NCT02583100

Improving Outcomes in Cleft Palate Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cleft Palate

Interventions

Type	Name	Description
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.
BEHAVIORAL	Routine Feedback	(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2015-10-21
• Last updated: 2021-06-24

Locations

6 sites across 2 countries: United States, Canada