Back to resultsImproving Outcomes in Cleft Palate Surgery
Primary Purpose
Cleft Palate
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intensive Feedback
Routine Feedback
Sponsored by
About this trial
This is an interventional health services research trial for Cleft Palate
Eligibility Criteria
Inclusion Criteria:
Active surgeon performing cleft palate repair in the US or Canada.
Exclusion Criteria:
none
Sites / Locations
- Phoenix Children's Hospital
- Duke Children's Hospital
- Cincinnati Children's Hospital Medical Center
- Penn State Hershey Craniofacial Clinic
- Seattle Children's Hospital
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive Feedback
Routine Feedback
Arm 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.
Participants in this arm will receive routine feedback on their complication rates.
Outcomes
Primary Outcome Measures
Oro-nasal Fistula
Presence or absence of fistula of the palate
Secondary Outcome Measures
Full Information
NCT ID
NCT02583100
First Posted
October 20, 2015
Last Updated
June 23, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02583100
Brief Title
Improving Outcomes in Cleft Palate Surgery
Official Title
Improving Outcomes in Cleft Palate Surgery Through an Audit and Feedback Intervention Directed at Surgeons
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive Feedback
Arm Type
Experimental
Arm 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.
Arm Title
Routine Feedback
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive routine feedback on their complication rates.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Feedback
Intervention Description
(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.
Intervention Type
Behavioral
Intervention Name(s)
Routine Feedback
Intervention Description
(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial
Primary Outcome Measure Information:
Title
Oro-nasal Fistula
Description
Presence or absence of fistula of the palate
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active surgeon performing cleft palate repair in the US or Canada.
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Grossoehme
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Sitzman, MD
Organizational Affiliation
Phoenix Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Duke Children's Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Penn State Hershey Craniofacial Clinic
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
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Improving Outcomes in Cleft Palate Surgery
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