Trial Outcomes & Findings for Mindful Hand Hygiene for Healthcare Workers (NCT NCT05261282)
NCT ID: NCT05261282
Last Updated: 2026-03-09
Results Overview
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. The scale could be broken into the subscales of Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity, or presented as a total score. The total FFMQ score is presented here on a scale from 1-5. Lower scores (1) mean less mindful, while higher scores (5) indicate the respondent is more mindful.
COMPLETED
NA
343 participants
Month 1
2026-03-09
Participant Flow
Participants were recruited based on work role at 2 VA Medical Centers between 11/7/2022 and 4/17/2024
In total, 474 physicians and nurses were approached to participate. Of those approached, 456 were eligible (either a registered nurse working on one of 6 participating nursing units or a physician on a randomly selected medicine team)
Participant milestones
| Measure |
Mindful Hand Hygiene Intervention
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
173
|
|
Overall Study
Participated in a Group Discussion
|
148
|
0
|
|
Overall Study
Completed at Least 1 Module
|
92
|
0
|
|
Overall Study
Completed Baseline Survey
|
139
|
145
|
|
Overall Study
Completed 1-Month (Post-Intervention) Survey
|
114
|
103
|
|
Overall Study
Completed 7-Month (Sustainability) Survey
|
98
|
99
|
|
Overall Study
Physicians Enrolled
|
108
|
113
|
|
Overall Study
Nurses Enrolled
|
62
|
60
|
|
Overall Study
COMPLETED
|
64
|
70
|
|
Overall Study
NOT COMPLETED
|
106
|
103
|
Reasons for withdrawal
| Measure |
Mindful Hand Hygiene Intervention
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
15
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Missing at least 1 survey or intervention task
|
98
|
88
|
Baseline Characteristics
In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
Baseline characteristics by cohort
| Measure |
Mindful Hand Hygiene Intervention
n=170 Participants
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=173 Participants
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-54
|
133 participants
n=150 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
137 participants
n=150 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
270 participants
n=300 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=170 Participants
|
15 Participants
n=173 Participants
|
23 Participants
n=343 Participants
|
|
Age, Customized
55 or older
|
17 participants
n=150 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
13 participants
n=150 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
30 participants
n=300 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
|
Sex: Female, Male
Female
|
85 Participants
n=150 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
90 Participants
n=149 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
175 Participants
n=299 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
|
Sex: Female, Male
Male
|
65 Participants
n=150 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
59 Participants
n=149 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
124 Participants
n=299 Participants • In total, 170 enrolled in the intervention and 173 enrolled in the control arm. However, several individuals did not complete the demographic information on the survey. Therefore, the number reported for specific demographic fields may be less than the total enrolled.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=170 Participants
|
0 Participants
n=173 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Asian
|
50 Participants
n=170 Participants
|
47 Participants
n=173 Participants
|
97 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=170 Participants
|
0 Participants
n=173 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=170 Participants
|
11 Participants
n=173 Participants
|
28 Participants
n=343 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=170 Participants
|
74 Participants
n=173 Participants
|
138 Participants
n=343 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=170 Participants
|
5 Participants
n=173 Participants
|
9 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=170 Participants
|
36 Participants
n=173 Participants
|
71 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=170 Participants
|
133 Participants
n=173 Participants
|
274 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=170 Participants
|
25 Participants
n=173 Participants
|
46 Participants
n=343 Participants
|
|
Region of Enrollment
United States
|
170 Participants
n=170 Participants
|
173 Participants
n=173 Participants
|
343 Participants
n=343 Participants
|
|
The Five Facet Mindfulness Questionnaire
|
3.25 units on a scale
STANDARD_DEVIATION 0.47 • n=139 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
3.31 units on a scale
STANDARD_DEVIATION 0.48 • n=142 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
3.28 units on a scale
STANDARD_DEVIATION 0.47 • n=281 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
|
The Well Being Index
|
3.01 units on a scale
STANDARD_DEVIATION 2.41 • n=138 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
2.61 units on a scale
STANDARD_DEVIATION 2.77 • n=141 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
2.81 units on a scale
STANDARD_DEVIATION 2.60 • n=279 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
|
Perceptions Survey for Healthcare Workers
|
92.1 units on a scale
STANDARD_DEVIATION 10.0 • n=137 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
92.5 units on a scale
STANDARD_DEVIATION 10.4 • n=139 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
92.3 units on a scale
STANDARD_DEVIATION 10.2 • n=276 Participants • Not all participants completed a baseline survey, and of those who did, some chose to skip some of the item questions.
