Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
- Conditions
- Cleft PalateCleft Lip and PalateCleft Lip
- Interventions
- Procedure: cleft lip repairProcedure: gingivoperiosteoplastyProcedure: cleft palate repairProcedure: LeFort-1 maxillary repositioningProcedure: oronasal fistula repairProcedure: pharyngoplastyProcedure: rhinoplastyOther: speech therapyProcedure: myringotomy and tympanostomy tube placementProcedure: presurgical orthopedicsProcedure: orthodontiaDevice: sound amplification for hearing
- Registration Number
- NCT02702869
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
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:
1. 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
2. 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
- 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
- Atypical (Tessier) facial clefts
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description uCL(A) presurgical orthopedics Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A)P pharyngoplasty Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). uCL(A)P orthodontia Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). bCL(A) rhinoplasty Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A) cleft lip repair Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A) LeFort-1 maxillary repositioning Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A) rhinoplasty Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A)P oronasal fistula repair Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). uCL(A) speech therapy Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A) gingivoperiosteoplasty Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A) orthodontia Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A)P cleft lip repair Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). uCL(A)P LeFort-1 maxillary repositioning Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). bCL(A) cleft lip repair Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). bCL(A) speech therapy Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). uCL(A)P cleft palate repair Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). bCL(A) LeFort-1 maxillary repositioning Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). bCL(A) presurgical orthopedics Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). bCL(A)P cleft lip repair Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). bCL(A)P gingivoperiosteoplasty Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). bCL(A)P orthodontia Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). bCL(A)P presurgical orthopedics Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). bCL(A)P sound amplification for hearing Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). CP cleft palate repair Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). CP LeFort-1 maxillary repositioning Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). CP myringotomy and tympanostomy tube placement Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). uCL(A)P gingivoperiosteoplasty Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). uCL(A)P rhinoplasty Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). bCL(A)P cleft palate repair Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). bCL(A)P LeFort-1 maxillary repositioning Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). bCL(A)P myringotomy and tympanostomy tube placement Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). CP speech therapy Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). uCL(A)P myringotomy and tympanostomy tube placement Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). uCL(A)P speech therapy Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). uCL(A)P presurgical orthopedics Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). bCL(A) gingivoperiosteoplasty Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). bCL(A) orthodontia Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). bCL(A)P rhinoplasty Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). CP pharyngoplasty Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). CP sound amplification for hearing Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). uCL(A)P sound amplification for hearing Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). CP oronasal fistula repair Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). bCL(A)P oronasal fistula repair Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). bCL(A)P pharyngoplasty Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). bCL(A)P speech therapy Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV).
- Primary Outcome Measures
Name Time Method Breathing: Patient-reported outcomes related to nasal and oral breathing ~22 years of age Uses the NOSE PROM
Aesthetics: Patient-reported outcomes related to appearance ~22 years of age Uses the CLEFT-Q PROM
Speech: intelligibility ~22 years of age Utilizes the intelligibility in context scale (ICS)
Speech: velopharyngeal competence ~22 years of age Aesthetics: Clinical assessment of nasolabial and facial aesthetics ~22 years of age Speech: articulation ~22 years of age Utilizes the modified percent correct consonants (mPCC) scale
Speech: patient-reported outcomes related to speech and speaking ~22 years of age Utilizes the CLEFT-Q PROM
Hearing: puretone average ~5 years of age Dental: occlusion (Uses modifications of the GOSLON scale) ~22 years of age Dental: patient-reported outcomes related to mastication ~22 years of age Uses the CLEFT-Q PROM
Dental: dmft and DMFT scores ~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) ~22 years of age Dental: patient-reported outcomes related to oral health ~22 years of age Uses the COHIP PROM
Patient-reported outcomes related to eating/drinking ~22 years of age Uses the CLEFT-Q PROM
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Johns Hopkins - All Children's Hospital (JHACH)
🇺🇸Saint Petersburg, Florida, United States
Washington University - St. Louis Children's Hospital (WUSTL)
🇺🇸Saint Louis, Missouri, United States
Duke University - Duke Children's Hospital & Health Center
🇺🇸Durham, North Carolina, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Wake Forest University - Brenner Children's Hospital
🇺🇸Winston-Salem, North Carolina, United States
University of Texas at Houston - Children's Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Harvard University - Boston Children's Hospital (BCH)
🇺🇸Boston, Massachusetts, United States
Orlando Health - Arnold Palmer Hospital for Children
🇺🇸Orlando, Florida, United States
Dalhousie University - IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
University of Florida - Shands Hospital
🇺🇸Gainesville, Florida, United States