[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"shared-decision-making\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:shared-decision-making":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,46,73,101,137,168,199,232,271,301,335,361,389],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100642173","empowering-monterey-bay-residents-for-activated-collaborative-and-equitable-care-100642173",false,"NCT07652359","Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care","EMBRACE - Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care","EMBRACE","Inclusion Criteria:\n\n* Participants must be receiving clinical care by a primary care physician in the Monterey area\n* Participants must be 18 years or older.\n* Participants must speak either English or Spanish.\n* Participants must be able to consent verbally in English or Spanish to all study procedures.\n* Participants must self-identify as a racial\u002Fethnic minorities OR identify as having low-income status\n\nExclusion Criteria:\n\n\\- Patients unable to respond to survey questions in either English or Spanish.","ALL","18 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of the EMBRACE Study is to evaluate whether a facilitated intervention improves shared decision-making (SDM) and patient activation among low-income and minority individuals more than usual care only. The ultimate goal is to enhance SDM and patient activation in care.",[27,28,29,30],"Shared Decision-Making","Quality of Life","Advanced Illness","Terminal Illness",[32,33],"Goals of care","Advanced care planning","NOT_YET_RECRUITING","2026-06-10",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":21},"2026-10-01",{"date":42,"type":21},"2030-01-01",{"name":44,"class":45},"Stanford University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100642989","impact-and-experiences-of-using-decisions-aids-in-outpatient-mental-health-100642989","NCT07637747","Impact and Experiences of Using Decisions Aids in Outpatient Mental Health.","DAN-SHARE. Impact and Experiences of Using Decisions Aids in Hospital Outpatient Mental Health Settings. A Mixed Methods Study on Shared Decision-making Practice in the Danish Mental Healthcare","Inclusion Criteria:\n\n* Age ≥ 18 years\n* In treatment for a mental health disorder in one of the participating settings of the study\n\nExclusion Criteria:\n\n* Unable to understand Danish language\n* Unable to provide verbal and written informed consent\n* Diagnosed with cognitive impairment or dementia",{"count":54,"type":21},62,[24],"DAN-SHARE is a study on shared decision-making (SDM) in Danish mental healthcare that investigates the impact of a decision aid, the Decision Helper™, on patient involvement in treatment decision-making in hospital outpatient mental health settings. The study also explores patients' and healthcare professionals' understanding and experiences of using the Decision Helper™ as part of decision-making practice in mental healthcare.",[58],"Shared Decision Making",[60,61,62],"Mental health","Share decision making","decision aids","RECRUITING","2026-06-09",{"date":35,"type":38},{"date":67,"type":38},"2026-04-15",{"date":69,"type":21},"2027-12-31",{"name":71,"class":45},"University of Southern Denmark",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":72},"100639938","development-and-evaluation-of-an-online-shared-decision-making-educational-program-for-nurses-and-patients-with-chronic-diseases-100639938","NCT07589673","Development and Evaluation of an Online Shared Decision-Making Educational Program for Nurses and Patients With Chronic Diseases","Inclusion Criteria for Nurse:\n\n* Registered nurses currently providing direct patient care in participating general hospitals\n* Able to understand the purpose and procedures of the study and provide informed consent\n* Able to use a computer, tablet, or smartphone to access the online program\n\nExclusion Criteria for Nurse:\n\n* Not currently engaged in direct patient care\n* Unable to clearly express willingness to participate\n* Unable to complete the educational program or questionnaires because of technical or language limitations\n\nInclusion Criteria for Patients:\n\n* Adults aged 19 years or older living in the community\n* Diagnosed with one or more chronic diseases requiring ongoing management, including but not limited to hypertension, diabetes mellitus, dyslipidemia, arthritis, chronic respiratory disease, or cardiovascular disease, with at least 3 months elapsed since diagnosis\n* Able to understand the purpose and procedures of the study and provide informed consent\n* Able to read and respond to survey questions\n* Able to use a computer, tablet, or smartphone to access the online program\n\nExclusion Criteria for Patients:\n\n* Cognitive impairment or communication problems that make participation difficult\n* Unable to complete the educational