Mindful Hand Hygiene to Reduce Infections Among Veterans While Enhancing Provider Well-Being
Phase: NA
Conditions: Burnout, Mental Health
Sponsor: VA Office of Research and Development

IIR 19-097: Mindful Hand Hygiene to Reduce Infections Among 
Veterans While Enhancing Provider Well-Being 
Funding Agency: VA Health Services Research and Development 
Principal Investigator: M. Todd Greene, PhD 
Co-Principal Investigator: Sanjay Saint, MD, MPH 
Multi-Site Project – Sites with Subject Participation 
LTC Charles S. Kettles VA Medical Center, Ann Arbor, MI – (506) 
Michael E. DeBakey VA Medical Center, Houston, TX -  
Support Site Only - No Subject Participation 
VA Palo Alto Healthcare System, Palo Alto, CA - 
1&7Version: 05/31/2023 

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Abstract 
Objectives: Hand hygiene is a key element of preventing healthcare-associated 
infection (HAI), yet maintaining healthcare provider adherence to this basic practice 
remains challenging.  Mindfulness is an approach that can help clinicians shed 
preconceived biases through nonjudgmental awareness and more broadly facilitate 
improvements in patient safety.  While targeted interventions and bundled approaches 
to improve hand hygiene adherence and reduce HAI have been implemented, 
interventions incorporating introspective techniques, such as mindfulness, are limited. 
The goal of this study is to utilize a mindfulness-based approach to optimize provider 
hand hygiene adherence, improve provider well-being and enhance the quality and 
safety of care delivered to Veterans.  
Research Plan: We will conduct a randomized controlled mixed-methods trial at 2 
diverse VHA hospitals. Physicians and nurses randomized to the intervention arm will 
receive mindfulness education and tools to prompt mindfulness during hand hygiene. 
Measures of hand hygiene (adherence, duration, and perceptions) and measures of 
provider mindfulness and well-being will be collected and compared between the 
intervention and control groups.  
Methods: Participants in this study will include physicians and nurses at the LTC 
Charles S. Kettles Veterans Affairs (VA) Medical Center (Ann Arbor VAMC) and the 
Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, TX.  Participants in 
the intervention groups will receive mindfulness education, participate in mindfulness 
guided discussions, will be encouraged to use a mindfulness mobile application as a 
practice reminder and additional resource, and be instructed to integrate moments of 
mindfulness with repeated moments of hand hygiene during the course of caring for 
patients. The control groups will receive no such education or intervention and will 
continue usual care.  All participants will be asked to complete a survey aimed at 
measuring mindfulness, well-being, and hand hygiene perceptions at baseline, after 
completion of the intervention period, and at 6 months follow-up.  To evaluate the 
impact the intervention has on hand hygiene, hand hygiene observations will be 
conducted on each participating unit and physician team.  We will also conduct a 
qualitative evaluation (intervention participants only) to better understand the perception 
of the intervention and assess any barriers or facilitators encountered.  For this 
evaluation, we will conduct individual or group interviews as well as audio record the 
guided discussions with participants.  
Clinical Relevance: At the conclusion of the study, we will aim to have a hand hygiene-
based mindfulness intervention package that we can subsequently work to deploy more 
broadly across VHA hospitals to improve the safety of Veterans and the well-being of 
those providing their healthcare. 

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List of Abbreviations 
Ann Arbor VAMC 
Lieutenant Colonel Charles S. Kettles Veterans Affairs Medical Center 
 
App 
 
 
Mobile application 
 
CCMR  
 
Center for Clinical Management Research 
 
CMARRS 
 
Center for Mobile Apps Research Services 
 
FFMQ  
 
Five Facet Mindfulness Questionnaire 
 
HAI 
 
 
Healthcare-associated infection 
 
iOS 
 
 
Apple Mobile Operating System 
 
IPA 
 
 
Intergovernmental Personnel Agreements 
 
IQuEST 
 
Center for Innovations in Quality, Effectiveness and Safety 
 
IRB 
 
 
Institutional review board 
 
LTC 
 
 
Lieutenant Colonel 
 
MEDVAMC 
 
Michael E. DeBakey Veterans Affairs Medical Center 
 
MI 
 
 
Michigan 
 
PD/PI  
 
Project Director/Principal investigator 
 
PSHW  
 
Perceptions Survey for Healthcare Workers 
 
PTSD  
 
Post-traumatic stress disorder 
 
STREAM 
 
Skills Training for Resilience, Effectiveness, and Mindfulness 
 
TX 
 
 
Texas 
 
U of M  
 
University of Michigan 
 
VA 
 
 
Veterans Affairs 
 
VAAAHS 
 
Veterans Affairs Ann Arbor Healthcare System 
 
VHA 
 
 
Veterans Health Administration 
 
WBI 
 
 
Well-Being Index 
 
 
 

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Contents 
Protocol Title: ............................................................................................................................. 5 
1.0 
Study Personnel .............................................................................................................. 5 
2.0 
Introduction ..................................................................................................................... 6 
3.0 
Objectives ......................................................................................................................11 
4.0 
Resources and Personnel ..............................................................................................12 
5.0 
Study Procedures ...........................................................................................................16 
5.1 Study Design ...................................................................................................................16 
5.2 Recruitment Methods.......................................................................................................27 
5.3 Informed Consent Procedures .........................................................................................30 
5.4 Inclusion/Exclusion Criteria ..............................................................................................31 
5.5 Study Evaluations ............................................................................................................31 
5.6 Data Analysis ..................................................................................................................33 
5.7 Withdrawal of Subjects ....................................................................................................35 
6.0 
Reporting ........................................................................................................................35 
7.0 
Privacy and Confidentiality .............................................................................................36 
8.0 
Communication Plan ......................................................................................................36 
9.0 
References ...................................................................................................................37 
 
 
 

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Protocol Title:  Mindful Hand Hygiene to Reduce Infections Among 
Veterans While Enhancing Provider Well-Being 
1.0 
Study Personnel 
LTC Charles S. Kettles VA Medical Center (Ann Arbor VAMC), Ann Arbor, MI 
 
Personnel 
Role on 
Project 
Title – Affiliation 
Email 
Phone 
M. Todd Greene, 
PhD, MPH 
Principal 
Investigator 
Research Health Science Specialist 
VA Center for Clinical Management 
Research (CCMR), Ann Arbor VAMC; 
Associate Research Scientist, Division 
of Hospital Medicine University of 
Michigan (U of M)  
Michael.Greene2
@va.gov; 
mtgreene@med.u
mich.edu  
 
Sanjay Saint, 
MD, MPH 
Co-Principal 
Investigator 
Chief of Medicine, VA Ann Arbor 
Healthcare System (VAAAHS); 
George Dock Professor of Internal 
Medicine, U of M 
saint@med.umich
.edu 
 
Molly Harrod, 
PhD 
Co-
Investigator 
Director Qualitative Methods Core, VA 
CCMR 
Molly.Harrod@va.
gov 
 
Nathan 
Houchens, MD 
Co-
Investigator 
Associate Chief of Medicine VAAAHS 
nathanho@med.u
mich.edu  
 
Virginia Sheffield 
Co-
Investigator 
Clinical Assistant Professor, VAAAHS 
vmmorris@med.u
mich.edu 
 
Staff 
 
 
 
 
David Clive 
Research 
Assistant 
VA CCMR 
David.Clive@va.g
ov  
 
Jason Engle, 
MPH 
Research 
Assistant 
WOC – U of M Hospital Medicine 
Jason.Engle@va.
gov 
 
Karen Fowler, 
MPH 
Project 
Manager 
VA CCMR 
Karen.Fowler@va
.gov 
 
Serene Jacob, 
MSN 
Research 
Nurse 
VAAAHS Department of Medicine 
Serene.Jacob@v
a.gov 
 
Latoya Kuhn, 
MPH 
Project 
Manager 
VA CCMR 
Latoya.Kuhn@va.
gov 
 
Martha Quinn 
Qualitative 
Analyst 
WOC – U of M School of Public Health marthaq@umich.
edu 
 
David Ratz 
Data Analyst 
VA CCMR 
David.Ratz@va.g
ov  
 
Erica Paulos 
Data Analyst 
VA CCMR 
Erica.Paulos@va.
gov 
 

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Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX 
 
VA Palo Alto Healthcare System, Palo Alto, CA 
2.0 
Introduction 
Appropriate hand hygiene is essential in infection prevention, yet hand hygiene 
adherence among healthcare providers remains a challenge. Hand hygiene is widely 
accepted as a crucial component of infection prevention in healthcare settings,1-4 and 
guidelines providing specific recommendations to promote proper hand hygiene and 
reduce transmission of pathogenic microorganisms among patients and providers have 
been widely disseminated.5,6 Despite this, adherence with hand hygiene guidelines 
remains low.7 Additionally, hand hygiene adherence has been shown to vary by hospital 
location, provider type, and specific hand hygiene moments - with adherence rates 
lower among physicians (versus nurses), and before (versus after) patient contact.7 
Numerous behavioral model studies have demonstrated that hand hygiene perceptions, 
beliefs and attitudes - such as perceived social pressure from superiors, colleagues and 
administrators, the belief in role modeling for other colleagues, the belief that 
healthcare-associated infection (HAI) can be severe for patients and that hand hygiene 
is effective at preventing HAI, and having a positive attitude towards hand hygiene - are 
associated with hand hygiene adherence.8-10 While numerous interventions focusing on 
improving hand hygiene among healthcare providers have been introduced, success 
Personnel 
Role on 
Project 
Title – Affiliation 
Email 
Phone 
Barbara Trautner, 
MD, PhD 
Co-I; Site 
Principal 
Investigator 
Research Investigator MEDVAMC 
Center for Innovations in Quality, 
Effectiveness and Safety (IQUEST) 
Professor of Infectious Diseases, 
Baylor College of Medicine 
Barbara.Trautner
@va.gov; 
trautner@bcm.ed
u  
 
Prathit Kulkarni, 
MD 
Co-
Investigator 
Assistant Chief of Medicine 
MEDVAMC; Assistant Professor of 
Infectious Diseases, Baylor College of 
Medicine 
pakulkar@bcm.ed
u 
 
Laura Dillon 
Research 
Assistant 
Health Service Specialist, MEDVAMC 
Laura.Dillon2@va
.gov  
 
Michelle Espiritu 
Research 
Assistant 
Research Coordinator, MEDVAMC 
Michelle.Espiritu
@va.gov  
 
Personnel 
Role on 
Project 
Title – Affiliation 
Email 
Phone 
Jason Owen, 
PhD 
Co-
Investigator 
Co-Director VA Center for Mobile 
Apps Research Services (CMARRS) 
Jason.Owen@va.
gov  
 

