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Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) (ACCQUIREnet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02702869
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2016
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date October 16, 2015
First Posted Date March 9, 2016
Last Update Posted Date October 20, 2020
Actual Study Start Date October 2016
Estimated Primary Completion Date December 2031   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2016)
  • Speech: intelligibility [ Time Frame: ~5 years of age ]
    Utilizes the intelligibility in context scale (ICS)
  • Speech: intelligibility [ Time Frame: ~8 years of age ]
    Utilizes the intelligibility in context scale (ICS)
  • Speech: intelligibility [ Time Frame: ~12 years of age ]
    Utilizes the intelligibility in context scale (ICS)
  • Speech: intelligibility [ Time Frame: ~22 years of age ]
    Utilizes the intelligibility in context scale (ICS)
  • Speech: velopharyngeal competence [ Time Frame: ~5 years of age ]
  • Speech: velopharyngeal competence [ Time Frame: ~8 years of age ]
  • Speech: velopharyngeal competence [ Time Frame: ~12 years of age ]
  • Speech: velopharyngeal competence [ Time Frame: ~22 years of age ]
  • Speech: articulation [ Time Frame: ~5 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale
  • Speech: articulation [ Time Frame: ~8 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale
  • Speech: articulation [ Time Frame: ~12 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale
  • Speech: articulation [ Time Frame: ~22 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale
  • Speech: patient-reported outcomes related to speech and speaking [ Time Frame: ~8 years of age ]
    Utilizes the CLEFT-Q PROM
  • Speech: patient-reported outcomes related to speech and speaking [ Time Frame: ~12 years of age ]
    Utilizes the CLEFT-Q PROM
  • Speech: patient-reported outcomes related to speech and speaking [ Time Frame: ~22 years of age ]
    Utilizes the CLEFT-Q PROM
  • Hearing: puretone average [ Time Frame: ~5 years of age ]
  • Dental: dmft and DMFT scores [ Time Frame: ~5 years of age ]
    Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
  • Dental: dmft and DMFT scores [ Time Frame: ~12 years of age ]
    Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
  • Dental: dmft and DMFT scores [ Time Frame: ~22 years of age ]
    Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
  • Dental: occlusion (Uses modifications of the GOSLON scale) [ Time Frame: ~5 years of age ]
  • Dental: occlusion (Uses modifications of the Bauru scale) [ Time Frame: ~5 years of age ]
  • Dental: occlusion (Uses modifications of the GOSLON scale) [ Time Frame: ~12 years of age ]
  • Dental: occlusion (Uses modifications of the Bauru scale) [ Time Frame: ~12 years of age ]
  • Dental: occlusion (Uses modifications of the GOSLON scale) [ Time Frame: ~22 years of age ]
  • Dental: occlusion (Uses modifications of the Bauru scale) [ Time Frame: ~22 years of age ]
  • Dental: patient-reported outcomes related to mastication [ Time Frame: ~8 years of age ]
    Uses the CLEFT-Q PROM
  • Dental: patient-reported outcomes related to mastication [ Time Frame: ~12 years of age ]
    Uses the CLEFT-Q PROM
  • Dental: patient-reported outcomes related to mastication [ Time Frame: ~22 years of age ]
    Uses the CLEFT-Q PROM
  • Dental: patient-reported outcomes related to oral health [ Time Frame: ~8 years of age ]
    Uses the COHIP PROM
  • Dental: patient-reported outcomes related to oral health [ Time Frame: ~12 years of age ]
    Uses the COHIP PROM
  • Dental: patient-reported outcomes related to oral health [ Time Frame: ~22 years of age ]
    Uses the COHIP PROM
  • Patient-reported outcomes related to eating/drinking [ Time Frame: ~8 years of age ]
    Uses the CLEFT-Q PROM
  • Patient-reported outcomes related to eating/drinking [ Time Frame: ~12 years of age ]
    Uses the CLEFT-Q PROM
  • Patient-reported outcomes related to eating/drinking [ Time Frame: ~22 years of age ]
    Uses the CLEFT-Q PROM
  • Breathing: Patient-reported outcomes related to nasal and oral breathing [ Time Frame: ~8 years of age ]
    Uses the NOSE PROM
  • Breathing: Patient-reported outcomes related to nasal and oral breathing [ Time Frame: ~12 years of age ]
    Uses the NOSE PROM
  • Breathing: Patient-reported outcomes related to nasal and oral breathing [ Time Frame: ~22 years of age ]
    Uses the NOSE PROM
  • Aesthetics: Patient-reported outcomes related to appearance [ Time Frame: ~8 years of age ]
    Uses the CLEFT-Q PROM
  • Aesthetics: Patient-reported outcomes related to appearance [ Time Frame: ~12 years of age ]
    Uses the CLEFT-Q PROM
  • Aesthetics: Patient-reported outcomes related to appearance [ Time Frame: ~22 years of age ]
    Uses the CLEFT-Q PROM
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~2 years of age ]
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~5 years of age ]
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~8 years of age ]
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~12 years of age ]
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~22 years of age ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
Official Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 22 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients born with cleft lip and/or palate are eligible for inclusion in this study.
Condition
  • Cleft Lip
  • Cleft Palate
  • Cleft Lip and Palate
Intervention
  • Procedure: cleft lip repair
    Other Name: cheiloplasty
  • Procedure: cleft palate repair
    Other Name: palatoplasty
  • Procedure: oronasal fistula repair
  • Procedure: pharyngoplasty
    Other Name: sphincteroplasty
  • Procedure: gingivoperiosteoplasty
  • Procedure: LeFort-1 maxillary repositioning
    Other Name: orthognathic surgery
  • Procedure: rhinoplasty
  • Procedure: myringotomy and tympanostomy tube placement
  • Other: speech therapy
  • Procedure: orthodontia
  • Procedure: presurgical orthopedics
    Other Names:
    • nasoalveolar molding
    • dentofacial orthopedics
    • Georgiade-Latham appliance
    • Latham appliance
  • Device: sound amplification for hearing
    Other Name: hearing aid
Study Groups/Cohorts
  • 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).
    Interventions:
    • Procedure: cleft lip repair
    • Procedure: gingivoperiosteoplasty
    • Procedure: LeFort-1 maxillary repositioning
    • Procedure: rhinoplasty
    • Other: speech therapy
    • Procedure: orthodontia
    • Procedure: 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).
    Interventions:
    • Procedure: cleft lip repair
    • Procedure: cleft palate repair
    • Procedure: oronasal fistula repair
    • Procedure: pharyngoplasty
    • Procedure: gingivoperiosteoplasty
    • Procedure: LeFort-1 maxillary repositioning
    • Procedure: rhinoplasty
    • Procedure: myringotomy and tympanostomy tube placement
    • Other: speech therapy
    • Procedure: orthodontia
    • Procedure: presurgical orthopedics
    • Device: 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).
    Interventions:
    • Procedure: cleft lip repair
    • Procedure: gingivoperiosteoplasty
    • Procedure: LeFort-1 maxillary repositioning
    • Procedure: rhinoplasty
    • Other: speech therapy
    • Procedure: orthodontia
    • Procedure: 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).
    Interventions:
    • Procedure: cleft lip repair
    • Procedure: cleft palate repair
    • Procedure: oronasal fistula repair
    • Procedure: pharyngoplasty
    • Procedure: gingivoperiosteoplasty
    • Procedure: LeFort-1 maxillary repositioning
    • Procedure: rhinoplasty
    • Procedure: myringotomy and tympanostomy tube placement
    • Other: speech therapy
    • Procedure: orthodontia
    • Procedure: presurgical orthopedics
    • Device: 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).
    Interventions:
    • Procedure: cleft palate repair
    • Procedure: oronasal fistula repair
    • Procedure: pharyngoplasty
    • Procedure: LeFort-1 maxillary repositioning
    • Procedure: myringotomy and tympanostomy tube placement
    • Other: speech therapy
    • Device: sound amplification for hearing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: March 3, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2031
Estimated Primary Completion Date December 2031   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Atypical (Tessier) facial clefts
Sex/Gender
Sexes Eligible for Study: All
Ages up to 22 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02702869
Other Study ID Numbers Pro00104806
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Alexander C Allori, MD, MPH Duke University
PRS Account Duke University
Verification Date October 2020