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Abstract Background This project engages patients and physicians in the development of Decision Boxes, short clinical topic summaries covering medical questions that have no single best answer. Decision Boxes aim to prepare the clinician to communicate the risks and benefits of the available options to the patient so they can make an informed decision together. Methods Seven researchers (including four practicing family physicians) selected 10 clinical topics relevant to primary care practice through a Delphi survey. We then developed two one-page prototypes on two of these topics: prostate cancer screening with the prostate-specific antigen test, and prenatal screening for trisomy 21 with the serum integrated test. We presented the prototypes to purposeful samples of family physicians distributed in two focus groups, and patients distributed in four focus groups. We used the User Experience Honeycomb to explore barriers and facilitators to the communication design used in Decision Boxes. All discussions were transcribed, and three researchers proceeded to thematic content analysis of the transcriptions. The coding scheme was first developed from the Honeycomb’s seven themes (valuable, usable, credible, useful, desirable, accessible, and findable), and included new themes suggested by the data. Prototypes were modified in light of our findings. Results Three rounds were necessary for a majority of researchers to select 10 clinical topics. Fifteen physicians and 33 patients participated in the focus groups. Following analyses, three sections were added to the Decision Boxes: introduction, patient counseling, and references. The information was spread to two pages to try to make the Decision Boxes less busy and improve users’ first impression. To try to improve credibility, we gave more visibility to the research institutions involved in development. A statement on the boxes’ purpose and a flow chart representing the shared decision-making process were added with the intent of clarifying the tool’s purpose. Information about the risks and benefits according to risk levels was added to the Decision Boxes, to try to ease the adaptation of the information to individual patients. Conclusion Results will guide the development of the eight remaining Decision Boxes. A future study will evaluate the effect of Decision Boxes on the integration of evidence-based and shared decision making principles in clinical practice.

Abstract Background Decision Boxes are summaries of the most important benefits and harms of health interventions provided to clinicians before they meet the patient, to prepare them to help patients make informed and value-based decisions. Our objective is to explore the barriers and facilitators to using Decision Boxes in clinical practice, more precisely factors stemming from (1) the Decision Boxes themselves, (2) the primary healthcare team (PHT), and (3) the primary care practice environment. Methods/design A two-phase mixed methods study will be conducted. Eight Decision Boxes relevant to primary care, and written in both English and in French, will be hosted on a website together with a tutorial to introduce the Decision Box. The Decision Boxes will be delivered as weekly emails over a span of eight weeks to clinicians of PHTs (family physicians, residents and nurses) in five primary care clinics located across two Canadian provinces. Using a web-questionnaire, clinicians will rate each Decision Box with the Information Assessment Method (cognitive impacts, relevance, usefulness, expected benefits) and with a questionnaire based on the Theory of Planned Behavior to study the determinants of clinicians’ intention to use what they learned from that Decision Box in their patient encounter (attitude, social norm, perceived behavioral control). Web-log data will be used to monitor clinicians’ access to the website. Following the 8-week intervention, we will conduct semi-structured group interviews with clinicians and individual interviews with clinic administrators to explore contextual factors influencing the use of the Decision Boxes. Data collected from questionnaires, focus groups and individual interviews will be combined to identify factors potentially influencing implementation of Decision Boxes in clinical practice by clinicians of PHTs. Conclusions This project will allow tailoring of Decision Boxes and their delivery to overcome the specific barriers identified by clinicians of PHTs to improve the implementation of shared decision making in this setting.

Abstract Background Applying evidence is one of the most challenging steps of evidence-based clinical practice. Healthcare professionals have difficulty interpreting evidence and translating it to patients. Decision boxes are summaries of the most important benefits and harms of diagnostic, therapeutic, and preventive health interventions provided to healthcare professionals before they meet the patient. Our hypothesis is that Decision boxes will prepare clinicians to help patients make informed value-based decisions. By acting as primers, the boxes will enhance the application of evidence-based practices and increase shared decision making during the clinical encounter. The objectives of this study are to provide a framework for developing Decision boxes and testing their value to users. Methods/Design We will begin by developing Decision box prototypes for 10 clinical conditions or topics based on a review of the research on risk communication. We will present two prototypes to purposeful samples of 16 family physicians distributed in two focus groups, and 32 patients distributed in four focus groups. We will use the User Experience Model framework to explore users' perceptions of the content and format of each prototype. All discussions will be transcribed, and two researchers will independently perform a hybrid deductive/inductive thematic qualitative analysis of the data. The coding scheme will be developed a priori from the User Experience Model's seven themes (valuable, usable, credible, useful, desirable, accessible and findable), and will include new themes suggested by the data (inductive analysis). Key findings will be triangulated using additional publications on the design of tools to improve risk communication. All 10 Decision boxes will be modified in light of our findings. Discussion This study will produce a robust framework for developing and testing Decision boxes that will serve healthcare professionals and patients alike. It is the first step in the development and implementation of a new tool that should facilitate decision making in clinical practice.

Abstract Background To explore ways to reduce the overuse of antibiotics for acute respiratory infections (ARIs), we conducted a pilot clustered randomized controlled trial (RCT) to evaluate DECISION+, a training program in shared decision making (SDM) for family physicians (FPs). This pilot project demonstrated the feasibility of conducting a large clustered RCT and showed that DECISION+ reduced the proportion of patients who decided to use antibiotics immediately after consulting their physician. Consequently, the objective of this study is to evaluate, in patients consulting for ARIs, if exposure of physicians to a modified version of DECISION+, DECISION+2, would reduce the proportion of patients who decide to use antibiotics immediately after consulting their physician. Methods/design The study is a multi-center, two-arm, parallel clustered RCT. The 12 family practice teaching units (FPTUs) in the network of the Department of Family Medicine and Emergency Medicine of Université Laval will be randomized to a DECISION+2 intervention group (experimental group) or to a no-intervention control group. These FPTUs will recruit patients consulting family physicians and residents in family medicine enrolled in the study. There will be two data collection periods: pre-intervention (baseline) including 175 patients with ARIs in each study arm, and post-intervention including 175 patients with ARIs in each study arm (total n = 700). The primary outcome will be the proportion of patients reporting a decision to use antibiotics immediately after consulting their physician. Secondary outcome measures include: 1) physicians and patients' decisional conflict; 2) the agreement between the parties' decisional conflict scores; and 3) perception of patients and physicians that SDM occurred. Also in patients, at 2 weeks follow-up, adherence to the decision, consultation for the same reason, decisional regret, and quality of life will be assessed. Finally, in both patients and physicians, intention to engage in SDM in future clinical encounters will be assessed. Intention-to-treat analyses will be applied and account for the nested design of the trial will be taken into consideration. Discussion DECISION+2 has the potential to reduce antibiotics use for ARIs by priming physicians and patients to share decisional process and empowering patients to make informed, value-based decisions. Trial Registration ClinicalTrials.gov: NCT01116076