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has been limited. Further, it is not well understood which components of multi-faceted 
interventions are most effective in achieving optimal hand hygiene adherence.11 As 
recently emphasized in the ongoing COVID-19 pandemic, vigilant hand hygiene 
remains one of the most important elements of preventing infectious disease 
transmission and innovative strategies for effectively improving hand hygiene among 
healthcare providers are still needed. Strategies promoting hand hygiene in Veterans 
Health Administration (VHA) hospitals have the potential to reduce HAI risk and improve 
Veteran health. 
Negative components of well-being including fatigue, depression, burnout (physical 
or mental collapse caused by overwork or stress), and anxiety/stress have increased in 
recent years among healthcare providers. The COVID-19 crisis will likely continue to 
present unique challenges to healthcare systems and further degrade provider well-
being. Healthcare provider burnout is prevalent, increasingly common across healthcare 
settings, and may negatively influence providers’ ability to maintain safe practices. 
Professional burnout and dissatisfaction with work-life balance has increased among 
physicians in recent years; with more than half of physicians reporting at least 1 sign of 
professional burnout.12 Additionally, symptoms of burnout are greater among physicians 
compared to the general working population,12,13 regardless of physician career stage.13 
Importantly, poor well-being and burnout are associated with increased risk of patient 
safety incidents, poorer quality of care due to reduced professionalism, decreased 
patient satisfaction,14-18 and decreased productivity.19 Burnout among nurses is also 
prevalent and poses similar threats to quality of care. Factors such as unit-level 
management, social capital, workload, and nursing burnout are associated with job 
satisfaction, turnover intentions, patient satisfaction, patient falls, HAIs, and medication 
errors.20 High levels of burnout among nurses is associated with lower ratings of quality 
of care independent of practice environment, suggesting that reducing nurse burnout 
may be an effective strategy for improving quality of care in hospitals.21 A study of 
nurses from a Veterans Affairs (VA) hospital showed that increased nurse burnout was 
associated with the perception of lower patient safety.22 After adjustment for patient 
acuity and nurse and hospital characteristics, associations between nursing burnout and 
increased HAI have been reported.23 Importantly, nurse burnout has been shown to be 
negatively associated with adherence to hand hygiene, highlighting an opportunity for 
interventions promoting well-being among nursing staff.24  
There are cognitive biases in clinical settings. A large body of literature 
demonstrates the existence of cognitive bias among clinicians,25 which may impact 
decision making. A key factor known to induce cognitive bias is a stressful and 
demanding work environment.26,27 Clinical practice requires healthcare providers to 
prioritize many responsibilities and shift quickly between patient care and administrative 
tasks. These shifts cause distractions, which can impact performance and increase 
stress. Dealing with these types of stressors often compels providers to adopt quick and 
reactive behavior rather than responding with a focused or efficient approach. As 
illustrated by Daniel Kahneman’s seminal work on dual-process theory,28,29 a decrease 
in cognitive effort leads to reliance on System 1 thinking, which is fast, reflexive, and 
vulnerable to bias and error.30,31 This results in a lack of System 2 thinking, which is 
slower and involves more analytical decision-making. Under stress, individuals are 
known to make decisions before all available options are systematically considered.32 

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We believe that dual-process theory, though with known limitations,33 is a helpful 
heuristic model for understanding how busy healthcare providers make decisions. 
Stressful situations likely result in providers relying heavily on System 1 thinking. When 
healthcare providers are busy at work, they don't have natural moments to pause, be 
present, and switch from System 1 to System 2 thinking. Not having that pause can lead 
to cognitive biases, which can result in decisions that are not fully informed by System 2 
thinking. The practice of mindfulness teaches presence.  
Mindfulness increases System 2 critical thinking and has shown promise in clinical 
settings. Mindfulness is an intervention known to be successful in decreasing biased 
decision-making and increasing higher-order, System 2 cognitive processing.34 Several 
studies in the psychology literature link mindfulness to enhanced executive 
functioning.35 Additionally, mindfulness facilitates insight problem-solving36 and ethical 
decision-making.37 Noone and colleagues demonstrated that mindfulness enhanced the 
ability to analyze and evaluate evidence and arguments.38 This makes mindfulness an 
ideal intervention to facilitate presence, which can result in switching from System 1 to 
System 2 thinking, thereby impacting decision-making. Mindfulness could prompt 
providers to engage in System 2 thinking and improve patient safety by prompting 
providers to shed preconceived cognitive and implicit39 biases through nonjudgmental 
awareness. Several articles have pointed to mindfulness as a potential intervention to 
increase patient safety and decrease diagnostic error.30,40 Mindfulness is also known to 
reduce cognitive bias.41,42 The mechanism involves a regulation of one’s attention and 
awareness towards the present moment.43 In recent years, mindfulness-based 
interventions have been applied to clinical practice, demonstrating success in reducing 
symptoms of stress, burnout and depression among attending physicians, residents, 
interns, medical students and nurses.44-54 
 
PRELIMINARY STUDIES  
Members of the proposed study team have conducted numerous studies on hand 
hygiene adoption, improvement and sustainability.55-61 This includes a systematic 
literature review on brief mindfulness interventions involving healthcare providers.44 Our 
review found that brief, mindfulness-based interventions modified to accommodate busy 
provider schedules yielded improvements in levels of stress, anxiety, mindfulness, 
resiliency, and burnout among hospital-based physicians and nurses.44 A recent meta-
analysis has shown that online mindfulness interventions can be more convenient and 
cost-effective, while yielding substantial reductions in stress and moderate 
improvements in mindfulness.62 Prior proof-of-concept work has shown that brief online 
modules and peer- supported group sessions among healthcare professionals lead to 
changes in the intended direction for perceived stress, burnout, mindfulness, resilience, 
and in providing calm, compassionate care.63-65 Additionally, increased doses of online 
training are associated with more frequent and sustainable mind-body practices.66 In a 
recent survey, physicians have reiterated the importance of social and organizational 
support in maintaining physician health.67 
Official direct observation data from the VA Ann Arbor Healthcare System 
(VAAAHS) from fiscal year 2019 (October 2018 - September 2019) shows average 
hand hygiene compliance was 90%, with compliance slightly lower on room entry (89%) 

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than exit (92%). By comparison, covert secret shopper data at VAAAHS during fiscal 
year 2019 found lower hand hygiene compliance at both room entry (85%) and exit 
(81%). During fiscal year 2019 at the Michael E. DeBakey VA Medical Center 
(MEDVAMC), the average hand hygiene adherence based on random direct 
observations was 77%. Although not readily available, we can reasonably assume that 
covert observations at MEDVAMC would yield slightly lower adherence rates, as seen 
at VAAAHS. These data demonstrate that opportunities to improve hand hygiene 
adherence exist at the proposed study sites. Additionally, the act of performing hand 
hygiene might not always correspond to properly performing hand hygiene. Preliminary 
data on hand hygiene duration at the proposed study sites is lacking and the proposed 
study will allow for assessments of proper hand hygiene (20 seconds of rubbing).  
While baseline data on provider composite measures of well-being are not readily 
available for the proposed study sites, data from the VA All Employee Survey from 2019 
demonstrate degrees of physician and nurse burnout exist at both of the proposed sites. 
At both sites, physician and nurse survey respondents on average reported feeling 
burned out from their work (physical exhaustion domain) from at least once a month to 
several times per month. While the responses for emotional exhaustion were slightly 
more favorable, respondents still reported worrying that their job was hardening them 
emotionally at least once per month. Additionally, the current and ongoing COVID-19 
pandemic has imposed unprecedented demands on healthcare workers that will likely 
contribute to detrimental and lasting impacts on provider well-being.68-70 As such, 
implementing and assessing initiatives to enhance and sustain hand hygiene practices 
and promote provider well-being will continue to be important in quality healthcare.70,71 
In a hand hygiene-based mindfulness intervention pilot study of almost 1,300 hand 
hygiene observations, we found significantly improved adherence to hand hygiene 
practices after a mindfulness intervention (Table 1). Additionally, the intervention led to 
a nearly 4% increase in observed mindfulness behaviors.72 Qualitative findings from the 
study indicated that physicians held favorable views of the idea of practicing 
mindfulness in clinical settings and that doing so could result in improved physician well-
being and provider-patient relationships.72 These findings give us confidence that 
practicing mindfulness in clinical settings is feasible, can modify clinician behavior to 
improve hand hygiene and combat HAI, and has the potential to improve provider well-
being.  
 
 

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Table 1: Mindfulness Intervention Impact on Hand Hygiene72  
Key: CI = confidence interval; aMindful Moments were observed moments of pause during hand hygiene or 
before entering the patient room, such as closing eyes or taking a deep breath. 
 
INNOVATION & IMPACT 
Deploying mindfulness during hand hygiene as a novel approach to optimize hand 
hygiene adherence and duration and improve provider well-being, thereby potentially 
reducing risk of HAI in Veterans: The act of hand hygiene prior to entering and upon 
exiting a patient’s room presents a prompt to practice mindfulness. A moment-by-
moment awareness of the various steps of hand hygiene (e.g., pausing, noticing the 
sound and feeling of water and soap flowing onto the hands or alcohol gel being 
massaged into the palms) creates an ideal opportunity for moments of reflection during 
busy clinical duties, and could help create an environment where providers can develop 
clarity, insight, and increase presence and awareness. Promoting integration of hand 
hygiene and mindful moments presents opportunities to utilize brief but sufficient time 
periods as a means of both pausing to be mindful and promoting proper duration of 
hand hygiene (i.e., rubbing for 20 seconds).7,73  
Our conceptual model of how an increase in mindfulness can impact provider well-
being and Veteran outcomes is illustrated in Figure 1. Encouraging, and ultimately 
embedding, learned 
mindfulness behaviors within 
hand hygiene moments among 
providers has the potential to 
improve provider well-being. 
Moreover, the positive, internal 
feedback experienced through 
mindful hand hygiene moments 
may directly boost and sustain 
hand hygiene adherence and 
duration, thereby decreasing 
risk of pathogen transmission. 
Improvements in provider well-
being and hand hygiene have 
the potential to jointly reduce 
Observations 
Intervention 
Control 
P-value 
N 
Change from Baseline % 
(95% CI) 
N 
Change from Baseline % 
(95% CI) 
Hand Hygiene 
Physician Type 
 
 
 
 
 
Attending 
132 
14.1 (-1.1, 29.5) 
113 
-5.7 (-15.9, 4.5) 
0.035 
Senior Resident 
90 
24.7 (5.4, 44.0) 
81 
0.2 (-15.5, 15.9) 
0.064 
Intern 
136 
10.0 (-2.6, 22.6) 
215 
4.2 (-6.4, 14.9) 
0.007 
Medical Student 
267 
4.7 (-4.4, 14.0) 
265 
7.7 (0.2, 15.1) 
0.003 
Mindful Momentsa 
621 
3.7 (1.3, 6.0) 
662 
0.9 (-0.4, 2.3) 
0.021 

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HAI and improve the quality and safety of healthcare delivered to Veterans. Additionally, 
although beyond the scope of what we plan to assess in the proposed study, an 
increase in mindfulness has the potential to directly reduce HAIs through promoting 
focused decision-making (e.g., the decision of whether or not to place a urinary or 
central catheter).  
There are several aspects of this proposal that are novel with respect to 
mindfulness. First, building on the successes demonstrated and qualitative information 
gained in our pilot project assessing the impact of brief mindfulness on hand hygiene 
adherence and mindful behavior,72 we plan to expand the mindfulness intervention 
duration and bolster the intervention content with self-directed mindfulness training and 
practice via online educational modules, mobile app based tools and reminders, and 
increased facilitated group discussions on mindfulness. The mindfulness mobile app we 
propose to use has previously been deployed among Veterans as a tool for reducing 
stress and maintaining healthy coping practices. Extending the mobile app’s scope of 
impact from Veterans to providers has not been studied, will be an excellent use of VHA 
resources, and will substantially contribute to the patient safety literature. Second, in 
addition to monitoring potential differences in hand hygiene adherence and mindfulness, 
we will be monitoring differences in hand hygiene duration and perceptions. Third, 
although numerous prior studies have evaluated the impact of mindfulness-based 
interventions on levels of provider burnout, anxiety, and stress, the proposed study will 
be the first study that we are aware of that will formally evaluate the impact of self-
directed and group-facilitated mindfulness practices specifically reinforced during 
repetitive moments of hand hygiene on provider well-being. Finally, we will engage 
Veterans to provide insights and suggestions on all phases of the proposed provider-
facing intervention. This work, if successful, will form the foundation of larger-scale 
implementation and dissemination projects to further benefit VHA healthcare providers 
and Veteran patients in the United States (US).  
3.0 
Objectives 
This study has three specific aims:  
1) To evaluate the effectiveness of a hand hygiene-based mindfulness intervention 
on provider hand hygiene adherence, duration, and perceptions.  
2) To evaluate the effectiveness of a hand hygiene-based mindfulness intervention 
on measures of provider mindfulness and well-being.  
3) To identify the barriers, facilitators, and perceptions of a hand hygiene-based 
mindfulness intervention in the hospital.   
The overall goal is to optimize provider hand hygiene adherence, improve provider 
well-being and enhance the quality and safety of care delivered to Veterans. Our 
hypothesis is that an intervention focused towards healthcare providers on promoting 
the use of hand hygiene as a moment to practice mindfulness will result in improved 
levels of mindfulness practices, well-being, and use of proper hand hygiene among 
providers. 

