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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04282733
Other study ID # GCO 19-1849
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 18, 2021
Est. completion date May 12, 2021

Study information

Verified date January 2024
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 34
Est. completion date May 12, 2021
Est. primary completion date May 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Employees on the Units Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mount Sinai Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pain scores 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 Discharge time Duration from discharge order to discharge time. 1-3 months pre-intervention, 1-3 months post-intervention
Secondary Change in Narcotic usage Aggregate total narcotics administered/patient hours on unit. 1-3 months pre-intervention, 1-3 months post-intervention
Secondary Change in Patient Satisfaction survey 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. 1-3 months pre-intervention, 1-3 months post-intervention
Secondary Change in Perceived Stress Scale (PSS) survey 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.
Secondary Change in number of Staff sick days Number of total staff sick days. 1-3 months pre-intervention, 1-3 months post-intervention
Secondary Change in number of staff injuries Number of total staff injuries 1-3 months pre-intervention, 1-3 months post-intervention
Secondary Change in number of workers compensation claims Number of total workers compensation claims 1-3 months pre-intervention, 1-3 months post-intervention
Secondary Change in number of discharges before noon Number of discharges before noon as a hospital metric tracked for efficiency. 1-3 months pre-intervention, 1-3 months post-intervention
Secondary Change in Staff handwashing rates Routinely tracked by anonymous observers 1-3 months pre-intervention, 1-3 months post-intervention
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