Clinical Trial: Prospective Data-collection System for the Comprehensive Appraisal of Cleft Care

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Implementation of a Learning Health-care System at the Duke Cleft & Craniofacial Center to Enable Comprehensive Appraisal of Cleft Care for Outcomes Assessment, Comparative Effectiveness Research,

Brief Summary: A system for prospective data-collection is being implemented by the Duke Cleft & Craniofacial Center so that it 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 Summary:

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 at the Duke Cleft & Craniofacial Center.

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 the Duke Cleft & Craniofacial Center will be invited to participate in this project. Data will be maintained in a local, secured database. This database will likely serve as a model for a future multi-site condition-specific registry that will permit inter-center comparisons.

The IRB protocol details methods of quality assurance and data monitoring and auditing. Data dictionaries employed in the construction of the Duke CleftKit protocol include the ICHOM Standard Set of Outcome Measures for Cleft Lip and Palate and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.


Sponsor: Duke University

Current Primary Outcome:

  • Speech: intelligibility [ Time Frame: ~5 years of age ]
    Utilizes the intelligibility in context scale (ICS)
  • Speech: intelligibility [ Time Frame: ~8 years of age ]
    Utilizes the intelligibility in context scale (ICS)
  • Speech: intelligibility [ Time Frame: ~12 years of age ]
    Utilizes the intelligibility in context scale (ICS)
  • Speech: intelligibility [ Time Frame: ~22 years of age ]
    Utilizes the intelligibility in context scale (ICS)
  • 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 ]
    Utilizes the modified percent correct consonants (mPCC) scale
  • Speech: articulation [ Time Frame: ~8 years of age ]
    Utilizes the modified percent correct consonants (mPCC) scale
  • Speech: articulation [ Time Frame: ~12 years of age ]
    Utilizes the modified percent correct

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Duke University

    Dates:
    Date Received: October 16, 2015
    Date Started: October 2016
    Date Completion: December 2026
    Last Updated: October 17, 2016
    Last Verified: October 2016