program or questionnaires because of technical or language limitations","19 Years",{"count":81,"type":21},288,[24],"This study aims to develop and evaluate an online shared decision-making (SDM) educational program for nurses and patients with chronic diseases. Shared decision-making is a process in which healthcare professionals and patients make health-related decisions together based on the best available evidence and the patient's values and preferences. The study includes an evaluation phase. In the evaluation phase, the program will be tested among nurses working in general hospitals and adults with chronic diseases living in the community. Outcomes related to shared decision-making will be assessed at baseline, immediately after the 4-week program, and 1 month later. The study is expected to improve shared decision-making competence, experience, and preparedness among both nurses and patients.",[85,86],"Chronic Disease","Shared Decision-making",[88,89,90,91],"Shared decision-making","Chronic disease","Online education","Decision support","2026-05-21",{"date":94,"type":38},"2026-05-26",{"date":96,"type":21},"2026-05-10",{"date":98,"type":21},"2027-04-03",{"name":100,"class":45},"Chungnam National University",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":118,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":72},"100638712","pulse---patient-understanding-and-learning-through-structured-education---effectiveness-and-implementation-of-patient-education-videos-in-a-new-pediatric-cardiology-clinic-a-stepped-wedge-cluster-randomized-trial-100638712","NCT07594041","PULSE - Patient Understanding and Learning Through Structured Education - Effectiveness and Implementation of Patient Education Videos in a New Pediatric Cardiology Clinic: A Stepped Wedge Cluster Randomized Trial","PULSE","Inclusion Criteria:\n\nPediatric patients (ages 0-18 years) presenting for outpatient pediatric cardiology evaluation Caregiver present and able to complete surveys Referral reason matches available video topic (during intervention periods)\n\nExclusion Criteria:\n\nEmergency or urgent consultations Caregiver unable to read\u002Funderstand English or Spanish Patient\u002Ffamily opts out of study participation",{"count":109,"type":21},300,[24],"This study is looking at whether short educational videos shown during pediatric cardiology visits can help families better understand their child's condition while also making clinic visits run more efficiently. Families coming to a pediatric cardiology clinic may watch short videos related to why they are there (for example: chest pain, heart murmurs, fainting, sports clearance, or Kawasaki disease). The videos are meant to explain common heart-related conditions and answer questions before the doctor comes into the room.\n\nResearchers want to see if this:\n\n* helps parents and patients learn more,\n* improves satisfaction with the visit,\n* helps families feel more involved in decisions,\n* and reduces the amount of time doctors spend repeating the same explanations.\n\nHow the study works:\n\nOne clinic site in San Antonio, TX will start using the videos at different times. Researchers will compare clinic visits before and after the videos are introduced.\n\nWho is included:\n\nChildren being seen in pediatric cardiology clinics and their caregivers. Pregnant women referred for fetal heart evaluations may also be included.\n\nWhat information is collected:\n\nClinic timing information (such as wait times and doctor visit length), Satisfaction surveys, Optional knowledge questionnaires, Basic medical record information needed for the study.\n\nRisk level: The study is considered \"minimal risk.\" Patients are still getting normal medical care. No drugs, devices, or experimental treatments are being tested.\n\nPrivacy protections: Data will be stored on secure hospital systems. Researchers plan to remove identifying information when analyzing results. Medical record numbers are only temporarily used to connect survey data with clinic data.\n\nWhy the study matters:\n\nThe clinic hopes the videos can make visits less stressful, improve understanding for families, and help doctors spend more time on personalized care instead of repeating the same explanations over and over. It may also help clinics work more efficiently and reduce delays.",[113,114,115,116,86,117],"Cardiology","Pediatric Cardiac Surgery","Education","Patient Education","Outpatient Clinics, Hospital",[119,120,121,122,123,124,125,126,127],"patient education","videos","outpatient","pediatric","cardiology","pediatric cardiology","shared decision making","outpatient clinic","implementation science","2026-05-12",{"date":130,"type":38},"2026-05-18",{"date":132,"type":21},"2026-05",{"date":134,"type":21},"2027-12",{"name":136,"class":45},"Driscoll Children's Hospital",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":148,"conditions":149,"keywords":155,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100498909","phase-2-the-impact-of-a-patient-decision-aid-on-treatment-choices-for-patients-with-an-unexpected-malignant-colorectal-polyp-100498909","NCT05776381","The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp","The Impact of an In-consultation Patient Decision Aid on Treatment Choices and Outcomes of Management for Patients With an Unexpected Malignant Colorectal Polyp A Non-randomized Clinical Phase II Study","Inclusion Criteria:\n\n* Histopathologically verified malignant colorectal polyp removed endoscopically and CT-scan (and MRI if the malignant polyp was situated in the rectum) shows N0, M0 disease.