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Mindful Hand Hygiene for Healthcare Workers

Primary Purpose

Burnout, Mental Health

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Hand Hygiene
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Burnout focused on measuring Mindfulness, Hand Hygiene, Health Personnel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Nurses on participating unit
  • Physician on an inpatient medical team, including attending, senior resident, and intern physicians

Exclusion Criteria:

  • Medical students
  • Surgical attendings
  • Physicians on sub-specialty teams

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting
  • Michael E. DeBakey VA Medical Center, Houston, TXRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindful Hand Hygiene Intervention

Control Arm

Arm Description

Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.

Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.

Outcomes

Primary Outcome Measures

The Five Facet Mindfulness Questionnaire (FFMQ) - Baseline
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. Scores are combined into the following subscales - Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity as well as a total score. Scores on the Observing, Describing, Acting with Awareness, and Nonjudging subscales range from 8-40, while the Nonreactivity subscale ranges from 7-35. The total FFMQ scores can range from 39-195. Lower scores mean less mindful, while higher scores indicate the respondent is more mindful. Scores can also be averaged for each subscale (1-5)
Perceptions Survey for Healthcare Workers (PSHW) - Baseline
Participants will also be asked to complete 8 questions on healthcare-associated infection and hand hygiene perceptions selected from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization. PSHW questions cover behavioral, normative, and control beliefs, as well as self-reported hand hygiene adherence. Individual question responses will be assessed on scales of 1-4, 1-7 or 0-100. Higher scores indicate higher importance of the practice.
Well-Being Index - Baseline
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, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk).
The Five Facet Mindfulness Questionnaire (FFMQ) - Post-Intervention
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. Scores are combined into the following subscales - Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity as well as a total score. Scores on the Observing, Describing, Acting with Awareness, and Nonjudging subscales range from 8-40, while the Nonreactivity subscale ranges from 7-35. The total FFMQ scores can range from 39-195. Lower scores mean less mindful, while higher scores indicate the respondent is more mindful. Scores can also be averaged for each subscale (1-5).
Well-Being Index - Post-Intervention
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, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk).
Perceptions Survey for Healthcare Workers (PSHW) - Post-Intervention
Participants will also be asked to complete 8 questions on healthcare-associated infection and hand hygiene perceptions selected from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization. PSHW questions cover behavioral, normative, and control beliefs, as well as self-reported hand hygiene adherence. Individual question responses will be assessed on scales of 1-4, 1-7 or 0-100. Higher scores indicate higher importance of the practice.
The Five Facet Mindfulness Questionnaire (FFMQ) - 6-months Post-Intervention
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. Scores are combined into the following subscales - Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity as well as a total score. Scores on the Observing, Describing, Acting with Awareness, and Nonjudging subscales range from 8-40, while the Nonreactivity subscale ranges from 7-35. The total FFMQ scores can range from 39-195. Lower scores mean less mindful, while higher scores indicate the respondent is more mindful. Scores can also be averaged for each subscale (1-5).
Well-Being Index - 6-months Post-Intervention
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, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk).
Perceptions Survey for Healthcare Workers (PSHW) - 6-months Post-Intervention
Participants will also be asked to complete 8 questions on healthcare-associated infection and hand hygiene perceptions selected from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization. PSHW questions cover behavioral, normative, and control beliefs, as well as self-reported hand hygiene adherence. Individual question responses will be assessed on scales of 1-4, 1-7 or 0-100. Higher scores indicate higher importance of the practice.

Secondary Outcome Measures

Hand Hygiene - Habituation
Research assistants will conduct covert direct observations of hand hygiene moments during weekdays. The metric will include whether the physician or nurse used hand rub, washed with soap and water, or did not wash their hands before entering and after exiting a patient room. Duration of hand hygiene will also be measured upon room exit.
Hand Hygiene - Intervention
Research assistants will conduct covert direct observations of hand hygiene moments during weekdays. The metric will include whether the physician or nurse used hand rub, washed with soap and water, or did not wash their hands before entering and after exiting a patient room. Duration of hand hygiene will also be measured upon room exit.
Hand Hygiene - Post-Intervention
Research assistants will conduct covert direct observations of hand hygiene moments during weekdays. The metric will include whether the physician or nurse used hand rub, washed with soap and water, or did not wash their hands before entering and after exiting a patient room. Duration of hand hygiene will also be measured upon room exit.