|
PRIMARY outcome
Timeframe: Month 1Population: Intent to treat population. Of the 170 enrolled in the intervention, 114 returned a 1-month survey, however 5 were dropped from this analysis due to incomplete data. Of the 173 enrolled in the control arm, 103 returned a 1-month survey, but 2 were dropped from this analysis due to incomplete data..
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. The scale could be broken into the subscales of Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity, or presented as a total score. The total FFMQ score is presented here on a scale from 1-5. Lower scores (1) mean less mindful, while higher scores (5) indicate the respondent is more mindful.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=109 Participants
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=101 Participants
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
The Five Facet Mindfulness Questionnaire (FFMQ) - Post-Intervention
|
3.46 units on a scale
Standard Deviation 0.50
|
3.35 units on a scale
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: Month 1Population: Intent to treat population. Of the 170 enrolled in the intervention, 114 returned a 1-month survey, however 3 were dropped from this analysis due to incomplete data. Of the 173 enrolled in the control arm, 103 returned a 1-month survey, but 2 were dropped from this analysis due to incomplete data..
The 9-question Well-Being Index (WBI) assesses distress across a variety of dimensions including fatigue, depression, burnout, stress, and quality of life, and has been validated for use in physicians, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk). Lower scores indicate better well being.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=111 Participants
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=101 Participants
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Well-Being Index - Post-Intervention
|
2.19 units on a scale
Standard Deviation 2.40
|
2.29 units on a scale
Standard Deviation 2.75
|
PRIMARY outcome
Timeframe: Month 1Population: Intent to treat population. Of the 170 enrolled in the intervention, 114 returned a 1-month survey, however 4 were dropped from this analysis due to incomplete data. Of the 173 enrolled in the control arm, 103 returned a 1-month survey, but 3 were dropped from this analysis due to incomplete data.
The question assessing how often respondents felt they performed hand hygiene when required from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization was used. This question is scored on a scale of 0-100%. Higher scores indicate higher perception of performing hand hygiene when required.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=110 Participants
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=100 Participants
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Percentage of Situations Performing Hand Hygiene When Required (Self-Perception) - Post-Intervention
|
92.65 percentage
Standard Deviation 7.59
|
92.94 percentage
Standard Deviation 8.52
|
PRIMARY outcome
Timeframe: Month 7Population: Intent to treat population. Of the 170 enrolled in the intervention, 98 returned a 7-month survey, however 7 were dropped from this analysis due to incomplete data. Of the 173 enrolled in the control arm, 99 returned a 7-month survey, but 2 were dropped from this analysis due to incomplete data..
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. The scale could be broken into the subscales of Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity, or presented as a total score. The total FFMQ score is presented here on a scale from 1-5. Lower scores (1) mean less mindful, while higher scores (5) indicate the respondent is more mindful.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=91 Participants
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=97 Participants
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
The Five Facet Mindfulness Questionnaire (FFMQ) - Sustainability
|
3.49 units on a scale
Standard Deviation 0.46
|
3.39 units on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Month 7Population: Intent to treat population. Of the 170 enrolled in the intervention, 98 returned a 7-month survey, however 8 were dropped from this analysis due to incomplete data. Of the 173 enrolled in the control arm, 99 returned a 7-month survey, but 2 were dropped from this analysis due to incomplete data..
