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Prospective Data-collection System for the Comprehensive Appraisal of Cleft Care (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 : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
A system for prospective data-collection is being implemented by Duke University on behalf of the Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) so that 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.

Condition or disease Intervention/treatment
Cleft Lip Cleft Palate Cleft Lip and Palate 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

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. Data will be maintained in a local, secured database. This database will likely serve as a model for a future multi-site condition-specific registry that will permit inter-center comparisons.

The IRB protocol details methods of quality assurance and data monitoring and auditing. Data dictionaries employed in the construction of the Duke CleftKit protocol include the ICHOM Standard Set of Outcome Measures for Cleft Lip and Palate and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 22 Years
Official Title: Allied Cleft & Craniofacial Quality-Improvement and Reserach Network (ACCQUIREnet): Implementation of a Learning Health-care System for Cleft & Craniofacial Centers to Enable Comprehensive Appraisal of Cleft Care for Outcomes Assessment, Quality Improvement, and Research
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2031
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Procedure: cleft lip repair
Other Name: cheiloplasty

Procedure: gingivoperiosteoplasty
Procedure: LeFort-1 maxillary repositioning
Other Name: orthognathic surgery

Procedure: rhinoplasty
Other: speech therapy
Procedure: orthodontia
Procedure: presurgical orthopedics
Other Names:
  • nasoalveolar molding
  • dentofacial orthopedics
  • Georgiade-Latham appliance
  • Latham appliance

uCL+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).
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

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).
Procedure: cleft lip repair
Other Name: cheiloplasty

Procedure: gingivoperiosteoplasty
Procedure: LeFort-1 maxillary repositioning
Other Name: orthognathic surgery

Procedure: rhinoplasty
Other: speech therapy
Procedure: orthodontia
Procedure: presurgical orthopedics
Other Names:
  • nasoalveolar molding
  • dentofacial orthopedics
  • Georgiade-Latham appliance
  • Latham appliance

bCL+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).
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

CP
Children with cleft secondary palate. Subgroup analysis by severity (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV).
Procedure: cleft palate repair
Other Name: palatoplasty

Procedure: oronasal fistula repair
Procedure: pharyngoplasty
Other Name: sphincteroplasty

Procedure: LeFort-1 maxillary repositioning
Other Name: orthognathic surgery

Procedure: myringotomy and tympanostomy tube placement
Other: speech therapy



Primary Outcome Measures :
  1. Speech: intelligibility [ Time Frame: ~5 years of age ]
    Utilizes the intelligibility in context scale (ICS)

  2. Speech: intelligibility [ Time Frame: ~8 years of age ]
    Utilizes the intelligibility in context scale (ICS)

  3. Speech: intelligibility [ Time Frame: ~12 years of age ]
    Utilizes the intelligibility in context scale (ICS)

  4. Speech: intelligibility [ Time Frame: ~22 years of age ]
    Utilizes the intelligibility in context scale (ICS)

  5. Speech: velopharyngeal competence [ Time Frame: ~5 years of age ]
  6. Speech: velopharyngeal competence [ Time Frame: ~8 years of age ]
  7. Speech: velopharyngeal competence [ Time Frame: ~12 years of age ]
  8. Speech: velopharyngeal competence [ Time Frame: ~22 years of age ]
  9. Speech: articulation [ Time Frame: ~5 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale

  10. Speech: articulation [ Time Frame: ~8 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale

  11. Speech: articulation [ Time Frame: ~12 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale

  12. Speech: articulation [ Time Frame: ~22 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale

  13. Speech: patient-reported outcomes related to speech and speaking [ Time Frame: ~8 years of age ]
    Utilizes the CLEFT-Q PROM

  14. Speech: patient-reported outcomes related to speech and speaking [ Time Frame: ~12 years of age ]
    Utilizes the CLEFT-Q PROM

  15. Speech: patient-reported outcomes related to speech and speaking [ Time Frame: ~22 years of age ]
    Utilizes the CLEFT-Q PROM

