Supplemental Material for Shared Decision-Making for Youth Psychotherapy: A Preliminary Randomized Clinical Trial on Facilitating Personalized Treatment

BACKGROUND Shared decision-making (SDM) is particularly important in oncology since many treatments involve serious side effects, and treatment decisions involve a trade-off of benefits and risks. However, implementation of SDM in oncology care is challenging and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM, but is considered time-consuming. OBJECTIVE This study addresses the effectiveness of an individual SDM training program, using the concept of deliberate practice. METHODS This multicentre single-blinded randomized clinical trial will be performed in 12 Dutch hospitals. Clinicians involved in decisions with oncology patients are invited to participate in the study and are allocated to the control group or intervention group. All clinicians will record 3 decision-making processes, with 3 different oncology patients. Clinicians in the intervention group receive the SDM-intervention: completing E-learnings, reflecting on feedback reports, doing a self-assessment and defining 1-3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group do not receive the SDM-intervention until the end of the study. The primary outcome will be the extent in which clinicians involve their patients in the decision-making process, as scored using the OPTION-5 instrument. As secondary outcome patients will rate their perceived involvement in the decision-making and the duration of the consultations will be registered. RESULTS We hypothesize that clinicians exposed to this intervention are more likely to adopt SDM behaviours than clinicians who do not. A secondary aim is to evaluate whether patients perceive more involvement in the decision-making process. CONCLUSIONS This theory-based and blended approach will increase our knowledge about effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target knowledge, attitude and skills of clinicians. Patients are involved in the design and implementation of the study. CLINICALTRIAL This trial is retrospectively registered (Netherlands Trial Registry number NL9647; August 03, 2021, https://www.trialregister.nl/trial/9647). All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. Approval for the study was obtained from the Ethical Review Board (medical research ethics committee Delft and Leiden, the Netherlands (N20.170)).

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Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial

BMC Psychiatry ◽

10.1186/s12888-017-1218-1 ◽

2017 ◽

Vol 17 (1) ◽

Cited By ~ 5

Author(s):

Mio Ishii ◽

Yasuyuki Okumura ◽

Naoya Sugiyama ◽

Hana Hasegawa ◽

Toshie Noda ◽

...

Keyword(s):

Clinical Trial ◽

Decision Making ◽

Randomized Clinical Trial ◽

Shared Decision Making ◽

Shared Decision ◽

First Admission

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Strategies to facilitate shared decision-making about pediatric oncology clinical trial enrollment: A systematic review

Patient Education and Counseling ◽

10.1016/j.pec.2018.02.001 ◽

2018 ◽

Vol 101 (7) ◽

pp. 1157-1174 ◽

Cited By ~ 10

Author(s):

Eden G. Robertson ◽

Claire E. Wakefield ◽

Christina Signorelli ◽

Richard J. Cohn ◽

Andrea Patenaude ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Decision Making ◽

Shared Decision Making ◽

Pediatric Oncology ◽

Shared Decision ◽

Oncology Clinical Trial ◽

Clinical Trial Enrollment

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Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions

JCO Oncology Practice ◽

10.1200/jop.19.00772 ◽

2020 ◽

Vol 16 (9) ◽

pp. e859-e867

Author(s):

Rachel S. Hianik ◽

Gavin P. Campbell ◽

Eli Abernethy ◽

Colleen Lewis ◽

Christina S. Wu ◽

...

Keyword(s):

