[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02702869":3,"trial-entities:NCT02702869":289,"trial-summary:NCT02702869":297},{"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":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":94,"secondary_outcomes":166,"sex":167,"minimum_age":168,"maximum_age":169,"healthy_volunteers":170,"eligibility_criteria":171,"std_ages":183,"locations":186,"central_contacts":273,"overall_officials":274,"references":278,"see_also_links":279},"NCT02702869","Pro00104806","Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)","Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet): Prospective Data-collection System and Learning Health-care Network for the Comprehensive Appraisal of Cleft and Craniofacial Care","ENROLLING_BY_INVITATION","2031-12","2026-01","2026-01-07","2016-10","Duke University","OTHER",true,"The Allied Cleft \\& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes instruments. Participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and\u002For palate (CL\u002FP), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.","The purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and\u002For palate (CL\u002FP) treated by the cleft and craniofacial centers that participate in ACCQUIREnet.\n\nAdoption of this prospective data-collection system has two principal goals:\n\n1. To enable on-demand and scheduled review of cleft-care-related safety and outcomes data and team performance for the purpose of internal audits and continuous quality improvement; and\n2. To permit participation in multi-site, collaborative quality-improvement projects and\u002For research networks that require usage of these standardized data-collection methods. (These collaborations are described in corresponding IRB protocols and data-transfer agreements. Patient privacy and confidentiality is protected at all times.)\n\nAll patients with CL\u002FP treated at cleft and craniofacial centers participating in ACCQUIREnet will be invited to participate in this project. Duke University serves as the coordinating center and statistical support center for the study. Data are maintained in a local, secured database.\n\nThe IRB protocol details methods of quality assurance, data monitoring, and auditing. Data dictionaries employed in ACCQUIREnet include the CleftCap REDCap project template, CleftKit Common Data Model (an extension of the PCORnet Common Data Model), the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.",[19,20,21],"Cleft Lip","Cleft Palate","Cleft Lip and Palate",[23,24,25,26,27,28],"cleft lip","cleft palate","cleft lip and palate","cleft alveolus","multidisciplinary team","interdisciplinary team","OBSERVATIONAL",null,[],{"count":33,"type":34},1000,"ESTIMATED",[36,46,52,55,60,63,68,71,74,77,80,88],{"type":37,"name":38,"armGroupLabels":39,"otherNames":44},"PROCEDURE","cleft lip repair",[40,41,42,43],"bCL(A)","bCL(A)P","uCL(A)","uCL(A)P",[45],"cheiloplasty",{"type":37,"name":47,"armGroupLabels":48,"otherNames":50},"cleft palate repair",[49,41,43],"CP",[51],"palatoplasty",{"type":37,"name":53,"armGroupLabels":54},"oronasal fistula repair",[49,41,43],{"type":37,"name":56,"armGroupLabels":57,"otherNames":58},"pharyngoplasty",[49,41,43],[59],"sphincteroplasty",{"type":37,"name":61,"armGroupLabels":62},"gingivoperiosteoplasty",[40,41,42,43],{"type":37,"name":64,"armGroupLabels":65,"otherNames":66},"LeFort-1 maxillary repositioning",[49,40,41,42,43],[67],"orthognathic surgery",{"type":37,"name":69,"armGroupLabels":70},"rhinoplasty",[40,41,42,43],{"type":37,"name":72,"armGroupLabels":73},"myringotomy and tympanostomy tube placement",[49,41,43],{"type":14,"name":75,"armGroupLabels":76},"speech