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

Duke University

Status: Invitation-only

Conditions: Cleft Palate; Cleft Lip; Cleft Lip and Palate

Treatments: Procedure: oronasal fistula repair; Procedure: gingivoperiosteoplasty; Procedure: cleft palate repair; Procedure: cleft lip repair; Other: speech therapy; Procedure: rhinoplasty; Procedure: myringotomy and tympanostomy tube placement; Procedure: orthodontia; Procedure: LeFort-1 maxillary repositioning; Procedure: pharyngoplasty; Device: sound amplification for hearing; Procedure: presurgical orthopedics

Study type: Observational

Funder types: Other

Identifiers

NCT02702869

Pro00104806

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 1 day to 22 years old

Volunteers: No 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

Trial design

1,000 participants in 5 patient groups

uCL(A)

Description:

Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).

Treatment:

Procedure: LeFort-1 maxillary repositioning

Procedure: presurgical orthopedics

Procedure: orthodontia

Procedure: rhinoplasty

Other: speech therapy

Procedure: gingivoperiosteoplasty

Procedure: cleft lip repair

uCL(A)P

Description:

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).

Treatment:

Procedure: pharyngoplasty

Procedure: LeFort-1 maxillary repositioning

Procedure: presurgical orthopedics

Procedure: orthodontia

Procedure: myringotomy and tympanostomy tube placement

Procedure: rhinoplasty

Other: speech therapy

Procedure: gingivoperiosteoplasty

Procedure: cleft palate repair

Procedure: cleft lip repair

Device: sound amplification for hearing

Procedure: oronasal fistula repair

bCL(A)

Description:

Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).

Treatment:

Procedure: LeFort-1 maxillary repositioning

Procedure: presurgical orthopedics

Procedure: orthodontia

Procedure: rhinoplasty

Other: speech therapy

Procedure: gingivoperiosteoplasty

Procedure: cleft lip repair

bCL(A)P

Description:

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).

Treatment:

Procedure: pharyngoplasty

Procedure: LeFort-1 maxillary repositioning

Procedure: presurgical orthopedics

Procedure: orthodontia

Procedure: myringotomy and tympanostomy tube placement

Procedure: rhinoplasty

Other: speech therapy

Procedure: gingivoperiosteoplasty

Procedure: cleft palate repair

Procedure: cleft lip repair

Device: sound amplification for hearing

Procedure: oronasal fistula repair

CP

Description:

Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II).

Treatment:

Procedure: pharyngoplasty

Procedure: LeFort-1 maxillary repositioning

Procedure: myringotomy and tympanostomy tube placement

Other: speech therapy

Procedure: cleft palate repair

Device: sound amplification for hearing

Procedure: oronasal fistula repair