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inoperable due to comorbidity\n* Known residual tumor left in situ after local resection, \\>N0 or \\>M0",{"count":145,"type":21},110,[147],"PHASE2","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.\n\nShared 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.\n\nThis 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.",[58,150,151,152,153,154],"Colonic Polyp","Decision Aids","Rectal Polyp","Colorectal Polyp","Colorectal Cancer",[156,157,158,58],"non-randomized trial","malignant colorectal polyp","Patient Decision aid","2026-04-29",{"date":161,"type":38},"2026-04-30",{"date":163,"type":21},"2028-02-01",{"date":165,"type":21},"2033-02-01",{"name":167,"class":45},"Vejle Hospital",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":176,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100631175","decision-aid-for-women-newly-diagnosed-with-breast-cancer-100631175","NCT07497256","Decision Aid for Women Newly Diagnosed With Breast Cancer","Effectiveness and Cost-effectiveness of a Multimodal Shared Decision-Making Decision Aid ( BCT Aid) for Women Newly Diagnosed With Breast Cancer","BCT Aid","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Newly diagnosed with breast cancer, with clinical stage 0-II, or stage III eligible for breast-conserving surgery after neoadjuvant chemotherapy.\n3. Clinically eligible for breast-conserving surgery and considering one of the following surgical options: breast-conserving surgery, mastectomy, or mastectomy with reconstruction.\n4. Clinically eligible for adjuvant therapy after surgery.\n5. Able to access the internet via smartphone.\n6. Able to read, speak, and understand Mandarin.\n\nExclusion Criteria:\n\n1. Male breast cancer patients.\n2. Clinically eligible for only one surgical option or not candidates for surgery.\n3. Have a history of other malignancies, except adequately treated cervical carcinoma in situ and basal cell carcinoma of the skin.\n4. Presence of psychiatric disorders, visual or hearing impairments, or cognitive impairment.","FEMALE",{"count":178,"type":21},160,[24],"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:\n\nDoes 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.\n\nParticipants will:\n\nBe randomly assigned to either the intervention group (receiving the BCT Aid intervention for 6 months) or the control group (usual care).\n\nComplete 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.\n\nHave clinical outcomes (breast-conserving surgery rate) and health resource utilization data collected from medical records.",[182,183,58,184,28],"Breast Cancer","Decision Aid","Cost Effectiveness",[186,187,188,125,189],"breast cancer","decision aid","decision conflict","cost effectiveness","2026-04-26",{"date":161,"type":38},{"date":193,"type":21},"2026-04-01",{"date":195,"type":21},"2027-10",{"name":197,"class":45},"Xiamen University",3,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":176,"minAge":207,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":218,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":72},"100634727","decision-aid-for-elective-egg-freezing-100634727","NCT07543445","Decision Aid for Elective Egg Freezing","Knowledge, Decision-making, and Oocyte Cryopreservation Outcomes in Taiwanese Women Considering Elective Egg Freezing: a Randomized Controlled Trial","DAEEF","Inclusion Criteria:\n\n* Women aged 20 years or older.\n* Currently considering elective egg freezing (EEF).\n* Able to communicate and read Chinese fluently.\n* Have access to the internet and a mobile device (smartphone, tablet, or computer) to complete online questionnaires.\n\nExclusion Criteria:\n\n* Individuals who have previously completed oocyte cryopreservation.\n* Women undergoing fertility preservation due to malignancy (i.e., breast cancer).\n* Postmenopausal women.","20 Years",{"count":209,"type":21},120,[24],"The goal of this clinical trial is to evaluate whether a culturally tailored decision aid can improve decision-making and clinical outcomes for Taiwanese women considering elective egg freezing.\n\nThe main questions it aims to answer are:\n\nDoes the decision aid improve women's knowledge about elective egg freezing and help clarify their personal values? Does the decision aid reduce decision regret and psychological distress after making a decision about egg freezing?\n\nResearchers will compare women who use the decision aid with those who receive standard counseling to see if the tool improves knowledge, reduces distress and regret, and leads to better clinical outcomes (such as completing egg freezing or achieving a higher number of frozen oocytes).\n\nParticipants will:\n\n* Complete questionnaires assessing their baseline knowledge, attitudes, and values regarding egg freezing\n* Receive either the decision aid or standard counseling\n* Complete follow-up questionnaires to assess knowledge, distress, and decision regret\n* Have their clinical outcomes recorded, including whether they undergo egg freezing and the number of oocytes retrieved and frozen",[213,214,183,215,58,216,217],"Elective Egg Freezing","Oocyte Cryopreservation","Egg Freezing","Assisted Reproductive Technology","Fertility Preservation",[219,220,221,187,125,222,223],"elective egg freezing","planned oocyte cryopreservation","fertility preservation","assisted reproductive technology","randomized controlled trial",{"date":225,"type":38},"2026-04-21",{"date":227,"type":21},"2026-04-13",{"date":229,"type":21},"2031-12-31",{"name":231,"class":45},"National Taiwan University Hospital",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":240,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":72},"100581929","rct-of-nlp-based-feedback-for-improving-sdm-in-men-with-localized-prostate-cancer-100581929","NCT06856694","RCT of NLP-Based Feedback for Improving SDM in Men With Localized Prostate Cancer","Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer","NLP RCT","Inclusion Criteria:\n\nPhysician Inclusion Criteria\n\n(1) Physicians who typically counsel prostate cancer patients (Urology, Radiation Oncology, Medical Oncology)\n\nPatient Inclusion Criteria\n\n1. Patients undergoing initial treatment consultation for clinically localized prostate cancer;\n2. Patients with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy;\n3. Ability to read and write in English.\n\nPatient Exclusion Criteria:\n\n1. Under 18 years of age;\n2. Subjects with difficulty communicating or dementia;\n3. Non-English speakers, given that our NLP-based tools cannot be used with languages other than English;\n4. Patients with locally advanced or metastatic prostate cancer;\n5. Patients who have already been treated for clinically localized prostate cancer.","MALE",{"count":242,"type":21},283,[24],"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:\n\n1. 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\n2. 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.\n\nIn 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.\n\nThe 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.",[246,58,247],"Prostate Cancer","Risk Communication",[249,250,251,252,253,254,255,256,257,258,259,260,261],"prostate cancer","shared","decision","risk","communication","physician risk","natural language processing","NLP","artificial intelligence","AI","cluster","randomize","chatGPT","2025-12-05",{"date":264,"type":38},"2025-12-11",{"date":266,"type":38},"2025-10-22",{"date":268,"type":21},"2029-12",{"name":270,"class":45},"Cedars-Sinai Medical Center",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":278,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":287,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":300},"100605853","developing-an-innovative-decision-support-tool-for-pediatric-neuromuscular-scoliosis-100605853","NCT07167927","Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis","Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis - Aims 2 and 3","Inclusion criteria:\n\n* Parent-child dyads of children with neuromuscular scoliosis who speak English and Spanish.\n* Child is between ages 8-21 years of age and they are coming into the pediatric orthopaedic surgery clinic for consultation about potential surgery for NMS.\n* NMS is defined as having neurologic impairment (NI) and scoliosis using relevant ICD-9 or ICD-10 codes from Feudtner, et al. 2014 or Berry, et al. 2012. or a qualifying diagnosis per the Pediatric Spine Study Group definition of NMS.\n* All pediatric orthopaedic surgeons and neurosurgeons who treat neuromuscular scoliosis at our study sites will be eligible participants.\n\nExclusion criteria:\n\n* Families whose child with NMS is less than 8 years of age at time of orthopaedic consultation because surgery at a younger age usually indicates an atypical case.\n* Children with the diagnosis of Duchenne's or Becker's muscular dystrophy due to potential disease modifying therapies that may alter curve progression.","8 Years",{"count":145,"type":21},[24],"The goal of this pilot hybrid type I efficacy\u002Fimplementation 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.