Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
NCT ID: NCT02702869
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1000 participants
OBSERVATIONAL
2016-10-31
2031-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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uCL(A)
Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).
cleft lip repair
gingivoperiosteoplasty
LeFort-1 maxillary repositioning
rhinoplasty
speech therapy
orthodontia
presurgical orthopedics
uCL(A)P
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).
cleft lip repair
cleft palate repair
oronasal fistula repair
pharyngoplasty
gingivoperiosteoplasty
LeFort-1 maxillary repositioning
rhinoplasty
myringotomy and tympanostomy tube placement
speech therapy
orthodontia
presurgical orthopedics
sound amplification for hearing
bCL(A)
Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).
cleft lip repair
gingivoperiosteoplasty
LeFort-1 maxillary repositioning
rhinoplasty
speech therapy
orthodontia
presurgical orthopedics
bCL(A)P
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).
cleft lip repair
cleft palate repair
oronasal fistula repair
pharyngoplasty
gingivoperiosteoplasty
LeFort-1 maxillary repositioning
rhinoplasty
myringotomy and tympanostomy tube placement
speech therapy
orthodontia
presurgical orthopedics
sound amplification for hearing
CP
Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II).
cleft palate repair
oronasal fistula repair
pharyngoplasty
LeFort-1 maxillary repositioning
myringotomy and tympanostomy tube placement
speech therapy
sound amplification for hearing
Interventions
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cleft lip repair
cleft palate repair
oronasal fistula repair
pharyngoplasty
gingivoperiosteoplasty
LeFort-1 maxillary repositioning
rhinoplasty
myringotomy and tympanostomy tube placement
speech therapy
orthodontia
presurgical orthopedics
sound amplification for hearing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
1 Day
22 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Alexander C Allori, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of Florida - Shands Hospital
Gainesville, Florida, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Orlando Health - Arnold Palmer Hospital for Children
Orlando, Florida, United States
Johns Hopkins - All Children's Hospital (JHACH)
St. Petersburg, Florida, United States
Maine Medical Center
Portland, Maine, United States
Harvard University - Boston Children's Hospital (BCH)
Boston, Massachusetts, United States
Washington University - St. Louis Children's Hospital (WUSTL)
St Louis, Missouri, United States
Duke University - Duke Children's Hospital & Health Center
Durham, North Carolina, 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
Dalhousie University - IWK Health Centre
Halifax, Nova Scotia, Canada
Countries
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Related Links
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Duke Cleft \& Craniofacial Center
Official web site for ICHOM Standard Set for cleft lip and/or palate, upon which the Duke project is based
ACCQUIREnet web site
Other Identifiers
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Pro00104806
Identifier Type: -
Identifier Source: org_study_id
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