therapy",[49,40,41,42,43],{"type":37,"name":78,"armGroupLabels":79},"orthodontia",[40,41,42,43],{"type":37,"name":81,"armGroupLabels":82,"otherNames":83},"presurgical orthopedics",[40,41,42,43],[84,85,86,87],"nasoalveolar molding","dentofacial orthopedics","Georgiade-Latham appliance","Latham appliance",{"type":89,"name":90,"armGroupLabels":91,"otherNames":92},"DEVICE","sound amplification for hearing",[49,41,43],[93],"hearing aid",[95,99,101,103,105,107,108,109,110,113,114,115,116,119,120,121,123,126,127,128,130,132,133,134,135,136,139,140,141,144,145,146,148,149,150,153,154,155,157,158,159,162,163,164,165],{"measure":96,"description":97,"timeFrame":98},"Speech: intelligibility","Utilizes the intelligibility in context scale (ICS)","~5 years of age",{"measure":96,"description":97,"timeFrame":100},"~8 years of age",{"measure":96,"description":97,"timeFrame":102},"~12 years of age",{"measure":96,"description":97,"timeFrame":104},"~22 years of age",{"measure":106,"timeFrame":98},"Speech: velopharyngeal competence",{"measure":106,"timeFrame":100},{"measure":106,"timeFrame":102},{"measure":106,"timeFrame":104},{"measure":111,"description":112,"timeFrame":98},"Speech: articulation","Utilizes the modified percent correct consonants (mPCC) scale",{"measure":111,"description":112,"timeFrame":100},{"measure":111,"description":112,"timeFrame":102},{"measure":111,"description":112,"timeFrame":104},{"measure":117,"description":118,"timeFrame":100},"Speech: patient-reported outcomes related to speech and speaking","Utilizes the CLEFT-Q PROM",{"measure":117,"description":118,"timeFrame":102},{"measure":117,"description":118,"timeFrame":104},{"measure":122,"timeFrame":98},"Hearing: puretone average",{"measure":124,"description":125,"timeFrame":98},"Dental: dmft and DMFT scores","Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth",{"measure":124,"description":125,"timeFrame":102},{"measure":124,"description":125,"timeFrame":104},{"measure":129,"timeFrame":98},"Dental: occlusion (Uses modifications of the GOSLON scale)",{"measure":131,"timeFrame":98},"Dental: occlusion (Uses modifications of the Bauru scale)",{"measure":129,"timeFrame":102},{"measure":131,"timeFrame":102},{"measure":129,"timeFrame":104},{"measure":131,"timeFrame":104},{"measure":137,"description":138,"timeFrame":100},"Dental: patient-reported outcomes related to mastication","Uses the CLEFT-Q PROM",{"measure":137,"description":138,"timeFrame":102},{"measure":137,"description":138,"timeFrame":104},{"measure":142,"description":143,"timeFrame":100},"Dental: patient-reported outcomes related to oral health","Uses the COHIP PROM",{"measure":142,"description":143,"timeFrame":102},{"measure":142,"description":143,"timeFrame":104},{"measure":147,"description":138,"timeFrame":100},"Patient-reported outcomes related to eating\u002Fdrinking",{"measure":147,"description":138,"timeFrame":102},{"measure":147,"description":138,"timeFrame":104},{"measure":151,"description":152,"timeFrame":100},"Breathing: Patient-reported outcomes related to nasal and oral breathing","Uses the NOSE PROM",{"measure":151,"description":152,"timeFrame":102},{"measure":151,"description":152,"timeFrame":104},{"measure":156,"description":138,"timeFrame":100},"Aesthetics: Patient-reported outcomes related to appearance",{"measure":156,"description":138,"timeFrame":102},{"measure":156,"description":138,"timeFrame":104},{"measure":160,"timeFrame":161},"Aesthetics: Clinical assessment of nasolabial and facial aesthetics","~2 years of age",{"measure":160,"timeFrame":98},{"measure":160,"timeFrame":100},{"measure":160,"timeFrame":102},{"measure":160,"timeFrame":104},[],"ALL","1 Day","22 Years",false,{"inclusion":172,"exclusion":180,"raw_text":182},[173,174,175,176,177,178,179],"Typical orofacial clefts, of which subtypes are:","Unilateral or bilateral cleft lip","Unilateral or bilateral cleft lip and alveolus","Unilateral or bilateral cleft lip and alveolus and palate","Unilateral or bilateral cleft lip and palate","Overt cleft palate","Occult cleft palate",[181],"Atypical (Tessier) facial clefts","Inclusion Criteria:\n\n* Typical orofacial clefts, of which subtypes are:\n* Unilateral or bilateral cleft lip\n* Unilateral or bilateral cleft lip and alveolus\n* Unilateral or bilateral cleft lip and alveolus and palate\n* Unilateral or bilateral cleft lip and palate\n* Overt cleft palate\n* Occult cleft palate\n\nExclusion Criteria:\n\n* Atypical (Tessier) facial clefts",[184,185],"CHILD","ADULT",[187,196,203,210,217,225,233,241,249,256,264],{"facility":188,"city":189,"state":190,"zip":191,"country":192,"geoPoint":193},"University of Florida - Shands Hospital","Gainesville","Florida","32608","United States",{"lat":194,"lon":195},29.65163,-82.32483,{"facility":197,"city":198,"state":190,"zip":199,"country":192,"geoPoint":200},"Joe DiMaggio Children's Hospital","Hollywood","33021",{"lat":201,"lon":202},26.0112,-80.14949,{"facility":204,"city":205,"state":190,"zip":206,"country":192,"geoPoint":207},"Orlando Health - Arnold Palmer Hospital for Children","Orlando","32806",{"lat":208,"lon":209},28.53834,-81.37924,{"facility":211,"city":212,"state":190,"zip":213,"country":192,"geoPoint":214},"Johns Hopkins - All Children's Hospital (JHACH)","St. Petersburg","33701",{"lat":215,"lon":216},27.77086,-82.67927,{"facility":218,"city":219,"state":220,"zip":221,"country":192,"geoPoint":222},"Maine Medical Center","Portland","Maine","04102",{"lat":223,"lon":224},43.65737,-70.2589,{"facility":226,"city":227,"state":228,"zip":229,"country":192,"geoPoint":230},"Harvard University - Boston Children's Hospital (BCH)","Boston","Massachusetts","02115",{"lat":231,"lon":232},42.35843,-71.05977,{"facility":234,"city":235,"state":236,"zip":237,"country":192,"geoPoint":238},"Washington University - St. Louis Children's Hospital (WUSTL)","St Louis","Missouri","63110",{"lat":239,"lon":240},38.62727,-90.19789,{"facility":242,"city":243,"state":244,"zip":245,"country":192,"geoPoint":246},"Duke University - Duke Children's Hospital & Health Center","Durham","North Carolina","27710",{"lat":247,"lon":248},35.99403,-78.89862,{"facility":250,"city":251,"state":244,"zip":252,"country":192,"geoPoint":253},"Wake Forest University - Brenner Children's Hospital","Winston-Salem","27157",{"lat":254,"lon":255},36.09986,-80.24422,{"facility":257,"city":258,"state":259,"zip":260,"country":192,"geoPoint":261},"University of Texas at Houston - Children's Memorial Hermann Hospital","Houston","Texas","77030",{"lat":262,"lon":263},29.76328,-95.36327,{"facility":265,"city":266,"state":267,"zip":268,"country":269,"geoPoint":270},"Dalhousie University - IWK Health Centre","Halifax","Nova Scotia","B3K 6R8","Canada",{"lat":271,"lon":272},44.64269,-63.57688,[],[275],{"name":276,"affiliation":13,"role":277},"Alexander C Allori, MD, MPH","PRINCIPAL_INVESTIGATOR",[],[280,283,286],{"label":281,"url":282},"Duke Cleft \\& Craniofacial Center","https:\u002F\u002Fwww.dukehealth.org\u002Fpediatric-treatments\u002Fpediatric-plastic-and-reconstructive-surgery\u002Fcleft-lip-and-cleft-palate",{"label":284,"url":285},"Official web site for ICHOM Standard Set for cleft lip and\u002For palate, upon which the Duke project is based","http:\u002F\u002Fwww.ichom.org\u002Fmedical-conditions\u002Fcleft-lip-palate\u002F",{"label":287,"url":288},"ACCQUIREnet web site","http:\u002F\u002Faccquire.net",{"nct_id":4,"conditions":290,"biomarkers":296},[19,291,292,293,294,295],"Cleft Lip, Alveolus, and Palate","Cleft Lip and Alveolus","Cleft palate with cleft lip","Occult Cleft Palate","Overt Cleft Palate",[],{"nct_id":4,"found":170,"summary":30,"prompt_version":30}]