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Enrolling by Invitation

NCT Number: NCT02702869

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

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.

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Key information

Conditions

Cleft Lip Cleft Lip and Palate Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

1 day–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dalhousie University - IWK Health Centre, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cleft lip repair

Procedure

Other names: cheiloplasty

cleft palate repair

Procedure

Other names: palatoplasty

oronasal fistula repair

Procedure

pharyngoplasty

Procedure

Other names: sphincteroplasty

gingivoperiosteoplasty

Procedure

LeFort-1 maxillary repositioning

Procedure

Other names: orthognathic surgery

Rhinoplasty

Procedure

myringotomy and tympanostomy tube placement

Procedure

Speech therapy

Other

orthodontia

Procedure

presurgical orthopedics

Procedure

Other names: nasoalveolar molding, dentofacial orthopedics, Georgiade-Latham appliance, Latham appliance

sound amplification for hearing

Device

Other names: hearing aid

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Acronym: ACCQUIREnet

Important dates

Study start
2016
Primary completion
2031
Study completion
2031
First posted
Mar 9, 2016
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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