Improving Outcomes in Cleft Palate Surgery
1 other identifier
interventional
7
2 countries
6
Brief Summary
This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJune 24, 2021
June 1, 2021
2.9 years
October 20, 2015
June 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Oro-nasal Fistula
Presence or absence of fistula of the palate
12 weeks
Study Arms (2)
Intensive Feedback
EXPERIMENTALParticipants 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.
Routine Feedback
ACTIVE COMPARATORParticipants in this arm will receive routine feedback on their complication rates.
Interventions
(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.
(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial
Eligibility Criteria
You may qualify if:
- Active surgeon performing cleft palate repair in the US or Canada.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Phoenix Children's Hospital
Phoenix, Arizona, 85013, United States
Duke Children's Hospital
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Penn State Hershey Craniofacial Clinic
Hershey, Pennsylvania, 17033, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Grossoehme
Children's Hospital Medical Center, Cincinnati
- STUDY DIRECTOR
Thomas Sitzman, MD
Phoenix Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2015
First Posted
October 21, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
June 24, 2021
Record last verified: 2021-06