[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patient-comprehension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patient-comprehension":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,59,90],{"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":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100648462","digital-supported-versus-standard-consent-for-advanced-therapeutic-endoscopy-100648462",false,"NCT07723105","Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy","Digital-Supported Versus Standard Informed Consent for Advanced Therapeutic Endoscopy: A Pragmatic Multicenter Randomized Trial","DIGI-CONSENT","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Scheduled to undergo elective advanced therapeutic endoscopy\n* Able to provide informed consent for study participation\n* Able to engage with study materials in a language supported by the site\n* Willing and able to complete study questionnaires and follow-up assessments\n\nExclusion Criteria:\n\n* Emergent or urgent procedures where the consent process cannot reasonably incorporate the study intervention\n* Inability or unwillingness to provide informed consent for study participation\n* Requirement for substitute decision-maker consent for the procedural decision itself, if this precludes meaningful use of the study intervention\n* Severe cognitive, visual, hearing, or communication limitations not adequately accommodated by site resources\n* Inability to complete the planned pre-procedural assessments\n* Prior enrollment in this study for the same procedural episode\n* Any clinical situation in which the treating endoscopist determines that study participation would be unsafe or inappropriate","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will evaluate whether a digital-supported informed consent process improves patient understanding before advanced therapeutic endoscopy procedures.\n\nPatients undergoing advanced therapeutic endoscopy are often asked to make decisions about procedures that may be complex and involve important risks, benefits, and alternatives. Standard informed consent is usually provided through discussion with the treating physician. However, this process can vary between clinicians and may be affected by time pressures in busy endoscopy units.\n\nIn this study, eligible adult patients scheduled for elective advanced therapeutic endoscopy will be randomly assigned to one of two consent pathways. One group will receive standard physician-led informed consent. The other group will receive a digital-supported consent pathway that includes a standardized procedure-specific educational video, an offline artificial intelligence-based question-answering tool, and final confirmation with the treating physician before the procedure.\n\nThe digital tool is designed to provide plain-language information about the procedure, including why it is being done, expected benefits, common and serious risks, alternatives, what to expect before and after the procedure, and the patient's right to ask questions or decline the procedure. The AI question-answering tool will use only investigator-approved educational content and will not provide individualized medical advice. Questions requiring patient-specific medical judgment will be directed back to the treating clinical team.\n\nThe main outcome of the study is patient comprehension of the consent information, measured after the assigned consent process and before the procedure. The study will also evaluate patient anxiety, satisfaction, confidence in decision-making, usability of the consent process, workflow outcomes, and consent-related safety or ethical concerns.",[27,28,29,30,31],"Informed Consent","Patient Education","Patient Comprehension","Therapeutic Endoscopy","Digital Health",[33,34,35,36,37,38,39,40,41,42,43,44,45],"Digital consent","Informed consent","Advanced endoscopy","Therapeutic endoscopy","Patient comprehension","Patient education","Artificial intelligence","AI question-answering tool","Video-based consent","Patient satisfaction","Pre-procedural anxiety","Pragmatic randomized trial","Endoscopy workflow","NOT_YET_RECRUITING","2026-07-20",{"date":49,"type":50},"2026-07-23","ACTUAL",{"date":52,"type":21},"2026-09-01",{"date":54,"type":21},"2028-03-01",{"name":56,"class":57},"Unity Health Toronto","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":58},"100592588","study-ehr-risk-stratification-tools-100592588","NCT06995378","Study EHR Risk Stratification Tools","Evaluation of Patient and Provider Facing EHR-embedded Risk Stratification Tools","Inclusion Criteria:\n\n* Age 65 years or older\n* Hemoglobin A1c in the prediabetes range (5.7- but not including 6.0%)\n\nExclusion Criteria:\n\n* Have lab results outside the defined inclusion range\n* No UCLA primary care provider\n* Age \\\u003C65 years\n* Eligibility for Surveys:\n\nAll randomized participants are eligible to receive study surveys. No additional eligibility criteria apply for survey participation.