- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282733
Mindfulness Rounds Initiative - A Short Mindfulness-Based Program for A Busy Workplace
Mindfulness Rounds Initiative - An 8-Week, Short Session, Mindfulness Based Protocol for On-Site Delivery of Stress Reduction Practices
Study Overview
Status
Intervention / Treatment
Detailed Description
"Mindfulness Rounds" Care-giver well-being is recognized as an important goal in decreasing burnout, increasing job satisfaction, and may have implications in improving quality of care and patient satisfaction. Mindfulness training is a well-studied tool used to enhance care-giver well-being. The impact of a Mindfulness training experience for caregivers, support staff, and patients and their families working together in a hospital unit on patient satisfaction has not been well studied, if at all. The researchers propose instituting a pilot program of Mindfulness Rounds on a given hospital unit and assessing the effect on employee well-being, patient satisfaction, and quality of care.
Introduction:
The physical and mental health of healthcare practitioners (HCPs) has become an area of attention and research in recent years as HCP burnout and suicide are now openly discussed concerns in medicine. Well-being education is now a required curricula component by the Accreditation Council for Graduate Medical Education (ACGME). Mindfulness is a technique and philosophical concept which has received significant attention in the medical literature as a tool for increasing HCP well-being.
Mindfulness describes the idea of maintaining a conscious presence in the present, of avoiding obsessing about the past or the future, and of continuously being aware of, and grateful for, the things we have in life as opposed to the things we don't. Mindfulness-Based Stress Reduction (MBSR) is one particular system, developed by Jon Kabat-Zinn over 30 years ago, which has been built into a well-structured certified training program for teaching mindfulness. Numerous studies have used MBSR or similar techniques to advance HCP psychologic well-being, and while some have investigated a variety of HCP training techniques to improve the patient experience, few have sought to explore a relationship between the impact of mindfulness training for HCP on patient satisfaction, quality of care outcomes, and HCP overall health. To the investigators' knowledge, no one has sought to bring mindfulness education to an entire hospital unit - physicians, nurses, support staff, as well as patients and their families wherever possible - with the goal of improving both HCP and the overall patient experience.
The researchers propose instituting a pilot program of Mindfulness Rounds on a given hospital unit and assessing the effect on employee well-being, patient satisfaction, and quality of care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Mount Sinai Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Employees on the Units
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness Rounds
Participants will be exposed to thrice weekly Mindfulness Rounds education on the Unit; participation in the actual sessions is voluntary.
|
Throughout the 8-week study period, a different mindfulness practice will be introduced weekly in 3 separate 15-minute live sessions.
Posters describing the particular "practice of the week" will be placed around the Unit as visual reminders to encourage actual practice.
|
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No Intervention: Control
No intervention will take place on this Unit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain scores
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Patient pain scores are routinely collected by Nursing and entered into the electronic medical record (EMR).
Full pain scale from 0-10, higher score indicates more pain.
|
1-3 months pre-intervention, 1-3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discharge time
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Duration from discharge order to discharge time.
|
1-3 months pre-intervention, 1-3 months post-intervention
|
|
Change in Narcotic usage
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Aggregate total narcotics administered/patient hours on unit.
|
1-3 months pre-intervention, 1-3 months post-intervention
|
|
Change in Patient Satisfaction survey
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Pres-Ganey survey to assess patient satisfaction.
Pres-Ganey Survey: 24 item instrument, each item scored: very poor (score = 0), poor (25), fair (50), good (75) and very good (100).
Full scale from 0 - 100, higher score indicates more satisfaction.
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1-3 months pre-intervention, 1-3 months post-intervention
|
|
Change in Perceived Stress Scale (PSS) survey
Time Frame: Within 1 month prior to intervention, within one month post the intervention.
|
This is a validated survey tool to assess an individual's perceived stress.
Full scale range from 0 to 40, higher score indicates higher perceived stress.
|
Within 1 month prior to intervention, within one month post the intervention.
|
|
Change in number of Staff sick days
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Number of total staff sick days.
|
1-3 months pre-intervention, 1-3 months post-intervention
|
|
Change in number of staff injuries
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Number of total staff injuries
|
1-3 months pre-intervention, 1-3 months post-intervention
|
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Change in number of workers compensation claims
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Number of total workers compensation claims
|
1-3 months pre-intervention, 1-3 months post-intervention
|
|
Change in number of discharges before noon
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Number of discharges before noon as a hospital metric tracked for efficiency.
|
1-3 months pre-intervention, 1-3 months post-intervention
|
|
Change in Staff handwashing rates
Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention
|
Routinely tracked by anonymous observers
|
1-3 months pre-intervention, 1-3 months post-intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Jeffrey Zahn, MD, ICAHN School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GCO 19-1849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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