Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620263
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Stress Ulcer Prophylaxis Practices in the Intensive Care Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ensuring Guideline Adherence and Cost Savings in Stress Ulcer Prophylaxis Practices in the Intensive Care Unit a Pre-Post Education Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
guideline
Brief Summary:
The present study aimed to examine the adherence of proton pump inhibitors PPIs commonly recommended for stress ulcer prevention SUP in patients in the intensive care unit ICU according to an international guideline The objective of the study was to enhance the adherence of SUP prescriptions to the guideline therefore preventing potential adverse effects and avoidable financial burden and consequently attaining cost reduction
Detailed Description:
Background Intensive care unit ICU patients are prone to developing stress-related gastrointestinal GI bleeding which is associated with increased morbidity and mortality Respiratory failure hypotension coagulopathy and especially prolonged mechanical ventilation MV are the most critical clinically significant risk factors for GI bleeding in patients Many studies have shown that invasive MV for 48 hours or longer and coagulopathy are two independent risk factors for clinically significant upper GI bleeding in ICU patients
Stress ulcer prophylaxis SUP is widely practiced in ICUs worldwide and is often up to 70 used inappropriately Proton pump inhibitors PPI are among the most commonly used medications in critically ill patients for SUP However the inappropriate and quite inconsistent use of PPIs in ICUs has added unnecessary costs enhanced risks related to adverse drug reactions and possible complications like pneumonia Clostridium difficile infections hypomagnesemia and bone fractures
A few studies have assessed adherence with SUP guidelines and institutional standards under the surveillance of a pharmacist The results of these studies implied that pharmacist supervision reduced the inappropriate use of SUP in patients and its associated healthcare costs One of these studies noted that the intervention and adjustment of pharmacists reduced the incidence of inappropriate use of SUP and its associated costs from 2675 and 2433 per 100 patient days pre-intervention to 714 and 23980 per 100 patient days post-intervention with pamplt0001 The same study emphasized that a comprehensive multidisciplinary approach must be implemented to decrease inappropriate SUP use in the ICU
The aim of this study is to enhance adherence to the guidelines through an educational program focused on reducing inappropriate use of SUP in the ICU The goal is to promote appropriate use of SUP based on indications leading to cost savings
Methods Study Design and Participants This study was designed as a non-randomized controlled prospective study created according to the pre-post education evaluation model It was conducted in the anesthesia and reanimation ICU of a training and research hospital between January 2024 and July 2024 6 months The study was conducted in pre-education PreEd and post-education PostEd In PreEd the SUP use of patients in the ICU was observed observationally for three months January 1 2024 - April 1 2024 In the study the SUP education program in the ICU was implemented for ICU physicians after examining the patient data in the first three months of the study In the 3-month PostEd after the education program April 3 2024 - July 3 2024 SUP was only used in patients in the ICU and no intervention was observed Throughout the study period the appropriateness of SUP uses for the indication was evaluated according to the Sociedade Portuguesa de Cuidados SPC SUP guideline
Education Program The education program was organized on April 3 2024 after completing the 3-month PreEd review The 1-hour education program was presented face-to-face to ICU physicians by a clinical pharmacist and an intensive care specialist physician The content of the education included education on SUP pathophysiology of stress ulcer SUP riskbenefit situations guidelines for SUP introduction of appropriate SUP criteria according to the SPC SUP guideline and frequently inappropriate SUP prescription situations in ICU and the correct time to stop SUP The evaluations obtained during the PreEd review in the ICU were also presented to the physicians participating in the education
Data Collection Sociodemographic information disease and medication history existing laboratory values coagulation parameters procalcitonin c-reactive protein etc culture results MV status nutritional status GI system bleeding status pneumonia status presence of Clostiridioides difficile appropriateinappropriate SUP use days and costs were obtained from the patientamp39s treatment file and the hospital information management system with the utmost respect for personal privacy conditions
