improving long-term care resident health and well-being. Results from our trial are anticipated in 2024.

Clinician-Spoken Plain Language in Health Care Encounters: A Qualitative Analysis to Assess Measurable Elements.

PURPOSE: Good communication and use of plain language in health care encounters improve outcomes, including emotional health, symptom resolution, and functional status. Yet there is limited research on how to measure and report spoken plain language, which is the use of familiar, clear language. The authors aimed to describe key, measurable elements of spoken plain language that can be assessed and reported back to clinicians for self-reflection. METHOD: The authors conducted secondary analysis of transcripts from recorded encounters between breast cancer surgeons and patients with early-stage breast cancer. Two coders used a hybrid qualitative analysis with a framework based on U.S. Federal Plain Language Guidelines. To develop major themes, they examined (1) alignment with the Guidelines and (2) code frequencies within and across transcripts. They also noted minor themes. RESULTS: From 74 transcripts featuring 13 surgeons, the authors identified 2 major themes representing measurable elements of spoken plain language: (1) clinicians had a propensity to use both explained and unexplained medical terms, and (2) clinicians delivered information using either short turns (one unit of someone speaking) with 1 topic or long turns with multiple topics. There were 3 minor themes that were not indicative of whether or not clinicians used spoken plain language. First, clinicians regularly used absolute risk communication techniques. Second, question-asking techniques varied and included open-ended, close-ended, and comprehension checks. Third, some clinicians used imagery to describe complex topics. CONCLUSIONS: Clinicians' propensity to use medical terms with and without explanation and parse encounters into shorter or longer turns are measurable elements of spoken plain language. These findings will support further research on the development of a tool that can be used in medical education and other settings. This tool could provide direct and specific feedback to improve the plain language practices of clinicians in training and beyond.

Evaluation of the nurse-assisted eHealth intervention 'eHealth@Hospital-2-Home' on self-care by patients with heart failure and colorectal cancer post-hospital discharge: protocol for a randomised controlled trial.

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).

Digital Mental Health and Its Discontents: Assumptions About Technology That Create Barriers to Equitable Access.

Despite the potential of digital mental health interventions to aid recovery for people with serious mental illness, access to these digital tools remains a key barrier. In this column, the authors discuss three key assumptions that shape the integration of digital mental health tools into community health settings: clinical context, digital literacy, and financial burden. Clinical contexts have shifted with the increased use of telehealth, altering intervention environments; access to a mobile device is not the same as digital literacy; and digital mental health care is not necessarily affordable. Context-centered study design through ethnography will facilitate transfer of digital resources to real-world settings.

Evaluating the effect of Conversation Cards on agenda-setting in annual diabetes status visits: A multi-method study.

OBJECTIVE: To evaluate Conversation Cards for shared agenda-setting between patients and nurses in status visits for type 2 diabetes. METHODS: Non-randomized comparison of survey responses between intervention and control groups. Content analysis of interview data of patient experiences from a purposive sample of the intervention group. RESULTS: The survey included 52 patients in the intervention and 55 in the control group. Survey data showed no significant differences between the groups. Regardless of the intervention, patients experienced that topics relevant to them were addressed. One in four patients rated the Conversation Cards as very supportive. Interview data indicated that the Conversation Cards added structure, commitment to the conversation, and support to raise topics not previously considered diabetes related. CONCLUSION: Topics of concern were addressed in both intervention and control groups. The Conversation Cards for agenda-setting clarified a mutually agreed structure of the conversation, eased raising hitherto ignored topics, and increased engagement. PRACTICE IMPLICATIONS: The Conversation Cards have potential to improve shared agenda-setting, but implementation requires efforts from both parties. Patients are expected to consider their concerns and take an active part in agenda-setting. Nurses are expected to collaborate with the patient in the agenda-setting, which might challenge the nurses' habitual practice.

Is There Room for Individual Patient-Specified Preferences in the Patient-Reported Outcome Measurement Revolution?

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.

The Costs of Implementing a Conversation Aid for Uterine Fibroids in Multiple Health Care Settings.

