Clinical trial NCT02702869: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cleft Lip
Cleft Palate
Cleft Lip and Palate
Keywords: cleft lip
cleft palate
cleft lip and palate
cleft alveolus
multidisciplinary team
interdisciplinary team
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients born with cleft lip and/or palate are eligible for inclusion in this study.

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.

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

Primary outcomes:
measure: Speech: intelligibility
timeFrame: ~5 years of age
measure: Speech: intelligibility
timeFrame: ~8 years of age
measure: Speech: intelligibility
timeFrame: ~12 years of age
measure: Speech: intelligibility
timeFrame: ~22 years of age
measure: Speech: velopharyngeal competence
timeFrame: ~5 years of age
measure: Speech: velopharyngeal competence
timeFrame: ~8 years of age
measure: Speech: velopharyngeal competence
timeFrame: ~12 years of age
measure: Speech: velopharyngeal competence
timeFrame: ~22 years of age
measure: Speech: articulation
timeFrame: ~5 years of age
measure: Speech: articulation
timeFrame: ~8 years of age
measure: Speech: articulation
timeFrame: ~12 years of age
measure: Speech: articulation
timeFrame: ~22 years of age
measure: Speech: patient-reported outcomes related to speech and speaking
timeFrame: ~8 years of age
measure: Speech: patient-reported outcomes related to speech and speaking
timeFrame: ~12 years of age
measure: Speech: patient-reported outcomes related to speech and speaking
timeFrame: ~22 years of age
measure: Hearing: puretone average
timeFrame: ~5 years of age
measure: Dental: dmft and DMFT scores
timeFrame: ~5 years of age
measure: Dental: dmft and DMFT scores
timeFrame: ~12 years of age
measure: Dental: dmft and DMFT scores
timeFrame: ~22 years of age
measure: Dental: occlusion (Uses modifications of the GOSLON scale)
timeFrame: ~5 years of age
measure: Dental: occlusion (Uses modifications of the Bauru scale)
timeFrame: ~5 years of age
measure: Dental: occlusion (Uses modifications of the GOSLON scale)
timeFrame: ~12 years of age
measure: Dental: occlusion (Uses modifications of the Bauru scale)
timeFrame: ~12 years of age
measure: Dental: occlusion (Uses modifications of the GOSLON scale)
timeFrame: ~22 years of age
measure: Dental: occlusion (Uses modifications of the Bauru scale)
timeFrame: ~22 years of age
measure: Dental: patient-reported outcomes related to mastication
timeFrame: ~8 years of age
measure: Dental: patient-reported outcomes related to mastication
timeFrame: ~12 years of age
measure: Dental: patient-reported outcomes related to mastication
timeFrame: ~22 years of age
measure: Dental: patient-reported outcomes related to oral health
timeFrame: ~8 years of age
measure: Dental: patient-reported outcomes related to oral health
timeFrame: ~12 years of age
measure: Dental: patient-reported outcomes related to oral health
timeFrame: ~22 years of age
measure: Patient-reported outcomes related to eating/drinking
timeFrame: ~8 years of age
measure: Patient-reported outcomes related to eating/drinking
timeFrame: ~12 years of age
measure: Patient-reported outcomes related to eating/drinking
timeFrame: ~22 years of age
measure: Breathing: Patient-reported outcomes related to nasal and oral breathing
timeFrame: ~8 years of age
measure: Breathing: Patient-reported outcomes related to nasal and oral breathing
timeFrame: ~12 years of age
measure: Breathing: Patient-reported outcomes related to nasal and oral breathing
timeFrame: ~22 years of age
measure: Aesthetics: Patient-reported outcomes related to appearance
timeFrame: ~8 years of age
measure: Aesthetics: Patient-reported outcomes related to appearance
timeFrame: ~12 years of age
measure: Aesthetics: Patient-reported outcomes related to appearance
timeFrame: ~22 years of age
measure: Aesthetics: Clinical assessment of nasolabial and facial aesthetics
timeFrame: ~2 years of age
measure: Aesthetics: Clinical assessment of nasolabial and facial aesthetics
timeFrame: ~5 years of age
measure: Aesthetics: Clinical assessment of nasolabial and facial aesthetics
timeFrame: ~8 years of age
measure: Aesthetics: Clinical assessment of nasolabial and facial aesthetics
timeFrame: ~12 years of age
measure: Aesthetics: Clinical assessment of nasolabial and facial aesthetics
timeFrame: ~22 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida - Shands Hospital
state: Florida
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: Orlando
country: United States
facility: Orlando Health - Arnold Palmer Hospital for Children
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins - All Children's Hospital (JHACH)
state: Florida
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Harvard University - Boston Children's Hospital (BCH)
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University - St. Louis Children's Hospital (WUSTL)
state: Missouri
city: Durham
country: United States
facility: Duke University - Duke Children's Hospital & Health Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University - Brenner Children's Hospital
state: North Carolina
city: Houston
country: United States
facility: University of Texas at Houston - Children's Memorial Hermann Hospital
state: Texas
city: Halifax
country: Canada
facility: Dalhousie University - IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: Duke University
name: Alexander C Allori, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: