[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06595914":3,"trial-entities:NCT06595914":110,"trial-summary:NCT06595914":114},{"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":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":53,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":14,"eligibility_criteria":72,"std_ages":87,"locations":90,"central_contacts":99,"overall_officials":100,"references":101,"see_also_links":109},"NCT06595914","PRO00051478","Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury","ENROLLING_BY_INVITATION","2027-08","2025-07","2026-07-17","2024-09-11","Medical College of Wisconsin","OTHER",false,"The purpose of this study is to develop and validate ways to provide better patient education and clinical management for individuals who go to the emergency department (ED) with concussion or mild traumatic brain injury (mTBI).","The study will address three aims: (1) identify factors that help and hinder providing in-ED education to patients with mTBI prior to discharge; (2) examine the impact of tailored implementation strategies on ED providers' provision of in-ED patient education; and (3) evaluate the impact of providing patient education in the ED and through a mobile Health (mHealth) tool post-discharge on patient-level outcomes after mTBI.",[18,19],"Concussion, Mild","Traumatic Brain Injury",[21,22,23,24],"Education","Systems of care","Emergency department","Implementation science","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[28],"NA",{"count":30,"type":31},5831,"ESTIMATED",[33],{"type":13,"name":34,"description":35,"armGroupLabels":36},"Clinical implementation strategies","Clinical implementation strategies, selected based on ED clinician survey\u002Finterview findings from Aim 1 using the Implementing Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation science framework",[37],"Clinicians",[39,43,46,50],{"measure":40,"description":41,"timeFrame":42},"Change in patient-level penetration-electronic health record (EHR)","Change in the percentage of concussion\u002FmTBI-related encounters for which an mTBI patient handout was documented in the Epic After Visit Summary (Aim 2 outcome)","Pre-intervention baseline period (estimated study onset to 1 year later); post- intervention follow-up period (estimated 18 months from study onset to 1 year later)",{"measure":44,"description":45,"timeFrame":42},"Change in patient-level penetration-patient reported outcome (PRO)","Change in the percentage of concussion\u002FmTBI-related encounters for which patients reported having received mTBI patient education before ED discharge (Aim 2 outcome)",{"measure":47,"description":48,"timeFrame":49},"Self-efficacy to manage mTBI symptoms","Patient ratings on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Self-Efficacy for Managing Symptoms, a 20-point scale based on 4 Likert-type items with 5 response options each (higher scores = more confidence) (Aim 3 outcome).","Day 1 post-ED visit, Day 30 post-ED visit",{"measure":51,"description":52,"timeFrame":49},"mTBI symptom burden","Patient-rated Rivermead Post Concussion Symptoms Questionnaire total score (range 0-64; higher scores = more severe injury-related symptoms) (Aim 3 outcome).",[54,58,62,66],{"measure":55,"description":56,"timeFrame":57},"Change in percentage of trauma cases resulting in mTBI diagnosis","Change in the percentage of ED encounters for a traumatic injury resulting in a diagnosis of concussion or mTBI","Pre-intervention baseline period (estimated study onset to 1 year later); post-intervention follow-up period (estimated 18 months from study onset to 1 year later)",{"measure":59,"description":60,"timeFrame":61},"Patient-rated mTBI knowledge","Patient-rated mTBI knowledge, measured with a 24-item True\u002FFalse scale (total score range 0-24; higher scores = greater knowledge). Questions ask about common and uncommon mTBI symptoms and common misconceptions about mTBI signs and recovery.","Day 30 post-ED visit",{"measure":63,"description":64,"timeFrame":65},"Patient-rated clinical care satisfaction at Day 1","Collected on a 5-point scale with the options Very Satisfied, Somewhat Satisfied, Neither Satisfied Nor Dissatisfied, Somewhat Dissatisfied, and Very Dissatisfied. The question is \"How satisfied are you with the care you received for head injury in the Emergency Department?\"","Day 1 post-ED visit",{"measure":67,"description":68,"timeFrame":61},"Patient-rated clinical care satisfaction at Day 30","Collected on a 5-point scale with the options Very Satisfied, Somewhat Satisfied, Neither Satisfied Nor Dissatisfied, Somewhat Dissatisfied, and Very Dissatisfied. The question is \"How satisfied are you with the care you received for head injury since leaving the emergency department?