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4.0 
Resources and Personnel 
The study will be conducted with participants at the Lieutenant Colonel (LTC) 
Charles S. Kettles VA Medical Center (Ann Arbor VAMC) – the main hospital in the 
VAAAHS -  and at the MEDVAMC.  All activities at both active study sites (Ann Arbor 
VAMC and MEDVAMC) will be conducted in accordance with the VA Central 
Institutional Review Board (IRB) approved protocol.  While there is a co-investigator 
(Jason Owen, PhD) located at the VA Palo Alto Healthcare System, there will not be 
any subject recruitment at that site.  Instead, Dr. Owen will assist with scientific 
expertise and oversee development and use of the Mindfulness Coach mobile app – 
described in more detail below.  The modifications to the app itself to tailor for use with 
healthcare providers will be done with Vertical, as they helped develop the original app 
and are familiar with VA data security requirements.  We will also contract with Ohio 
State University for use of their online mindfulness training modules as part of our 
intervention. The Ann Arbor VAMC will be the coordinating site, with all data being 
stored and analyzed together at the VAAAHS Center for Clinical Management Research 
(CCMR).   
 
ANN ARBOR VAMC PERSONNEL (ANN ARBOR, MI) 
M. Todd Greene, PhD, Principal Investigator Dr. Greene, an epidemiologist, is a 
Research Health Science Specialist at the VA Ann Arbor CCMR and an Associate 
Research Scientist in the University of Michigan (U of M), Division of Hospital Medicine. 
Dr. Greene is the Program Manager for the Ann Arbor VA/U of M Patient Safety 
Enhancement Program. His research interests include epidemiologic methods, hospital 
acquired infections, and patient safety and quality of care enhancement. Dr. Greene has 
knowledge of study design, implementation, and data analysis of both clinical 
observational studies and randomized controlled trials. As a Principal Investigator, Dr. 
Greene will work closely with Dr. Saint in sharing primary responsibility for this project 
as described in the leadership plan. His specific responsibilities will include serving as 
the corresponding Project Director/Principal Investigator (PD/PI) for the project and 
supervising the project staff. Dr. Greene will be responsible for the organization and 
daily operation of the project and will have primary responsibility for design and 
assessment, as well as all logistics related to data collection and data management. Dr. 
Greene will participate in the data collection activities associated with the project, 
including the both quantitative and qualitative data. Dr. Greene will work closely with Dr. 
Saint and co-investigators in developing and conducting the intervention and 
interpreting findings. Dr. Greene will also take the lead with dissemination of final 
results. 
 
Sanjay Saint, MD, MPH, co-Principal Investigator  Dr. Saint is the Chief of Medicine 
at the LTC Charles S. Kettles VAMC, the George Dock Professor of Internal Medicine at 
the U of M, Director of the VA/U of M Patient Safety Enhancement Program, and a core 
faculty member of the VA CCMR Health Services Research & Development. His 
professional interests are in enhancing patient safety by preventing healthcare-
associated complications; translating research findings into practice; and medical 
decision-making (including cognitive errors). Dr. Saint will work with Dr. Greene to 

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supervise the project staff, make budgetary decisions, lead project development and 
implementation, and disseminate the final results. Dr. Saint will also supervise the 
qualitative team as well as chair all stakeholder advisory panel meetings. 
 
Molly Harrod, Ph.D., Co-Investigator Dr. Harrod is a trained medical anthropologist 
and a Research Health Science Specialist at the VA CCMR, where she is Director of 
the Qualitative Core. Dr. Harrod’s expertise is in conducting interviews, engaging in 
observations, and coding and analyzing qualitative data. Dr. Harrod will supervise the 
qualitative analysis for this project and provide expertise in medical anthropology. She 
will: 1) develop the qualitative methods and interview guides; 2) participate in interviews 
and data collection; 3) supervise Ms. Quinn in identifying and coding common themes 
from the qualitative data using a VA approved qualitative analysis program like 
MaxQDA; and 4) assist with manuscript preparation. 
 
Nathan Houchens, MD, Co-Investigator Dr. Houchens is the Associate Chief of 
Medicine at the Ann Arbor VAMC and an Assistant Professor in the Department of 
Internal Medicine at the U of M Medical School.  Dr. Houchens’ research interests 
include communication in healthcare settings, empathy, resilience, medical 
education, and mindfulness.  For this project Dr. Houchens will serve, along with Dr. 
Sheffield, as a site mindfulness champion at the Ann Arbor VAMC and assist with 
development and implementation of the intervention. He will also co-lead the 
mindfulness meetings with intervention participants. He will also participate in the 
interpretation of the results and dissemination of study findings. 
 
Virginia Sheffield, MD, Co-Investigator. Dr. Sheffield is a Clinical Assistant Professor 
with the Department of Medicine at the VA Ann Arbor Healthcare System, and with the 
Division of Hospital Medicine at the University of Michigan. Her interests are in diversity, 
equity, and inclusion, and medical education. For this project she will serve as a site 
mindfulness champion at the VAAAHS and assist with development and implementation 
of the intervention. She will co-lead the intervention mindfulness meetings with Dr. 
Houchens. She will also participate in the interpretation of the results and dissemination 
of study findings.   
 
David Clive, Research Assistant David Clive will serve as a research assistant at the 
Ann Arbor, MI site.  He will be carefully trained in protection of human subjects and will 
work closely with the project manager. For this project he will communicate with local 
staff about the project, recruit participants, obtain informed consent, conduct hand 
hygiene observations, collect survey data, and perform data entry.  
 
Jason Engle, Research Assistant. Mr. Engle is a recent graduate of the University of 
Michigan School of Public Health, with a degree in Epidemiology.  He has worked with 
Dr. Saint and the Patient Safety Enhancement Program for approximately 5 years as a 
research assistant.  For this project, Mr. Engle will work under the direction of the 
project manager Ms. Fowler.  He will be responsible for creating study databases, 
communicating with local staff about the project, recruiting participants, obtaining 

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informed consent, conducting the blinded hand hygiene observations, collecting survey 
data, and performing data entry for the project.  
 
Karen Fowler, MPH, Project Manager Ms. Fowler is an Epidemiologist with 20 years 
of experience in project management with the VA CCMR. She has been working with 
Dr. Saint for the past 10 years on patient safety related projects, including the VA Ann 
Arbor Patient Safety Center of Inquiry and several national healthcare-associated 
infection prevention collaboratives. For this project, Ms. Fowler will help coordinate 
activities between all project investigators and staff. She will prepare IRB applications 
and materials for project team meetings. She will supervise the research assistant 
activities and coordinate the Ann Arbor qualitative team visits to the study sites and 
participate in the qualitative interviews, as well as coordinate intervention 
implementation activities. She will also help prepare presentations, reports, and 
manuscripts for this project.  
 
Serene Jacob, MSN, Research Nurse. Ms. Jacob is a Research Nurse for the VA Ann 
Arbor Healthcare System Medicine Service. She has worked at the VA Ann Arbor for 14 
years in various roles. She is also a clinical instructor at Washtenaw Community 
College and the University of Michigan, instructing nursing students. For this project Ms. 
Jacob will help with subject recruitment, data collection, study observations, and serving 
as a nurse mindfulness champion.   
 
Latoya Kuhn, MPH, Project Manager Ms. Kuhn also has 20 years of experience in 
project management with the VA CCMR. She is a senior project manager with the VA/U 
of M Patient Safety Enhancement Program. For this project, Ms. Kuhn will assist Ms. 
Fowler will management of all project activities as needed.  This will include 
coordination of activities between sites, supervision of research assistants and data 
collection, management of IRB, and prepare presentations, reports, and manuscripts for 
this project.  
 
Erica Paulos, MA Data Analyst. Ms. Paulos is a new data analyst with the 
VA/University of Michigan Patient Safety Enhancement Program. She has completed 
postgraduate studies in mathematics at Harvard University and a Master of Arts in 
Economics at the University of Michigan. She will take over as the data analyst for this 
project from Mr. Ratz and will be responsible for all statistical analyses under the 
direction of Dr. Greene. Ms. Paulos will begin on the project in May 2023.  
 
David Ratz, MS Data Analyst Mr. Ratz is an experienced data analyst with the 
VA/University of Michigan Patient Safety Enhancement Program. He has expertise in 
statistical methods and will serve as the data analyst for this project. He will be 
responsible for all statistical analyses under the direction of Dr. Greene. Mr. Ratz’s effort 
will not begin until Year 2 after data collection has begun for the project.  
 

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IPA: Martha Quinn, MPH, Qualitative Analyst. Ms. Quinn is a Senior Research Area 
Specialist in Evaluation and Policy at the U of M School of Public Health. Her expertise 
is in conducting interviews, and coding and analyzing qualitative data. Ms. Quinn will 
support the qualitative analysis for this project under the direction of Dr. Harrod. She will 
work on the project under an Intergovernmental Personnel Agreement (IPA). She will: 1) 
lead the qualitative interviews at all sites; 2) take primary responsibility for the coding 
and qualitative analysis of the interview data using a VA approved qualitative analysis 
software like MAXQDA; and 3) assist with manuscript preparation. 
 
MICHAEL E. DEBAKEY VAMC PERSONNEL (HOUSTON TX) 
Barbara Trautner, MD, Site PI/Co-Investigator Dr. Trautner is a staff physician 
clinician-investigator at the MEDVAMC and an investigator at the Center for Innovations 
in Quality, Effectiveness, and Safety (IQuESt). Dr. Trautner is a Professor at 
Department of Medicine at Baylor College of Medicine. She also has secondary 
appointments with the Department of Surgery and the Department of Virology and 
Molecular Biology at Baylor College of Medicine. Dr. Trautner will serve as the site 
principal investigator for MEDVAMC in Houston, Texas. As site PI, she will be the 
primary supervisor for the research assistants who will be conducting subject 
recruitment and data collection at the MEDVAMC. She will also advise on the 
recruitment and data collection procedures at the Houston VA, in collaboration with Dr. 
Prathit Kulkarni. Dr. Trautner will also participate in developing the intervention and will 
participate in the interpretation, application, and dissemination of the study findings.  
 
