Hand Hygiene
Conditions
Keywords
Hand Hygiene, Non-sterile glove use
Brief summary
The necessity of Hand hygiene (HH) before donning non-sterile gloves is unknown. Furthermore, because of the additional time required to cleanse hands and then don gloves, as well as the cumbersome nature of applying gloves to recently washed hands, this practice leads to non-compliance with both HH and glove use - placing patients at risk. In a pilot study, the investigators performed a randomized trial of 230 healthcare workers and demonstrated no difference in total bacterial colony counts or identification of pathogenic bacteria from the gloves of persons who either performed HH or did not perform HH prior to putting on non-sterile gloves. If unnecessary, HH before non-sterile glove use wastes valuable time, which might otherwise be spent engaged in direct patient care. And removing this unnecessary step may lead to increased compliance with infection prevention measures. In Aim A, the investigators will perform a multi-center randomized control trial to evaluate the efficacy of a direct gloving strategy to improve compliance with infection prevention practices. In Aim B, the investigators will perform a nested multi-center validation study, where the gloved hands of healthcare workers will be randomly sampled to determine bacterial contamination of non-sterile gloves after donning.
Detailed description
This study seeks to investigate alternative strategies to hand hygiene (HH) and glove use in situations where glove use is required to perform health care activities in an effort to increase compliance with infection prevention efforts. HH is the cornerstone of infection prevention. Despite the importance of and increased focus on HH, compliance remains low in healthcare settings (40% on average in a large meta-analysis). Insufficient time, high workload and under staffing are important barriers. Glove use, which is common and increasing, is another major barrier. New strategies are needed that improve time and efficiency particularly in settings where glove use is required (e.g. Contact Precautions). One area for further study is the requirement for HH prior to non-sterile glove use. This is a recommended practice with poor compliance that may be unnecessary. Furthermore, it may lead to reduced compliance with other recommended infection prevention practices, such as glove use. In this proposal the investigators identify a novel strategy of directly gloving without performing HH prior to non-sterile glove use as a potential solution. In this study the investigators aim to perform a multicenter, cluster-randomized trial to evaluate the efficacy of direct gloving to improve compliance with infection prevention practices (i.e. HH and glove use). Herein, the investigators will evaluate the safety and efficacy of directly gloving (compared to performing HH prior to glove use) and assess whether this strategy will lead to increased compliance with both HH and glove use. The investigators previously demonstrated the safety of this strategy in a single-center randomized controlled pilot trial where the investigators found no difference in bacterial contamination of gloves of healthcare providers who either performed or did not perform HH prior to donning non-sterile gloves. Thus, with potentially no added benefit and in a setting where the investigators know that HH compliance is the lowest (i.e. prior to glove use), mandating HH prior to donning gloves as recommended in current guidelines could actually reduce both HH and glove compliance, placing patients at increased risk for developing infection.
Interventions
Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.
Sponsors
Study design
Eligibility
Inclusion criteria
For Aim B Inclusion Criteria: * Health professional at one of the study sites * Has direct interaction with patients at study sites (healthcare worker)
Exclusion criteria
* \<18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms | 1 year | Healthcare workers in the usual care group will be recorded as compliant if hand hygiene AND glove use is observed at room entry; healthcare workers in the intervention group only need to have glove use observed to be considered compliant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms | 1 year | Proportion of healthcare worker compliance with glove use upon entry to Contact Precaution-patient rooms for both groups |
| Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room | 1 year | Proportion of healthcare worker compliance with hand hygiene upon entry into non-contact precaution patient rooms |
| Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room | 1 year | Proportion of healthcare worker compliance with hand hygiene upon exit from any patient room |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Bacterial Colony Count | 1 year | Mean bacterial colony count from gloves of healthcare workers in the intervention and control units |
Countries
United States
Participant flow
Recruitment details
Units within each hospital were recruited to participate in the baseline study. Observation of healthcare worker hand hygiene and glove use were observed during the baseline period. Units with similar hand hygiene and glove use compliance were approached for participation in the study.
Participants by arm
| Arm | Count |
|---|---|
| Donning Non-Sterile Gloves Without HH In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves is NOT necessary.
Donning Non-Sterile Gloves without hand hygiene: Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.
Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms. | 633 |
| Donning Non-Sterile Gloves Without HH In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves is NOT necessary.
Donning Non-Sterile Gloves without hand hygiene: Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.
Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms. | 6 |
| HH Before Donning Non-Sterile Gloves In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.
Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms. | 927 |
| HH Before Donning Non-Sterile Gloves In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.
Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms. | 7 |
| Total | 1,573 |
Baseline characteristics
| Characteristic | Total | HH Before Donning Non-Sterile Gloves | Donning Non-Sterile Gloves Without HH |
|---|---|---|---|
| Adherence to expected practice at entry to contact precaution rooms | 518 Participants | 282 Participants | 236 Participants |
| Age, Customized Unknown | 1560 Participants | 927 Participants | 633 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex/Gender, Customized Unknown | 1560 Participants | 927 Participants | 633 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6,700 | 0 / 6,158 |
| other Total, other adverse events | 0 / 6,700 | 0 / 6,158 |
| serious Total, serious adverse events | 0 / 6,700 | 0 / 6,158 |
Outcome results
Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms
Healthcare workers in the usual care group will be recorded as compliant if hand hygiene AND glove use is observed at room entry; healthcare workers in the intervention group only need to have glove use observed to be considered compliant.
Time frame: 1 year
Population: The number analyzed is the number of observations made within each group of units randomized
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Donning Non-Sterile Gloves Without Hand Hygiene | Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms | 1297 Participants |
| Hand Hygiene Before Donning Non-Sterile Gloves | Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms | 954 Participants |
Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room
Proportion of healthcare worker compliance with hand hygiene upon entry into non-contact precaution patient rooms
Time frame: 1 year
Population: The number analyzed is the number of observations made within each group of units randomized
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Donning Non-Sterile Gloves Without Hand Hygiene | Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room | 1111 Participants |
| Hand Hygiene Before Donning Non-Sterile Gloves | Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room | 951 Participants |
Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room
Proportion of healthcare worker compliance with hand hygiene upon exit from any patient room
Time frame: 1 year
Population: The number analyzed is the number of observations made within each group of units randomized
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Donning Non-Sterile Gloves Without Hand Hygiene | Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room | 1525 Participants |
| Hand Hygiene Before Donning Non-Sterile Gloves | Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room | 1587 Participants |
Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms
Proportion of healthcare worker compliance with glove use upon entry to Contact Precaution-patient rooms for both groups
Time frame: 1 year
Population: The number analyzed is the number of observations made within each group of units randomized
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Donning Non-Sterile Gloves Without Hand Hygiene | Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms | 1297 Participants |
| Hand Hygiene Before Donning Non-Sterile Gloves | Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms | 1530 Participants |
Mean Total Bacterial Colony Count
Mean bacterial colony count from gloves of healthcare workers in the intervention and control units
Time frame: 1 year
Population: The number analyzed is the number of observations made within each group of units randomized
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Donning Non-Sterile Gloves Without Hand Hygiene | Mean Total Bacterial Colony Count | 16.3 Colony forming units |
| Hand Hygiene Before Donning Non-Sterile Gloves | Mean Total Bacterial Colony Count | 9.5 Colony forming units |