Decision-making Conversations Research Articles

The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators.

Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching and navigationintervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm. Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching and navigationsession about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods. We will assess whether a decision coaching and patient navigation intervention can feasibly and effectivelysupport high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations. This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022. Version 1, April 10, 2024.

A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol

Background Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations. Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion The iFraP trial will answer important questions about the effectiveness of the new ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407

Comparing direct medical care costs of patients with bladder cancer who received an ileal conduit vs. neobladder in the year following cystectomy

PurposeBladder cancer is 1 of the most costly cancers, however there is limited research on medical care costs by type of urinary diversion. The objective of our study was to compare medical care costs of the 2 most common urinary diversions in the year following radical cystectomy. MethodsThe Bladder Cancer Quality of Life Study included patients diagnosed with bladder cancer who underwent radical cystectomy and received an ileal conduit (IC, n = 821) or neobladder (NB, n = 181) in 3 integrated health systems. Medical care costs per patient per quarter were estimated for the year following cystectomy. Multivariable generalized linear models with a gamma distribution and log link were used to estimate mean monthly medical care costs (2022 USD$), adjusted for patient demographic and clinical characteristics. ResultsIn multivariable analysis, mean monthly costs per quarter were not significantly different between IC and NB patients in the 12 months following cystectomy. Overall, mean monthly costs in IC and NB patients were highest during the first quarter and decreased thereafter. Factors associated with higher mean costs across all quarters included presence of any complications and advanced tumor stage at cystectomy (all P < 0.001). ConclusionOur study addresses an important knowledge gap by quantifying the medical costs of bladder cancer patients by urinary diversion type and comparing costs of different treatment approaches. Studies that assess patient-reported outcomes and out-of-pocket costs, by urinary diversion type, are warranted to inform treatment decision-making and cost conversations.

Refining, implementing, and evaluating an anesthesia choice conversation aid for older adults with hip fracture: protocol for a stepped wedge cluster randomized trial

BackgroundHip 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.MethodsThe 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT06438640

Discourse Analysis in End-of-Life Communication: A Systematic Review

ABSTRACT Discourse analysis (DA) has emerged as a valuable method for examining communication between participants in end-of-life (EOL) care. However, there remains a gap in synthesizing the findings of discourse analytic studies focused on communication within EOL care settings. The aim of this study was to synthesize DA studies in EOL care. A systematic review was conducted following the Preferred Reporting Items for Systematic Review and Meta-Analyses (Prisma) guidelines. An electronic database of Web of Science (WOS), MEDLINE, PubMed, and Embase was performed. 14 peer-reviewed studies published in English before January 10 2024, were included. Thematic analysis identified three overarching themes: (1) caregivers’ discursive stances on EOL care, (2) discursive practices of participants in shared decision-making conversations, and (3) discursive resources in talking illness trajectories. Findings suggest that DA has the potential to provide insights into understanding communication practices in EOL care and examining an individual’s stance on issues about EOL care, thus informing clinical practice and improving patient-centered care.

Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association.

Hypertension is a leading risk factor for cardiovascular morbidity and mortality. Despite the widespread availability of both pharmacological and lifestyle therapeutic options, blood pressure control rates across the globe are worsening. In fact, only 23% of individuals with high blood pressure in the United States achieve treatment goals. In 2023, the US Food and Drug Administration approved renal denervation, a catheter-based procedure that ablates the renal sympathetic nerves, as an adjunctive treatment for patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. This approval followed the publication of multiple randomized clinical studies using rigorous trial designs, all incorporating renal angiogram as the sham control. Most but not all of the new generation of trials reached their primary end point, demonstrating modest efficacy of renal denervation in lowering blood pressure across a spectrum of hypertension, from mild to truly resistant. Individual patient responses vary, and further research is needed to identify those who may benefit most. The initial safety profile appears favorable, and multiple ongoing studies are assessing longer-term efficacy and safety. Multidisciplinary teams that include hypertension specialists and adequately trained proceduralists are crucial to ensure that referrals are made appropriately with full consideration of the potential risks and benefits. Incorporating patient preferences and engaging in shared decision-making conversations will help patients make the best decisions given their individual circumstances. Although further research is clearly needed, renal denervation presents a novel treatment strategy for patients with uncontrolled blood pressure.