The 9-question Well-Being Index (WBI) assesses distress across a variety of dimensions including fatigue, depression, burnout, stress, and quality of life, and has been validated for use in physicians, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk). Lower scores indicate better well-being.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=90 Participants
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=97 Participants
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Well-Being Index - Sustainability
|
1.96 units on a scale
Standard Deviation 2.60
|
1.89 units on a scale
Standard Deviation 2.70
|
PRIMARY outcome
Timeframe: Month 7Population: Intent to treat population. Of the 170 enrolled in the intervention, 98 returned a 7-month survey, however 7 were dropped from this analysis due to incomplete data. Of the 173 enrolled in the control arm, 99 returned a 7-month survey, but 4 were dropped from this analysis due to incomplete data..
The question assessing how often respondents felt they performed hand hygiene when required from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization was used. This question is scored on a scale of 0-100%. Higher scores indicate higher perception of performing hand hygiene when required.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=91 Participants
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=95 Participants
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Percentage of Situations Performing Hand Hygiene When Required (Self-Perception) - Sustainability
|
92.82 Percentage
Standard Deviation 7.89
|
93.88 Percentage
Standard Deviation 7.69
|
SECONDARY outcome
Timeframe: Month 0Population: Physicians and nurses were observed for performing hand hygiene (either alcohol-based hand rub or soap and water) before patient room entry during a run-in habituation period to stabilize baseline behavior. Since this occurred prior to randomization, study arm comparisons and inferences cannot be made. The exact number of individual participants is unknown since the data was collected anonymously. The number provided is a rough estimate based on unit staffing at this time.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Hand hygiene was marked yes if a physician or nurse used hand rub or washed with soap and water before entering a patient room.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=4927 Room Entries
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Hand Hygiene Room Entry - Habituation
|
2413 Room Entries
|
—
|
SECONDARY outcome
Timeframe: Month 0Population: Physicians and nurses were observed for performing hand hygiene (either alcohol-based hand rub or soap and water) after patient room exit during a run-in habituation period to stabilize baseline behavior. Since this occurred prior to randomization, study arm comparisons and inferences cannot be made. The exact number of individual participants is unknown since the data was collected anonymously. The number provided is a rough estimate based on unit staffing at this time.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Hand hygiene was marked yes if a physician or nurse used hand rub or washed with soap and water upon exit from a patient room.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=5297 Room Exits
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Hand Hygiene Room Exit - Habituation
|
3232 Room Exits
|
—
|
SECONDARY outcome
Timeframe: Month 0Population: Duration in seconds was recorded for nurses and only attending physicians who performed hand hygiene at room exit during the run-in habituation period, prior to randomization. Arm comparisons cannot be made. Due to multiple physicians exiting at the same time, only attendings were chosen for measurement of duration. The exact number of individual participants is unknown since the data was collected anonymously. The number provided is a rough estimate based on unit staffing at this time.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Duration in seconds of hand hygiene was measured upon room exit for nurses and attending physicians.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=2337 Hand Hygiene on Room Exit
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
|
|---|---|---|
|
Duration Hand Hygiene Room Exit - Habituation
|
8.78 Seconds
Standard Deviation 7.58
|
—
|
SECONDARY outcome
Timeframe: Month 1Population: Physicians and nurses were observed during the intervention period for performing hand hygiene (either using alcohol-based hand rub or soap and water) before entry into a patient room. The unit of measure is the number of times a physician or nurse was observed entering a patient room. The exact number of individuals observed is unknown since the data was collected anonymously, however the number enrolled in the study is used as an estimate.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Hand hygiene was marked yes if a physician or nurse used hand rub or washed with soap and water before entering a patient room.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=4180 Room Entries
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
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Control Arm
n=4310 Room Entries
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
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Hand Hygiene Room Entry - Intervention Period
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2631 Room Entries
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2722 Room Entries
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SECONDARY outcome
Timeframe: Month 1Population: Physicians and nurses were observed during the intervention period for performing hand hygiene (either using alcohol-based hand rub or soap and water) upon exit from a patient room. The unit of measure is the number of times a physician or nurse was observed exiting a patient room. The exact number of individuals observed is unknown since the data was collected anonymously, however the number enrolled in the study is used as an estimate.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Hand hygiene was marked yes if a physician or nurse used hand rub or washed with soap and water upon exit from a patient room.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=4567 Room Exits
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
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Control Arm
n=4646 Room Exits
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
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Hand Hygiene Room Exit - Intervention Period
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3022 Room Exits
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3209 Room Exits
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SECONDARY outcome
Timeframe: Month 1Population: Duration in seconds was recorded for nurses and only attending physicians who performed hand hygiene upon room exit. Due to multiple physicians exiting the room at the same time, only one type (attendings) was chosen for measurement of duration. The exact number of individuals observed is unknown since the data was collected anonymously, however the number enrolled in the study is used as an estimate.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Duration in seconds of hand hygiene was measured upon room exit for nurses and attending physicians.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=1701 Hand Hygiene on Exit
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
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Control Arm
n=1814 Hand Hygiene on Exit
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
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Duration Hand Hygiene Room Exit - Intervention Period
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9.67 Seconds
Standard Deviation 5.99
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9.41 Seconds
Standard Deviation 6.84
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SECONDARY outcome
Timeframe: Months 2-13Population: Physicians and nurses were observed during the sustainability period for performing hand hygiene (either using alcohol-based hand rub or soap and water) before entry into a patient room. The unit of measure is the number of times a physician or nurse was observed entering a patient room. The exact number of individuals observed is unknown since the data was collected anonymously, however the number enrolled in the study is used as an estimate. Fewer physicians were observed during this period.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Hand hygiene was marked yes if a physician or nurse used hand rub or washed with soap and water before entering a patient room.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=1988 Room Entries
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=1806 Room Entries
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
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|---|---|---|
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Hand Hygiene Room Entry - Sustainability
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931 Room Entries
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759 Room Entries
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SECONDARY outcome
Timeframe: Months 2-13Population: Physicians and nurses were observed during the sustainability period for performing hand hygiene (either using alcohol-based hand rub or soap and water) upon exit from a patient room. The unit of measure is the number of times a physician or nurse was observed exiting a patient room. The exact number of individuals observed is unknown since the data was collected anonymously, however the number enrolled in the study is used as an estimate. Fewer physicians were observed during this period.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Hand hygiene was marked yes if a physician or nurse used hand rub or washed with soap and water upon exit from a patient room.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=170 Participants
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=1915 Room Exits
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
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|---|---|---|
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Hand Hygiene Room Exit - Sustainability
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1110 Room Exits
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1031 Room Exits
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SECONDARY outcome
Timeframe: Months 2-13Population: Duration in seconds was recorded for nurses and only attending physicians who performed hand hygiene upon room exit. The exact number of individual participants is unknown since the data was collected anonymously. The exact number of individuals observed is unknown since the data was collected anonymously, however the number enrolled in the study is used as an estimate. Fewer physicians were observed during this period due to the service schedule.
Research assistants conducted covert direct observations of hand hygiene moments during weekdays on select medical and medical/surgical hospital units. Duration in seconds of hand hygiene was measured upon room exit for nurses and attending physicians.
Outcome measures
| Measure |
Mindful Hand Hygiene Intervention
n=1053 Hand Hygiene on Exit
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Mindful Hand Hygiene: Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
Control Arm
n=955 Hand Hygiene on Exit
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
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|---|---|---|
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Duration Hand Hygiene Room Exit - Sustainability
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7.18 Seconds
Standard Deviation 4.62
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7.16 Seconds
Standard Deviation 4.57
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Adverse Events
Mindful Hand Hygiene Intervention
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
M. Todd Greene, PhD, MPH
VA Center for Clinical Management Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place