PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia
Introduction Studies finding perioperative hyperglycaemia is associated with adverse patient outcomes in surgical procedures spurred the development of blood glucose guidelines at many institutions. In this trial, we will assess the implementation of a clinical decision support tool that is integrat...
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e072745.full |
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| author | Karen McCarthy Robert E Freundlich Matthew D McEvoy Matthew S Shotwell Svetlana Eden Miklos D Kertai Jonathan P Wanderer Matthew Zapf Dev Patel Patrick Henson Eunice Huang Leslie Fowler |
| author_facet | Karen McCarthy Robert E Freundlich Matthew D McEvoy Matthew S Shotwell Svetlana Eden Miklos D Kertai Jonathan P Wanderer Matthew Zapf Dev Patel Patrick Henson Eunice Huang Leslie Fowler |
| author_sort | Karen McCarthy |
| collection | DOAJ |
| description | Introduction Studies finding perioperative hyperglycaemia is associated with adverse patient outcomes in surgical procedures spurred the development of blood glucose guidelines at many institutions. In this trial, we will assess the implementation of a clinical decision support tool that is integrated into the intraoperative portion of our electronic health record and provides real-time best practice recommendations for intraoperative insulin dosing in surgical patients at high risk for hyperglycaemia.Methods and design We will assess this intervention using a sequential and repeated cross-over design at the institutional level with periods of time for wash-out, control and study intervention. The unit of analysis will be the surgical case. The primary outcome will be the frequency of hyperglycaemia (>180 mg/dL (10 mmol/L)) at first postoperative anaesthesia care unit measurement. There are several prespecified secondary analyses focused on perioperative glycaemic control.Discussion This protocol and statistical analysis plan describes the methodology, primary and secondary analyses. The PeRiOperative Glucose PRAgMatic (PROGRAM) trial was approved by the Vanderbilt University Institutional Review Board (IRB), Vanderbilt University Medical Center, Nashville, Tennessee, USA (IRB, 220991). The study results will be disseminated via publication in a peer-reviewed journal and presented at national scientific conferences. The results of PROGRAM trial will inform best practice for perioperative standardised insulin administration in surgical patients at high risk of hyperglycaemia.Trial registration number NCT05426096. |
| format | Article |
| id | doaj-art-dd57f3a0d6e244fabb1f8e2d75195de9 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-dd57f3a0d6e244fabb1f8e2d75195de92024-11-15T06:25:08ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2023-072745PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemiaKaren McCarthy0Robert E Freundlich1Matthew D McEvoy2Matthew S Shotwell3Svetlana Eden4Miklos D Kertai5Jonathan P Wanderer6Matthew Zapf7Dev Patel8Patrick Henson9Eunice Huang10Leslie Fowler11Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USAAnesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Pediatric Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USADepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USAIntroduction Studies finding perioperative hyperglycaemia is associated with adverse patient outcomes in surgical procedures spurred the development of blood glucose guidelines at many institutions. In this trial, we will assess the implementation of a clinical decision support tool that is integrated into the intraoperative portion of our electronic health record and provides real-time best practice recommendations for intraoperative insulin dosing in surgical patients at high risk for hyperglycaemia.Methods and design We will assess this intervention using a sequential and repeated cross-over design at the institutional level with periods of time for wash-out, control and study intervention. The unit of analysis will be the surgical case. The primary outcome will be the frequency of hyperglycaemia (>180 mg/dL (10 mmol/L)) at first postoperative anaesthesia care unit measurement. There are several prespecified secondary analyses focused on perioperative glycaemic control.Discussion This protocol and statistical analysis plan describes the methodology, primary and secondary analyses. The PeRiOperative Glucose PRAgMatic (PROGRAM) trial was approved by the Vanderbilt University Institutional Review Board (IRB), Vanderbilt University Medical Center, Nashville, Tennessee, USA (IRB, 220991). The study results will be disseminated via publication in a peer-reviewed journal and presented at national scientific conferences. The results of PROGRAM trial will inform best practice for perioperative standardised insulin administration in surgical patients at high risk of hyperglycaemia.Trial registration number NCT05426096.https://bmjopen.bmj.com/content/13/8/e072745.full |
| spellingShingle | Karen McCarthy Robert E Freundlich Matthew D McEvoy Matthew S Shotwell Svetlana Eden Miklos D Kertai Jonathan P Wanderer Matthew Zapf Dev Patel Patrick Henson Eunice Huang Leslie Fowler PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia BMJ Open |
| title | PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia |
| title_full | PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia |
| title_fullStr | PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia |
| title_full_unstemmed | PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia |
| title_short | PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia |
| title_sort | perioperative glucose pragmatic program trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia |
| url | https://bmjopen.bmj.com/content/13/8/e072745.full |
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