Improving Outcomes in Cleft Palate Surgery

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Cleft Palate

Treatments: Behavioral: Intensive Feedback; Behavioral: Routine Feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02583100

2015-5428

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Active surgeon performing cleft palate repair in the US or Canada.

Exclusion criteria

none

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Intensive Feedback

Experimental group

Description:

Participants in this arm will receive intensive feedback on their complication rates, surgical technique, and peri-operative surgical management from peer surgeons participating in the study.

Treatment:

Behavioral: Intensive Feedback

Routine Feedback

Active Comparator group

Description:

Participants in this arm will receive routine feedback on their complication rates.

Treatment:

Behavioral: Routine Feedback