Are Clinicians Ready for Safe Use of Stratified Therapy in Primary Biliary Cholangitis (PBC)? A Study of Educational Awareness.

BACKGROUND: Primary Biliary Cholangitis (PBC, formerly cirrhosis), is a chronic cholestatic liver disease which until spring 2016 had a single licensed therapy, Ursodeoxycholic acid (UDCA). Approximately 30% of patients do not respond to UDCA, and are high-risk for progressing to end stage liver disease, transplantation or death. A new era of stratified medicine with second-line therapies to treat high-risk disease is emerging, with the first such second-line agent obeticholic acid recently receiving FDA and EMA approval and entering practice. Recent experience in the USA of inappropriate use and associated deaths has highlighted concerns as to whether clinicians have the knowledge to implement second-line therapies appropriately and safely. METHODS: Online survey of knowledge regarding optimal PBC management in Gastroenterologists and Hepatologists in the USA; the first 100 completed responses from each group used for analysis. RESULTS: 80% of Hepatologists felt they were highly competent in their understanding of the importance of early diagnosis and early UDCA therapy in PBC compared with 65% of gastroenterologists. However, only 36% of Hepatologists and 30% of gastroenterologists felt competent at assessing response to UDCA. Competence in knowledge (mode of action, efficacy, and side effects) of second-line therapies and enrollment into trials was low among both groups. CONCLUSION: Significant knowledge gaps in clinicians managing PBC presents a problem in optimizing care. It is perhaps not surprising that knowledge of emerging second-line therapies is low, however more concerning is sub-optimal use of UDCA in real-life practice and the lack of confidence at assessing treatment response which should be a routine part of clinical practice to assess risk of disease progression and will be key in delivering stratified medicine.

A Practical Approach for Developing Shared Decision-Making Knowledge, Skills, and Capability for Busy Health Care Practitioners.

BACKGROUND: There has been substantial development of shared decision-making (SDM) methods and approaches in the past few decades, but despite this, building capability and scaling application of SDM in clinical practice remains a challenge. Here the authors describe the development and initial experience with a new virtual Practical Approach continuing education program for busy practicing clinicians who care for people with complex, chronic, and costly conditions who are frequently faced with preference-sensitive decisions. This program was designed to provide plain language training in SDM for real-world clinical practice using an easy 4-step approach that does not require prior training or formal education in SDM theory or methods. METHODS: The authors describe the development of the Practical Approach program using established evidence-based principles. The program was piloted in 4 different settings across 2 chronic conditions. Qualitative interviews of program participants were conducted to observe SDM attitudes and observed performance in repeated case-based simulation role-play exercises to assess knowledge and skills performance. RESULTS: The authors observed improved and more realistic SDM attitudes in qualitative interviews with program participants after exposure to the program compared to baseline, and they similarly observed improved knowledge and skills demonstrated in sequential simulations conducted as participants were exposed to the program. Post-program focus groups revealed that participants perceived the program to be feasible, acceptable, and useful. CONCLUSIONS: Initial experience with the Practical Approach program suggests that it may beneficially affect basic SDM knowledge, skills, and attitudes in busy practicing clinicians who are novices in SDM. It also has demonstrated initial feasibility, utility, and acceptability.

A Qualitative Study on the Impact and Feasibility of a Simulation-Based Program for Shared Decision-Making in Non-Small Cell Lung Cancer Care.

BACKGROUND: In the pursuit of improved clinical outcomes and patient experience in health care, shared decision-making (SDM) stands as a pivotal concept garnering increasing attention, but SDM utilization varies widely, often leading to confusion regarding team members' roles. This study explores knowledge, skills, and attitudes of oncology clinicians engaged in a pioneering educational initiative at a comprehensive cancer care center, aimed at enhancing frontline SDM capabilities. METHODS: Utilizing a prospective cohort qualitative approach, the team conducted interviews with 6 clinicians in a multidisciplinary oncology program who were engaged in an SDM continuing education program. In the program, participants were immersed in experiential learning activities including standardized didactic sessions and simulation-based SDM case role-play activities. RESULTS: Thematic analysis of interview data revealed 5 major categories: 1) perceptions of SDM; 2) training; 3) patient-centered care; 4) challenges and constraints; and 5) leadership buy-in. Participants perceived benefits, including adopting a better approach to integrate SDM into their practice, heightened engagement, emphasizing team collaboration, and embracing a patient-centric care model. CONCLUSIONS: This study underscores the transformative impact of education and training on enhancing SDM capabilities among oncology clinicians and is not intended for generalizability. By promoting a basic understanding and application of SDM principles, practicing clinicians can be better empowered to improve health care outcomes and experience. Our findings contribute to the broader endeavor of embedding practical SDM principles within clinical practice, thereby fostering a more patient-centered and effective health care environment.

Building Frontline Capability for Shared Decision-Making (SDM) in a Major Academic Oncology Center Caring for People With Non-Small Cell Lung Cancer: Performance Outcomes of a SDM Simulation Training Program.

BACKGROUND: There is a growing body of evidence on shared decision-making (SDM) training programs worldwide. However, there is wide variation in program design, duration, effectiveness, and evaluation in both academia (ie, medical school) and the practice setting. SDM training has been slow to integrate in practice settings. METHODS: A pilot study of 6 multidisciplinary clinicians was conducted using quantitative and qualitative methods to evaluate changes in participant understanding and implementation of SDM in the practice setting. A 2-rater criterion-based evaluation method was used to assess a simulation-based case study role-play program using 7 domains of SDM pre and post training. The authors assessed whether clinicians addressed each of the 7 domains or what fraction of each domain was addressed as part of their simulation case study role-play performance. Focus groups were conducted pre- and postintervention to provide feedback to participants and to understand the clinician experience in greater detail. RESULTS: The increase in improvement in SDM ranged from 17% to 37%, and 7 of 8 domains for which participants were rated showed significant improvement. The areas of greatest improvement were seen in determining a patient's goals/preferences, including risk tolerance regarding treatments (+37%) and values and self-efficacy (+37%). CONCLUSION: The results of this study reveal a significant shift in clinician awareness of a patient's goals, preferences, and values. Postintervention, clinicians began to understand the value of building a partnership with their patients whereby the patient becomes an active participant in their clinical care.