Clinical Trial ◽

Decision Making ◽

Clinical Trials ◽

Phase I ◽

Shared Decision Making ◽

Phase I Trial ◽

Performance Status ◽

Shared Decision ◽

Phase I Clinical Trials ◽

Decision Making Model

PURPOSE: Debate continues over whether explicit recommendations for a clinical trial should be included as an element of shared decision making within oncology. We aimed to determine if and how providers make explicit recommendations in the setting of phase I cancer clinical trials. METHODS: Twenty-three patient/provider conversations about phase I trials were analyzed to determine how recommendations are made and how the conversations align with a shared decision-making framework. In addition, 19 providers (9 of whose patient encounters were observed) were interviewed about the factors they consider when deciding whether to recommend a phase I trial. RESULTS: We found that providers are comprehensive in the factors they consider when recommending clinical trials. The two most frequently stated factors were performance status (89%) and patient preferences (84%). Providers made explicit recommendations in 19 conversations (83%), with 12 of those being for a phase I trial (12 [63%] of 19). They made these recommendations in a manner consistent with a shared decision-making model; 18 (95%) of the 19 conversations during which a recommendation was made included all steps, or all but 1 step, of shared decision making, as did 11 of the 12 conversations during which a phase I trial was recommended. In 7 (58%) of these later conversations, providers also emphasized the importance of the patient’s opinion. CONCLUSION: We suggest that providers not hesitate to make explicit recommendations for phase I clinical trials, because they are able to do so in a manner consistent with shared decision making. With further research, these results can be applied to other clinical trial settings.

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Using behavioral theory and shared decision-making to understand clinical trial recruitment: interviews with trial recruiters

Trials ◽

10.1186/s13063-021-05257-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jamie C. Brehaut ◽

Carolina Lavin Venegas ◽

Natasha Hudek ◽

Justin Presseau ◽

Kelly Carroll ◽

...

Keyword(s):

Clinical Trial ◽

Decision Making ◽

Behavior Change ◽

Shared Decision Making ◽

Thematic Analysis ◽

Pilot Trial ◽

Theoretical Domains Framework ◽

Shared Decision ◽

Trial Recruitment ◽

Clinical Trial Recruitment

Abstract Background Clinical trial recruitment is a continuing challenge for medical researchers. Previous efforts to improve study recruitment have rarely been informed by theories of human decision making and behavior change. We investigate the trial recruitment strategies reported by study recruiters, guided by two influential theoretical frameworks: shared decision-making (SDM) and the Theoretical Domains Framework (TDF) in order to explore the utility of these frameworks in trial recruitment. Methods We interviewed all nine active study recruiters from a multi-site, open-label pilot trial assessing the feasibility of a large-scale randomized trial. Recruiters were primarily nurses or master's-level research assistants with a range of 3 to 30 years of experience. The semi-structured interviews included questions about the typical recruitment encounter, questions concerning the main components of SDM (e.g. verifying understanding, directive vs. non-directive style), and questions investigating the barriers to and drivers of their recruitment activities, based on the TDF. We used directed content analysis to code quotations into TDF domains, followed by inductive thematic analysis to code quotations into sub-themes within domains and overarching themes across TDF domains. Responses to questions related to SDM were aggregated according to level of endorsement and informed the thematic analysis. Results The analysis helped to identify 28 sub-themes across 11 domains. The sub-themes were organized into six overarching themes: coordinating between people, providing guidance to recruiters about challenges, providing resources to recruiters, optimizing study flow, guiding the recruitment decision, and emphasizing the benefits to participation. The SDM analysis revealed recruiters were able to view recruitment interactions as successful even when enrollment did not proceed, and most recruiters took a non-directive (i.e. providing patients with balanced information on available options) or mixed approach over a directive approach (i.e. focus on enrolling patient in study). Most of the core SDM constructs were frequently endorsed. Conclusions Identified sub-themes can be linked to TDF domains for which effective behavior change interventions are known, yielding interventions that can be evaluated as to whether they improve recruitment. Despite having no formal training in shared decision-making, study recruiters reported practices consistent with many elements of SDM. The development of SDM training materials specific to trial recruitment could improve the informed decision-making process for patients.

