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NCT02583100 Clinical Trial

Improving Outcomes in Cleft Palate Surgery

Cleft Palate Clinical Trial

Official title:
Improving Outcomes in Cleft Palate Surgery Through an Audit and Feedback Intervention Directed at Surgeons

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02583100
Other study ID # 2015-5428
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date September 2018

Study information
Verified date June 2021
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.

Description:

This study will determine whether a surgeon-directed audit and feedback intervention reduces rates of oro-nasal fistula after cleft palate repair. Fistula is an important potential complication of cleft palate repair. The study also evaluates feasibility of standardized outcome measurement in the care of children with cleft lip and palate, acceptability of standardized measurement, and acceptability of the audit and feedback intervention among surgeons. The results of this research will improve child health by enabling cleft surgeons to critically evaluate and improve their patient's outcomes.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Active surgeon performing cleft palate repair in the US or Canada. Exclusion Criteria: none

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Intensive Feedback
(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial, (2) receive an analysis of their video-recorded operative technique by surgeon peers, (3) directly observe a peer surgeon with lower fistula rate, and (4) develop a personalized action plan with a target for improvement.
• Routine Feedback
(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial

Locations
Country Name City State
Canada Hospital for Sick Children Toronto Ontario
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Duke Children's Hospital Durham North Carolina
United States Penn State Hershey Craniofacial Clinic Hershey Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Seattle Children's Hospital Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oro-nasal Fistula Presence or absence of fistula of the palate 12 weeks
See also
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Completed NCT03170505 - Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage N/A
Recruiting NCT02595307 - Improving Informed Consent for Cleft Palate Repair N/A