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Enrolling by invitation NCT02702869

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

— Observational Cleft Lip Cleft Palate Cleft Lip and Palate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cleft lip repair, cleft palate repair, oronasal fistula repair, pharyngoplasty.
Who it may be relevant to
Registry conditions: Cleft Lip, Cleft Palate, Cleft Lip and Palate. Basic parameters: 1 Day — 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Speech: intelligibility [Time frame: ~5 years of age]
  • Speech: intelligibility [Time frame: ~8 years of age]
  • Speech: intelligibility [Time frame: ~12 years of age]
  • Speech: intelligibility [Time frame: ~22 years of age]
  • Speech: velopharyngeal competence [Time frame: ~5 years of age]
  • Speech: velopharyngeal competence [Time frame: ~8 years of age]
  • Speech: velopharyngeal competence [Time frame: ~12 years of age]
  • Speech: velopharyngeal competence [Time frame: ~22 years of age]
  • Speech: articulation [Time frame: ~5 years of age]
  • Speech: articulation [Time frame: ~8 years of age]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 10 centers
  • University of Florida - Shands Hospital — Gainesville
  • Joe DiMaggio Children's Hospital — Hollywood
  • Orlando Health - Arnold Palmer Hospital for Children — Orlando
  • Johns Hopkins - All Children's Hospital (JHACH) — St. Petersburg
  • Maine Medical Center — Portland
  • Harvard University - Boston Children's Hospital (BCH) — Boston
  • Washington University - St. Louis Children's Hospital (WUSTL) — St Louis
  • Duke University - Duke Children's Hospital & Health Center — Durham
  • … and 2 more centers
Canada · 1 center
  • Dalhousie University - IWK Health Centre — Halifax

Identifiers

NCT: NCT02702869 · Pro00104806

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