Mindful Hand Hygiene to Reduce Infections Among Veterans While Enhancing Provider Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 2
- 主要终点
- The Five Facet Mindfulness Questionnaire (FFMQ) - Post-Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nurses on participating unit
- •Physician on an inpatient medical team, including attending, senior resident, and intern physicians
排除标准
- •Medical students
- •Surgical attendings
- •Physicians on sub-specialty teams
研究组 & 干预措施
Mindful Hand Hygiene Intervention
Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.
干预措施: Mindful Hand Hygiene (Behavioral)
Control Arm
Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.
结局指标
主要结局
The Five Facet Mindfulness Questionnaire (FFMQ) - Post-Intervention
时间窗: Month 1
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. The scale could be broken into the subscales of Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity, or presented as a total score. The total FFMQ score is presented here on a scale from 1-5. Lower scores (1) mean less mindful, while higher scores (5) indicate the respondent is more mindful.
Well-Being Index - Post-Intervention
时间窗: Month 1
The 9-question Well-Being Index (WBI) assesses distress across a variety of dimensions including fatigue, depression, burnout, stress, and quality of life, and has been validated for use in physicians, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk). Lower scores indicate better well being.
Percentage of Situations Performing Hand Hygiene When Required (Self-Perception) - Post-Intervention
时间窗: Month 1
The question assessing how often respondents felt they performed hand hygiene when required from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization was used. This question is scored on a scale of 0-100%. Higher scores indicate higher perception of performing hand hygiene when required.
The Five Facet Mindfulness Questionnaire (FFMQ) - Sustainability
时间窗: Month 7
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. The scale could be broken into the subscales of Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity, or presented as a total score. The total FFMQ score is presented here on a scale from 1-5. Lower scores (1) mean less mindful, while higher scores (5) indicate the respondent is more mindful.
Well-Being Index - Sustainability
时间窗: Month 7
The 9-question Well-Being Index (WBI) assesses distress across a variety of dimensions including fatigue, depression, burnout, stress, and quality of life, and has been validated for use in physicians, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk). Lower scores indicate better well-being.
Percentage of Situations Performing Hand Hygiene When Required (Self-Perception) - Sustainability
时间窗: Month 7
The question assessing how often respondents felt they performed hand hygiene when required from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization was used. This question is scored on a scale of 0-100%. Higher scores indicate higher perception of performing hand hygiene when required.
次要结局
- Hand Hygiene Room Entry - Habituation(Month 0)
- Hand Hygiene Room Exit - Habituation(Month 0)
- Duration Hand Hygiene Room Exit - Habituation(Month 0)
- Hand Hygiene Room Entry - Intervention Period(Month 1)
- Hand Hygiene Room Exit - Intervention Period(Month 1)
- Duration Hand Hygiene Room Exit - Intervention Period(Month 1)
- Hand Hygiene Room Entry - Sustainability(Months 2-13)
- Hand Hygiene Room Exit - Sustainability(Months 2-13)
- Duration Hand Hygiene Room Exit - Sustainability(Months 2-13)