Full Information

First Posted
February 4, 2022
Last Updated
November 15, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05261282
Brief Title
Mindful Hand Hygiene for Healthcare Workers
Official Title
Mindful Hand Hygiene to Reduce Infections Among Veterans While Enhancing Provider Well-Being
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test an intervention focused towards promoting mindfulness among VA physicians and nurses. Mindfulness is a tool that can help people focus. It helps clear the mind of distractions and biases. Some physicians and nurses will be randomized to receive the study intervention, while others will not. The study intervention will include the following: 1) education about mindfulness; 2) group discussions about mindfulness; and 3) an optional mobile app to promote mindfulness. Participants randomized to the intervention will be encouraged to use the act of cleansing their hands as a prompt for practicing mindfulness. The study will test if this intervention will increase physician and nurse mindfulness. It will also test if it leads to improved well-being and use of proper hand hygiene.
Detailed Description
Physician and nurse well-being is important for providing high quality patient care. Many physicians and nurses suffer from stress, fatigue, psychological distress, depression, and burnout. This can lead to poor patient care. In this study, the investigators will use a repeat-measures randomized controlled mixed-methods trial to evaluate an intervention designed to improve healthcare provider well-being. The intervention will help physicians and nurses practice moments of mindfulness. Mindfulness is paying attention to the present moment. It can help people feel more aware instead of feeling like they are running on automatic pilot. The investigators will test if practicing mindfulness while cleaning hands before and after seeing patients will lead to improved well-being and hand hygiene. This is a multi-center, repeat-measures randomized controlled mixed-methods trial that will last 3 years. The primary objective of this phase 1/2 clinical trial is to implement and evaluate an intervention to improve physician & nurse well-being through promoting mindfulness. Secondary objectives include monitoring physician and nurse hand hygiene adherence and duration and conducting a qualitative assessment to evaluate the intervention. The study will enroll approximately 334 physicians and nurses from 2 VA Medical Centers (LTC Charles S. Kettles VA Medical Center, Ann Arbor, MI; and Michael E. DeBakey VA Medical Center, Houston, TX). 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. The investigators 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, the investigators will aim to recruit approximately 40 attendings, 72 residents and 80 nurses. The target study sample size is a total of 334 physicians and nurses (167 intervention/167 control). For Aim 3, the investigators plan to interview approximately 8 physician team members and 4-6 nurses from the intervention arm at each site. 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 seeking approval for their team to participate in the randomized controlled trial. If the attending physician from a team refuses participation, 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 the Ann Arbor VA (1 intervention, 1 control) and 4 medical/surgical units from Houston VA (2 intervention, 2 control) will be randomly selected to participate in the nurse portion of the project. The nurse manager for each 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. An independent statistician will allocate the physician teams and nursing units at both study sites 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 providing care as usual. Recruitment and Control Arm: Potential subjects will be recruited via email or in-person communications. Everyone who consents to participate (regardless of study arm) will be asked to complete baseline surveys containing validated scales measuring dispositional mindfulness, well-being, and hand hygiene perceptions. The Five Facet Mindfulness Questionnaire (FFMQ) 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, residents, and nurses. Participants will also be asked to complete 8 questions on healthcare-associated infections and hand hygiene perceptions selected from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization. Similar to other studies on hand hygiene perceptions guided by the constructs based on the Theory of Planned Behavior, 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. Completing the full survey questionnaire will take approximately 10 minutes. Habituation Period: To collect baseline data on hand hygiene adherence and duration for both study arms and to habituate providers to the presence of observers, 1 month of covert, unit-based hand hygiene observations will be conducted. Observation of hand hygiene adherence will include hand hygiene prior to patient room entry and after exiting the patient room. 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 since observers will not enter patient rooms and providers may practice hand hygiene while entering the patient room. Intervention Activities: Participants in the intervention will be asked to complete 3 self-directed online education modules on mindful practice developed by the Ohio State University Mind-Body Skills Training for Resilience, Effectiveness, and Mindfulness (STREAM) program (http://mind-bodyhealth.osu.edu). Subjects will receive compensation for completion of each online training module completed outside of their working hours. Participants will also be asked to participate in group-facilitated discussions with their site mindfulness champion where they will discuss using mindfulness during their work day. During these discussions, participants will be instructed to use the act of hand hygiene as a moment to pause and reflect - a mindful moment. The guided discussions will be recorded, transcribed, and used in the qualitative evaluation of the intervention. Intervention participants will also be given the option of using a self-directed mobile application to enhance their mindfulness education and practice. The study will use the Mindfulness Coach mobile app, which was developed by researchers at the National Center for Posttraumatic Stress Disorder, Dissemination & Training Division at the VA Palo Alto Health Care System. Post-Intervention Activities: The same measures that were collected during the pre-intervention period will again be collected during the post-intervention period. Subjects will be asked to complete the same survey once the 1-month intervention has ended. They will also be asked to complete the survey again 6-months post-intervention to assess sustainability. The research assistants will again conduct covert direct observations of hand hygiene moments during the intervention phase and 3-12 months post-intervention. Select subjects will also be asked to participate in qualitative interviews after the intervention is complete to provide: views on the intervention; overall perceptions of and experiences with mindfulness; barriers encountered while trying to implement the intervention during clinical practice; personal sense of well-being and whether or not the intervention had any effect on well-being; perceptions on whether or not practicing mindfulness during hand hygiene had any impact on hand hygiene adherence; and the potential benefits of using mindfulness in the clinical setting. Data Analysis: 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, the investigators 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, the investigators will assess changes and differences in hand hygiene perception based on responses to select questions from the PSHW. For Aim 2, mindfulness will be based on responses to the FFMQ and well-being will be based on responses to the WBI. Survey 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Mental Health
Keywords
Mindfulness, Hand Hygiene, Health Personnel

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a multi-center, repeat-measures, randomized controlled mixed-methods trial. 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). For nurses, 2-4 hospital units at each study site will be assigned to either intervention or control for the study period.
Masking
Outcomes Assessor
Masking Description
The research staff who conduct the hand hygiene observations for the physician teams will not know the randomization status of the physician teams. The investigators are unable to mask the research assistants from the randomization status of the nursing units.
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindful Hand Hygiene Intervention
Arm Type
Experimental
Arm Description
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Hand Hygiene
Intervention Description
Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
Primary Outcome Measure Information:
Title
The Five Facet Mindfulness Questionnaire (FFMQ) - Baseline
Description
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. Scores are combined into the following subscales - Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity as well as a total score. Scores on the Observing, Describing, Acting with Awareness, and Nonjudging subscales range from 8-40, while the Nonreactivity subscale ranges from 7-35. The total FFMQ scores can range from 39-195. Lower scores mean less mindful, while higher scores indicate the respondent is more mindful. Scores can also be averaged for each subscale (1-5)
Time Frame
Month 0
Title
Perceptions Survey for Healthcare Workers (PSHW) - Baseline
Description
Participants will also be asked to complete 8 questions on healthcare-associated infection and hand hygiene perceptions selected from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization. PSHW questions cover behavioral, normative, and control beliefs, as well as self-reported hand hygiene adherence. Individual question responses will be assessed on scales of 1-4, 1-7 or 0-100. Higher scores indicate higher importance of the practice.
Time Frame
Month 0
Title
Well-Being Index - Baseline
Description
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, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk).
Time Frame
Month 0
Title
The Five Facet Mindfulness Questionnaire (FFMQ) - Post-Intervention
Description
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. Scores are combined into the following subscales - Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity as well as a total score. Scores on the Observing, Describing, Acting with Awareness, and Nonjudging subscales range from 8-40, while the Nonreactivity subscale ranges from 7-35. The total FFMQ scores can range from 39-195. Lower scores mean less mindful, while higher scores indicate the respondent is more mindful. Scores can also be averaged for each subscale (1-5).
Time Frame
Month 1
Title
Well-Being Index - Post-Intervention
Description
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, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk).
Time Frame
Month 1
Title
Perceptions Survey for Healthcare Workers (PSHW) - Post-Intervention
Description
Participants will also be asked to complete 8 questions on healthcare-associated infection and hand hygiene perceptions selected from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization. PSHW questions cover behavioral, normative, and control beliefs, as well as self-reported hand hygiene adherence. Individual question responses will be assessed on scales of 1-4, 1-7 or 0-100. Higher scores indicate higher importance of the practice.
Time Frame
Month 1
Title
The Five Facet Mindfulness Questionnaire (FFMQ) - 6-months Post-Intervention
Description
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. Scores are combined into the following subscales - Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity as well as a total score. Scores on the Observing, Describing, Acting with Awareness, and Nonjudging subscales range from 8-40, while the Nonreactivity subscale ranges from 7-35. The total FFMQ scores can range from 39-195. Lower scores mean less mindful, while higher scores indicate the respondent is more mindful. Scores can also be averaged for each subscale (1-5).
Time Frame
Month 7
Title
Well-Being Index - 6-months Post-Intervention
Description
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, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk).