BACKGROUND: Health care organizations considering adopting a conversation aid (CA), a type of patient decision aid innovation, need information about the costs of implementation. OBJECTIVES: The aims of this study were to: (1) calculate the costs of introducing a CA in a study of supported implementation in 5 gynecologic settings that manage individuals diagnosed with uterine fibroids and (2) estimate the potential costs of future clinical implementation efforts in hypothetical settings. RESEARCH DESIGN: We used time-driven activity-based costing to estimate the costs of CA implementation at multiple steps: integration with an electronic health record, preimplementation, implementation, and sustainability. We then estimated costs for 2 disparate hypothetical implementation scenarios. SUBJECTS AND DATA COLLECTION: We conducted semistructured interviews with participants and examined internal documentation. RESULTS: We interviewed 41 individuals, analyzed 51 documents and 100 emails. Overall total implementation costs over ∼36 months of activities varied significantly across the 5 settings, ranging from $14,157 to $69,134. Factors influencing costs included size/complexity of the setting, urban/rural location, practice culture, and capacity to automate patient identification. Initial investments were substantial, comprising mostly personnel time. Settings that embedded CA use into standard workflows and automated identification of appropriate patients had the lowest initial investment and sustainability costs. Our estimates of the costs of sustaining implementation were much lower than initial investments and mostly attributable to CA subscription fees. CONCLUSION: Initiation and implementation of the interventions require significant personnel effort. Ongoing costs to maintain use are much lower and are a small fraction of overall organizational operating costs.

The impact of adding cost information to a conversation aid to support shared decision making about low-risk prostate cancer treatment: Results of a stepped-wedge cluster randomised trial.

BACKGROUND: Decision aids help patients consider the benefits and drawbacks of care options but rarely include cost information. We assessed the impact of a conversation-based decision aid containing information about low-risk prostate cancer management options and their relative costs. METHODS: We conducted a stepped-wedge cluster randomised trial in outpatient urology practices within a US-based academic medical center. We randomised five clinicians to four intervention sequences and enroled patients newly diagnosed with low-risk prostate cancer. Primary patient-reported outcomes collected postvisit included the frequency of cost conversations and referrals to address costs. Other patient-reported outcomes included: decisional conflict postvisit and at 3 months, decision regret at 3 months, shared decision-making postvisit, financial toxicity postvisit and at 3 months. Clinicians reported their attitudes about shared decision-making pre- and poststudy, and the intervention's feasibility and acceptability. We used hierarchical regression analysis to assess patient outcomes. The clinician was included as a random effect; fixed effects included education, employment, telehealth versus in-person visit, visit date, and enrolment period. RESULTS: Between April 2020 and March 2022, we screened 513 patients, contacted 217 eligible patients, and enroled 117/217 (54%) (51 in usual care, 66 in the intervention group). In adjusted analyses, the intervention was not associated with cost conversations (ß = .82, p = .27), referrals to cost-related resources (ß = -0.36, p = .81), shared decision-making (ß = -0.79, p = .32), decisional conflict postvisit (ß = -0.34, p= .70), or at follow-up (ß = -2.19, p = .16), decision regret at follow-up (ß = -9.76, p = .11), or financial toxicity postvisit (ß = -1.32, p = .63) or at follow-up (ß = -2.41, p = .23). Most clinicians and patients had positive attitudes about the intervention and shared decision-making. In exploratory unadjusted analyses, patients in the intervention group experienced more transient indecision (p < .02) suggesting increased deliberation between visit and follow-up. DISCUSSION: Despite enthusiasm from clinicians, the intervention was not significantly associated with hypothesised outcomes, though we were unable to robustly test outcomes due to recruitment challenges. Recruitment at the start of the COVID-19 pandemic impacted eligibility, sample size/power, study procedures, and increased telehealth visits and financial worry, independent of the intervention. Future work should explore ways to support shared decision-making, cost conversations, and choice deliberation with a larger sample. Such work could involve additional members of the care team, and consider the detail, quality, and timing of addressing these issues. PATIENT OR PUBLIC CONTRIBUTION: Patients and clinicians were engaged as stakeholder advisors meeting monthly throughout the duration of the project to advise on the study design, measures selected, data interpretation, and dissemination of study findings.