  16. Hearing: puretone average [ Time Frame: ~5 years of age ]
  17. Dental: dmft and DMFT scores [ Time Frame: ~5 years of age ]
    Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth

  18. Dental: dmft and DMFT scores [ Time Frame: ~12 years of age ]
    Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth

  19. Dental: dmft and DMFT scores [ Time Frame: ~22 years of age ]
    Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth

  20. Dental: occlusion (Uses modifications of the GOSLON scale) [ Time Frame: ~5 years of age ]
  21. Dental: occlusion (Uses modifications of the Bauru scale) [ Time Frame: ~5 years of age ]
  22. Dental: occlusion (Uses modifications of the GOSLON scale) [ Time Frame: ~12 years of age ]
  23. Dental: occlusion (Uses modifications of the Bauru scale) [ Time Frame: ~12 years of age ]
  24. Dental: occlusion (Uses modifications of the GOSLON scale) [ Time Frame: ~22 years of age ]
  25. Dental: occlusion (Uses modifications of the Bauru scale) [ Time Frame: ~22 years of age ]
  26. Dental: patient-reported outcomes related to mastication [ Time Frame: ~8 years of age ]
    Uses the CLEFT-Q PROM

  27. Dental: patient-reported outcomes related to mastication [ Time Frame: ~12 years of age ]
    Uses the CLEFT-Q PROM

  28. Dental: patient-reported outcomes related to mastication [ Time Frame: ~22 years of age ]
    Uses the CLEFT-Q PROM

  29. Dental: patient-reported outcomes related to oral health [ Time Frame: ~8 years of age ]
    Uses the COHIP PROM

  30. Dental: patient-reported outcomes related to oral health [ Time Frame: ~12 years of age ]
    Uses the COHIP PROM

  31. Dental: patient-reported outcomes related to oral health [ Time Frame: ~22 years of age ]
    Uses the COHIP PROM

  32. Patient-reported outcomes related to eating/drinking [ Time Frame: ~8 years of age ]
    Uses the CLEFT-Q PROM

  33. Patient-reported outcomes related to eating/drinking [ Time Frame: ~12 years of age ]
    Uses the CLEFT-Q PROM

  34. Patient-reported outcomes related to eating/drinking [ Time Frame: ~22 years of age ]
    Uses the CLEFT-Q PROM

  35. Breathing: Patient-reported outcomes related to nasal and oral breathing [ Time Frame: ~8 years of age ]
    Uses the NOSE PROM

  36. Breathing: Patient-reported outcomes related to nasal and oral breathing [ Time Frame: ~12 years of age ]
    Uses the NOSE PROM

  37. Breathing: Patient-reported outcomes related to nasal and oral breathing [ Time Frame: ~22 years of age ]
    Uses the NOSE PROM

  38. Aesthetics: Patient-reported outcomes related to appearance [ Time Frame: ~8 years of age ]
    Uses the CLEFT-Q PROM

  39. Aesthetics: Patient-reported outcomes related to appearance [ Time Frame: ~12 years of age ]
    Uses the CLEFT-Q PROM

  40. Aesthetics: Patient-reported outcomes related to appearance [ Time Frame: ~22 years of age ]
    Uses the CLEFT-Q PROM

  41. Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~2 years of age ]
  42. Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~5 years of age ]
  43. Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~8 years of age ]
  44. Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~12 years of age ]
  45. Aesthetics: Clinical assessment of nasolabial and facial aesthetics [ Time Frame: ~22 years of age ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients born with cleft lip and/or palate are eligible for inclusion in this study.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702869


Locations
Layout table for location information
United States, North Carolina
Duke Children's Hospital & Health Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Alexander C Allori, MD, MPH Duke University Health System

Additional Information:
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02702869    
Other Study ID Numbers: Pro00067808
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by Duke University:
cleft lip
cleft palate
cleft lip and palate
cleft alveolus
multidisciplinary team
interdisciplinary team
Additional relevant MeSH terms:
Layout table for MeSH terms
Cleft Palate
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities