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ACCQUIREnet

  • Status
    Accepting Candidates
  • Age
    1 Day - 22 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

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.

Details

Full study title Learning healthcare network for quality improvement and research in cleft lip and palate care: ACCQUIREnet
Protocol number OCR38062
ClinicalTrials.gov ID NCT02702869

Eligibility

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

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Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Mona Brenda Sayedul Huq
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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