Assessment of the Stress Ulcer Prophylaxis Use SUP use of ICU patients was evaluated throughout the week SUP practices of ICU patients and patient data were reviewed by a clinical pharmacist and an intensive care specialist and evaluated for compliance with the SPC SUP criteria in terms of indication 12 No intervention was made in the patientsamp39 SUP practices in either period
Sample Size For the studyamp39s sample size it was determined that there should be at least 42 patients in each period based on the literature data that inappropriate SUP use in patient groups is reduced by approximately 30 based on the calculation made on alpha 005 and 95 power values Considering the 15 loss margin it was decided to include 96 patients in the study with at least 48 patients each period
Definitions Authors defined significant GI bleeding as bleeding requiring a gastroscopy or blood transfusion upon clinician judgment C difficile infection was defined as the presence of relevant symptoms with positive fecal toxin andor polymerase chain reaction in ICU patients after initiation of SUP in the ICU
The rate of SUP use in appropriate indications was accepted as the percentage of PPIs used by a patient according to the SPC SUP guideline for the total number of hospital days
Outcomes Measurement Adherence rates to SPC SUP guideline and costs of nonadherence were primary outcome measurements
Inclusion and Exclusion Criteria Patients aged 18 years those with an ICU stay longer than 24 hours and those using PPIs for SUP were included in the study Patients with a diagnosis of gastric cancer history of GI those with subtotaltotal gastrectomy those using PPIs for treatment indications such as dual antiplatelet therapy and those admitted to the ICU with GI bleeding were excluded from the study
Statistical analysis The study used descriptive statistics including mean median standard deviation interquartile range IQR count and percentages to show continuous variables central tendency and variability For categorical variables frequency and percentages were given The Kolmogorov-Smirnov test was used to see if continuous variables followed the normal distribution The result was non-parametric The Mann-Whitney U tests were used to compare continuous variables between two groups Categorical data was compared using Chi-square tests A 95 confidence interval CI with a p-value less than 005 was considered statistically significant Analysis of the dataset was done on an overall basis with the help of IBM SPSS Statistics for Windows Version 290 Armonk New York IBM Corp Cost Savings Analysis This study compared the costs of SUP agents prescribed for inappropriate indications between PreEd and PostEd Finally the SUP cost per patient was determined by multiplying the number of appropriate and inappropriate days of use in both PreEd and PostEd by the cost of PPI Differences in the SUP costs between PreEd and PostEd are called cost-saving
The costs for the SUP agents were estimated using current drug prices available from the hospital where this study was conducted Thus ten pantoprazole intravenous IV ampules were accepted for 3 Only the costs related to PPIs have been calculated The calculation excluded nursing services and medical supplies
Stress ulcer prophylaxis SUP is widely practiced in ICUs worldwide and is often up to 70 used inappropriately Proton pump inhibitors PPI are among the most commonly used medications in critically ill patients for SUP However the inappropriate and quite inconsistent use of PPIs in ICUs has added unnecessary costs enhanced risks related to adverse drug reactions and possible complications like pneumonia Clostridium difficile infections hypomagnesemia and bone fractures
A few studies have assessed adherence with SUP guidelines and institutional standards under the surveillance of a pharmacist The results of these studies implied that pharmacist supervision reduced the inappropriate use of SUP in patients and its associated healthcare costs One of these studies noted that the intervention and adjustment of pharmacists reduced the incidence of inappropriate use of SUP and its associated costs from 2675 and 2433 per 100 patient days pre-intervention to 714 and 23980 per 100 patient days post-intervention with pamplt0001 The same study emphasized that a comprehensive multidisciplinary approach must be implemented to decrease inappropriate SUP use in the ICU
The aim of this study is to enhance adherence to the guidelines through an educational program focused on reducing inappropriate use of SUP in the ICU The goal is to promote appropriate use of SUP based on indications leading to cost savings