\n\nParticipants 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.",[283,284,285,58,286,151],"Children With Medical Complexity (CMC)","Multiple Chronic Conditions","Neuromuscular Scoliosis","Decision Support Systems, Clinical",[288,125,289,290,291],"children with medical complexity","values clarification","uncertainty communication","decision support tool","2025-12-04",{"date":262,"type":38},{"date":295,"type":38},"2025-10-21",{"date":297,"type":21},"2027-03-31",{"name":299,"class":45},"University of Utah",2,{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":321,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":72},"100608462","digital-preparation-for-bariatric-surgery-feasability-pilot-trial-100608462","NCT07201870","Digital Preparation for Bariatric Surgery: Feasability Pilot Trial","A Pilot Feasibility Study of the Implementation, Usability, Acceptability and Effectiveness of an Online Bariatric Surgery Preparation Platform","Pilot Be-Ready","Inclusion Criteria:\n\n* Be on the waiting list for metabolic and bariatric surgery at IUCPQ\n* not yet assessed by the local team and with an expected wait time of more than 6 months\n* understand French\n* Have an active email address\n\nExclusion Criteria:\n\n* Be part of the same household as someone already involved in this research project",{"count":310,"type":21},1050,[24],"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.\n\nTo 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.\n\nA 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.\n\nThe 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.\n\nOur hypotheses are:\n\n1. The Precare platform will exhibit high usability and acceptability.\n2. Testing the Precare platform in real clinical settings is viable and will yield promising results for improving patient readiness for Metabolic and Bariatric Surgery.",[314,315,316,317,318,319,320,58],"Obesity","Bariatric Surgery Patients","Online Education","eHealth Literacy","Online-Intervention","Usability Satisfaction","Implementation Strategies",[322,323,324,325],"obesity","bariatric surgery","preparation","education platform","2025-09-23",{"date":328,"type":38},"2025-10-01",{"date":330,"type":21},"2025-10-15",{"date":332,"type":21},"2028-10-01",{"name":334,"class":45},"Laval University",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":72},"100593825","post-operative-analgesic-selection-in-patients-planned-for-third-molar-extraction-after-undergoing-shared-decision-making-using-2--versus-3-option-decision-aids-100593825","NCT07011472","Post-Operative Analgesic Selection in Patients Planned for Third Molar Extraction After Undergoing Shared Decision Making Using 2- Versus 3-Option Decision-Aids","ACE Pilot 3: Decision Aid 2 Options vs 3 Options","Inclusion Criteria:\n\n* Be able to understand the informed consent.\n* Provide signed and dated informed consent form\n* Be able to understand all directions for data gathering instruments in English\n* Be willing and able to comply with all study procedures\n* Planning to undergo extraction of one or more 3rd molars\n* Be 18 years or older\n\nExclusion Criteria:\n\nWhile the actual analgesic prescribed to the patient may be different then the analgesic selected by the participant (their actual analgesic is NOT part of the research protocol) participants who self-report inability to take ibuprofen, acetaminophen or an opioid are not eligible since the decision aid is designed to help a patient select between a combination of ibuprofen\u002Facetaminophen and an opioid containing analgesic.\n\nParticipants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:\n\n* Prior participation in this study\n* Inability or refusal to provide informed consent","90 Years",{"count":344,"type":21},100,[24],"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.",[348,58],"Pain Management",[350,125,187,351],"Analgesic selection","non-opioid analgesic","2025-07-16",{"date":354,"type":38},"2025-07-18",{"date":356,"type":38},"2025-06-16",{"date":358,"type":21},"2026-05-30",{"name":360,"class":45},"Rutgers, The State University of New Jersey",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":176,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":198},"100575833","question-prompt-list-in-breast-cancer-patients-planned-for-neoadjuvant-chemotherapy-100575833","NCT06777420","Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy","Question Prompt List as a Tool to Promote Patient-physician Concordance in the Understanding of Information on Neoadjuvant Treatment in Breast Cancer: a Randomized Controlled Trial","QPL","Inclusion Criteria:\n\n* Patients with operable breast cancer eligible for systemic neoadjuvant therapy, according to current treatment guidelines.