Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01318213
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2011-03-16
Brief Title:
Benefits of Universal Glove and Gowning
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Effect of the Use of Universal Glove and Gowning on Healthcare Associated Infection Rates and Antibiotic Resistant Bacteria
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUGG
Brief Summary:
This study will test if doctors nurses and other people who take care of patients in hospitals wearing gloves and gown for all contact with patients in an intensive care unit ICU will
Decrease the chance of patients getting an infection while in the hospital
Decrease the chance of patients picking up bacteria as a result of being in the hospital
Decrease the time a patient spends in the ICU or in the hospital
Increase the frequency of adverse events
The study will also look at whether making doctors nurses and other people who take care of patients wear gloves and gown for all contact with patients will decrease the amount of time healthcare workers spend with patients
This study will gather information by comparing what happens in ICUs that continue to do what they were doing before the study with what happens in ICUs that require healthcare workers to wear gloves and gown for all contact with patients
This study will provide information that will help to make being in the hospital safer for all patients
Decrease the chance of patients getting an infection while in the hospital
Decrease the chance of patients picking up bacteria as a result of being in the hospital
Decrease the time a patient spends in the ICU or in the hospital
Increase the frequency of adverse events
The study will also look at whether making doctors nurses and other people who take care of patients wear gloves and gown for all contact with patients will decrease the amount of time healthcare workers spend with patients
This study will gather information by comparing what happens in ICUs that continue to do what they were doing before the study with what happens in ICUs that require healthcare workers to wear gloves and gown for all contact with patients
This study will provide information that will help to make being in the hospital safer for all patients
Detailed Description:
GOAL
The overall goal of this project is to determine the effectiveness of universal glove and gowning procedures in reducing healthcare-associated infection HAI rates and acquisition of antibiotic-resistant bacteria in the Intensive Care Unit ICU More specifically this project requires that a cluster-randomized trial CRT be designed and conducted to compare the effects of universal glove and gowning procedures as compared to the current standard of care in ICUs
STUDY DESIGN The study is a two arm cluster-randomized trial Randomization and analysis will be performed at the ICU level A secondary statistical analysis will be performed at the patient level
STUDY POPULATION Adult patients in medical surgical or combined medicalsurgical ICUs
SAMPLE SIZE Based on the power calculations presented in Appendix I for each of the CRT aims the study will use at least 18 ICU sites half for the universal gown and glove intervention and half for CDC standards of care only We will seek to maximize the number of ICUs involved to improve the scientific value of the study The study is presently powered for a 1-year intervention study if 18 ICUs are included After the 2 month pre-randomization period we will use the actual number of sites enrolled and our baseline estimates to see if we can achieve the same degree of power for a study intervention of less than a year
We have been able to recruit and retain 20 ICU sites Upon completion of the pre-randomization period and based upon revised power calculations we will complete a 9-month intervention
RANDOMIZATION Randomization with pair matching based on the baseline data collection of outcomes will be used
DATA ANALYSIS Analyses of all aims will be performed according to the intention-to-treat ITT paradigm at the ICU level and will accommodate the matched-pairs design
INTERVENTION
Aim 1 Perform a CRT in which healthcare workers in the intervention ICUs will wear gloves and gowns for all patient contact while the control units perform regular standard and contact precautions per CDC guidelines in their respective ICUs
Aim 1a Measure the colonization acquisition rates of antibiotic-resistant pathogens in both intervention and non-intervention ICUs
Aim 1b Measure the HAI rates of catheter-associated bloodstream infection catheter-associated urinary tract infection and ventilator-associated pneumonia in both intervention and non-intervention ICUs
Aim 1c Measure in-hospital 30-day mortality in both intervention and non-intervention ICUs
Aim 1d Measure hospital length of stay in both intervention and non-intervention ICUs
Aim 1e Measure the frequency of adverse events including frequency of healthcare worker visits and frequency of adverse events using an IHI adverse event tool
Aim 1f Statistically determine whether the intervention was effective in decreasing acquisition of antibiotic-resistant bacteria primary outcome reducing HAI rates secondary outcome decreasing in-hospital 30-day mortality secondary outcome decreasing length of stay secondary outcome and not increasing adverse events secondary outcome
HYPOTHESES
Hypothesis 1a Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will reduce antibiotic-resistant pathogen acquisition in at-risk patients
Hypothesis 1b Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease HAI rates
Hypothesis 1c Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease 30-day mortality
Hypothesis 1d Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease hospital length of stay
Hypothesis 1e Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will not lead to an increase of adverse events
