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

Last updated: January 27, 2025
Sponsor: Duke University
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

cleft lip repair

pharyngoplasty

orthodontia

Clinical Study ID

NCT02702869
Pro00104806
  • Ages 1-22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Atypical (Tessier) facial clefts

Study Design

Total Participants: 1000
Treatment Group(s): 12
Primary Treatment: cleft lip repair
Phase:
Study Start date:
October 01, 2016
Estimated Completion Date:
December 31, 2031

Study 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.

Connect with a study center

  • Dalhousie University - IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • University of Florida - Shands Hospital

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Orlando Health - Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Johns Hopkins - All Children's Hospital (JHACH)

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Harvard University - Boston Children's Hospital (BCH)

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Washington University - St. Louis Children's Hospital (WUSTL)

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Duke University - Duke Children's Hospital & Health Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forest University - Brenner Children's Hospital

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Texas at Houston - Children's Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.