Methods Study Design and Participants This study was designed as a non-randomized controlled prospective study created according to the pre-post education evaluation model It was conducted in the anesthesia and reanimation ICU of a training and research hospital between January 2024 and July 2024 6 months The study was conducted in pre-education PreEd and post-education PostEd In PreEd the SUP use of patients in the ICU was observed observationally for three months January 1 2024 - April 1 2024 In the study the SUP education program in the ICU was implemented for ICU physicians after examining the patient data in the first three months of the study In the 3-month PostEd after the education program April 3 2024 - July 3 2024 SUP was only used in patients in the ICU and no intervention was observed Throughout the study period the appropriateness of SUP uses for the indication was evaluated according to the Sociedade Portuguesa de Cuidados SPC SUP guideline
Education Program The education program was organized on April 3 2024 after completing the 3-month PreEd review The 1-hour education program was presented face-to-face to ICU physicians by a clinical pharmacist and an intensive care specialist physician The content of the education included education on SUP pathophysiology of stress ulcer SUP riskbenefit situations guidelines for SUP introduction of appropriate SUP criteria according to the SPC SUP guideline and frequently inappropriate SUP prescription situations in ICU and the correct time to stop SUP The evaluations obtained during the PreEd review in the ICU were also presented to the physicians participating in the education
Data Collection Sociodemographic information disease and medication history existing laboratory values coagulation parameters procalcitonin c-reactive protein etc culture results MV status nutritional status GI system bleeding status pneumonia status presence of Clostiridioides difficile appropriateinappropriate SUP use days and costs were obtained from the patientamp39s treatment file and the hospital information management system with the utmost respect for personal privacy conditions
Assessment of the Stress Ulcer Prophylaxis Use SUP use of ICU patients was evaluated throughout the week SUP practices of ICU patients and patient data were reviewed by a clinical pharmacist and an intensive care specialist and evaluated for compliance with the SPC SUP criteria in terms of indication 12 No intervention was made in the patientsamp39 SUP practices in either period
Sample Size For the studyamp39s sample size it was determined that there should be at least 42 patients in each period based on the literature data that inappropriate SUP use in patient groups is reduced by approximately 30 based on the calculation made on alpha 005 and 95 power values Considering the 15 loss margin it was decided to include 96 patients in the study with at least 48 patients each period
Definitions Authors defined significant GI bleeding as bleeding requiring a gastroscopy or blood transfusion upon clinician judgment C difficile infection was defined as the presence of relevant symptoms with positive fecal toxin andor polymerase chain reaction in ICU patients after initiation of SUP in the ICU
The rate of SUP use in appropriate indications was accepted as the percentage of PPIs used by a patient according to the SPC SUP guideline for the total number of hospital days
Outcomes Measurement Adherence rates to SPC SUP guideline and costs of nonadherence were primary outcome measurements
Inclusion and Exclusion Criteria Patients aged 18 years those with an ICU stay longer than 24 hours and those using PPIs for SUP were included in the study Patients with a diagnosis of gastric cancer history of GI those with subtotaltotal gastrectomy those using PPIs for treatment indications such as dual antiplatelet therapy and those admitted to the ICU with GI bleeding were excluded from the study
Statistical analysis The study used descriptive statistics including mean median standard deviation interquartile range IQR count and percentages to show continuous variables central tendency and variability For categorical variables frequency and percentages were given The Kolmogorov-Smirnov test was used to see if continuous variables followed the normal distribution The result was non-parametric The Mann-Whitney U tests were used to compare continuous variables between two groups Categorical data was compared using Chi-square tests A 95 confidence interval CI with a p-value less than 005 was considered statistically significant Analysis of the dataset was done on an overall basis with the help of IBM SPSS Statistics for Windows Version 290 Armonk New York IBM Corp Cost Savings Analysis This study compared the costs of SUP agents prescribed for inappropriate indications between PreEd and PostEd Finally the SUP cost per patient was determined by multiplying the number of appropriate and inappropriate days of use in both PreEd and PostEd by the cost of PPI Differences in the SUP costs between PreEd and PostEd are called cost-saving
The costs for the SUP agents were estimated using current drug prices available from the hospital where this study was conducted Thus ten pantoprazole intravenous IV ampules were accepted for 3 Only the costs related to PPIs have been calculated The calculation excluded nursing services and medical supplies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None