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

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

Decision making in metoidioplasty and phalloplasty gender-affirming surgery: a mixed methods study.

BACKGROUND: Gender-affirming surgical procedures, such as metoidioplasty and phalloplasty for those assigned female at birth, are complex and multistaged and involve risks. Individuals considering these procedures experience greater uncertainty or decisional conflict, compounded by difficulty finding trustworthy information. AIM: (1) To explore the factors contributing to decisional uncertainty and the needs of individuals considering metoidioplasty and phalloplasty gender-affirming surgery (MaPGAS) and (2) to inform development of a patient-centered decision aid. METHODS: This cross-sectional study was based on mixed methods. Adult transgender men and nonbinary individuals assigned female at birth at various stages of MaPGAS decision making were recruited from 2 study sites in the United States to participate in semistructured interviews and an online gender health survey, which included measures of gender congruence, decisional conflict, urinary health, and quality of life. Trained qualitative researchers conducted all interviews with questions to explore constructs from the Ottawa decision support framework. OUTCOMES: Outcomes included goals and priorities for MaPGAS, expectations, knowledge, and decisional needs, as well as variations in decisional conflict by surgical preference, surgical status, and sociodemographic variables. RESULTS: We interviewed 26 participants and collected survey data from 39 (24 interviewees, 92%) at various stages of MaPGAS decision making. In surveys and interviews, affirmation of gender identity, standing to urinate, sensation, and the ability to "pass" as male emerged as highly important factors for deciding to undergo MaPGAS. A third of survey respondents reported decisional conflict. Triangulation of data from all sources revealed that conflict emerged most when trying to balance the strong desire to resolve gender dysphoria through surgical transition against the risks and unknowns in urinary and sexual function, appearance, and preservation of sensation post-MaPGAS. Insurance coverage, age, access to surgeons, and health concerns further influenced surgery preferences and timing. CLINICAL IMPLICATIONS: The findings add to the understanding of decisional needs and priorities of those considering MaPGAS while revealing new complexities among knowledge, personal factors, and decisional uncertainty. STRENGTHS AND LIMITATIONS: This mixed methods study was codeveloped by members of the transgender and nonbinary community and yielded important guidance for providers and individuals considering MaPGAS. The results provide rich qualitative insights for MaPGAS decision making in US contexts. Limitations include low diversity and sample size; both are being addressed in work underway. CONCLUSIONS: This study increases understanding of the factors important to MaPGAS decision making, and results are being used to guide development of a patient-centered surgical decision aid and informed survey revision for national distribution.

"It helps us say what's important..." Developing Serious Illness Topics: A clinical visit agenda-setting tool.

BACKGROUND: Skillful communication with attention to patient and care partner priorities can help people with serious illnesses. Few patient-facing agenda-setting tools exist to facilitate such communication. OBJECTIVE: To develop a tool to facilitate prioritization of patient and care partner concerns during serious illness visits. PATIENT OR FAMILY INVOLVEMENT: Two family members of seriously ill individuals advised. METHODS: We performed a literature review and developed a prototype agenda-setting tool. We modified the tool based on cognitive interviews with patients, families and clinicians. We piloted the tool with patients, care partners and clinicians to gain an initial impression of its perceived value. RESULTS: Interviews with eight patients, eight care partners and seven clinicians, resulted in refinements to the initial tool, including supplementation with visual cues. In the pilot test, seven clinicians used the tool with 11 patients and 12 family members. Qualitatively, patients and care partners reported the guide helped them consider and assert their priorities. Clinicians reported the tool complemented usual practice. Most participants reported no distress, disruption or confusion. DISCUSSION: Patients, care partners and clinicians appreciated centering patient priorities in serious illness visits using the agenda-setting tool. More thorough evaluation is required. PRACTICAL VALUE: The agenda-setting tool may operationalize elements of good serious illness care.