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



Status:Recruiting
Conditions:Cosmetic, Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any - 22
Updated:11/10/2018
Start Date:October 2016
End Date:December 2026
Contact:Alexander C Allori, MD, MPH
Email:alexander@allorimd.info
Phone:919-668-3111

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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, and Quality Assurance and Improvement

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.

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.

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
We found this trial at
1
site
Durham, North Carolina
Principal Investigator: Alexander Allori, MD, MPH
Phone: 919-684-3815
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from
Durham, NC
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