Feasibility and acceptability of the ShareD dEciSIon making for patients with kidney failuRE to improve end-of-life care intervention: A pilot multicentre randomised controlled trial

BackgroundKidney failure is associated with a high disease burden and high mortality rates. National and international guidelines recommend health professionals involve patients with kidney failure in making decisions about end-of-life care, but implementation of these conversations within kidney services varies. We developed the DESIRE (ShareD dEciSIon-making for patients with kidney failuRE to improve end-of-life care) intervention from our studies investigating multiple decision maker needs and experiences of end-of-life care in kidney services. The DESIRE intervention's three components are a training programme for health professionals, a patient decision aid, and a kidney service consultation held to facilitate shared decision-making conversations about planning end-of-life care. ObjectivesTo assess the feasibility and acceptability of integrating the DESIRE intervention within kidney services. DesignA pilot study using a multicentre randomised controlled design. SettingFour Danish nephrology departments. ParticipantsPatients with kidney failure who were 75 years of age or above, their relatives, and health professionals. MethodsPatients were randomised to either the intervention or usual care. Feasibility data regarding delivering the intervention, the trial design, and outcome measures were collected through questionnaires and audio recordings at four points in time: before, during, post, and 3 months after the intervention. Acceptability data were collected through semi-structured interviews with patients and relatives, as well as a focus group with health professionals post the intervention. ResultsTwenty-seven patients out of the 32 planned were randomised either to the intervention (n= 14) or usual care (n= 13). In addition, four relatives and 12 health professionals participated. Follow-up was completed by 81 % (n= 22) of patient participants. We found that both feasibility and acceptability data suggested health professionals improved their decision support and shared decision-making skills via the training. Patient and relative participants experienced the intervention as supporting a shared decision-making process; from audio recordings, we showed health professionals were able to support proactively decision-making about end-of-life care within these consultations. All stakeholders perceived the intervention to be effective in promoting shared decision-making and relevant for supporting end-of-life care planning. ConclusionsParticipant feedback indicated that the DESIRE intervention can be integrated into practice to support patients, relatives, and health professionals in planning end-of-life care alongside the management of worsening kidney failure. Minimising exhaustion and enhancing engagement with the intervention should be a focus for subsequent refinement of the intervention. RegistrationThe study has been registered at ClinicalTrials.gov with the identifier: NCT05842772. Date of first recruitment: March 20, 2023.

Development of an Educational Brochure about Treatment Options for Pregnant Women with Opioid Use Disorders.

The goal of this study was to describe the development of an educational brochure for pregnant women with opioid use disorders (OUDs) about treatment options. Based on findings from a preliminary review of the literature, we drafted a brochure that addressed the following questions: (1) What are your options (Medication-Assisted Treatment (MAT) versus no treatment)? (2) What are the benefits of MAT? (3) What are the risks of MAT? (4) Can I take buprenorphine or methadone while breastfeeding? (5) Which medication should I choose? Clinicians and doulas (n = 19) who provide care to pregnant women with OUDs were recruited. Semi-structured interviews elicited participants' feedback on brochure content and their perceptions about brochure use for patient education. Thematic data analyses were performed. Three emergent themes were identified (suggested uses and settings of use, content revisions, and perceptions about the brochure) and used to refine the final brochure. This study provides valuable insights into the desired content of an educational brochure describing treatment options for pregnant women with OUDs from the provider's standpoint. Research is needed to assess the use of the brochure in shared decision-making conversations with providers about treatment.

Options for evaluating communication strategies in treatment and clinical trial discussions.

