[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07264062":3,"trial-entities:NCT07264062":109,"trial-summary:NCT07264062":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":15,"eligibility_criteria":75,"std_ages":82,"locations":85,"central_contacts":95,"overall_officials":96,"references":100,"see_also_links":108},"NCT07264062","1850120-11","MetSense Pilot and Feasibility","Optimizing Care to Prevent Diabetes and Promote Cardiovascular Health Among Younger Adults With Severe Mental Illness","ENROLLING_BY_INVITATION","2026-12-31","2026-02","2026-02-27","2025-12-01","Kaiser Permanente","OTHER",false,"People with serious mental illness have high risk for type 2 diabetes due to multiple risk factors, including the metabolic side effects of psychotropic medications that are used to treat these conditions. Type 2 diabetes is preventable through lifestyle and pharmacological interventions, but many people with serious mental illness do not receive regular screening for type 2 diabetes risk. In many health care settings, clinical pharmacists are increasingly managing patients with serious mental illness and have expertise in monitoring the metabolic side effects of psychotropic medications. This study evaluates the feasibility and acceptability of using a diabetes prediction model that is based on electronic health record data (the MetSense risk flag) to alert clinical pharmacists about patients who are at high diabetes risk, prompting these clinicians to prioritize diabetes risk management services.","MetSense is a clinical decision support tool that is being developed to help clinicians prioritize diabetes risk management services for patients with serious mental illness who have high diabetes risk. This study seeks to evaluate the feasibility, acceptability, and preliminary effectiveness of using the MetSense risk flag to prompt further evaluation of metabolic risk factors and to prioritize other diabetes risk management services, including diabetes risk screening, care coordination with patients' primary care physicians, and pharmacological management of diabetes risk. In this pragmatic, cluster-randomized trial, patients with serious mental illness will be allocated to 1 of 2 trial arms based on which clinical pharmacist manages their care. The clinical pharmacists will be randomized to view the MetSense risk flag (intervention arm) or to not view the MetSense risk flag (control arm, i.e., usual care). The primary outcome is completion of hemoglobin A1c laboratory testing. The study will also examine differences in clinician evaluation of metabolic risk factors, body mass index measurement, prediabetes diagnosis, diabetes diagnosis, primary care visits, metformin medication dispensing, hemoglobin A1c result, body mass index result, and clinician-reported acceptability and feasibility.",[19,20],"Serious Mental Illness","Type 2 Diabetes",[22,23,24,25,26],"serious mental illness","type 2 diabetes","diabetes prevention","prediction model","clinical decision support","INTERVENTIONAL","PREVENTION",[30],"NA",{"count":32,"type":33},20000,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","MetSense Risk Flag","The MetSense risk flag alerts the clinician if the patient has high diabetes risk and prompts additional diabetes risk management.",[40],"MetSense",{"type":14,"name":42,"description":43,"armGroupLabels":44},"Usual Care","Participants will receive usual care.",[42],[46],{"measure":47,"description":48,"timeFrame":49},"Percent with completed hemoglobin A1c test within 6 months.","Laboratory test completion","6 months",[51,54,57,60,63,66,69],{"measure":52,"description":53,"timeFrame":49},"Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months.","Electronic health record documentation via smartphrase",{"measure":55,"description":56,"timeFrame":49},"Percent with body mass index measurement within 6 months.","Body mass index recorded in the electronic health record",{"measure":58,"description":59,"timeFrame":49},"Percent with prediabetes diagnosis within 6 months.","Diagnosis documented in the electronic health record",{"measure":61,"description":62,"timeFrame":49},"Percent who attended a primary care visit within 6 months.","Visit documented in the electronic health record",{"measure":64,"description":65,"timeFrame":49},"Percent with metformin medication dispensed within 6 months.","Dispensing based on pharmacy records",{"measure":67,"description":68,"timeFrame":49},"Average hemoglobin A1c value based on the final measurement in 6 months.","Laboratory value",{"measure":70,"description":71,"timeFrame":49},"Average body mass index based on the final measurement in 6 months.","Value recorded in the electronic health record","ALL","18 Years",null,{"inclusion":76,"exclusion":80,"raw_text":81},[77,78,79],"Age 18 or older","Diagnosed with schizophrenia, another psychotic disorder, or bipolar disorder","Included in a clinical pharmacist population management program for serious mental illness within Kaiser Permanente Northern California",[],"Inclusion Criteria:\n\n* Age 18 or older\n* Diagnosed with schizophrenia, another psychotic disorder, or bipolar disorder\n* Included in a clinical pharmacist population management program for serious mental illness within Kaiser Permanente Northern California",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"city":88,"state":89,"zip":90,"country":91,"geoPoint":92},"KPNC Division of Research","Pleasanton","California","94588","United States",{"lat":93,"lon":94},37.66243,-121.87468,[],[97],{"name":98,"affiliation":87,"role":99},"Esti Iturralde, PhD","PRINCIPAL_INVESTIGATOR",[101,105],{"pmid":102,"type":103,"citation":104},"36569369","BACKGROUND","Iturralde E, Fazzolari L, Shia M, Slama N, Leang J, Awsare S, Nguyen LT. Closing the Care Gap for People with Severe and Persistent Mental Illness: Collaborative Care, Telehealth, and Clinical Pharmacy. NEJM Catal Innov Care Deliv. 2022 May;3(5):10.1056\u002FCAT.21.0417. doi: 10.1056\u002FCAT.21.0417.",{"pmid":106,"type":103,"citation":107},"38301189","Iturralde E, Fazzolari L, Slama NE, Alexeeff SE, Sterling SA, Awsare S, Koshy MT, Shia M. Telehealth Collaborative Care Led by Clinical Pharmacists for People With Psychosis or Bipolar Disorder: A Propensity Weighted Comparison With Usual Psychiatric Care. J Clin Psychiatry. 2024 Jan 29;85(1):23m14917. doi: 10.4088\u002FJCP.23m14917.",[],{"nct_id":4,"conditions":110,"biomarkers":116},[111,112,113,114,115],"Bipolar Disorder","Psychosis","Schizophrenia","Serious mental illness","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":74,"prompt_version":74}]