Prathit Kulkarni, MD, Co-Investigator Dr. Kulkarni is the Assistant Chief of Medicine 
at the Michael E. DeBakey VA Medical Center. He is an Infectious Diseases physician 
whose research interests include antimicrobial stewardship, infection control, healthcare 
epidemiology, quality improvement, and medical education. For this project, Dr. Kulkarni 
will assist Dr. Trautner with conducting the study at the Houston VAMC. He will assist 
with intervention development, supervision of research assistants, and leading the in-
person mindfulness sessions to intervention participants. He will also assist with 
manuscript preparation and dissemination activities. 
Laura Dillon, Research Assistant Laura Dillon will serve as a research assistant at the 
Houston, TX site.  She will be carefully trained in protection of human subjects and will 
work closely with the project manager. For this project she will communicate with local 
staff about the project, recruit participants, obtain informed consent, conduct hand 
hygiene observations, collect survey data, and perform data entry.  
 
Michelle Espiritu, Research Assistant Michelle Espiritu will serve as a research 
assistant at the Houston, TX site.  She will be carefully trained in protection of human 
subjects and will work closely with the project manager. For this project she will 
communicate with local staff about the project, recruit participants, obtain informed 
consent, conduct hand hygiene observations, collect survey data, and perform data 
entry.  
 

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VA PALO ALTO HEALTHCARE SYSTEM PERSONNEL (PALO ALTO, CA) 
Jason Owen, PhD, MPH, Co-Investigator. Dr. Owen is a Clinical Psychologist and 
mobile team lead with the VA National Center for PTSD’s Dissemination & Training 
Division in Palo Alto, CA. He is the co-director of the VA’s Center for Mobile Apps 
Research Services (CMARRS). He has extensive experience with developing and 
programming of mobile applications (apps) and conducting research using applications. 
Dr. Owen is also responsible for app-related data associated with VA mobile apps and 
led the development of the VA App Connect platform for conducting mobile app 
analytics, engagement tracking, and research integration. For this project, Dr. Owen will 
help us develop the mindfulness-based intervention. Specifically, he will help direct the 
customization of the application for use with providers and will assist in the collection of 
de-identified app analytics data and send to the VA Ann Arbor CCMR for analysis. He 
will also participate in manuscript and report preparation. 
5.0 
Study Procedures 
5.1 Study Design 
Research Design: A multi-center, repeat-measures randomized controlled mixed-
methods trial. 
Study Population: The proposed study will focus on Internal Medicine physicians who 
are part of inpatient care teams and nurses providing care on medical and 
medical/surgical units at LTC Charles S. Kettles VAMC in Ann Arbor, MI and 
MEDVAMC in Houston, TX. Medical students, surgical physicians, and physicians on 
sub-specialty teams will not be included. At both participating facilities the inpatient care 
teams are predominately composed of 1 attending, 1 senior resident, 2 interns, and up 
to 3 medical or physician assistant students. Interns and senior residents are usually 
assigned to a team for 4-week blocks (occasionally 2 weeks), while attendings rotate 
approximately every 2 weeks. The Ann Arbor VAMC has 3 medical or medical/surgical 
inpatient units, while MEDVAMC has 5 units. At both facilities each nursing unit employs 
between 20-30 nurses. We will aim to recruit approximately 30 attendings, 72 residents 
and 40 nurses at Ann Arbor VAMC. As MEDVAMC is larger, with a greater number of 
inpatient care teams and nursing units than the Ann Arbor VAMC, we will aim to recruit 
approximately 40 attendings, 72 residents and 90 nurses. Our target study sample size 
is a total of 344 physicians and nurses (167 intervention/177 control). For Aim 3, we 
plan to interview approximately 8 physician team members and 4-6 nurses from the 
intervention arm at each site. 
General Study Overview and Outcome Measures:  
A summary of the proposed study activities at each participating site is presented in 
Table 2 below. 
 
 

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      Table 2: Overview of Study Activities at Each Study Site 
Study Detail 
Physicians 
Nurses 
Target 
Attendings, senior residents and 
interns on inpatient medicine teams  
Nurses on medical or medical/surgical 
units 
Teams/Units 
Participating 
2 teams each month for 12 months 
randomized to intervention or 
control arm at each site 
2 units (1 intervention; 1 control) at 
Ann Arbor VAMC & 4 units (2 
intervention; 2 control) at MEDVAMC 
randomized once & followed for 12-
months 
Estimated number of 
participants 
107 intervention and 107 control  
20 intervention and 20 control at Ann 
Arbor VAMC; 40 intervention and 50 
control at MEDVAMC 
Habituation Period 
1 month 
1 month 
Habituation 
assessment 
x 
Unit-based hand hygiene 
observations 
x 
Unit-based hand hygiene 
observations 
Pre-Intervention 
Assessment  
x 
Survey (FFMQ, WBI, select 
PSHW) 
x 
Survey (FFMQ, WBI, select 
PSHW) 
Intervention Period 
2-4 weeks 
1 month 
Intervention 
Assessment  
 
x 
Hand hygiene observations  
x 
Survey given at end of 
intervention (FFMQ, WBI, 
select PSHW)  
x 
Mobile app data and usage  
x 
Hand hygiene observations  
x 
Survey given at end of 
intervention (FFMQ, WBI, select 
PSHW) 
x 
Mobile app data and usage 
 
x 
Completion of STREAM 
mindfulness modules 
x 
Completion of STREAM 
mindfulness modules 
 
x 
Transcripts from intervention 
guided discussions 
x 
Transcripts from intervention 
guided discussions 
 
x 
Qualitative interviews with ~8 
physicians per site 
x 
Qualitative interviews with ~4-6 
nurses per site 
6-month Follow-up 
x 
Emailed survey (FFMQ, WBI, 
select PSHW) 
x 
Survey emailed or given in 
person (FFMQ, WBI, select 
PSHW) 
Sustainability follow-
up 
x 
Select hand hygiene 
observations for ~10 
weekdays at 3-12 months 
follow-up 
x 
Hand hygiene observations for 1 
month at 12 months follow-up 
Habituation Period - To collect baseline data on hand hygiene adherence and duration 
and to habituate providers to the presence of observers, 1 month of covert, unit-based 
hand hygiene observations will be conducted. At the end of year 1, we will report out on 
observed hand hygiene rates.  Observation of hand hygiene adherence will include 
hand hygiene prior to patient room entry and after exiting the patient room (Appendix 
A). In US hospitals, the entry/exit method has been demonstrated to be feasible for 
observed hand hygiene adherence monitoring by overcoming line-of-sight issues and 
other barriers.74 Hand hygiene observers will not enter patient rooms or interfere in 
patient care. Observation of hand hygiene duration will be done when providers exit 
patient rooms, as observing hand hygiene duration upon room entry will not be feasible 

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since observers will not enter patient rooms. 
Pre-Intervention Assessment - To evaluate mindfulness and hand hygiene, inpatient 
medicine teams and nurses from medical and medical/surgical units at each 
participating hospital will be included. Following informed consent, physicians from 
selected teams and nurses from selected units will be asked to complete a survey 
containing validated scales measuring dispositional mindfulness, well-being, and hand 
hygiene perceptions (Appendix B). The Five Facet Mindfulness Questionnaire 
(FFMQ)75 is a validated instrument with favorable psychometric properties and consists 
of 39 questions. Additionally, participants will be asked to complete the Well-Being 
Index (WBI). The 9-question 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,76 residents,77 and nurses.78 Participants will also be asked to 
complete 8 questions on HAI and hand hygiene perceptions selected from the 
Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health 
Organization.79 Similar to other studies on hand hygiene perceptions guided by the 
constructs based on the Theory of Planned Behavior,8-10 the selected PSHW questions 
cover behavioral, normative, and control beliefs, as well as self-reported hand hygiene 
adherence. Participants will also be asked whether they meditate or perform any form of 
internal reflection prior to the study, as this may influence performance during the 
intervention. Questionnaire completion will take approximately 10 minutes. When 
feasible, surveys will be distributed in person with a postage-paid return envelope.  
Each survey will be labeled with a unique study ID number to allow us to track 
response.  When we are unable to distribute the surveys in person – for example, when 
a physician rotates to another facility during residency – the surveys will be distributed 
using an electronic survey tool such as Qualtrics or RedCap.  As physicians will need to 
access the survey’s from outside the VA firewall (if they have rotated to another facility), 
we will use programs hosted by the University of Michigan.  The informed consent 
document will include that survey data may be collected outside the VA firewall, 
however no personal identifiable information will be collected with the surveys to protect 
confidentiality.  Subjects will always have the choice to complete the survey on paper if 
they would prefer. 
Randomization – At each study site the participating physician teams and nursing units 
will be randomly assigned into one of two study arms (intervention/control). For 
physician teams, this will occur on a rolling basis for 12 months with 2 physician teams 
randomly selected at each site each month for participation (1 intervention, 1 control). 
Once randomized, an email will be sent to the initial attending of the team introducing 
the study and asking them to reply to the email if they would prefer to opt out and not 
have their team participate in the randomized controlled trial. If the attending physician 
from a team refuses to allow their team to participate, the next team identified from the 
randomized list will be approached to participate. If a new attending joins the team mid-
month, they will be approached to participate in the study, but will be automatically 
assigned to the same randomization group as the rest of their team.  
Similarly, a total of 2 medical/surgical units from VAAAHS (1 intervention, 1 control) 
and 4 medical/surgical units from MEDVAMC (2 intervention, 2 control) will be randomly 
selected to participate in the nurse portion of the project. The nurse manager for each 

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selected unit will then be approached to obtain approval for the unit to participate. If a 
nurse manager declines, the next unit on the list will be selected. 
For both physicians and nurses, an independent statistician will allocate the teams 
and units in a concealed fashion, using a computer-generated randomization schema. 
The physicians and nurses from the intervention groups will receive both independent 
and group-facilitated mindfulness education, will be encouraged to use a mindfulness 
mobile app as a practice reminder and additional resource, and instructed to integrate 
moments of mindfulness with repeated episodes of hand hygiene during the course of 
caring for patients. The control groups will receive no such education or intervention and 
will continue as usual.  
 
Mindfulness Intervention: We will work with a site-specific principal investigator (PI) 
and research assistants to facilitate intervention delivery. At each participating site, we 
will employ a train-the-trainer format and a member of the study team will serve as a 
mindfulness champion. They will be trained in mindfulness techniques, including 
completion of an online course and attending virtual meetings to standardize 
intervention methods between sites. Study PIs will also check in with mindfulness 
champions at each site on a monthly basis. The intervention will be delivered separately 
to physicians and nurses. For physicians, the intervention will be offered to attendings, 
senior residents and interns within the teams randomized to receive the intervention. 
The intervention will be offered to all nurses within the units randomized to receive the 
intervention. Components of the intervention are listed below.  
Self-Directed Components - Participants will be asked to complete self-directed, online 
mindfulness training modules developed by the Ohio State University Mind-Body Skills 
Training for Resilience, Effectiveness, and Mindfulness (STREAM) program.80 At the 
beginning of the intervention period, the curriculum will be described to participants as a 
way to help health professionals become more personally resilient and to be more 
effective in helping patients. The mindfulness training will include three modules: (a) 
Introduction to Mindfulness: The Body Scan, (b) Mindfulness in Daily Life, and (c) 
Mindfulness: Mindful Breathing and Sitting. As the modules were designed to be non-
linear and acquiring skills sequentially to advance through modules is not necessary, 
participants will be allowed to complete the modules in any order. Participants will also 
be allowed and encouraged to repeat modules as desired. Each module includes a 
case, embedded self-reflection exercises, descriptions of the evidence supporting the 
skill, hyperlinks to peer-reviewed research, links to free MP3 recordings to experience 
the practice and develop a new skill, and links to resources. This interactive, 
experiential learning was designed to help participants develop new skills quickly and 
easily. We will recommend that each skill be practiced five times for a week or more 
before moving ahead to the next skill. Each module takes approximately 20 minutes to 
complete. Participants can download or print certificates of module completion. The 
STREAM staff will generate and provide the study team with reports of participant 
module usage and completion to be tracked as a measure of intervention engagement. 
Instructions for participants to access these modules can be found in Appendix Q. 
Participants will be asked to complete these modules during off-duty hours, and as such 
will be offered $25 for each module they complete (Maximum of $75) as remuneration 

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to encourage completion of this key aspect of the intervention. 
The self-directed component will also include a mobile app to serve as an additional 
self-directed mindfulness practice tool and reminder. We will collaborate with 
researchers at the National Center for Posttraumatic Stress Disorder, Dissemination & 
Training Division at the VA Palo Alto Health Care System, to modify and incorporate the 
Mindfulness Coach (Figure 2). This mobile app contains information on the benefits of 
mindfulness, mindfulness exercises, strategies for overcoming barriers to practicing 
mindfulness, mindfulness practice reminders, and the ability to track progress. 
Mindfulness Coach, available for both iOS and Android platforms, is a free, anonymous, 
evidence-informed app. The app was originally designed to help Veterans with 
Posttraumatic Stress Disorder and related mental health concerns and has been 
updated by incorporating feedback from VA providers and Veterans about their app 
experiences. We will be employing a research version of the app in coordination with 
our app development team partners. Nurse participants will be offered the standard 
Mindfulness Coach Explorer app, while physician participants will be offered a slightly 
modified version of the mobile app – titled “Mindfulness for Clinicians”.  Following 
randomization, study staff will provide information to participants in the intervention arm 
to introduce the app, guide participants through features, and encourage use of the app 
as a tool and reminder for practicing mindfulness. Instructions for how to access the 
mobile application can be found in Appendix R. Additional reminders to practice 
mindfulness and incorporate mindfulness during hand hygiene moments will be sent to 
participants during the intervention period through regular, auto-generated email 
notifications. The research version of the app also includes push notifications regarding 
new coaching messages. Deidentified and encrypted app-use metrics will be captured 
via invitation codes, which unlocks the app and transmits which screens are accessed 
and duration. App data will be used as a measure of intervention engagement. 
 
Group-Facilitated Components - At each site, the site lead/mindfulness champion will 
lead guided discussions with participants that will focus on how principles of 
mindfulness can be used to influence a clinician’s state of mental presence, allowing for 
moments of clarity, insight, and reflection, and potentially enhanced provider and patient 
safety. Group discussions will address how principles of mindfulness can be 
 
 
Figure 2: Mindfulness Coach 2.0 Mobile App Interface 

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implemented to generate reflective pauses during moments of hand hygiene while 
providing clinical care. Discussion leads may share personal anecdotes and clinical 
examples of instances where stopping to be aware of physical and emotional state 
influenced decision-making, patient care, and personal feelings. As the group-facilitated 
discussions are also intended to foster a sense of interpersonal support, participants will 
be encouraged to participate in the discussion, provide insights on learning and 
practicing mindfulness, share experiences, and ask questions on integrating 
mindfulness into clinical and hand hygiene practices.  Discussions will also address 
questions and feedback on the self-directed components discussed above. For 
physician participants, group-facilitated discussions lasting approximately 15 minutes 
will be offered every other week throughout the intervention phase at each site. For 
nurse participants, group-facilitated discussions lasting up to 30 minutes will be offered 
every week throughout the intervention phase at each site. Given the circumstances 
brought on by the COVID-19 pandemic and to offer greater flexibility, these discussions 
will be conducted either in person or virtually through a VA approved online 
conferencing program such as Microsoft Teams or Zoom to promote participation and 
implementation fidelity across sites. These discussions will be audio recorded and 
transcribed as described in the qualitative data and analysis section below. Attendance 
at these meetings will be tracked as a measure of intervention engagement. Meeting 
logistics for the discussions will be addressed at each site accordingly and participants 
will be encouraged to attend as many discussions as possible.  
Promotion of Mindful Hand Hygiene Moments Component - Mindfulness is a moment-
by-moment practice that, to be effective, should be reinforced regularly. Our intent is to 
create a mindfulness movement within rounds to slow the brain between patients and 
become present to each new interaction.  Each mindful hand hygiene moment is a step 
towards greater provider well-being that can be renewed day after day and patient after 
patient. Because it is difficult to find moments to practice mindfulness during busy 
clinical days, hand hygiene will be promoted as the primary recurring prompt to pause, 
take a few deep breaths, be present, and accept whatever arises without judgment or 
reaction before entering and upon exiting a patient’s room. During this pause, a moment 
to reflect, crystallize thoughts, be fully present in the moment and visualize what may 
happen in the next encounter, while acknowledging and accepting internal emotions or 
feelings will be suggested. After randomization, study staff will provide participants in 
the intervention arm a guide for a moment of mindfulness during hand hygiene 
(Appendix C). Intervention participants will be offered personal sized hand hygiene 
dispensers to help promote hand hygiene.  To integrate the mindful moments with 
appropriate hand hygiene, participants will be encouraged to mindfully perform hand 
hygiene for at least 20 seconds.6  Under the train-the trainer format, mindfulness 
champions at each site will teach and promote mindfulness during hand hygiene during 
group discussions and other frequent co-worker encounters. Study staff will also provide 
further guidance and reminders via regular emails at the beginning and end of each 
week during the intervention period.  Pending pilot results assessing multiple factors 
(e.g., alert fatigue) reminders may also be integrated into the Mindfulness Coach app 
modifications. 
Intervention Assessment - Following randomization to the intervention or control arm, 
physician teams will be observed for hand hygiene for the remainder of their time on 

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that service rotation on weekdays (3-4 weeks). For the physician teams, which rotate 
each month, this process will be repeated monthly for 1 year with up to 24 patient-care 
teams from each participating site. Nurses from both the intervention and control 
medical/surgical units will be observed for hand hygiene for one month. Observers will 
be blinded to randomization of the physician teams and thus intervention status. Since 
nurses remain assigned to one unit for a much longer period of time, nursing units will 
only participate once during the study. This will result in two nursing units from VAAAHS 
and four nursing units from MEDVAMC participating. At the completion of the 
observations, the physicians and nurses will again be asked to complete FFMQ, WBI, 
and select PSHW questions. To assess sustainability of well-being, mindfulness, and 
hand hygiene perceptions, we will ask participants to repeat FFMQ, WBI, and select 
PSHW questions at 6-month post-intervention follow-up points. To assess sustainability 
of hand hygiene among physicians, select hand hygiene observations at 3 to 12 months 
post-intervention (based on team schedules) will be conducted. To assess hand 
hygiene sustainability among nurses, unit-based hand hygiene practices will be 
reassessed at 1-year post-intervention. To examine changes across survey time points, 
crosswalk files will be utilized. Participant names will not be on the survey. A study team 
member will assign the survey respondents an identification number to link repeat 
surveys. 
As part of the intervention we will also collect measures of fidelity.  This will include 
information from the Mindfulness Coach/Mindfulness for Clinicians mobile application 
including usage and responses from any assessments included in the app about the 
participant’s level of mindfulness.  We will also collect data on completion of the Ohio 
State University STREAM Mind Body modules.  This data will be completely de-
identified.  Both programs do not collect any personal identifiers.  Instead, participants 
will be asked to register with a study assigned code.  The de-identified user data for 
each code will be shared back with the study team to assess fidelity. 
 
Data Collection and Management: Field observational data collection will include 
hand hygiene adherence and duration using standardized templates for data collection. 
Research assistants will perform the observations and data entry. The research 
assistants will be blinded to the randomization of the physician teams, however, they 
will know which nursing units were assigned to the intervention. Study staff will covertly 
observe members of inpatient physician teams and nurses within specific units in their 
performance of hand hygiene as they enter and exit a patient’s room. Hand hygiene 
dispensers are located outside of patient’s rooms in the hallways and most staff use 
these dispensers before entering and upon exiting patient rooms which will be visible 
from the hallway.  Hand hygiene data will include whether a member washes their 
hands with soap and water, uses alcohol-based hand rub, or does not perform hand 
hygiene. In the event the observer is unable to visualize hand washing due to the 
location of the washbasin in the patient’s room or the rapid changes between providers 
as hand hygiene is performed, the observer will record this event as unknown. If a team 
member does not enter the patient’s room or the patient is not in the room, this will be 
recorded as no room entry. Hand hygiene duration will be captured for room exit 
observations for all nurse observations and for half of the attending observations.  
Duration will be recorded as the elapsed time of rubbing hands after dispensing hand 

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sanitizer product onto hands. The data collection tools (Appendix A) will capture 
whether the person observed is an attending, resident, intern, or nurse but will not 
include any individual names. Information on team or unit name will be collected so the 
data analyst can later identify the observation as intervention or control. Photos of all 
physician team members are posted on each inpatient unit or available online, which 
will allow research assistants to identify physician level (attending, senior resident, or 
intern). Since the research assistants will be blinded to intervention status of physicians 
and physicians will change teams during the follow-up observations, we will identify 
individual physician participants with a unique study ID on the data collection forms. 
Observers will not enter patient rooms.   
Data acquisition over the course of the study will span intervention/control groups 
that include inpatient physician care teams (up to 48 each at Ann Arbor VAMC and 
MEDVAMC) and nurses on medical/surgical acute care units (2 units at Charles S. 
Kettles VAMC and 4 units at MEDVAMC). Each physician team generally cares for 
approximately 10 patients per day, but this rate varies based on patient volume. For 
physician team observations hand hygiene will be observed for the attending, senior 
resident, and interns when entering a patient’s room. We will rotate observations on 
exiting patient rooms, with half of the observations focusing on hand hygiene of the 
physician team, and the other half focusing on the duration of hand hygiene by the 
attending. The number of observations per day may vary depending on the composition 
of the team and the structure of the morning team rounds. One or more team members 
may be missing on any given day due to planned days off or other commitments. 
Further, some teams review patient information in a conference room instead of visiting 
each patient as a large group. In this scenario, we will still observe the attending and 
other team members present during patient visits after table rounds.  
There could be a risk of a Hawthorne effect with conducting hand hygiene 
observations. Three basic, non-technological methods to help avoid or decrease the 
Hawthorne effect include: 1) letting healthcare workers habituate to unobtrusive and/or 
frequent observation; 2) using indirect methods to monitor hand hygiene adherence, 
such as monitoring consumption of hand sanitizer products; and 3) covertly observing 
hand hygiene adherence.81 To minimize the risk of Hawthorne effects for this project, 
research assistants will conduct wash-in period observations within units as a means of 
habituating physicians and nurses to being observed. Additionally, research assistants 
will not follow the inpatient teams. Instead, all observations will be done covertly from a 
randomly chosen location on one of the hospital units each day. As such, we anticipate 
that research assistants will be able to capture hand hygiene moments for 4-6 patient 
encounters per observation day. Due to the variable number of patients, team 
attendance and daily rounding structure, each day we expect to observe approximately 
8-24 before room entry and 4-12 after room exit hand hygiene moments, with an 
additional 2-3 measures of attending hand hygiene duration upon leaving the room. 
With roughly 10 observational days per attending team (M-F, no weekend or holiday 
observations) during the intervention period and up to 24 attending teams, we estimate 
we will collect the following physician data per arm at each site: 1,920-5,670 room entry 
hand hygiene moments, 960-2,880 room exit hand hygiene moments, and 480-720 
measurements of hand hygiene duration.  

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Covert observations within randomly selected areas within units will also be 
conducted for observing hand hygiene among nurse participants. Observations will be 
conducted for 1 month before the intervention and 1-month after the intervention.  On all 
participating units, observations of nurse hand hygiene while entering and exiting 
patient rooms will be conducted. Hand hygiene duration among all nurses will also be 
captured upon room exit. Nurses will be observed for approximately 4 hours per day 
during the first part of their shift, as all nurses typically check in with each patient at the 
start of their shift. From covert locations within the unit, the observers will only be able to 
observe approximately 10 rooms at a time. They will move their location in the unit each 
day to ensure representation from different nurses. The number of times a nurse enters 
each patient room will vary, but we estimate at minimum each nurse will enter each 
room once per hour. Therefore, observing 10 patient rooms for 4 hours per day, with 2 
observation points per entry would lead to approximately 80 hand hygiene moments 
observed per day per unit. Observing 3 units per arm for approximately 44 days total 
would lead to an estimated 7,040 nurse hand hygiene observations per study arm in 
total. As hand hygiene duration will also be recorded upon room exit, and estimated 
total of 3520 hand hygiene duration observations per study arm will be observed. In 
addition to the 1-month post-intervention observation period, we will also observe and 
collect 1 month of data on hand hygiene moments at 1-year post-intervention in the 
intervention and control units at both sites. 
Collected data will be transferred from the paper observation data tool into a study 
database. The data analyst and project manager will be able to link these covert 
observations accordingly to intervention or control groups based on team and unit 
name.  
Study surveys will be distributed in person using a paper survey and a postage-paid 
business reply envelope where feasible. Electronic surveys containing questions from 
FFMQ, WBI, and PSHW surveys will be generated. Study participants will be directed to 
a link to the survey tool (for the pre- and post-intervention, as well as 6-month post-
intervention follow-up periods) and responses will be saved to a database managed by 
the study team. 
Qualitative data will be collected to better understand the perception of the 
intervention and assess any barriers or facilitators encountered (Appendix D). The 
primary subjects will be nurses and physicians that participated in the intervention. For 
this evaluation we will conduct individual or group interviews with approximately 6 
nurses and 8 physicians at each site, for a total of 12 nurses and 16 physicians. In 
addition to the interviews, we will also audio record the site lead/mindfulness champion 
guided discussions with participants. During these guided discussions it is expected that 
participants will talk about their insights on learning and their own personal experiences 
practicing mindfulness during the intervention. All guided discussions, along with the 
interviews, will be recorded using Audacity software, Microsoft Teams, or Zoom for 
Government. The discussions and interviews will be conducted in person wherever 
feasible, however when not feasible, we will use Microsoft Teams, Zoom for 
Government, or phones to conduct these meetings virtually.  The audio recordings will 
be transcribed and de-identified for analysis. Transcripts will be reviewed and data 
central to the aims of this study will be extracted and analyzed.  

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Additional data on fidelity to the intervention will be collected. This will include de-
identified usage data from the OSU STREAM modules as well as the Mindfulness 
Coach/Mindfulness for Clinicians app.  For both of these, participants in the intervention 
will login using a specific project code.  No personal identifiers will be collected by either 
program.  De-identified data on usage including the number of people who accessed 
each module and usage of the Mindfulness Coach/Mindfulness for Clinicians app will be 
shared with study staff at VA CCMR to evaluate fidelity. 
All study data will be stored on a VA Ann Arbor CCMR secure server, accessible 
only by study staff. To protect subject confidentiality, unique study ID numbers will be 
used for all study surveys and study databases in lieu of names. Only study staff will 
have access to the cross-link file that could connect subjects to their ID number. Study 
documents including signed informed consent documents and data 
collection/observation sheets will be stored in a locked filing cabinet at each study site. 
We will follow approved VA guidelines, Records Control Schedule RCS 10-1, for the 
disposition of records following closure of the study.  
 
RISKS   
There are no physical risks associated with this research. However, as with any 
study, there is a risk to participants of inadvertent disclosure of personal information or a 
loss of confidentiality. We believe this risk is extremely low; we describe the multiple 
measures that we will take to protect our participants below. Additionally, participants 
may find it uncomfortable to answer some of the questions on the survey or during the 
interviews. They will be informed that they can skip any question. Finally, to minimize 
the risk of coercion, all potential subjects will be offered the opportunity to decline study 
participation with no penalty to VA employment, and will be informed that they may 
decide not to continue participation at any time. 
The principal investigators, Drs. Greene and Saint, take ultimate responsibility for 
ensuring the safety of the participants. Specifically, we intend to take several steps to 
ensure subject confidentiality and protect against the potential risks related to loss of 
confidentiality, and stress related to interviews.  
Throughout the study, IRB and privacy guidelines will be followed to ensure the 
privacy and integrity of the information we collect. Any breach of confidentiality will be 
immediately reported to the PD/PI and to the participating IRBs. In addition, any 
complaints/concerns expressed to the study staff will be immediately reported to the 
PD/PI and the IRB in accordance with existing policies and expectations. 
Aim 1: Hand hygiene observation data will not include any names in an attempt to 
protect subject confidentiality. The observation forms will record the team name or unit, 
the role of the individual, and what type of hand hygiene was performed (if any) upon 
entering and exiting a patient room. Duration of hand hygiene will also be recorded for 
all nurses and for attending physicians for half the observations. We will therefore be 
able to conduct analysis by intervention arm and physician type (attending, senior 
resident, or intern physician), or nurse. If the data collection forms were released, it 
might be possible to identify an individual’s hand hygiene compliance with the 
information collected. The research assistants will store the forms in a lock box during 

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transport to protect confidentiality. Once in a study office, the hand hygiene observation 
data will be entered into a study database on a secure VA server, with access only to 
study team members. The paper observation forms will be stored in a locked filing 
cabinet. 
Aim 2: All potential participants will be clearly informed that their participation is 
completely voluntary. Thus, an alternative course of action for each of them would be to 
not participate. Subjects will be asked to complete surveys with questions on 
mindfulness and well-being at multiple time points throughout the study. These surveys 
will be labeled with a unique study ID so study staff can link the survey to the subject. 
The crosswalk file that would identify the participants will be stored on a secure VA 
server with access to only study staff. The baseline survey will primarily be distributed in 
paper form when participants are recruited, after they have provided informed consent. 
The data from these surveys will be entered into a study database on a secure VA 
server and then stored in a locked filing cabinet. We will also distribute surveys 
electronically to those we are unable to approach in person. For example, nurses on the 
control units will be emailed an invitation to participate in the study survey instead of in 
person (Appendix E).  A reminder email will also be sent to non-respondents on the 
nurse control units to encourage participation (Appendix F).  We will also email the 1-
month and 6-month post-intervention (7 months from baseline) surveys to nurses on the 
intervention units, as well as physicians during follow-up since many resident physicians 
will rotate to other hospitals (Appendix G).  Similar to the nurse control’s, reminder 
emails will be sent to non-respondents at 1-week and 2-weeks after the initial mailing to 
encourage survey completion (Appendix F).  We will use an online survey program like 
Qualtrics which can be accessed outside of the VA firewall, since physicians may be 
completing the survey on a non-VA computer. The electronic surveys will not contain 
any individual identifiers. They will be labeled only with the unique study ID number and 
will ask questions about mindfulness, well-being and hand hygiene perceptions.  
There could be added risks associated with using the Mindfulness 
Coach/Mindfulness for Clinicians app in the intervention. The Mindfulness 
Coach/Mindfulness for Clinicians app was developed by VA researchers for use with 
Veteran patients, and it already meets VA privacy and security standards. The mobile 
app will provide education and exercises to practice mindfulness. We will collect usage 
data and responses to a self-assessment from the app. The mobile app does not itself 
collect any individual identifiers. When subjects are enrolled, they will be given a unique 
study id that will allow the study team to identify data collected from the app, using a 
crosswalk file. Files that link the interviewee with the study ID will be securely stored in 
an access restricted folder on a secured VA server in a separate location from the study 
data.  
Aim 3: We plan to record and transcribe the interviews and guided discussions in the 
intervention arm. The participants will be told they can ask for the recorder to be turned 
off at any time and they may skip questions that they may not wish to answer or end 
participation at any time. Psychological and social risks might be possible if 
confidentiality were breached for the interviews or discussions. To protect the 
interviewee’s confidentiality, the audio recordings will be labeled using unique study ID 
codes only. Participant names, other individual names, and facility names will not 

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appear in any of the transcripts. If such information is volunteered (despite instructions) 
by the participant in a taped session, it will be removed by the transcriptionist. Files that 
link the participant with a study ID will be securely stored in a restricted access folder on 
a secure server at Ann Arbor VA CCMR. The original audio recordings, and study 
transcripts will be electronically stored in restricted access folders on secure servers 
that can only be accessed by specified study personnel. At the end of the study, the 
linking information will be removed from the transcripts to protect confidentiality. All 
reports and transcripts from the qualitative recordings will be completely stripped of any 
identifiers to protect the confidentiality of all participants. No information that could 
identify a respondent will be reported. There are no physical risks associated with this 
aim. 
Any reports or manuscripts on this project will contain only aggregate, de-identified 
data. 
 
BENEFITS:   
This research study has an excellent risk/benefit ratio. While risks to participants are 
minimal, the benefits are great. Although the participants may not receive any direct 
benefit, participation in the study could improve hand hygiene adherence and provider 
well-being. This in turn could help prevent HAIs and improve the quality of care 
delivered to Veterans. If successful, this intervention could be spread throughout VHA to 
improve both provider well-being and patient safety. 
 
5.2 Recruitment Methods 
Recruitment and Informed Consent 
 
Aim 1: Participation in the randomized controlled trial portion of the study will involve 
obtaining a signed informed consent document from subjects. This process is described 
under Aim 2 below.  
We will seek a waiver of informed consent to conduct the hand hygiene observations 
for Aim 1 on each unit and with each physician team that participates in the trial. To help 
minimize a Hawthorne effect we will make these observations covertly by standing in 
the hallway and not following any one individual or team. If asked about our presence 
on the unit we will respond that we are there to study hospital workflow. The data 
collected will be de-identified, only indicating the role of the person observed (attending, 
senior, intern, or nurse). Hand hygiene is something that the hospital is already 
monitoring periodically and collecting hand hygiene data for this study will not put the 
observed healthcare providers at any increased risk.   
 
Aim 2: The providers will be recruited through multiple methods to increase the 
participation rate. 

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x Nurses: We estimate there will be approximately 20-30 nurses on each unit. We 
will recruit from 2 units at the Ann Arbor VAMC (approximately 20 intervention; 
20 control) and 4 units at the MEDVAMC (approximately 40 intervention; 50 
control), for a total of approximately 130 nurse participants. Nurses will be 
provided information about the study during unit meetings and through study 
flyers posted in the break room (Appendix H & I).  
o Nurses on the control units will only be asked to complete the 3 study 
surveys over a 7-month period. This can be done with a waiver of 
documented consent. Nurses on the control units will be given a study 
information letter with a paper survey and return envelope or emailed 
the study information letter with a link to complete the survey 
electronically (Appendix E). If they complete the survey, they are 
implying consent. A reminder email will be sent at 1-week and 2-weeks 
to non-respondents to encourage participation (Appendix F). 
o Nurses on intervention units will be sent an introductory email 
(Appendix J) with information about the study and asking to set up a 
time and place to discuss the study in more detail. If we are unable to 
reach the nurses through email, study staff will approach the nurses 
during their work shift and ask to set up a time to meet to discuss the 
study in private. Recruitment will occur in a private room or office using 
the attached recruitment script (Appendix K).  
x Physicians: We estimate enrolling approximately 35 attending physicians, 24 
senior residents, and 48 intern physicians into each arm of the study, which will 
result in a total of 214 physicians in total. All physicians from physician teams will 
be asked to participate in the randomized controlled trial and provide a signed 
informed consent. Each month one team at the Ann Arbor VAMC and 2 teams at 
MEDVAMC will be randomized to intervention and an equal number at each site 
will be randomized to control. A flyer describing the study (Appendix S) will be 
emailed (Appendix T) to teaching attendings to introduce the study. Before the 
beginning of the month, the initial attending physician on each selected team will 
be sent an email describing the study and giving them the option to opt out of 
their team being approached to participate (Appendix L). A time and place will 
be scheduled to discuss the study in more detail and obtain informed consent 
from the attending (Appendix M). Unless the attending indicates they do not 
want their team participating, the rest of the team will be sent an email describing 
the study (Appendix L). Then study staff will approach the senior resident and 
interns in the team rooms and ask to speak with them about the study (Appendix 
M). If there are others in the team room, the study staff will ask the residents to 
follow them to a private room to discuss the study in greater detail. If they are 
willing to participate, they will be asked to sign an informed consent document. 
The primary participants are the attending physicians on each team. If the initial 
attending declines allowing their team to participate, another team will be 
randomly selected and approached for participation. If any physicians choose to 
not participate, they will not be asked to participate in the intervention activities (if 
randomized to the intervention) or to complete the study surveys (both study 

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arms). However, hand hygiene data will still be collected using a waiver of 
informed consent. When a new attending starts on a team that has already been 
randomized, they will be recruited in a similar manner as the initial attending 
(email, followed by in person recruitment). If the 2nd attending on the team 
declines participation, the team is still considered enrolled, however the new 
attending will not be asked to participate in the intervention (if on an intervention 
team) or complete the study surveys. 
 
Aim 3: Interviews and Guided Discussions 
x Interviews: Select participants in the intervention arm will be asked to participate 
in the qualitative evaluation interviews to provide feedback about the intervention. 
We estimate enrolling 4-6 nurses and 8 physicians from each site.  The providers 
will be recruited via email (Appendix N) or in-person communication with study 
staff. If they agree, a day, time, and location for the interview will be arranged. At 
the Ann Arbor VAMC, these interviews can be conducted in person, or by phone 
if needed.  Members of the team from Ann Arbor plan to travel to MEDVAMC to 
conduct these interviews in person as well, since more information can be 
obtained through direct observation and face to face interactions.  However, if 
travel restrictions are in place or if someone is unable to attend an in-person 
meeting, the interview can be scheduled to occur either over the phone or using 
a VA approved conferencing program like Microsoft Teams or Zoom for 
Government.  The Ann Arbor qualitative team will provide a study information 
letter and review the purpose of the interview before obtaining verbal informed 
consent. As we will be audio recording – will will ask verbal permission to audio 
record at the start of the interview using the attached audio recording permission 
script (Appendix O). We will ask for a waiver of informed consent for this aim of 
the study as it poses minimal risk and a signed consent would be the only link 
between the subject and their interview, which would increase their risk of loss of 
confidentiality.    
x Guided Discussions: The signed informed consent that is obtained from all 
nurses and physicians in the intervention will include permission to record the 
guided discussion sessions. In addition, the mindfulness champion will ask all 
attendees at each guided discussion session if they are willing to have the 
session recorded and that they can ask to have the recorder turned off at any 
time for any reason (Appendix P). 
All subjects will be VA employees or trainees. As participation in this program will 
require extra time outside of their normal work duty to complete the three mindfulness 
educational modules, we will offer $25 remuneration per completed module (maximum 
of $75 for the project).  Each participant will be given a unique code to access these 
training modules.  Consultant Kathi Kemper will email the project manager every 1-2 
weeks with a list of which modules were completed and the associated unique codes.  
The staff in Ann Arbor will then check the cross-link file to identify to which subjects 
those codes correspond.  The gift cards will then be mailed to the participants for each 
completed module or distributed in person where feasible. This is to help promote 
completion of this key part of the intervention.  Participants will be told they will not be 

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eligible for remuneration if they complete the modules during their normal working 
hours. However, this will be done on an honor system as project staff will have no way 
to confirm when the modules were completed or what is the participant’s normal tour of 
duty. There will be no remuneration for any other aspect of the project. 
 
5.3 Informed Consent Procedures 
Subjects will be recruited for the project as described in section 5.2.  We will seek a 
waiver of informed consent to conduct the hand hygiene observations for Aim 1.   
All physician participants (i.e., those that are assigned to either the intervention or 
control arm of the study) will be asked to provide written informed consent with a HIPAA 
authorization.  The informed consent document will describe the randomized controlled 
trial including both arms of the study (intervention activities and control). It will also 
include information about the survey data that they would be asked to provide at 
baseline, 1-month, and 6-month post-intervention time-points.  This method of consent 
will allow the research assistants who will be obtaining the informed consent and also 
conducting the hand hygiene observations to be blinded to the intervention status of 
each participant. 
For nurse participants, we will seek a waiver of documented informed consent for 
the nurses on the units randomized as control.  These nurses will only be asked to 
complete surveys about mindfulness (Appendix B) at baseline, 1, month, 6 months 
post-intervention.  Completion of surveys falls under exemption category 2.  Completing 
the survey will imply their consent for their responses to be included in the study.  The 
nurses on the units randomized to the intervention will be asked to provide written 
informed consent to participate in the intervention which will outline all aspects of the 
intervention as well as the surveys. This change in consent strategy between the nurses 
and physician is because the research assistants will know which units are assigned to 
intervention and control.  It is not feasible to blind the research assistants to the 
intervention status of the nursing units, but we will be able to blind them to the status of 
the physicians.  As such, we are requesting the waiver of documented consent for the 
control nurses only to reduce burden in the hopes of increasing participation of this 
group. 
For the physicians (both intervention and control) and the nurses on the intervention 
units, consent will be obtained in a private room or office.  Trained research staff will 
explain the study and answer any questions.  If the eligible subjects choose to 
participate, they will then be asked to provide a signed informed consent which will 
cover the appropriate aspects of the study.   
For the interviews of a sample of intervention participants for Aim 3, the qualitative 
team will provide a study information letter and review the purpose of the interview 
before obtaining verbal informed consent. We will ask for a waiver of documented 
informed consent for this portion of the study as it poses minimal risk and a signed 
consent would be the only link between the subject and their interview, which would 
increase their risk of loss of confidentiality.  All study research staff will be trained in 
appropriate human subjects protection and the informed consent process.  To minimize 

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the risk of coercion, all potential subjects will be offered the opportunity to decline study 
participation with no penalty to VA employment, and will be informed that they may 
decide not to continue participation at any time.  As our subjects are VA staff, there will 
not be any protected health information collected as part of this project. 
 
5.4 Inclusion/Exclusion Criteria 
Aims 1 and 2: 
For the nurse portion of the trial, 1 inpatient hospital unit at Ann Arbor VAMC and 2 
units at MEDVAMC will be randomized to receive the intervention and an equal number 
of units at each site will be randomized to receive the control. All nurses on the selected 
units will be asked to participate in the voluntary study. Inclusion criteria are all nurses 
on the identified units. There are no exclusion criteria. 
For the physician portion of the trial, we will focus on inpatient physician teaching 
teams, which typically include 1 attending physician, 1 senior resident, and 2-3 intern 
physicians (Year 1 residents). Inclusion criteria are physicians on inpatient medical 
teams. Exclusion criteria are medical students, surgical attendings, and physicians on 
sub-specialty teams. Attending physicians may be on service multiple times per year. 
Attendings will be allowed to participate in multiple months, however, once a physician 
has been randomized to the intervention arm, they will no longer be eligible to 
participate in the control arm of the study. 
 
 
Aim 3:   
In this aim we will conduct a qualitative evaluation to better understand the 
perception of the intervention and assess any barriers or facilitators encountered. The 
primary subjects will be nurses and physicians that participated in the intervention. 
Inclusion criteria for this aim is being a nurse or physician that participated in the 
intervention. There are no exclusion criteria. 
 
5.5 Study Evaluations 
The following evaluations will be conducted.  Details can also be found in section 5.1 - 
Study Design. 
Field observational data collection will include hand hygiene adherence and duration 
using standardized templates for data collection (Appendix A). Collected data will be 
transferred from the paper observation data tool into a study database.  
All participants will be asked to complete a survey containing validated scales 
measuring dispositional mindfulness, well-being, and hand hygiene perceptions. The 
FFMQ75 is a validated instrument with favorable psychometric properties and consists of 
39 questions. Additionally, participants will be asked to complete the WBI. The 9-
question 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,76 residents,77 and nurses.78 Participants will also be asked to complete 8 

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questions on HAI and hand hygiene perceptions selected from the PSHW developed by 
the World Health Organization.79 Similar to other studies on hand hygiene perceptions 
guided by the constructs based on the Theory of Planned Behavior,8-10 the selected 
PSHW questions cover behavioral, normative, and control beliefs, as well as self-
reported hand hygiene adherence. Participants will also be asked whether they 
meditate or perform any form of internal reflection prior to the study, as this may 
influence performance during the intervention. Questionnaire completion will take 
approximately 10 minutes. No personal identifiable information will be collected. Paper 
survey distribution will be used wherever feasible, but electronic versions using 
Qualitrics will be available for physicians that have rotated to locations outside of the 
VA.  Study participants will be directed to a link to the survey tool (for the pre- and post-
intervention, as well as 6-month post-intervention follow-up periods) and responses will 
be saved to a database managed by the study team.  
Participants from the intervention groups will receive both independent and group-
facilitated mindfulness education, will be encouraged to use a mindfulness mobile app 
as a practice reminder and additional resource, and instructed to integrate moments of 
mindfulness with repeated episodes of hand hygiene during the course of caring for 
patients.  The control groups will receive no such education or intervention and will 
continue usual care. 
Details of each intervention component and measures of fidelity are as follows:  
x Participants will be asked to complete self-directed, online mindfulness training 
modules developed by the Ohio State University Mind-Body STREAM program. 
The mindfulness training will include three modules: (a) Introduction to 
Mindfulness, (b) Mindfulness in Daily Life, and (c) Mindful Breathing and Sitting.  
Participants will be given a unique code to use to access these training modules.  
The modules will not store or collect any personal identifying information.  
Consultant Dr. Kemper will share access data with the Ann Arbor project staff by 
that access code which will be used to measure fidelity to the intervention.   
x As part of the self-directed component participants will be encouraged to use the 
VA Mindfulness Coach or Mindfulness for Clinicians mobile app.  Participants 
can choose to download this app to their personal devices.  Co-investigator 
Jason Owen at the VA Palo Alto Healthcare System will collect de-identified data 
on app usage and share with the Ann Arbor team to measure fidelity to the 
intervention.  The mobile app does not collect any personal identifiers.   
x The group-facilitated component will include discussions focused on how 
principles of mindfulness can be used to influence a clinician’s state of mental 
presence, allowing for moments of clarity, insight, and reflection, and potentially 
enhanced provider and patient safety. Discussions will also address questions 
and feedback on the self-directed components discussed above. For physician 
participants, group-facilitated discussions lasting approximately 15 minutes will 
be offered every other week throughout the intervention phase at each site. For 
nurse participants, group-facilitated discussions lasting up to 30 minutes will be 
offered every week throughout the intervention phase at each site.  In addition to 

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recording these discussions for use in the qualitative study evaluation, 
attendance at these discussions will be recorded to assess fidelity.   
 
5.6 Data Analysis 
Quantitative Statistical Analysis (Aims 1 and 2): Differences in hand hygiene 
adherence and duration between intervention and control groups will be assessed using 
Fisher’s exact test and t-test, as appropriate. Risk differences in adherence to duration 
of hand hygiene will be calculated for both intervention and control groups. Because the 
primary outcomes for Aim 1 (i.e., hand hygiene adherence and duration) are expected 
to occur frequently, we will use generalized linear models to evaluate differences in 
hand hygiene adherence and duration for the intervention versus control group, with the 
Poisson distribution (log link) and robust error variance. Models will account for provider 
type and level, and will incorporate clustering by physician team (and separately for 
nursing unit). Statistical significance will be calculated for the intervention (intervention 
vs. control) coefficient.  
As a secondary outcome for Aim 1, we will assess changes and differences in hand 
hygiene perception based on response to select questions from PSHW. For Aim 2, 
mindfulness will be based on responses to FFMQ and well-being will be based on 
responses to WBI. FFMQ and WBI scales will be scored according to the published 
algorithms. Descriptive statistics will be used to summarize participant scores from pre- 
and post-intervention, as well as 6-month post-intervention follow-up assessments. 
Within-group paired-samples t-tests will be used to test for improvement in participant 
scores across the baseline, post-intervention (~14 days for physicians and 1-month for 
nurses), and 6-month post-intervention follow-up periods, for the intervention and 
control groups separately. Analyses will use list-wise deletion for missing data. 
Participants not completing all surveys will still be included in any analysis for which 
they provide data. For all analyses, p values less than 0.05 will be considered significant 
and all tests will be two-tailed. Analysis of covariance (ANCOVA) models will then be 
used to assess relative changes in mindfulness, well-being, and hand hygiene 
perceptions across groups, the most direct test of discriminant validity. In these models, 
post-test scores will be predicted by group status controlling for pre-test scores.  
Power - Based on a range of 10%-15% significant percent change in hand hygiene 
adherence from our pilot data,72 we are anticipating an expected increase in hand 
hygiene adherence due to the intervention from approximately 80% at baseline to 88%-
92% at follow-up. We will have 79.8% power to detect this 10% increase based on a 
fixed total sample size of 334 with a two-sided alpha of 0.05, assuming an average of 
60 observed hand hygiene opportunities per provider per measurement time point (i.e., 
intervention and follow-up), and taking into account clustering of data within 
site/team/unit (assumed Intraclass Correlation Coefficient=0.4).82 For assessing 
differences in the select PSHW questions we will have 70.1% power to detect an effect 
size of 0.15.83 For assessing differences in FFMQ and WBI scores, we will have >95% 
power to detect effect sizes ranging from 0.3 to 0.75 as found in prior studies.65,84,85  
 

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Qualitative Phase (Aim 3): In Aim 3, we will begin the process of identifying the 
facilitators and challenges of incorporating mindfulness into clinical practice and 
developing a deeper understanding of perceptions and experiences related to using 
mindfulness in the clinical setting. We will employ a case-study methodology, 
conducting semi-structured interviews. First, we will conduct interviews with intervention 
participants (attending physicians, senior residents, interns, and nurses) at each site. 
We will ask participants about their experience with mindfulness and opinions about 
using it as a possible tool to promote hand hygiene, infection prevention, and provider 
well-being. Interviews will occur at the conclusion of selected intervention phase 
observation periods. We will invite members of the intervention arms to discuss their 
experience of attempting mindful hand hygiene, the concept of mindfulness for 
healthcare providers in the inpatient setting, the hand hygiene-based mindfulness 
intervention components (i.e., online modules, mindfulness app, group-facilitated 
discussions, mindful hand hygiene moments), challenges to performing mindfulness, 
and the potential benefits for providers and patients. Based on the literature and our 
prior experience, data saturation is generally achieved after interviewing 10-12 
individuals at a site. We plan to interview approximately 8 physician team members and 
4-6 nurses at each site. Interviews will include a semi-structured interview guide 
(Appendix D) to stimulate discussion of the realities and challenges of practicing 
mindfulness through hand hygiene in the clinical setting. Second, qualitative data will 
also be collected and evaluated from each site’s group-facilitated guided discussions. 
During these guided discussions it is expected that participants will talk about their 
insights on learning and their own personal experiences practicing mindfulness during 
the intervention. All guided discussions, along with the interviews, will be recorded, de-
identified, and transcribed for analysis. These recordings will be transcribed internally by 
staff at the VA Ann Arbor CCMR offices.  The interviews and transcripts will be stored 
on secure VA CCMR servers with access limited to approved project staff. Transcripts 
will be reviewed and data central to the aims of this study will be extracted and 
analyzed. We will use the 7 aspects of Mindful Practice86 as they may relate to hand 
hygiene as a guide for data interpretation. 
All interviews will be conducted by 2 to 3 members our team and will generally 
include the study Principal Investigator Greene, other study co-investigators PD/PI 
Saint, or Co-Investigators Houchens and Sheffield, non-clinician qualitative experts 
Harrod or Quinn, and project support staff (the project manager or research assistant). 
All interviews will be audio-recorded and transcribed for analysis; field-notes and site 
materials will be preserved. Participants will be informed when the audio recording is in 
process and may request to stop the audio recording at any time.  
A descriptive-content analysis will be conducted on the qualitative data from 
interviews and group discussions.87 Three to four members of the study team will begin 
by independently reading a sample of interview and group discussion transcripts and 
together develop a preliminary coding scheme to help guide the analysis. A codebook 
will be created that includes both deductive codes, identified prior to coding based on 
key study categories, and inductive codes that emerge directly from the data. Two 
members of the study team will use this codebook, which will be revised periodically as 
additional codes emerge, to independently review and code all transcripts. If new codes 
emerge, previously coded transcripts will be re-analyzed to ensure consistency in the 

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application of codes. The two coders will meet regularly, and with other study team 
members as needed, to discuss and resolve any discrepancies in coding until 
agreement is reached. We will use a VA approved qualitative analysis program like 
MAXQDA (VERBI Software, Berlin, Germany) will be used to manage and organize the 
qualitative data. Once all of the data have been coded and entered into MAXQDA, 
members of the larger study team will identify key themes. All recordings and transcripts 
will be stored on a secure VA CCMR server, with access limited to approved study staff. 
 
5.7 Withdrawal of Subjects 
Subjects may choose to withdraw at any time without any penalty.  We will use the 
data collected up until the point of withdrawal.  There are no anticipated circumstances 
for subject withdrawal without subject consent. 
 
6.0 
Reporting 
Because this is a minimal risk study with no patient involvement, we do not 
anticipate any serious adverse events.  Study subjects will be physicians and nurses 
who will be asked to complete either paper or electronic surveys, participate in group 
led discussions, complete online training modules, and use an optional mobile 
application on mindfulness.  Hand hygiene compliance will be monitored covertly.  
Intervention participants will be encouraged to practice mindfulness and use hand 
hygiene as a moment of mindfulness.  Serious adverse events (SAEs) to be monitored 
include the following: 1) a breach of a participant’s confidentiality or privacy that involves 
potential risk to that participant or others, 2) deviations from VA IRB regulations and 
policies, and 3) unanticipated problems that involve social or economic harm instead of 
the physical or psychological harm associated with (UAPs) adverse events. SAEs will 
be prospectively tracked according to the following plan: reports of SAEs and protocol 
deviations will be made by the study team member who discovers the event, the site PI, 
or site project manager (if applicable) to the primary site (Ann Arbor) project manager. 
The primary site project manager and PI will report the event to the Central IRB 
(Primary Site IRB). Any SAEs and UAPs meeting the definition of serious will be 
reported within 5 business days of discovery to the Central IRB. AEs and UAPs that do 
not meet the definition of serious are to be reported to Ann Arbor project manager as 
they are discovered, and will be reported to the Central IRB in summary at the time of 
continuing review/project closure. Protocol deviations/violations that are likely to 
substantially adversely affect 1) the rights, safety, or welfare of a participant; 2) a 
participant’s willingness to continue participation; or 3) the integrity of the research data, 
including VA information security requirements will all be reported within 5 working days 
of being made aware of the occurrence.  Dr. Saint will be involved with all decisions 
related to the health and safety of subjects for this project.  We will also submit annual 
progress reports to the HSR&D Data Safety and Monitoring Board. 

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7.0 
Privacy and Confidentiality 
x Will you be accessing REAL SSNs?   NO   
The study will not use or disclose any protected health information (PHI). To protect 
subjects’ confidentiality, all study materials will be labeled using unique study ID codes 
only.  For example, participant names or other individual names will not appear in any of 
the surveys or interview transcripts.  If such information is volunteered (despite 
instructions) in a taped session or in a survey, it will be removed by the transcriptionist 
and/or other research staff.  Files that link the interviewee with a study ID will be 
securely stored in a restricted access folder on a secure VA CCMR server.  The original 
audio recordings and study transcripts will also be electronically stored in restricted 
access folders on secure servers that can only be accessed by specified study 
personnel.  At the end of the study, the linking information will be removed from the 
transcripts to protect confidentiality.  Any notes taken during the interviews and/or 
guided sessions will be typed up and stored on the secure CCMR Server in the study 
folder.  Hard copies of the notes will be stored in locked filing cabinets in the CCMR 
Suite on the 3rd Floor of Building 16 at the North Campus Research Complex.  Once 
the handwritten notes are typed up and checked for accuracy, the hard copies will be 
destroyed using the VA shredding service.  For all study data, we will follow approved 
VA guidelines, Records Control Schedule RCS 10-1, for the disposition of records 
following closure of the study. 
 
8.0 
Communication Plan 
Communication will occur through regular study team meetings. These monthly 
meetings will include discussion of the events since the prior meeting, and specifically if 
any problems/events have occurred. The PIs and the study team will work to address 
any problems/events to reduce the likelihood of occurrence in the future, to keep the 
risk to subjects as low as possible, and to maximize the potential study benefits. These 
team meetings will also be utilized to ensure that all relevant IRB policies and study 
procedures are being followed. These include: (1) all participants understand, agree to 
and provide informed consent (written or verbal as approved by the IRB) before 
participating; (2) strict adherence to a participant’s right to withdraw or refuse to answer 
questions will be maintained; (3) all data collection is completely confidential; (4) 
consent forms and identifying information are kept separate from the actual participant 
data; (6) all identifying information is kept locked at all times and sensitive computer 
files are maintained on a secured VA server; and (7) participants are informed in writing 
how to contact the site PD/PI, the study coordinator, and IRB office with any questions 
and/or concerns. Additional communication about the project will be conducted over 
email.  Dr. Greene, Dr. Trautner, and the project manager will remain in close contact 
regarding all multi-site study activities including recruitment procedures, recruitment 
status, intervention implementation, data collection and subject follow-up.   
 

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9.0 
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52. 
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intervention program for stress management among medical students: the 
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55. 
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