Clinical Research Directory

Decision Aid for Women Newly Diagnosed With Breast Cancer

The goal of this multi-center randomized controlled trial is to determine if the clinical decision aid (BCT Aid) works to help breast cancer patients participate in decision-making and make high-quality decisions, thereby improving the rate of breast-conserving surgery and quality of life. The main questions it aims to answer are: Does the BCT Aid significantly increase the rate of breast-conserving surgery compared to usual care? Does the BCT Aid reduce decision conflict and decision regret, while improving shared decision-making and quality of life? Does the BCT Aid demonstrate better cost-effectiveness in terms of health resource utilization? Researchers will compare the BCT Aid to usual care (standard clinical consultation) to evaluate the effectiveness and cost-effectiveness of BCT Aid. Participants will: Be randomly assigned to either the intervention group (receiving the BCT Aid intervention for 6 months) or the control group (usual care). Complete assessments including decision conflict and shared decision-making at baseline (T0), post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention), decision regret at T2 and T3, and quality of life at T0, T2, and T3, with additional EQ-5D-5L measurements at baseline, 3, 6, 9, and 12 months for cost-effectiveness analysis. Have clinical outcomes (breast-conserving surgery rate) and health resource utilization data collected from medical records.

Shared Decision-Making for Colorectal Cancer Screening in High-Risk First-Degree Relatives Aged 40-49

The primary objective of this study was to evaluate the impact of a constructed shared decision (SDM) intervention (offering an option between colonoscopy and immunochemical collapsible occult blood testing (fecal immunochemical test; FIT)) on improving the incidence of high colonoscopy stromal in patients aged 40-49 years with a close relative suffering from colorectal cancer, compared to standard care (direct referral for colonoscopy).

Redesigning Surgical Care for Patients in Wisconsin

This study evaluates strategies to train surgeons to use Better Conversations, an evidence-based communication framework designed to improve informed consent by helping patients understand the goals of surgery, the downsides of treatment, and what to expect. Better Conversations supports deliberation, patient preparation, and alignment of decisions with patient goals, addressing known shortcomings in traditional informed consent. The purpose of this study is to compare two methods of surgeon training: (1) training delivered by an education specialist using audit and feedback, and (2) training supported by computerized automation that identifies elements of Better Conversations in de-identified transcripts of surgical consultations. The central question is whether the automated training program is non-inferior to the specialist-delivered program. Approximately 60 surgeons from two academic health systems will be randomized to one of these training approaches. Each surgeon will complete a didactic session, have outpatient surgical consultations audio-recorded for feedback, and complete assessment recordings after training. Patients of enrolled surgeons will complete surveys before and after their surgeon's training to evaluate patient-reported communication outcomes. Findings from this study will assess the effectiveness, feasibility, and acceptability of automated training and support the development of a larger pragmatic study to evaluate the broader effects of Better Conversations on patient outcomes.

RCT of NLP-Based Feedback for Improving SDM in Men With Localized Prostate Cancer

The purpose of the research is to assess the impact of a natural language processing + artificial intelligence (NLP+AI)-based risk communication feedback system to improve quality of risk communication of key tradeoffs during prostate cancer consultations among physicians and to improve patient decision making. In this cluster randomized trial, an evaluable 259 patients with newly diagnosed clinically localized prostate cancer will be cluster randomized within an evaluable 24 physicians to: 1. a control arm, in which patients will receive standard of care treatment consultations along with AUA-endorsed educational materials on treatment risks and benefits (for patients) and on SDM (for physicians) or 2. an experimental arm, in which patients and participating physicians will receive NLP+AI-based feedback on what was said about key tradeoffs within approximately 72 hours of the consultation to assist with decision making. Physicians will additionally be provided with grading of their risk communication for each visit based on an a priori defined framework for quality of risk communication and recommendations for improvement. In both study arms, there will be an audio-recorded follow-up phone or video call between the physician and patient to allow for further discussion of risk and clarifying any areas of ambiguity, which will be qualitatively analyzed to see if areas of poor communication were rectified. After the follow-up phone call, patients and participating physicians will be asked to complete a very brief survey about their experience. The study plans to test whether receiving NLP+AI-based feedback improves decisional conflict, shared decision making, and appropriateness of treatment choice over the standard of care in patients undergoing treatment consultations for prostate cancer. Study staff will also test whether providing feedback and grading of risk communication to physicians affects quality of physician risk communication, since providing feedback will promote more accountability for the quality of information provided to patients. The study will also analyze data from the control arm of the randomized controlled trial to understand variation in risk communication of key tradeoffs in relevant subgroups of tumor risk (low-, intermediate-, and high-risk), provider specialty (Urology, Radiation Oncology, Medical Oncology), and patient sociodemographics.

Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis

The goal of this pilot hybrid type I efficacy/implementation trial is to assess a newly developed decision support tool patients, parents, and providers to use during surgical treatment decision making for neuromuscular scoliosis (NMS). Results from this pilot will inform the design of a future larger effectiveness trial of the decision support tool. Participants will either receive usual care or receive the decision support tool. Researchers will assess the decision made, decision quality, individual affective, cognitive, and behavioral effects, and feasibility and acceptability of tool use. They will also collect potential barriers and facilitators to implementation and feedback about the tool and study design to maximize likelihood of successful deployment of the tool into clinical practice and inform the design of a future trial. The outcomes measures will be used to inform potential effect size estimates to inform a future trial.

Digital Preparation for Bariatric Surgery: Feasability Pilot Trial

Metabolic and bariatric surgery (MBS) is in increasing demand due to the growing prevalence of severe obesity and the cumulating evidence of long-term benefits on weight loss, cardiometabolic and functional health outcomes, and quality of life for individuals living with severe obesity. The time spent on the waiting list for an MBS follow the same trend with an estimated waiting time of more than 18 months and rising. The lack of resources and multidisciplinary capabilities among MBS centers impacts the quality of care and outcomes, which greatly contributes to delayed surgery. In 2023, 31% of patients who had an initial appointment with the MBS nurse at the Quebec Heart and Lung Institute - Laval University(IUCPQ) did not proceed with the surgery due to fear, uncertainty, or timing issues. Additionally, 49% reported that their concerns (e.g., financial, home support) were not addressed before MBS. These data highlight the urgent need to implement strategies to optimize wait time and ensure that MBS preparation is tailored to patients' expectations. Telehealth has significantly impacted surgical preparation, including for MBS, by enhancing accessibility, reducing dropout rates, and maintaining clinical outcomes that are comparable to traditional in-person visits but it requires real-time multidisciplinary execution, limiting the applicability for MBS waiting list patients. An interesting complement to telehealth intervention is online education platforms which offer digital flexibility, a significant advantage over in-person session. To date, most MBS online resources are fee-based or driven by commercial interests and lack of clinical evidence, which raises concerns about their efficacy and safety for users who are seeking reliable support during their MBS journey. A free online education platform could optimize the time spent on the MBS waiting list by increasing patients' readiness for MBS, furnishing invaluable insights into the patient journey to MBS, and empowering individuals undergoing MBS. The IUCPQ is in the process of working on the care trajectory of patients with obesity. The Healthcare Direction and the Bariatric Surgery Clinic decided to use a platform called Precare. This platform offers personalized educational content as well as a calendar and appointment management system. It has been accredited by the Quebec Ministry of Health and Social Services. The present research focuses on the pilot testing the implementation and effectiveness of the PreCare solution for patients awaiting bariatric surgery at the IUCPQ. The objectives of the research proposal are: 1) To assess the usability and acceptability of the Precare platform using a mixed design methodology; 2) To evaluate the logistical feasibility of using the platform in a clinical setting; 3) To determine whether extensive self-questionnaire assessments may impact the use of the Precare platform; 4) To explore barriers and facilitators to enhance patient engagement and knowledge retention; and 5) To derive estimates variables related to gender, ethnicity, cultural background, learners and psychological profiles for future phases. Our hypotheses are: 1. The Precare platform will exhibit high usability and acceptability. 2. Testing the Precare platform in real clinical settings is viable and will yield promising results for improving patient readiness for Metabolic and Bariatric Surgery.