CRITERIA FOR EVALUATION
Primary Outcome
The primary outcome of interest is the acquisition of an antibiotic-resistant pathogen specifically Vancomycin-resistant Enterococcus VRE or Methicillin Resistant Staphylococcus AureusMRSA as determined by peri-anal surveillance cultures for VRE and by nasal surveillance cultures for MRSA The outcomes will be analyzed both individually and collectively ie VRE MRSA and VRE or MRSA
Acquisition will be defined as
1 A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen and
2 Any subsequent surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen
Secondary Outcomes
The HAI rates to be measured will consist of catheter-associated bloodstream infection catheter-associated urinary tract infection and ventilator-associated pneumonia rates Hospital length of stay and 30-day mortality will also be measured as secondary outcomes Adverse events are also a secondary outcome and will be measured using the frequency of healthcare worker visits and the frequency of adverse events as measured by an IHI tool
The overall goal of this project is to determine the effectiveness of universal glove and gowning procedures in reducing healthcare-associated infection HAI rates and acquisition of antibiotic-resistant bacteria in the Intensive Care Unit ICU More specifically this project requires that a cluster-randomized trial CRT be designed and conducted to compare the effects of universal glove and gowning procedures as compared to the current standard of care in ICUs
STUDY DESIGN The study is a two arm cluster-randomized trial Randomization and analysis will be performed at the ICU level A secondary statistical analysis will be performed at the patient level
STUDY POPULATION Adult patients in medical surgical or combined medicalsurgical ICUs
SAMPLE SIZE Based on the power calculations presented in Appendix I for each of the CRT aims the study will use at least 18 ICU sites half for the universal gown and glove intervention and half for CDC standards of care only We will seek to maximize the number of ICUs involved to improve the scientific value of the study The study is presently powered for a 1-year intervention study if 18 ICUs are included After the 2 month pre-randomization period we will use the actual number of sites enrolled and our baseline estimates to see if we can achieve the same degree of power for a study intervention of less than a year
We have been able to recruit and retain 20 ICU sites Upon completion of the pre-randomization period and based upon revised power calculations we will complete a 9-month intervention
RANDOMIZATION Randomization with pair matching based on the baseline data collection of outcomes will be used
DATA ANALYSIS Analyses of all aims will be performed according to the intention-to-treat ITT paradigm at the ICU level and will accommodate the matched-pairs design
INTERVENTION
Aim 1 Perform a CRT in which healthcare workers in the intervention ICUs will wear gloves and gowns for all patient contact while the control units perform regular standard and contact precautions per CDC guidelines in their respective ICUs
Aim 1a Measure the colonization acquisition rates of antibiotic-resistant pathogens in both intervention and non-intervention ICUs
Aim 1b Measure the HAI rates of catheter-associated bloodstream infection catheter-associated urinary tract infection and ventilator-associated pneumonia in both intervention and non-intervention ICUs
Aim 1c Measure in-hospital 30-day mortality in both intervention and non-intervention ICUs
Aim 1d Measure hospital length of stay in both intervention and non-intervention ICUs
Aim 1e Measure the frequency of adverse events including frequency of healthcare worker visits and frequency of adverse events using an IHI adverse event tool
Aim 1f Statistically determine whether the intervention was effective in decreasing acquisition of antibiotic-resistant bacteria primary outcome reducing HAI rates secondary outcome decreasing in-hospital 30-day mortality secondary outcome decreasing length of stay secondary outcome and not increasing adverse events secondary outcome
HYPOTHESES
Hypothesis 1a Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will reduce antibiotic-resistant pathogen acquisition in at-risk patients
Hypothesis 1b Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease HAI rates
Hypothesis 1c Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease 30-day mortality
Hypothesis 1d Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease hospital length of stay
Hypothesis 1e Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will not lead to an increase of adverse events
CRITERIA FOR EVALUATION
Primary Outcome
The primary outcome of interest is the acquisition of an antibiotic-resistant pathogen specifically Vancomycin-resistant Enterococcus VRE or Methicillin Resistant Staphylococcus AureusMRSA as determined by peri-anal surveillance cultures for VRE and by nasal surveillance cultures for MRSA The outcomes will be analyzed both individually and collectively ie VRE MRSA and VRE or MRSA
Acquisition will be defined as
1 A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen and
2 Any subsequent surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen
Secondary Outcomes
The HAI rates to be measured will consist of catheter-associated bloodstream infection catheter-associated urinary tract infection and ventilator-associated pneumonia rates Hospital length of stay and 30-day mortality will also be measured as secondary outcomes Adverse events are also a secondary outcome and will be measured using the frequency of healthcare worker visits and the frequency of adverse events as measured by an IHI tool
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSA290200600015i | OTHER_GRANT | AHRQ PRISM No HHSA29032002T | None |