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Mindfulness Rounds Initiative - A Short Mindfulness-Based Program for A Busy Workplace

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ClinicalTrials.gov Identifier: NCT04282733
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Zahn, Icahn School of Medicine at Mount Sinai

Brief Summary:
An 8 week course of mindfulness education and practices will be presented to all staff, patients, and visitors voluntarily attending the thrice weekly presentations. The goal is to reduce staff stress, improve communication, enhance patient satisfaction, and improve quality of care.

Condition or disease Intervention/treatment Phase
Healthcare Practitioner Stress Patient Satisfaction Behavioral: Mindfulness Rounds Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants are staff on two hospital units tending to the same patient population with the same policies and protocols - postpartum patients. One unit will have the Mindfulness Rounds Initiative ass the intervention, the other will not. Both units will be evaluated against each other, and against themselves in a pre-/post- design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Rounds Initiative - An 8-Week, Short Session, Mindfulness Based Protocol for On-Site Delivery of Stress Reduction Practices
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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.
Behavioral: Mindfulness Rounds
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.

No Intervention: Control
No intervention will take place on this Unit



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Discharge time [ Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention ]
    Duration from discharge order to discharge time.

  2. Change in Narcotic usage [ Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention ]
    Aggregate total narcotics administered/patient hours on unit.

  3. 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.

  4. 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.

  5. 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.

  6. Change in number of staff injuries [ Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention ]
    Number of total staff injuries

  7. 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

  8. 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.

  9. Change in Staff handwashing rates [ Time Frame: 1-3 months pre-intervention, 1-3 months post-intervention ]
    Routinely tracked by anonymous observers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Employees on the Units

Exclusion Criteria:

- none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282733


Contacts
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Contact: Jeffrey Zahn, MD 917-363-2431 Jeffrey.zahn@mountsinai.org
Contact: James Leader 212-241-7251 James.leader@mountsinai.org

Locations
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United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Principal Investigator: Jeffrey Zahn, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Jeffrey Zahn, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Jeffrey Zahn, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04282733    
Other Study ID Numbers: GCO 19-1849
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Zahn, Icahn School of Medicine at Mount Sinai:
Mindfulness
Stress
pain scores
patient satisfaction
Perceived Stress Scale
MBSR