Engaging Adolescents in Decisions About Return of Genomic Research Results

Recent recommendations to return children's results for adult-onset conditions to parents anytime whole exome or genome sequencing is performed, as well as growing expectations to return research results to participants on a large-scale basis, mean adolescents will increasingly be engaged in assenting (\<age 18) and consenting (\>age 18) to return of genomic research results. There is an urgent need to understand adolescents' informational preferences and to create ethically informed, scalable processes that empower adolescents from diverse backgrounds to participate in the decision-making process about learning genomic results. This research will provide important insights into adolescents' choices, as well as the ethical, legal and societal implications of engaging adolescents in making choices about learning genomic results in genomic research and community-based research settings.

Post-Operative Analgesic Selection in Patients Planned for Third Molar Extraction After Undergoing Shared Decision Making Using 2- Versus 3-Option Decision-Aids

This research protocol is exploring a behavioral intervention: shared decision making with the use of a decision aid to select a post-operative analgesic. Specifically, the investigators will examine the impact of shared decision making on analgesic selection for acute pain management when 2 options are presented to the patient as compared to 3 options which includes an opioid prescription for "just-in-case" pain management. The investigators hypothesize that significantly more patients will choice an opioid option when the "just-in-case option is included.

Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy

Preoperative chemotherapy has been shown to be at least as effective as postoperative chemotherapy in breast cancer patients and has seen increased use over time. The decision regarding neoadjuvant treatment is complex, as various aspects need to be considered, and the patient's role in the decision-making process is central. The information provided by doctors to patients about preoperative treatment can be complicated, including details about treatment options, treatment plans, and side effects. If this information is not conveyed adequately, there is a risk of misunderstandings, which can lead to increased anxiety and stress for patients regarding their decisions. In oncology, question prompt lists (QPL) have been used as a tool to support patients by improving the information conveyed by doctors in various contexts where complex decisions need to be made. Studies have shown that QPL can facilitate better information exchange. However, their use in discussions about preoperative treatment for breast cancer patients has not been studied. Furthermore, evidence from randomized studies on the use of QPL in clinical practice is very limited. The aim of this study is to investigate whether the use of QPL during patient consultations involving discussions about neoadjuvant chemotherapy can improve information exchange in various aspects: understanding of the treatment; anxiety about the decision; participation in the decision-making process; patient-doctor communication; and decision-related conflict.

The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp

Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy. Shared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process. This is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.

Empowering Caregivers in ADHD Treatment: Standard Care Vs. Decision Aid, Coaching, and AI Support

The goal of this clinical trial is to evaluate different decision-support interventions to help parents make informed treatment decisions for their children with ADHD. The study will compare four approaches to assess their impact on decision-making quality, decisional conflict, and treatment adherence among parents of children aged 6-17 years diagnosed with ADHD. The main questions it aims to answer are: Does providing parents with decision-support tools improve decision-making quality compared to standard care? Do decision aid, decision aid + decision coaching, and AI-driven support further enhance parental self-efficacy, knowledge, and adherence to treatment decisions? Standard care (physician consultation only) A written decision aid (structured booklet) Decision aid + decision coaching (booklet + one-on-one coaching session) AI-driven support (interaction with an AI tool) Participants will: Complete a baseline questionnaire before the intervention Receive their assigned decision-support intervention (if applicable) Complete follow-up questionnaires at 2 weeks and 3 months after the intervention Report on treatment decisions and medication adherence over 3 months This study will determine whether structured decision aids, coaching, or AI-driven tools improve parental decision-making and treatment adherence in ADHD care.