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

Sponsor

Duke University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02702869

Collaborator

(none)

1,000

Enrollment

Locations

182

Anticipated Duration (Months)

125

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 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:

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2031

Anticipated Study Completion Date :

Dec 1, 2031

Arms and Interventions

Arm	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: cleft palate repair Other Names: palatoplasty Procedure: oronasal fistula repair Procedure: pharyngoplasty Other Names: sphincteroplasty Procedure: gingivoperiosteoplasty Procedure: LeFort-1 maxillary repositioning Other Names: 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 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: cleft palate repair Other Names: palatoplasty Procedure: oronasal fistula repair Procedure: pharyngoplasty Other Names: sphincteroplasty Procedure: gingivoperiosteoplasty Procedure: LeFort-1 maxillary repositioning Other Names: 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 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: cleft palate repair Other Names: palatoplasty Procedure: oronasal fistula repair Procedure: pharyngoplasty Other Names: sphincteroplasty Procedure: LeFort-1 maxillary repositioning Other Names: orthognathic surgery Procedure: myringotomy and tympanostomy tube placement Other: speech therapy Device: sound amplification for hearing Other Names: hearing aid

Outcome Measures

Primary Outcome Measures

Speech: intelligibility [~5 years of age]
Utilizes the intelligibility in context scale (ICS)
Speech: intelligibility [~8 years of age]
Utilizes the intelligibility in context scale (ICS)
Speech: intelligibility [~12 years of age]
Utilizes the intelligibility in context scale (ICS)
Speech: intelligibility [~22 years of age]
Utilizes the intelligibility in context scale (ICS)
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 [~5 years of age]
Utilizes the modified percent correct consonants (mPCC) scale
Speech: articulation [~8 years of age]
Utilizes the modified percent correct consonants (mPCC) scale
Speech: articulation [~12 years of age]
Utilizes the modified percent correct consonants (mPCC) scale
Speech: articulation [~22 years of age]
Utilizes the modified percent correct consonants (mPCC) scale
Speech: patient-reported outcomes related to speech and speaking [~8 years of age]
Utilizes the CLEFT-Q PROM
Speech: patient-reported outcomes related to speech and speaking [~12 years of age]
Utilizes the CLEFT-Q PROM
Speech: patient-reported outcomes related to speech and speaking [~22 years of age]
Utilizes the CLEFT-Q PROM
Hearing: puretone average [~5 years of age]
Dental: dmft and DMFT scores [~5 years of age]
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Dental: dmft and DMFT scores [~12 years of age]
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Dental: dmft and DMFT scores [~22 years of age]
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
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 [~8 years of age]
Uses the CLEFT-Q PROM
Dental: patient-reported outcomes related to mastication [~12 years of age]
Uses the CLEFT-Q PROM
Dental: patient-reported outcomes related to mastication [~22 years of age]
Uses the CLEFT-Q PROM
Dental: patient-reported outcomes related to oral health [~8 years of age]
Uses the COHIP PROM
Dental: patient-reported outcomes related to oral health [~12 years of age]
Uses the COHIP PROM
Dental: patient-reported outcomes related to oral health [~22 years of age]
Uses the COHIP PROM
Patient-reported outcomes related to eating/drinking [~8 years of age]
Uses the CLEFT-Q PROM
Patient-reported outcomes related to eating/drinking [~12 years of age]
Uses the CLEFT-Q PROM
Patient-reported outcomes related to eating/drinking [~22 years of age]
Uses the CLEFT-Q PROM
Breathing: Patient-reported outcomes related to nasal and oral breathing [~8 years of age]
Uses the NOSE PROM
Breathing: Patient-reported outcomes related to nasal and oral breathing [~12 years of age]
Uses the NOSE PROM
Breathing: Patient-reported outcomes related to nasal and oral breathing [~22 years of age]
Uses the NOSE PROM
Aesthetics: Patient-reported outcomes related to appearance [~8 years of age]
Uses the CLEFT-Q PROM
Aesthetics: Patient-reported outcomes related to appearance [~12 years of age]
Uses the CLEFT-Q PROM
Aesthetics: Patient-reported outcomes related to appearance [~22 years of age]
Uses the CLEFT-Q PROM
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida - Shands Hospital	Gainesville	Florida	United States	32608
2	Orlando Health - Arnold Palmer Hospital for Children	Orlando	Florida	United States	32806
3	Johns Hopkins - All Children's Hospital (JHACH)	Saint Petersburg	Florida	United States	33701
4	Harvard University - Boston Children's Hospital (BCH)	Boston	Massachusetts	United States	02115
5	Washington University - St. Louis Children's Hospital (WUSTL)	Saint Louis	Missouri	United States	63110
6	Duke University - Duke Children's Hospital & Health Center	Durham	North Carolina	United States	27710
7	Wake Forest University - Brenner Children's Hospital	Winston-Salem	North Carolina	United States	27157
8	University of Texas at Houston - Children's Memorial Hermann Hospital	Houston	Texas	United States	77030