11083 Background: Nationally, participation in oncology clinical trials is low, with lack of representation of women and ethnic and racial minorities. Interventions to increase patient enrollment in clinical trials and to ensure equity are necessary to improve cancer care for all patients. Shared decision-making conversations are in physicians’ control and are amenable to intervention. However, we must understand the current communication strategies used by medical oncologists in their discussions with patients about high-stakes treatment decisions, including participation in clinical trials. Methods: This was an observational qualitative study conducted between Jan 2022 to Feb 2023. We recruited US medical oncologists who routinely treat colon cancer and have access to clinical trials. Oncologists participated in a simulated, recorded telehealth encounter with a standardized patient recently diagnosed with advanced colon cancer and referred for discussion of treatment options, including a possible clinical trial. Oncologists were provided with the same background information on the patient. Four actors, a Black female, Black male, White female, and White male, were trained to represent the same patient with the same values. Results: 107 physicians at 42 academic institutions across 27 states were contacted via email, 47 responded (44%). 26 consented, and 21 completed the study. Participants were a median age of 41 (range 31-71 years), 48% female, 29% Asian, 5% Black. Encounter length ranged from 28:25 to 76:12 minutes (average 44:05 min). One to four treatment options were discussed during the encounter, including standard of care (1 or 2 options), clinical trial, and best supportive care. Clinical trials were explicitly discussed in nearly all (20/21) conversations and were introduced as an option 1st (1/20), 2nd (5/20), 3rd (12/20), 4th (2/20). Clinical trial discussion length ranged from 3:34 to 19:40 min (average 8:30 min). Discussions were shorter with Black vs White patient, average time 7:00 vs 10:00 min, respectively (p = 0.05), female vs male patient was 9:53 vs 7:34 min, respectively (p = 0.12). Recommendations varied from strong recommendation for a clinical trial (9/21), decision deferred to patient (9/21), recommendation for standard of care (3/21). Conclusions: The way oncologists discuss treatment options with their patients powerfully influences the outcome of the conversation and potentially the decision to participate in a clinical trial. In our study, fewer than half of academic GI oncologists recommend a trial. There is significant variability in option talk including the order as well as the content, duration, detail, and recommendations. Clinical trial discussions were shorter for Black patients. A structured approach to this complex decision-making conversation may help oncologists communicate treatment options to patients in a more equitable and effective way.

Medical record prompts improve the frequency and documentation of dizziness and driving conversations in the ENT balance clinic.

Driving capacity is affected by vestibular disorders and the medications used to treat them. Driving is not considered during medical consultations, with 92 per cent of patients attending a centre for dizziness not discussing it with the doctor. To investigate if medical record prompts facilitate dizziness and driving conversations in ENT balance clinics. A questionnaire was designed to reflect the current standards of practice and advice given regarding driving and dizziness during balance clinic consultations. Medical record prompts facilitated the improved frequency and recording of shared decision-making conversations about driving and dizziness in 98 per cent of consultations. This study highlights the benefits of medical record prompts for documented and accurate shared decision-making conversations surrounding dizziness, vertigo, vestibular conditions and driving. This potentially improves safety for all road users, and protects the patient and clinician in the event of road traffic accidents and medico-legal investigations.

Abstract PO3-12-05: Patient (pt)-provider communication challenges about side effects/toxicities from metastatic breast cancer (mBC) treatments