\n\nExclusion Criteria:\n\n* Patients with locally advanced breast cancer where neoadjuvant therapy is mandatory rather than a treatment option.\n* Patients with cognitive impairment that are assessed from treating physician as unable to participate.\n* Patients who cannot speak\u002Fread neither Swedish nor English.",{"count":370,"type":21},218,[24],"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.\n\nThe 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.\n\nIn 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.\n\nThe 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.",[374,375,58],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Neoadjuvant Therapy",[186,377,378,379,125],"neoadjuvant therapy","question prompt list","patient-physician communication","2025-04-16",{"date":382,"type":38},"2025-04-20",{"date":384,"type":38},"2025-03-01",{"date":386,"type":21},"2027-02",{"name":388,"class":45},"Region Örebro County",{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":17,"minAge":397,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100583068","effectiveness-of-decision-support-for-cardiovascular-risk-management-in-people-with-cardiovascular-disease-100583068","NCT06871514","Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease","2-DECIDE: A Stepped-Wedge Multicenter Study on the Effectiveness of a Multicomponent Intervention With Shared Decision-Making to Improve Cardiovascular Risk Management in Adults With Established Atherosclerotic Cardiovascular Disease","2-DECIDE","Inclusion criteria:\n\n* Established ASCVD\n\n  * At least 30 days since last CVD event and\u002For the diagnosis of ASCVD. If no CVD events have occurred, imaging confirming ASCVD must have been conducted at least 30 days prior.\n  * Documented ASCVD (defined according to the 2021 European Society of Cardiology guideline), which includes ASCVD established clinically or demonstrated unequivocally by imaging:\n* Clinically documented ASCVD includes previous myocardial infarction, acute coronary syndrome, coronary revascularization (Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery (CABG)), and other arterial revascularization procedures, ischemic stroke or transient ischemic attack, and peripheral artery disease (from Fontaine stage II). Angina pectoris (stable) without imaging evidence of atherosclerosis does not qualify as ASCVD.\n* ASCVD unambiguously identified through imaging, includes significant stenosis (\\>50%) on coronary angiography, computed tomography angiography, or carotic ultrasound. It also includes aortic aneurysms measuring ≥3cm. Only Carotid Intima-Media Thickness measurements (cIMT), Coronary Artery Calcium scoring or abnormal ankle-brachial index scores without evidence of stenosis, do not qualify as ASCVD.\n* Age 40-80 years (to allow for individual risk predictions with the SMART2 model\n* Patient attending the Cardiology or Vascular Medicine outpatient clinic\n* Sufficient understanding of the Dutch language (due to the questionnaires being administered in Dutch).\n* Written informed consent must be provided. Although the proposed intervention is not subject to the WMO, informed consent is required for the collection and processing of data, including the distribution of questionnaires.\n\nExclusion criteria:\n\n* Patients currently participating in other interventional medication studies, or studies that directly affect the therapy plan\n* Remaining life expectancy of less than 2 years as assessed by a consulting healthcare professional (these patients have no indication for cardiovascular risk management)\n* Patients for whom individual risk predictions with the SMART2 model are not feasible:\n\n  * Systolic Blood Pressure (SBP) \\\u003C90 mmHg or \\>200 mmHg\n  * Total cholesterol \\\u003C2.5mmol\u002FL or \\>8 mmol\u002FL\n  * High-Density Lipoprotein (HDL) cholesterol \\\u003C0.6mmol\u002FL or \\>2.5 mmol\u002FL\n  * Low-Density Lipoprotein (LDL) \\\u003C0.1 mmol\u002FL or \\>7.4 mmol \u002FL\n  * Estimated Glomerular Filtration Rate (eGFR) \\\u003C30ml\u002Fmin\u002F1.73m2 or dialysis\n  * Active treatment for malignity, pregnancy, history of organ transplantation, or liver failure\n* Previous participation in 2-DECIDE","40 Years","80 Years",{"count":400,"type":21},1200,[24],"This study aims to improve the way patients with cardiovascular diseases are informed about their treatment options. It explores methods to support shared decision-making between patients and doctors. In some cases, doctors will take extra time to discuss treatment options in detail. To assess the impact, some patients will be asked to complete questionnaires after their clinic visits.",[404,405],"Atherosclerotic Cardiovascular Diseases","Shared-decision Making","2025-03-11",{"date":408,"type":38},"2025-03-12",{"date":410,"type":38},"2025-02-18",{"date":412,"type":21},"2028-12-31",{"name":414,"class":45},"dr.Frank L.J. Visseren",8]