\n\nHgbA1c of 6.0 or above is not eligible.","65 Years",{"count":68,"type":21},1200,[24],"This study evaluates whether adding machine learning-based risk information to electronic health record (EHR) lab result messages helps older adults better understand their risk of developing diabetes and influences their emotional responses, quality of life, and healthcare use.\n\nEligible participants are adults aged 65 years and older with a UCLA primary care provider and a hemoglobin A1c level in the range (5.7-6.0%). Participants are identified automatically at the time their lab results are processed and are randomly assigned to receive either standard lab result messages or modified messages that include a \"very low risk\" label generated by a machine learning model.\n\nAll participants who are randomized are invited to complete two surveys: one shortly after their lab result is posted in MyChart and a follow-up survey approximately 30 days later. The study also uses de-identified EHR data to examine patterns of healthcare utilization and progression to diabetes. Provider comments related to lab result messaging will be analyzed to explore differences in response patterns between the two groups.",[72,73,29],"Prediabetes","Health Communication",[72,75,76,77,78,79,29],"Machine Learning","Risk Stratification","Electronic Health Record","Lab Result Communication","Predictive Modeling","RECRUITING","2026-07-07",{"date":83,"type":50},"2026-07-09",{"date":85,"type":50},"2026-05-27",{"date":87,"type":21},"2029-09",{"name":89,"class":57},"University of California, Los Angeles",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":58},"100631825","comparing-original-patient-educational-materials-vs-ai-simplified-materials-to-improve-patient-comprehension-and-health-literacy-100631825","NCT07505719","Comparing Original Patient Educational Materials vs. AI-Simplified Materials to Improve Patient Comprehension and Health Literacy","AI-Simplified Patient Educational Materials: Investigating the Potential for Improved Patient Comprehension and Health Literacy","Inclusion Criteria:\n\n* Parents or guardians of pediatric patients receiving treatment at Hospital for Special Surgery\n\nExclusion Criteria:\n\n* Non-English Speaking\n* primary occupation is in healthcare\n* participants with prior knowledge on the condition pertaining to the material (osteogenesis imperfecta)",true,{"count":99,"type":21},80,[24],"Poor health literacy and patient comprehension have been associated with adverse health outcomes. Patient educational materials (PEMs) are articles that are intended to assist patients in their understanding of a given medical condition. Given that the average American adult reads at the 8th grade level, the American Medical Association and the Center for Disease Control recommend PEM be written at the 6th grade level. However, literature has found the majority of PEMs to be written significantly higher than the 8th grade level. In order to improve their readability, a number of studies have displayed the effectiveness of large language models (LLMs) such as ChatGPT to simplify the text of a given PEM. Despite the improvement in readability, the effectiveness of these simplified PEMs on improving patient comprehension of the AI augmented material has yet to be investigated.\n\nThe purpose of our study is to test whether the improvement in readability found in AI-simplified PEMs corresponds to a greater understanding of the material compared to the original PEM. Understanding if AI-simplified PEM truly improves comprehension could further support this use case for AI and aid providers and healthcare organizations in improving the health literacy of their patients.\n\nThis study aims to answer the following question:\n\nDo AI simplified PEMs improve the comprehension of pediatric orthopaedic conditions?\n\nResearchers will compare AI-simplified PEMs to their original, unmodified counterparts in order to see if there is any difference in post reading comprehension of the participants.\n\nParticipation in the study will include:\n\n* A brief baseline survey (e.g. demographics and educational attainment)\n* A randomly assigned reading of either the original PEM or the AI simplified version.\n* A 10 question post-reading multiple choice quiz",[103,104,29,105],"Artificial Intelligence (AI)","Health Literacy","Patient Educational Material",[107,104,29,105],"Artificial Intelligence","2026-04-02",{"date":110,"type":50},"2026-04-03",{"date":112,"type":50},"2026-02-13",{"date":114,"type":21},"2027-05",{"name":116,"class":57},"Hospital for Special Surgery, New York"]