Abstract Introduction: Treatment decisions for ER+/HER2- mBC may be influenced by pt knowledge about treatment side effects, which is shaped by pt-provider communication. We conducted a survey of pts with ER+/HER2- mBC to better understand pt expectations and experiences of treatment toxicities, the extent they were discussed by the pts’ medical team (MT), and the sources/types of side effect information pts prefer. Methods: The 55-question, online ESR1 QUAlity of Life Survey 3 (EQUALS 3) survey was emailed to US pts from the Cure Media Group and authors’ contacts, and posted to private BC Facebook and Twitter pt groups for 2 weeks in June 2023. Eligible pts had ER+/HER2- mBC and reported changing treatments due to progression. Pts received a $10 gift card at survey completion. Survey answers were descriptively summarized. Results: 213 pts completed the survey; they were &amp;lt; 60 yrs of age (77%), White (44%) or Hispanic/Latino (48%), peri-/postmenopausal (54%), and urban-area residents (51%); and had college education (71%) and household income &amp;gt;$50K (66%). Most pts were on 2nd (36%) or 3rd+ (51%) therapy lines. Current mBC treatments were endocrine therapy ± targeted agent (70%), antibody-drug conjugate (8%), chemotherapy (11%), and others (10%). Most pts’ oncologists were female (65%), BC specialists (51%), and from an academic hospital (61%). Only half (49%) of surveyed pts felt extremely/very comfortable discussing side effects with their MT. Although 86% felt well informed about treatment toxicities, MTs did not proactively ask about pts’ greatest concerns on side effects for 15% of pts, nor about what side effects pts would find tolerable or intolerable for 25%. Oncologist/MT inquired about acceptability of side effects most often with treatment change (25%) or when brought up by the pt (20%), and at every single visit for only 19% of pts. Most pts felt extremely prepared for treatment toxicities (78%) and well prepared to manage them (86%), but 19% of pts still felt that their MT did not provide optimal guidance on managing potential side effects. Pt-centered conversations were most often missing: what rare but serious side effects to expect (44%), how to deal with potential side effects (39%), and what common side effects to expect (32%). Pts also reported that the likelihood of experiencing side effects (40%), what rare but serious side effects to expect (39%), and how to deal with potential side effects (28%) were not well presented. To facilitate treatment decisions, pts would like more time discussing treatment options (48%) or side effects (39%); additional written or visual resources on side effects (29%, 23%, respectively) or efficacy (39%, 8%); and the ability to ask questions and receive meaningful answers (39%), talk to other pts (20%), or listen to videos of their stories (11%). Pt testimonials (45%), toxicity descriptions/examples (42%), and toxicity management strategies (36%) were the most common additional forms of information that pts would like to have had on side effects. Conclusion: In this survey of pts with ER+/HER2- mBC, not all pts were comfortable discussing treatment toxicities with their MT, but MTs are mostly addressing side effects. However, there is still room for communication improvement and additional forms of toxicity information are needed for optimal decision-making. Despite generally feeling well prepared for toxicities, a significant proportion of pts report that the range and specifics of side effects and how to manage them were missing or not well presented in MT discussions. This survey highlights the need to improve both provider and pt education with the goal of effectively communicating toxicity specifics of mBC therapies, as well as the need for standardized pt education tools detailing risks and benefits of mBC therapies to assist pts in shared decision-making conversations. Citation Format: Sarah Sammons, Jane Meisel, Timothy Pluard, Kelly Shanahan, Fumiko Chino, Dario Trapani, Dominic Carroll, Monica Kozlowski, Elizabeth Attias, Nicole Kuderer. Patient (pt)-provider communication challenges about side effects/toxicities from metastatic breast cancer (mBC) treatments [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-12-05.

Abstract PO1-10-06: Understanding clinical meaningfulness in metastatic breast cancer treatment decision-making: experiences and perspectives of patients, caregivers, and clinicians

Abstract Background: While many clinical and non-clinical factors inform metastatic breast cancer (mBC) treatment recommendations; patient preferences, values, and care goals also influence how treatment options are weighed, deliberated, and decided upon. Additionally, in the mBC care setting, clinical meaningfulness and clinically meaningful outcomes (e.g., survival, quality-of-life) are important factors to consider along the care continuum. However, the extent to which patients and their oncology care team align on the interpretation and use of these concepts during treatment decision-making has not been well elucidated. This study examined perspectives on the concepts of (i) clinical meaningfulness and (ii) clinically meaningful outcomes associated with mBC treatment among five key stakeholder groups: patients, caregivers, oncologists, advanced practice providers (APPs), and oncology nurses. Methods: Qualitative semi-structured in-person and web-based focus groups were conducted between March and June 2023 among: (i) people living with mBC; (ii) unpaid or informal caregivers to people with mBC; and providers involved in the care of patients with mBC, including (iii) oncologists, (iv) APPs (i.e., physician assistants and nurse practitioners), and (v) oncology nurses. Discussion guides were developed to elicit stakeholder perspectives on clinical meaningfulness and clinically meaningful outcomes to help identify areas of convergence and divergence between and within stakeholder groups. All discussions were audio recorded and transcribed. The constant comparative approach was used to identify key themes. Results: Twenty-two focus groups were conducted with 50 patients, 24 caregivers, 8 oncologists, 13 APPs, and 17 oncology nurses. Overall, patients and caregivers were unfamiliar with the concepts of clinical meaningfulness and clinically meaningful outcomes, underscoring the critical need for using accessible and patient-friendly terminology in treatment decision-making discussions. While some providers were familiar with these concepts, they reported not using these terms when discussing treatment recommendations with patients. Although some provider participants thought clinical meaningfulness described quantitative endpoints (e.g., additional months of survival), participants across all stakeholder groups described patients’ abilities to achieve life goals (e.g., participation in milestone events and social activities, ability to travel) as paramount. Recommendations for improving treatment decision-making discussions included taking a patient-centered approach, with inclusive, dynamic patient-provider discussions and continuous evaluation of patient priorities across the care continuum, not just at diagnosis. Meaningful outcomes beyond overall survival need to be considered, including quality of life, progression-free survival, minimal or manageable side effects, and improvement in symptom burden and functioning. Across all stakeholders, participants stressed that outcomes considered meaningful are highly individualized and dynamic, evolving over time as patients move through the treatment journey and life stages. Conclusions: Clinical meaningfulness is poorly understood and not often considered in the clinical setting when making mBC treatment decisions, highlighting a need for accessible and patient-friendly terminology in mBC treatment decision-making conversations. While participants valued overall survival, the importance of meaningful outcomes that support patients’ quality of life was emphasized. Study findings can be used to inform both practice and clinical research to better capture meaningful outcomes for patients. Citation Format: Stephanie Graff, Emily Freeman, Meaghan Roach, Rozanne Wilson, Ricki Fairley, Mary Gullatte, Jeanne Stemland, Becky Chan, Paulina Wochal, Julie Katz, Suepattra May-Slater. Understanding clinical meaningfulness in metastatic breast cancer treatment decision-making: experiences and perspectives of patients, caregivers, and clinicians [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-10-06.

Abstract PO2-11-11: 'Who’s gonna take care of my babies?' The Impact of Children on Treatment Decisions for Women with Metastatic Breast Cancer: A qualitative analysis

Abstract Background: Many treatment options exist for metastatic breast cancer and decisions may be based on pathology, oncology clinician preference, performance status, financial considerations, patient values, or a combination of these factors. Some studies have characterized the importance that family and a strong support system can have on treatment decisions, but few have explicitly examined the impact that children—and grandchildren—have on treatment decisions in metastatic breast cancer (mBC). This qualitative study examined how being a parent or grandparent influences treatment decisions for women with metastatic breast cancer. Methods: A qualitative sub-analysis was conducted with a purposive diverse sample of thirteen women with metastatic breast cancer in the Eastern United States. Women of color were specifically oversampled relative to the regional population. Semi-structured interviews were conducted to explore treatment decision making, clinician-patient communication, and patient values relevant to their treatment decisions. Interviews were recorded, professionally transcribed, and coded by three independent coders. Any coding discrepancies were resolved through discussion. Thematic analysis identified recurrent themes important to women diagnosed with mBC. Results: Nearly 50% of the participants were women of color and of the 13 participants, 12 had children. When asked about what factors were important to them when making treatment decisions, a list of more than 10 themes emerged. Five participants said that children and grandchildren impacted their treatment decisions and were a crucial part of their cancer care. Other significant themes that emerged were side effects (54% of participants) and quality of life (46% of participants). Women who expressed that children were their top priority were also concerned about “looking sick” in front of their children. For women who said their grandchildren were the most important factor, being able to watch their grandchildren grow up was the primary motivator for their treatment decisions. Among the women who identified that side effects and quality of life were important, children either provided supportive care, helped with activities of daily living, or were too young to provide support. Conclusions: The presence of children and the relationships women with mBC have with their children was primary in making treatment decisions for their cancer. Of the participants in our study, having children—and grandchildren—rivaled other important factors such as quality of life and side effects of treatment, indicating the need to explore the impact that children have on cancer care as it is currently a poorly understood phenomenon. However, it is important not to make assumptions about patient treatment preferences based on whether women with mBC have children, instead, shared decision-making conversations should determine what is most important when deciding on a treatment plan. Future tools should integrate questions about family and children, and how these considerations may impact treatment decisions. Citation Format: Katherine Tomczik, Lorinda Coombs. 'Who’s gonna take care of my babies?' The Impact of Children on Treatment Decisions for Women with Metastatic Breast Cancer: A qualitative analysis [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-11-11.

Protocol for a trial-based economic evaluation analysis of a complex digital health intervention including a computerised decision support tool: the iFraP intervention

Background Digital health interventions (DHI) are associated with significant promise. In recent years, the need to assess the value of these healthcare technologies has motivated a debate regarding the suitability of existing economic evaluation methods in the context of DHI evaluation. Some have argued that robust economic evaluation methods may not be capable of capturing relevant DHI’s characteristics. Others consider that assessing the value of DHI might not be feasible. This protocol paper challenges that view. More specifically, it describes early Health Technology Assessments (HTA) methods to rigorously assess the value for money of a complex intervention including a digital decision support tool i.e., Improving uptake of Fracture Prevention drug treatments (iFraP) as a tracer intervention. iFraP is a complex intervention consisting of a computerised decision support tool, a clinician training package, and information resources to facilitate shared decision-making, increase informed medicine initiation and reduce levels of medicine discontinuation. iFraP’s development was motivated by a view that good quality shared decision-making conversations have the potential to improve levels of osteoporosis medicine uptake. Methods An early economic evaluation of the iFraP intervention was designed to identify, measure, and evaluate the costs and health benefits of iFraP compared to usual practice in Fracture Liaison Services (FLSs). A within-trial cost-effectiveness from the perspective of the National Health Service and Personal Social Service in England will be conducted using patient’s self-reported health related quality of life (HRQoL) and resource use from the iFraP randomised controlled trial. Microanalysis will be used to estimate iFraP’s intervention cost. Finally, Bayesian Value of Information analysis will allow us to estimate an upper bound for the potential health benefits gained from reducing uncertainty on the impact of the iFraP intervention to support uptake and adherence with osteoporosis medicines. Trial registration ISRCTN10606407 - https://doi.org/10.1186/ISRCTN10606407

A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol.

Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person's life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations.Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. The iFraP trial will answer important questions about the effectiveness of the new 'iFraP' osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407.

Maternity healthcare professionals’ experiences of supporting women in decision-making for labour and birth: a qualitative study

ObjectivesTo explore and characterise maternity healthcare professionals’ (MHCPs) experience and practice of shared decision-making (SDM), to inform policy, research and practice development.DesignQualitative focus group study.SettingLarge Maternity Unit in the Southwest...

Managing STEMIs without a Catheterization Lab: A Simulated Scenario to Improve Emergency Clinician Recognition and Execution of Thrombolysis in the Setting of Rural STEMI Management.

Managing STEMIs without a Catheterization Lab: A Simulated Scenario to Improve Emergency Clinician Recognition and Execution of Thrombolysis in the Setting of Rural STEMI Management.

Patient decision-making in the era of transcarotid artery revascularization

ObjectiveThe National Coverage Determination on carotid stenting by Medicare in October 2023 stipulates that patients participate in a shared decision-making (SDM) conversation with their proceduralist before an intervention. However, to date, there is no validated SDM tool that incorporates transcarotid artery revascularization (TCAR) into its decision platform. Our objective was to elicit patient and surgeon experiences and preferences through a qualitative approach to better inform the SDM process surrounding carotid revascularization. MethodsWe performed longitudinal perioperative semistructured interviews of 20 participants using purposive maximum variation sampling, a qualitative technique designed for identification and selection of information-rich cases, to define domains important to participants undergoing carotid endarterectomy or TCAR and impressions of SDM. We also performed interviews with nine vascular surgeons to elicit their input on the SDM process surrounding carotid revascularization. Interview data were coded and analyzed using inductive content analysis coding. ResultsWe identified three important domains that contribute to the participants' ultimate decision on which procedure to choose: their individual values, their understanding of the disease and each procedure, and how they prefer to make medical decisions. Participant values included themes such as success rates, “wanting to feel better,” and the proceduralist's experience. Participants varied in their desired degree of understanding of carotid disease, but all individuals wished to discuss each option with their proceduralist. Participants' desired medical decision-making style varied on a spectrum from complete autonomy to wanting the proceduralist to make the decision for them. Participants who preferred carotid endarterectomy felt outcomes were superior to TCAR and often expressed a desire to eliminate the carotid plaque. Those selecting TCAR felt it was a newer, less invasive option with the shortest procedural and recovery times. Surgeons frequently noted patient factors such as age and anatomy, as well as the availability of long-term data, as reasons to preferentially select one procedure. For most participants, their surgeon was viewed as the most important source of information surrounding their disease and procedure. ConclusionsSDM surrounding carotid revascularization is nuanced and marked by variation in patient preferences surrounding autonomy when choosing treatment. Given the mandate by Medicare to participate in a SDM interaction before carotid stenting, this analysis offers critical insights that can help to guide an efficient and effective dialog between patients and providers to arrive at a shared decision surrounding therapeutic intervention for patients with carotid disease.

Patient Characteristics and the Extent to Which Clinicians Involve Patients in Decision Making: Secondary Analyses of Pooled Data.

The occurrence of shared decision making (SDM) in daily practice remains limited. Various patient characteristics have been suggested to potentially influence the extent to which clinicians involve patients in SDM. To assess associations between patient characteristics and the extent to which clinicians involve patients in SDM. We conducted a secondary analysis of data pooled from 10 studies comparing the care of adult patients with (intervention) or without (control) a within-encounter SDM conversation tool. We included studies with audio(-visual) recordings of clinical encounters in which decisions about starting or reconsidering treatment were discussed. In the original studies, the Observing Patient Involvement in Decision Making 12-items (OPTION12 item) scale was used to code the extent to which clinicians involved patients in SDM in clinical encounters. We conducted multivariable analyses with patient characteristics (age, gender, race, education, marital status, number of daily medications, general health status, health literacy) as independent variables and OPTION12 as a dependent variable. We included data from 1,614 patients. The between-arm difference in OPTION12 scores was 7.7 of 100 points (P < 0.001). We found no association between any patient characteristics and the OPTION12 score except for education level (p = 0.030), an association that was very small (2.8 points between the least and most educated), contributed mostly by, and only significant in, control arms (6.5 points). Subanalyses of a stroke prevention trial showed a positive association between age and OPTION12 score (P = 0.033). Most characteristics showed no association with the extent to which clinicians involved patients in SDM. Without an SDM conversation tool, clinicians devoted more efforts to involve patients with higher education, a difference not observed when the tool was used. Most sociodemographic patient characteristics show no association with the extent to which clinicians involve patients in shared decision making.Clinicians devoted less effort to involve patients with lower education, a difference that was not observed when a shared decision-making conversation tool was used.SDM conversation tools can be useful for clinicians to better involve patients and ensure patients get involved equally regardless of educational background.

Challenges Addressing Lung Cancer Screening for Patients With Multimorbidity in Primary Care: A Qualitative Study.

Many individuals who are eligible for lung cancer screening have comorbid conditions complicating their shared decision-making conversations with physicians. The goal of our study was to better understand how primary care physicians (PCPs) factor comorbidities into their evaluation of the risks and benefits of lung cancer screening and into their shared decision-making conversations with patients. We conducted semistructured interviews by videoconference with 15 PCPs to assess the extent of shared decision-making practices and explore their understanding of the intersection of comorbidities and lung cancer screening, and how that understanding informed their clinical approach to this population. We identified 3 themes. The first theme was whether to discuss or not to discuss lung cancer screening. PCPs described taking additional steps for individuals with complex comorbidities to decide whether to initiate this discussion and used subjective clinical judgment to decide whether the conversation would be productive and beneficial. PCPs made mental assessments that factored in the patient's health, life expectancy, quality of life, and access to support systems. The second theme was that shared decision making is not a simple discussion. When PCPs did initiate discussions about lung cancer screening, although some believed they could provide objective information, others struggled with personal biases. The third theme was that ultimately, the decision to be screened was up to the patient. Patients had the final say, even if their decision was discordant with the PCP's advice. Shared decision-making conversations about lung cancer screening differed substantially from the standard for patients with complex comorbidities. Future research should include efforts to characterize the risks and benefits of LCS in patients with comorbidities to inform guidelines and clinical application.