Antimicrobial Stewardship in Pediatric Surgery (AbxPS)
16 marca 2018 zaktualizowane przez: Dr Anna Shawyer, Alberta Children's Hospital
An Antimicrobial Stewardship Intervention Program in Pediatric Surgery
Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis patients do not require antibiotics after appendectomy. Although guidelines and recommendations exist to decrease post-operative antibiotic mis-use after appendectomy, surgeons continue to prescribe unwarranted antibiotics.
The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric Surgery will decrease the use of un-warranted antibiotics.
Przegląd badań
Status
Wycofane
Warunki
Interwencja / Leczenie
Szczegółowy opis
Many surgeons continue to treat non-perforated or "borderline perforated" appendicitis with postoperative antibiotics despite an evidence-based definition of perforation (in the pediatric surgical literature) and many guidelines and recommendations that specify that no postoperative antibiotics are required. Children with perforated appendicitis are also often treated with longer-than-necessary courses of antibiotics. Although surgeons may feel that they only prescribe additional doses on occasion, evidence suggests that this behavior occurs in over 50% of children with non-perforated appendicitis.
These additional doses contribute to a longer length of stay, excess costs to the health care system, and disrupt patient flow. Additionally, the patients are exposed to more antibiotics and their potential for adverse effects (such as incorrect dose, incorrect medication, allergic reaction, antimicrobial resistance or c difficile infection).
Antimicrobial stewardship programs have been successful in pediatrics and adult general surgery in curbing unwarranted antibiotic use, but have never been evaluated in pediatric general surgery.
Typ studiów
Obserwacyjny
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
Nie starszy niż 18 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka prawdopodobieństwa
Badana populacja
The study population is the pediatric surgeons at our institution who will have their antibiotic prescribing audited.
Opis
Inclusion Criteria:
- Participant (surgeon) is a pediatric surgeon at McMaster Children's Hospital and takes care of patients under the age of 18 who undergo appendectomy.
- Participant (surgeon) is able to read, write and understand English.
- Participant (surgeon) is able to provide informed consent.
Exclusion Criteria:
- Participant (surgeon) only has patients who undergo drain insertion, PICC line insertion or a secondary operation during the same admission
- Participant (surgeon) only has patients who do not undergo operation (i.e. "conservative management with interval appendectomy)
- Participant (surgeon) does not provide informed consent
- Participant (surgeon) does not understand written and spoken English diagnosis other than appendicitis at time of operation
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
NO Antimicrobial Stewardship Program
Prospective cohort of children who undergo appendectomy for acute appendicitis (perforated and non-perforated) BEFORE the implementation of the Antimicrobial Stewardship Program.
|
|
|
WITH Antimicrobial Stewardship Program
Prospective cohort of children who undergo appendectomy for acute appendicitis (perforated and non-perforated) WITH the implementation of the Antimicrobial Stewardship Program.
|
Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis
Ramy czasowe: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Includes both intravenous and oral antibiotics prescribed, both during the time frame from admission until discharge, in addition to any prescription given for home, oral antibiotics.
Measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative intravenous antibiotics for non-perforated appendicitis
Ramy czasowe: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
measured as number of days (ie number of doses divided by number of doses-per-day)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Postoperative oral antibiotics for non-perforated appendicitis
Ramy czasowe: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
measured as number of days (ie number of doses divided by number of doses-per-day)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative fever
Ramy czasowe: Length of admission
|
Rectal temperature above 100.4ºF
(38ºC), measured as yes/no and on what postoperative day Oral temperature above 100ºF (37.8ºC)
Axillary (armpit) temperature above 99ºF (37.2ºC)
Ear (tympanic membrane) temperature above 100.4ºF
(38ºC) in rectal mode or 99.5ºF (37.5ºC) in oral mode Forehead (temporal artery) temperature above 100.4ºF
(38ºC)
|
Length of admission
|
|
Readmission within 30 days
Ramy czasowe: Within 30 days of discharge
|
Need for readmission within 30 days of discharge, measured as yes/no
|
Within 30 days of discharge
|
|
Peripherally inserted intravenous catheter (PICC)
Ramy czasowe: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for PICC insertion for long term antibiotics, intravenous fluids or parenteral nutrition, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Drain insertion
Ramy czasowe: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for a drain insertion (by interventional radiology) for postoperative abscess, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Re-operation
Ramy czasowe: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for re-operation on the same admission, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Length of Stay
Ramy czasowe: Length of admission
|
Measured in days (from date of admission until date of discharge)
|
Length of admission
|
|
Adverse reaction to antibiotic
Ramy czasowe: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no in addition to description of reaction (eg hives, shortness of breath)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Wrong medication/Wrong dose
Ramy czasowe: From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no in addition to description of problem (wrong dose, wrong medication)
|
From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
|
|
C difficile infection
Ramy czasowe: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no based on stool assay
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Anna Shawyer, MS, MSc, Alberta Children's Hospital
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- St Peter SD, Sharp SW, Holcomb GW 3rd, Ostlie DJ. An evidence-based definition for perforated appendicitis derived from a prospective randomized trial. J Pediatr Surg. 2008 Dec;43(12):2242-5. doi: 10.1016/j.jpedsurg.2008.08.051.
- Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038.
- Srigley JA, Brooks A, Sung M, Yamamura D, Haider S, Mertz D. Inappropriate use of antibiotics and Clostridium difficile infection. Am J Infect Control. 2013 Nov;41(11):1116-8. doi: 10.1016/j.ajic.2013.04.017. Epub 2013 Aug 7.
- Rangel SJ, Fung M, Graham DA, Ma L, Nelson CP, Sandora TJ. Recent trends in the use of antibiotic prophylaxis in pediatric surgery. J Pediatr Surg. 2011 Feb;46(2):366-71. doi: 10.1016/j.jpedsurg.2010.11.016.
- Ghaleb MA, Barber N, Franklin BD, Wong IC. The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Arch Dis Child. 2010 Feb;95(2):113-8. doi: 10.1136/adc.2009.158485. Epub 2010 Feb 4.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 stycznia 2015
Zakończenie podstawowe (Oczekiwany)
1 grudnia 2015
Ukończenie studiów (Oczekiwany)
1 grudnia 2015
Daty rejestracji na studia
Pierwszy przesłany
8 października 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 października 2014
Pierwszy wysłany (Oszacować)
22 października 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 marca 2018
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
16 marca 2018
Ostatnia weryfikacja
1 marca 2018
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ACH PedSurg ACS 002
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