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Results from a focus group evaluating TrialTALK, a designed conversation to facilitate cancer treatment shared decision making.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.31_suppl.34 ◽

2019 ◽

Vol 37 (31_suppl) ◽

pp. 34-34

Author(s):

Toby Christopher Campbell ◽

Erin Kennedy ◽

Selina Schmocker

Keyword(s):

Clinical Trial ◽

Decision Making ◽

Focus Group ◽

Cancer Treatment ◽

Shared Decision Making ◽

Information Needs ◽

Treatment Options ◽

Treatment Decision ◽

Shared Decision ◽

Treatment Decision Making

34 Background: Cancer treatment decision making involves timely, high-risk, shared decision-making conversations between patients, their families, and their oncologists. These conversations are a prime target for a carefully designed, easy to interpret approach to facilitate preference-sensitive decision-making. The TrialTALK approach has two core elements: a verbal approach and a pen & paper diagram. The diagram includes the diagnosis with prognostic implications, available treatment options along with estimates for efficacy and anticipated impact on daily life. The verbal conversation corresponds to the diagram and includes a phrase to encourage deliberation and empathic responses. Here, we report the results of a focus group conducted in Toronto comparing two approaches to a cancer decision making conversation. Methods: Our focus group was comprised of 9 patients, all with incurable malignancy. They observed a live reading of an actual transcript of a cancer treatment decision making conversation between a patient and oncologist who presented three options: observation, chemotherapy, and a clinical trial. The investigators re-organized the conversation, reusing as many words as possible, into the TrialTALK framework. No new information was introduced. After watching each scene, participants discussed and rated the conversation for information needs and indicated the decision. Results: Three (33%) said rated the standard conversation as meeting their informational needs while 7/9 (78%) reported needs were met by the designed approach. Decision making preferences following the conversations are shown in the table. Patients reported feeling the physician in the designed conversation was more prepared; they felt greater trust and confidence; they valued the paper diagram; they felt more empowered and engaged in the decision. Conclusions: A designed conversation may improve patient understanding, influence decision making, while also enhancing the patient-physician relationship. Clinical trial information: NCT03656276. [Table: see text]

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A randomized clinical trial of TrialTALK, a communication tool to facilitate treatment-related shared decision making.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.34_suppl.45 ◽

2018 ◽

Vol 36 (34_suppl) ◽

pp. 45-45

Author(s):

Toby Christopher Campbell ◽

Mallory Jasicki ◽

Kristine L Kwekkeboom ◽

Margaret L Schwarze ◽

Amy Zelenski ◽

...

Keyword(s):

Clinical Trial ◽

Decision Making ◽

Shared Decision Making ◽

Intervention Group ◽

Average Score ◽

Control Group ◽

Trial Participation ◽

Training Methods ◽

Shared Decision ◽

Communication Tool

45 Background: Cancer treatment decision making involves timely, high-risk, life altering shared decision-making conversations between patients, their families, and their oncologists. As such, these conversations are a prime target for a carefully designed, easy to interpret approach to facilitate preference-sensitive decision making. Patients need several important pieces of information delivered in a way that is easy to interpret. The TrialTALK approach has two core elements: a verbal approach and a pen and paper (P&P) diagram. The P&P diagram includes the diagnosis with prognostic implications, all available treatment options including best supportive care alone, estimates for efficacy, and anticipated impact on daily life. The verbal conversation corresponds to the diagram and includes a phrase to encourage deliberation, and empathic responses. Our trial is evaluating the effectiveness of TrialTALK to influence decision making, in particular clinical trial participation. Here, we report the results of the initial oncologist training. Methods: 28 oncologists volunteered to participate and were randomly assigned to control (Group A, n=13) or intervention (Group B, n=15). Oncologists in the intervention group each received two hours of training, including simulated conversations with feedback and optional 1:1 follow up for troubleshooting. At the conclusion of training, oncologists completed a video-recorded simulated encounter with an actor. Trainers reviewed P&P diagrams in real time and provided feedback. Results: We used a fidelity checklist to assess effectiveness of the training. We considered ≥ 14 points out of a possible 20 as an acceptable use of TrialTALK. The average score was 14.8 ± 2. Scores ranged 10-18. 12 of 15 intervention oncologists demonstrated adoption of the tool after 2 hours of training. Conclusions: Oncologist can effectively learn to use TrialTALK. The ongoing study will estimate preliminary efficacy of the TrialTALK intervention in regards to patient decision making and participation in clinical trials.

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