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 medical/surgical 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 Aureus(MRSA), 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 (i.e., 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.
