[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05373771":3,"trial-entities:NCT05373771":88,"trial-summary:NCT05373771":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":38,"sex":46,"minimum_age":16,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":60,"locations":63,"central_contacts":77,"overall_officials":82,"references":86,"see_also_links":87},"NCT05373771","00114249","Sickle Cell Improvement: Enhancing Care in the Emergency Department","RECRUITING","2027-08-31","2023-08","2023-08-14","2021-09-01","Medical College of Wisconsin","OTHER",true,"Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black. The disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality of life. The National Heart, Lung and Blood Institute, as well as the American Society of Hematology, have endorsed pain management guidelines regarding the timeliness of care for children presenting with these acute pain crises. These evidence-based guidelines are infrequently followed, resulting in increased pain and hospitalizations. In additional to other barriers to following the guideline, structural racism has been proposed as a significant contributor and the New England Journal of Medicine recently called for the institution of SCD-specific pain management protocols to combat structural racism and reduce time to opioid administration. The investigators' long-term goal is to improve the care and health outcomes of children with acute painful vaso-occlusive crisis treated in the emergency department. The overall aim of the investigators is to test a care pathway using multifaceted implementation strategies to increase guideline adherent care for children in the emergency department with acute painful vaso-occlusive crisis.",null,[18],"Sickle Cell Crisis",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},5328,"ESTIMATED",[28],{"type":13,"name":29,"description":30,"armGroupLabels":31},"Care pathway","Implementation of care pathway as part of hybrid type 2 implementation effectiveness study",[32],"Post-intervention",[34],{"measure":35,"description":36,"timeFrame":37},"Timeliness of receipt of opioids","The percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose","A maximum of about 6 hours as all opioids received during the ED stay will be captured",[39,42],{"measure":40,"description":41,"timeFrame":37},"Median time to opioids","Median time from arrival to first opioid and then subsequent opioids",{"measure":43,"description":44,"timeFrame":45},"Percent of children hospitalized","Disposition of hospitalization or discharge home","A maximum of about 6 hours as that is the typical maximum time to disposition for patients","ALL","18 Years",false,{"inclusion":50,"exclusion":54,"raw_text":59},[51,52,53],"ED visit for uncomplicated pain crisis","Sickle cell disease","Receipt of at least one opioid",[55,56,57,58],"Acute chest syndrome","Fever \\> 38.5 in the ED","priapism","sickle cell trait","Inclusion Criteria:\n\n* ED visit for uncomplicated pain crisis\n* Sickle cell disease\n* Receipt of at least one opioid\n\nExclusion Criteria:\n\n* Acute chest syndrome\n* Fever \\> 38.5 in the ED\n* priapism\n* sickle cell trait",[61,62],"CHILD","ADULT",[64],{"facility":65,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":74},"Children's Wisconsin","Milwaukee","Wisconsin","53226","United States",[71],{"name":72,"role":73},"David Brousseau","CONTACT",{"lat":75,"lon":76},43.0389,-87.90647,[78],{"name":79,"role":73,"phone":80,"email":81},"David Brousseau, MD, MS","(302) 651-4000","david.brousseau@nemours.org",[83],{"name":79,"affiliation":84,"role":85},"Nemours Children's Health","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Sickle Cell Disease",[],{"nct_id":4,"found":14,"summary":93,"prompt_version":102},{"design":94,"status":95,"heading":6,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an interventional study that plans to enroll 5328 participants. It is testing a care pathway as part of a hybrid type 2 implementation effectiveness study.","completed","This study is looking at ways to improve care for children with sickle cell disease (SCD) when they visit the emergency department (ED) for a pain crisis. It's testing a \"care pathway,\" which is a set of guidelines for how medical staff should manage these situations. The goal is to see if using this care pathway helps children receive pain medication (opioids) more quickly. You might be able to join if you are 18 years old or younger, have sickle cell disease, are visiting the ED for an uncomplicated pain crisis, and have received at least one opioid. You cannot join if you have acute chest syndrome, a fever over 38.5 degrees Celsius in the ED, priapism, or sickle cell trait. The study aims to enroll 5328 participants, but its current status is unclear.","The primary endpoint measures the timeliness of receiving opioids, capturing all opioids received during the ED stay, up to a maximum of about 6 hours.",134,"Not specified in the trial record.","Not stated in the trial record.",[29],"v2"]