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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cleft Lip and Palate; Cleft Palate; Cleft Lip
• Intervention / Treatment: Procedure: cleft lip repair; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics; Procedure: cleft palate repair; Procedure: oronasal fistula repair; Procedure: pharyngoplasty; Procedure: myringotomy and tympanostomy tube placement; Device: sound amplification for hearing

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
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Dalhousie University - IWK Health Centre
• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida - Shands Hospital
    • Hollywood, Florida, United States, 33021
      • Joe DiMaggio Children's Hospital
    • Orlando, Florida, United States, 32806
      • Orlando Health - Arnold Palmer Hospital for Children
    • St. Petersburg, Florida, United States, 33701
      • Johns Hopkins - All Children's Hospital (JHACH)
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard University - Boston Children's Hospital (BCH)
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University - St. Louis Children's Hospital (WUSTL)
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University - Duke Children's Hospital & Health Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University - Brenner Children's Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas at Houston - Children's Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 22 years (Child, Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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 Names: cheiloplasty; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Other Names: orthognathic surgery; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics; Other Names: nasoalveolar molding; dentofacial orthopedics; Georgiade-Latham appliance; Latham appliance
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).	Procedure: cleft lip repair; Other Names: cheiloplasty; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Other Names: orthognathic surgery; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics; Other Names: nasoalveolar molding; dentofacial orthopedics; Georgiade-Latham appliance; Latham appliance; Procedure: cleft palate repair; Other Names: palatoplasty; Procedure: oronasal fistula repair; Procedure: pharyngoplasty; Other Names: sphincteroplasty; Procedure: myringotomy and tympanostomy tube placement; Device: sound amplification for hearing; Other Names: hearing aid
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 Names: cheiloplasty; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Other Names: orthognathic surgery; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics; Other Names: nasoalveolar molding; dentofacial orthopedics; Georgiade-Latham appliance; Latham appliance
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).	Procedure: cleft lip repair; Other Names: cheiloplasty; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Other Names: orthognathic surgery; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics; Other Names: nasoalveolar molding; dentofacial orthopedics; Georgiade-Latham appliance; Latham appliance; Procedure: cleft palate repair; Other Names: palatoplasty; Procedure: oronasal fistula repair; Procedure: pharyngoplasty; Other Names: sphincteroplasty; Procedure: myringotomy and tympanostomy tube placement; Device: sound amplification for hearing; Other Names: hearing aid
CP; Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II).	Procedure: LeFort-1 maxillary repositioning; Other Names: orthognathic surgery; Other: speech therapy; Procedure: cleft palate repair; Other Names: palatoplasty; Procedure: oronasal fistula repair; Procedure: pharyngoplasty; Other Names: sphincteroplasty; Procedure: myringotomy and tympanostomy tube placement; Device: sound amplification for hearing; Other Names: hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech: intelligibility	Utilizes the intelligibility in context scale (ICS)	~5 years of age
Speech: intelligibility	Utilizes the intelligibility in context scale (ICS)	~8 years of age
Speech: intelligibility	Utilizes the intelligibility in context scale (ICS)	~12 years of age
Speech: intelligibility	Utilizes the intelligibility in context scale (ICS)	~22 years of age
Speech: velopharyngeal competence		~5 years of age
Speech: velopharyngeal competence		~8 years of age
Speech: velopharyngeal competence		~12 years of age
Speech: velopharyngeal competence		~22 years of age
Speech: articulation	Utilizes the modified percent correct consonants (mPCC) scale	~5 years of age
Speech: articulation	Utilizes the modified percent correct consonants (mPCC) scale	~8 years of age
Speech: articulation	Utilizes the modified percent correct consonants (mPCC) scale	~12 years of age
Speech: articulation	Utilizes the modified percent correct consonants (mPCC) scale	~22 years of age
Speech: patient-reported outcomes related to speech and speaking	Utilizes the CLEFT-Q PROM	~8 years of age
Speech: patient-reported outcomes related to speech and speaking	Utilizes the CLEFT-Q PROM	~12 years of age
Speech: patient-reported outcomes related to speech and speaking	Utilizes the CLEFT-Q PROM	~22 years of age
Hearing: puretone average		~5 years of age
Dental: dmft and DMFT scores	Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth	~5 years of age
Dental: dmft and DMFT scores	Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth	~12 years of age
Dental: dmft and DMFT scores	Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth	~22 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)		~5 years of age
Dental: occlusion (Uses modifications of the Bauru scale)		~5 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)		~12 years of age
Dental: occlusion (Uses modifications of the Bauru scale)		~12 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)		~22 years of age
Dental: occlusion (Uses modifications of the Bauru scale)		~22 years of age
Dental: patient-reported outcomes related to mastication	Uses the CLEFT-Q PROM	~8 years of age
Dental: patient-reported outcomes related to mastication	Uses the CLEFT-Q PROM	~12 years of age
Dental: patient-reported outcomes related to mastication	Uses the CLEFT-Q PROM	~22 years of age
Dental: patient-reported outcomes related to oral health	Uses the COHIP PROM	~8 years of age
Dental: patient-reported outcomes related to oral health	Uses the COHIP PROM	~12 years of age
Dental: patient-reported outcomes related to oral health	Uses the COHIP PROM	~22 years of age
Patient-reported outcomes related to eating/drinking	Uses the CLEFT-Q PROM	~8 years of age
Patient-reported outcomes related to eating/drinking	Uses the CLEFT-Q PROM	~12 years of age
Patient-reported outcomes related to eating/drinking	Uses the CLEFT-Q PROM	~22 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing	Uses the NOSE PROM	~8 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing	Uses the NOSE PROM	~12 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing	Uses the NOSE PROM	~22 years of age
Aesthetics: Patient-reported outcomes related to appearance	Uses the CLEFT-Q PROM	~8 years of age
Aesthetics: Patient-reported outcomes related to appearance	Uses the CLEFT-Q PROM	~12 years of age
Aesthetics: Patient-reported outcomes related to appearance	Uses the CLEFT-Q PROM	~22 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics		~2 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics		~5 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics		~8 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics		~12 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics		~22 years of age

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Alexander C Allori, MD, MPH, Duke University

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimated): March 9, 2016

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cleft lip; cleft palate; cleft lip and palate; multidisciplinary team; cleft alveolus; interdisciplinary team
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cleft Lip; Cleft Palate; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Equipment and Supplies; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Digestive System Surgical Procedures; Rehabilitation of Speech and Language Disorders; Electrical Equipment and Supplies; Wearable Electronic Devices; Plastic Surgery Procedures; Perioperative Care; Dentistry; Cosmetic Techniques; Biliary Tract Surgical Procedures; Sensory Aids; Otorhinolaryngologic Surgical Procedures; Ostomy; Hearing Tests; Diagnostic Techniques, Otological; Otologic Surgical Procedures; Myotomy; Sphincterotomy; Surgery, Oral; Nasal Surgical Procedures; Preoperative Care; Speech Therapy; Hearing Aids; Sphincterotomy, Transduodenal; Orthognathic Surgery; Rhinoplasty; Middle Ear Ventilation; Orthodontics; Nasoalveolar Molding; Audiometry
• Other Study ID Numbers: Pro00104806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a collaborative research network. All data processing happens at the coordinating center, with results reviewed by the participating centers.