Healthcare Practitioner StressNCT04282733
Mindfulness Rounds Initiative - A Short Mindfulness-Based Program for A Busy Workplace
A study testing Mindfulness Rounds in people with Healthcare Practitioner Stress and Patient Satisfaction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Practitioner Stress, Patient Satisfaction
- What is being tested?
- Mindfulness Rounds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 12 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employees on the Units
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Rounds Initiative - An 8-Week, Short Session, Mindfulness Based Protocol for On-Site Delivery of Stress Reduction Practices
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.
Read the 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.
- Being tested
- Mindfulness Rounds
- Keywords
- Mindfulness, Stress, pain scores, patient satisfaction, Perceived Stress Scale, MBSR
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness RoundsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Rounds | Experimental | Participants will be exposed to thrice weekly Mindfulness Rounds education on the Unit; participation in the actual sessions is voluntary. Receives: Behavioral: Mindfulness Rounds |
| Control | No intervention | No intervention will take place on this Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
Secondary outcomes (9)
Discharge time
Duration from discharge order to discharge time.
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
Change in Narcotic usage
Aggregate total narcotics administered/patient hours on unit.
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
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.
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
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.
Measured: Within 1 month prior to intervention, within one month post the intervention.
Change in number of Staff sick days
Number of total staff sick days.
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
Change in number of staff injuries
Number of total staff injuries
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
Change in number of workers compensation claims
Number of total workers compensation claims
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
Change in number of discharges before noon
Number of discharges before noon as a hospital metric tracked for efficiency.
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
Change in Staff handwashing rates
Routinely tracked by anonymous observers
Measured: 1-3 months pre-intervention, 1-3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start18 Mar 2021
- Primary completion12 May 2021
- Study completion12 May 2021
Why it stopped: No post-intervention survey completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare Practitioner StressStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 as 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Zahn, Icahn School of Medicine at Mount Sinai
- Investigators
- Jeffrey Zahn, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282733
- Sponsor's protocol ID
- GCO 19-1849
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Rounds Initiative - An 8-Week, Short Session, Mindfulness Based Protocol for On-Site Delivery of Stress Reduction Practices
- ClinicalTrials.gov ID
- NCT04282733
- Acronym / sponsor ID
- GCO 19-1849
- Keywords
- Mindfulness, Stress, pain scores, patient satisfaction, Perceived Stress Scale, MBSR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No post-intervention survey completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 as the intervention, the other will not. Both units will be evaluated against each other, and against themselves in a pre-/post- design.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Rounds | Experimental | Behavioral: Mindfulness RoundsParticipants will be exposed to thrice weekly Mindfulness Rounds education on the Unit; participation in the actual sessions is voluntary. |
| Control | No intervention | –No intervention will take place on this Unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employees on the Units
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness RoundsThroughout 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. | Behavioural | Mindfulness Rounds |
Primary outcome
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.
9 secondary outcomes
Discharge time
Time frame: 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
Change in Patient Satisfaction survey
Time frame: 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.
Change in number of Staff sick days
Time frame: 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
Change in number of workers compensation claims
Time frame: 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
Change in Staff handwashing rates
Time frame: 1-3 months pre-intervention, 1-3 months post-intervention
Results and safety
The study was stopped early (reason given: No post-intervention survey completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Zahn, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Rounds in people with Healthcare Practitioner Stress and Patient Satisfaction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No post-intervention survey completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain scores (time frame: 1-3 months pre-intervention, 1-3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.