Time Frame
Month 7
Title
Perceptions Survey for Healthcare Workers (PSHW) - 6-months Post-Intervention
Description
Participants will also be asked to complete 8 questions on healthcare-associated infection and hand hygiene perceptions selected from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization. PSHW questions cover behavioral, normative, and control beliefs, as well as self-reported hand hygiene adherence. Individual question responses will be assessed on scales of 1-4, 1-7 or 0-100. Higher scores indicate higher importance of the practice.
Time Frame
Month 7
Secondary Outcome Measure Information:
Title
Hand Hygiene - Habituation
Description
Research assistants will conduct covert direct observations of hand hygiene moments during weekdays. The metric will include whether the physician or nurse used hand rub, washed with soap and water, or did not wash their hands before entering and after exiting a patient room. Duration of hand hygiene will also be measured upon room exit.
Time Frame
Month 0
Title
Hand Hygiene - Intervention
Description
Research assistants will conduct covert direct observations of hand hygiene moments during weekdays. The metric will include whether the physician or nurse used hand rub, washed with soap and water, or did not wash their hands before entering and after exiting a patient room. Duration of hand hygiene will also be measured upon room exit.
Time Frame
Month 1
Title
Hand Hygiene - Post-Intervention
Description
Research assistants will conduct covert direct observations of hand hygiene moments during weekdays. The metric will include whether the physician or nurse used hand rub, washed with soap and water, or did not wash their hands before entering and after exiting a patient room. Duration of hand hygiene will also be measured upon room exit.
Time Frame
Months 2-13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nurses on participating unit Physician on an inpatient medical team, including attending, senior resident, and intern physicians Exclusion Criteria: Medical students Surgical attendings Physicians on sub-specialty teams
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael T Greene, PhD MPH BS
Phone
(734) 936-4795
Email
michael.greene2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjay K Saint, MD MPH
Phone
(734) 615-8341
Email
Sanjay.Saint@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Todd Greene, PhD MPH BS
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Trautner, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason E. Owen, PhD MPH
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjay K. Saint, MD MPH
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen E Fowler, MPH
Phone
(734) 845-3611
Email
karen.fowler@va.gov
First Name & Middle Initial & Last Name & Degree
Michael Todd Greene, PhD MPH BS
First Name & Middle Initial & Last Name & Degree
Sanjay K. Saint, MD MPH
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Trautner, MD
Phone
713-440-4438
Email
barbara.trautner@va.gov
First Name & Middle Initial & Last Name & Degree
Prathit Kulkarni
Phone
(713) 794-7070
Email
pakulkar@bcm.edu
First Name & Middle Initial & Last Name & Degree
Barbara Trautner, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified, anonymized dataset will be created. Members of the scientific community who would like a copy of the final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at Jennifer.Burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Final data sets will be copied onto a DVD. Limited data sets will be encrypted; and the password will be sent to the requestor via e-mail. The DVD will be sent to the requestor via FedEx.
IPD Sharing Time Frame
After the final publication from this study.
IPD Sharing Access Criteria
De-identified data will be provided after requesters sign a Letter of Agreement (LOA) detailing the mechanisms by which the data will be kept secure. The LOA will also state that the recipient will not attempt to identify any individual in the data, will not share the data outside of their research team, and will provide information on any files to be linked to the data. The dataset will not include PII and all dates will be changed to integers to allow for calculation of time periods.

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Mindful Hand Hygiene for Healthcare Workers

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