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This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Feedback | Experimental | 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. |
|
| Routine Feedback | Active Comparator | Participants in this arm will receive routine feedback on their complication rates. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Feedback | Behavioral | (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oro-nasal Fistula | Presence or absence of fistula of the palate | 12 weeks |
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Inclusion Criteria:
Active surgeon performing cleft palate repair in the US or Canada.
Exclusion Criteria:
none
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Grossoehme | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Thomas Sitzman, MD | Phoenix Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85013 | United States | ||
| Duke Children's Hospital |
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| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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|
| Routine Feedback | Behavioral | (1) receive feedback regarding their individual fistula rate and those of all other participants in the trial |
|
| 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 |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |