Non-variceal upper gastrointestinal bleeding Digestive System Other diseases of digestive system
Conditions
Interventions
Control group:
Health care professionals in control clusters will receive the published guidelines and corresponding algorithm on managing NVUGIB patients.
Experimental group:
In addition to the gui
Sponsors
AstraZeneca Canada Inc. (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cluster-level inclusion criteria: Participating hospitals will be selected based on: 1. A recognised level of prior patient accrual into one of the many registries we have carried out nationally in NVUGIB (RUGBE, REASON, and DURABLE - a national utilisation study of in-hospital acid suppressants, with over 8500 prescriptions) 2. A minimum size of 75 beds required, with weekly hospitalisation of at least 4 - 5 patients with NVUGIB (data from site eligibility questionnaire and previous registries) 3. The availability of a trained digestive endoscopist who can provide urgent gastroscopy within 24 (week-days) to 48 hours (week-ends) of presentation (availability of trained on-call endoscopy assistants not required since 60% of Canadian centres do not have one) 4. Access to an in-house intensive care unit (ICU), and surgical support 5. Existence of an institutional electronic pharmacy database Patient-level inclusion criteria: The charts of the patients will be included for: 1. A patient aged 18 or over, either sex 2. Patients treated during the study duration (or the baseline evaluation period) 3. Primary or secondary discharge diagnoses of NVUGIB (per charted International Classification of Disease, 10th Revision [ICD-10] code). Additional confirmation of NVUGIB using patient symptoms will be done as previous.
Exclusion criteria
Exclusion criteria: Patient-level exclusion criteria: The charts of patients will be excluded if: 1. Patients were initially assessed at another institution for the present episode of NVUGIB and subsequently transferred to the participating site 2. There was presentation with NVUGIB to an Emergency Room (ER) not requiring admission to hospital 3. Endoscopy noted no gastro-duodenal ulcer bleeding, to ensure patient homogeneity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Because of their clinical importance, we have identified the combination of the two main guidelines that apply to the high-risk patient population as primary outcomes which is the adherence to both guidelines G10 and G17. G10: "mono-therapy with injection or thermal coagulation is an effective haemostatic technique for high-risk stigmata; but, the combination is superior to either alone", and G17: that "an intravenous bolus followed by continuous-infusion proton-pump inhibitor is effective in decreasing rebleeding in patients who have undergone successful endoscopic therapy". Adherence to G10 and G17 is defined as the proportion of patients with bleeding ulcers exhibiting high risk stigmata (active bleeding, visible vessel, and adherent clots) treated endoscopically with injection followed by thermal therapy and who thereafter also receive an IV PPI for a correct indication at a correct dosing (high dose pantoprazole 80 mg bolus followed by 8 mg/hour following the endoscopic therapy for a total of 72 hours (both ±12 hours), in patients undergoing successful endoscopic haemostasis for a high risk bleeding ulcer). As part of a pre-planned sensitivity analysis, the endoscopic therapy criterion will be broadened to accept performance of successful endoscopic haemostasis using either thermal or clips application alone, in keeping with persistent controversy and evolving data. The pharmacotherapy criterion is the definition of appropriate use we adopted in the nation-wide DURABLE audit of in-hospital PPI prescribing. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adherence to the different guidelines are defined as follows: 1.1. To G10 or G17 alone (an additional definition will assess adherence of G17 with administration of both bolus and infusion for correct indications and durations, but at incorrect dosing levels, and segregate incorrect dosing errors into underuse and overuse) 1.2. To G5b: "Early stratification of patients into low- and high-risk categories for rebleeding and mortality, based on clinical/endoscopic criteria, is important for proper management. Available prognostic scales may be used to assist in decision-making", as identification of a recorded Rockall score in the patient chart. 1.3. To G6: "Early endoscopy (in the first 24 hours) with risk classification by clinical/endoscopic criteria allows for safe and prompt discharge of patients classified as low risk; improves patient outcomes for high-risk patients; and reduces resource utilisation for patients classified as either low or high risk", as the performance of endoscopy within 24 hours of onset of presentation to the emergency room (or of onset of symptoms for in-patients) 1.4. A review of the endoscopic records will assess the correct decision as to the performance of endoscopic therapy or not according to the guidelines 7: 1.4.1. G7a: "A finding of low-risk endoscopic stigmata (a clean-based ulcer or a non-protuberant pigmented dot in an ulcer bed) is not an indication for endoscopic haemostatic therapy" 1.4.2. G7b: "A finding of a clot in an ulcer bed warrants targeted irrigation in an attempt at dislodgment, with appropriate treatment of the underlying lesion" 1.4.3. G7c: "A finding of high-risk endoscopic stigmata (active bleeding or a visible vessel in an ulcer bed) is an indication for immediate endoscopic haemostatic therapy", regardless of the chosen method 1.5. G18: "In patients awaiting endoscopy, empirical therapy with a high-dose proton pump inhibitor should be considered", for which any dose or method of administration is accepta | — |
Countries
Canada
Outcome results
None listed