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

Cleft Lip and Palate Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02702869
• Other study ID #: Pro00104806
• Status: Enrolling by invitation
• Start date: October 2016
• Est. completion date: December 2031

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 2031
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate
• Cleft Palate

Intervention

Procedure:
• cleft lip repair

• cleft palate repair

• oronasal fistula repair

• pharyngoplasty

• gingivoperiosteoplasty

• LeFort-1 maxillary repositioning

• rhinoplasty

• myringotomy and tympanostomy tube placement

Other:
• speech therapy

Procedure:
• orthodontia

• presurgical orthopedics

Device:
• sound amplification for hearing

Locations

Country	Name	City	State
Canada	Dalhousie University - IWK Health Centre	Halifax	Nova Scotia
United States	Harvard University - Boston Children's Hospital (BCH)	Boston	Massachusetts
United States	Duke University - Duke Children's Hospital & Health Center	Durham	North Carolina
United States	University of Florida - Shands Hospital	Gainesville	Florida
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	University of Texas at Houston - Children's Memorial Hermann Hospital	Houston	Texas
United States	Orlando Health - Arnold Palmer Hospital for Children	Orlando	Florida
United States	Maine Medical Center	Portland	Maine
United States	Washington University - St. Louis Children's Hospital (WUSTL)	Saint Louis	Missouri
United States	Johns Hopkins - All Children's Hospital (JHACH)	Saint Petersburg	Florida
United States	Wake Forest University - Brenner Children's Hospital	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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

External Links

•   ACCQUIREnet web site
•   Duke Cleft & Craniofacial Center
•   Official web site for ICHOM Standard Set for cleft lip and/or palate, upon which the Duke project is based