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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 18
- 主要终点
- Breathing: Patient-reported outcomes related to nasal and oral breathing
研究概览
简要总结
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/or palate (CL/P), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.
详细描述
The purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and/or palate (CL/P) treated by the cleft and craniofacial centers that participate in ACCQUIREnet.
Adoption of this prospective data-collection system has two principal goals:
- 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
- To permit participation in multi-site, collaborative quality-improvement projects and/or 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.)
All patients with CL/P 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.
The 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Atypical (Tessier) facial clefts
结局指标
主要结局
Breathing: Patient-reported outcomes related to nasal and oral breathing
时间窗: ~22 years of age
Uses the NOSE PROM
Aesthetics: Patient-reported outcomes related to appearance
时间窗: ~22 years of age
Uses the CLEFT-Q PROM
Speech: intelligibility
时间窗: ~22 years of age
Utilizes the intelligibility in context scale (ICS)
Speech: velopharyngeal competence
时间窗: ~22 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
时间窗: ~22 years of age
Speech: articulation
时间窗: ~22 years of age
Utilizes the modified percent correct consonants (mPCC) scale
Speech: patient-reported outcomes related to speech and speaking
时间窗: ~22 years of age
Utilizes the CLEFT-Q PROM
Hearing: puretone average
时间窗: ~5 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
时间窗: ~22 years of age
Dental: patient-reported outcomes related to mastication
时间窗: ~22 years of age
Uses the CLEFT-Q PROM
Dental: dmft and DMFT scores
时间窗: ~22 years of age
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Dental: occlusion (Uses modifications of the Bauru scale)
时间窗: ~22 years of age
Dental: patient-reported outcomes related to oral health
时间窗: ~22 years of age
Uses the COHIP PROM
Patient-reported outcomes related to eating/drinking
时间窗: ~22 years of age
Uses the CLEFT-Q PROM
Speech: intelligibility
时间窗: ~5 years of age
Utilizes the intelligibility in context scale (ICS)
Speech: intelligibility
时间窗: ~8 years of age
Utilizes the intelligibility in context scale (ICS)
Speech: intelligibility
时间窗: ~12 years of age
Utilizes the intelligibility in context scale (ICS)
Speech: velopharyngeal competence
时间窗: ~5 years of age
Speech: velopharyngeal competence
时间窗: ~8 years of age
Speech: velopharyngeal competence
时间窗: ~12 years of age
Speech: articulation
时间窗: ~5 years of age
Utilizes the modified percent correct consonants (mPCC) scale
Speech: articulation
时间窗: ~8 years of age
Utilizes the modified percent correct consonants (mPCC) scale
Speech: articulation
时间窗: ~12 years of age
Utilizes the modified percent correct consonants (mPCC) scale
Speech: patient-reported outcomes related to speech and speaking
时间窗: ~8 years of age
Utilizes the CLEFT-Q PROM
Speech: patient-reported outcomes related to speech and speaking
时间窗: ~12 years of age
Utilizes the CLEFT-Q PROM
Dental: dmft and DMFT scores
时间窗: ~5 years of age
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Dental: dmft and DMFT scores
时间窗: ~12 years of age
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Dental: occlusion (Uses modifications of the GOSLON scale)
时间窗: ~5 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
时间窗: ~5 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
时间窗: ~12 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
时间窗: ~12 years of age
Dental: patient-reported outcomes related to mastication
时间窗: ~8 years of age
Uses the CLEFT-Q PROM
Dental: patient-reported outcomes related to mastication
时间窗: ~12 years of age
Uses the CLEFT-Q PROM
Dental: patient-reported outcomes related to oral health
时间窗: ~8 years of age
Uses the COHIP PROM
Dental: patient-reported outcomes related to oral health
时间窗: ~12 years of age
Uses the COHIP PROM
Patient-reported outcomes related to eating/drinking
时间窗: ~8 years of age
Uses the CLEFT-Q PROM
Patient-reported outcomes related to eating/drinking
时间窗: ~12 years of age
Uses the CLEFT-Q PROM
Breathing: Patient-reported outcomes related to nasal and oral breathing
时间窗: ~8 years of age
Uses the NOSE PROM
Breathing: Patient-reported outcomes related to nasal and oral breathing
时间窗: ~12 years of age
Uses the NOSE PROM
Aesthetics: Patient-reported outcomes related to appearance
时间窗: ~8 years of age
Uses the CLEFT-Q PROM
Aesthetics: Patient-reported outcomes related to appearance
时间窗: ~12 years of age
Uses the CLEFT-Q PROM
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
时间窗: ~2 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
时间窗: ~5 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
时间窗: ~8 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
时间窗: ~12 years of age
次要结局
未报告次要终点