\"","ALL","18 Years",null,{"inclusion":73,"exclusion":79,"raw_text":86},[74,75,76,77,74,75,78],"Seen and discharged from a Froedtert \\& MCW emergency department.","Age 18 or older.","Has a clinical diagnosis of TBI, as reflected by a relevant International Classification of Disease-10th Edition (ICD-10) code or other evidence (e.g., diagnosis and educational information in the After Visit Summary)","Speaks English or Spanish.","Has a clinical diagnosis of TBI, as reflected by a relevant ICD-10 code or other evidence (e.g., diagnosis and educational information in the After Visit Summary). Note that for evaluation of Secondary Aim #1 (% trauma patients with an mTBI diagnosis), a broader sample of emergency department patients evaluated for trauma will be evaluated).",[80,81,82,83,84,85],"In protective custody.","On psychiatric hold.","Is not own decision maker (e.g., activated healthcare power of attorney).","Indicated Do Not Contact in their research contact preferences.","Left the emergency department prematurely (e.g., against medical advice).","History of serious health condition that, in the opinion of the investigator, would interfere with engagement in or validity of the survey (e.g., active thought disorder; terminal cancer; dementia).","Inclusion Criteria:\n\nED clinicians:\n\n• Faculty attending physician, advanced practice professional (APP), resident, fellow, or nurse who practices in an eligible Froedtert \\& Medical College of Wisconsin (MCW) emergency department\n\nPatients-Survey Cohort:\n\n* Seen and discharged from a Froedtert \\& MCW emergency department.\n* Age 18 or older.\n* Has a clinical diagnosis of TBI, as reflected by a relevant International Classification of Disease-10th Edition (ICD-10) code or other evidence (e.g., diagnosis and educational information in the After Visit Summary)\n* Speaks English or Spanish.\n\nPatients-Chart Review Only:\n\n* Seen and discharged from a Froedtert \\& MCW emergency department.\n* Age 18 or older.\n* Has a clinical diagnosis of TBI, as reflected by a relevant ICD-10 code or other evidence (e.g., diagnosis and educational information in the After Visit Summary). Note that for evaluation of Secondary Aim #1 (% trauma patients with an mTBI diagnosis), a broader sample of emergency department patients evaluated for trauma will be evaluated).\n\nExclusion Criteria:\n\nED clinicians:\n\n• Providers that do not practice in a Froedtert \\& Medical College of Wisconsin emergency department.\n\nPatients-Survey Cohort.\n\n* In protective custody.\n* On psychiatric hold.\n* Is not own decision maker (e.g., activated healthcare power of attorney).\n* Indicated Do Not Contact in their research contact preferences.\n* Left the emergency department prematurely (e.g., against medical advice).\n* History of serious health condition that, in the opinion of the investigator, would interfere with engagement in or validity of the survey (e.g., active thought disorder; terminal cancer; dementia).\n\nPatients-Chart Review Only:\n\n• Minors under the age of 18.",[88,89],"ADULT","OLDER_ADULT",[91],{"facility":12,"city":92,"state":93,"zip":94,"country":95,"geoPoint":96},"Milwaukee","Wisconsin","53226","United States",{"lat":97,"lon":98},43.0389,-87.90647,[],[],[102,106],{"pmid":103,"type":104,"citation":105},"8551320","BACKGROUND","King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007\u002FBF00868811.",{"pmid":107,"type":104,"citation":108},"28851459","Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186\u002Fs13012-017-0635-3.",[],{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Concussion",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This interventional study plans to include about 5831 participants. It will look at how different strategies affect patient education and outcomes.","completed","Improving Patient Education for Mild Traumatic Brain Injury","This study aims to improve how patients with concussion or mild traumatic brain injury (mTBI) receive education both in the emergency department (ED) and after they go home. Researchers will use \"Clinical implementation strategies\" to help ED staff provide better education. They will also look at how a mobile health (mHealth) tool can help patients after they leave the hospital. The study wants to see if these efforts lead to better patient understanding and ability to manage their symptoms. You might be able to join if you are 18 or older and are seen and discharged from a Froedtert & Medical College of Wisconsin emergency department. The study is currently unclear on its recruitment status and plans to enroll about 5831 people.","Patient outcomes, such as self-efficacy to manage mTBI symptoms, will be measured on Day 1 and Day 30 after an emergency department visit.",122,"If you are a patient, you would be part of a survey cohort after being seen and discharged from an emergency department. Your self-efficacy (confidence in managing symptoms) will be measured on Day 1 and Day 30 after your ED visit.","Not stated in the trial record.",[34],"v2"]