BurnoutTEAM-ICUNCT04441632
Effect of Positive Attitudes on Behavior and Wellness
A study testing Positive feedback in people with Burnout and Stress, Emotional, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe, but none more than to the providers on the front-line. The purpose of the study is to first, assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare providers battling COVID-19 together… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Stress, Emotional
- What is being tested?
- Positive feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 30 Jul 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Front-line healthcare providers in the Medical Intensive Care Unit (MICU): nurses, respiratory therapists, resident physicians, fellow physicians, and attending physicians
Who cannot join
- Healthcare providers providing only consultatory care in the MICU
- Front-line healthcare providers not working in the MICU during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: The Impact of Positive Reinforcement on Teamwork Climate, Resiliency, and Burnout During the COVID-19 Pandemic: the TEAM-ICU Study (Transforming Employee Attitudes Via Messaging Strengthens Interconnection, Communication, and Unity)
The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe, but none more than to the providers on the front-line. The purpose of the study is to first, assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare providers battling COVID-19 together in a medical ICU (MICU). Secondly, the investigators hope to then assess the effects of simple positive feedback on transforming culture and attitudes during times of major stress.
- Conditions
- Burnout, Stress, Emotional
- Being tested
- Positive feedback
- Keywords
- wellness, healthcare, burnout, COVID
- Medical subject headings
- Burnout, Psychological, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive feedbackBehavioural
Participants will submit positive feedback comments to their colleagues (anonymously or signed, participant-dependent) through an anonymous survey link, a minimum of twice weekly to 6 uniquely different individuals over a 4 week period (total minimum 24 unique individuals over the study period).
| Study group | Role | What they receive |
|---|---|---|
| Positive feedback | Other | Participants in the study will provide consistent positive feedback to the colleagues they work with in the medical ICU (MICU) over a 4 week duration. Receives: Behavioral: Positive feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teamwork climate, as measured by selected items from the validated Safety Attitude Questionnaire (SAQ)
The SAQ measures teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. The six items assessing teamwork climate will be used. 5 point likert scale is used. Mean of the items - 1 * 25 will convert each participant's results to a 100 point scale (0, 25, 50, 75, 100 points).
Measured: 4 weeks
Resiliency, as measured by the validated Brief Resilience Scale (BRS)
The BRS is comprised of 6 items on a likert scale. Responses varying from 1-5 for all six items give a total range of 6-30. This sum will be divided by the total number of questions for a final score.
Measured: 4 weeks
Burnout, as validated by the single-item burnout scale inventory
This single item inventory provides 5 definitions of burnout that the participant will choose that most closely fits their personal level of burnout at the moment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start15 Jun 2020
- Primary completion26 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jack Green, Cedars-Sinai Medical Center
- Investigators
- Jack Green, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441632
- Sponsor's protocol ID
- STUDY00000786
- Acronym
- TEAM-ICU
- Status last verified
- Aug 2020
- First submitted
- 18 Jun 2020
- Last updated
- 12 Aug 2020
- 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Positive Reinforcement on Teamwork Climate, Resiliency, and Burnout During the COVID-19 Pandemic: the TEAM-ICU Study (Transforming Employee Attitudes Via Messaging Strengthens Interconnection, Communication, and Unity)
- ClinicalTrials.gov ID
- NCT04441632
- Acronym / sponsor ID
- TEAM-ICU / STUDY00000786
- Conditions
- Burnout, Stress, Emotional
- Keywords
- wellness, healthcare, burnout, COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 26 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 22 Jun 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.
The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe, but none more than to the providers on the front-line. The purpose of the study is to first, assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare providers battling COVID-19 together in a medical ICU (MICU). Secondly, the investigators hope to then assess the effects of simple positive feedback on transforming culture and attitudes during times of major stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive feedback | Other | Behavioral: Positive feedbackParticipants in the study will provide consistent positive feedback to the colleagues they work with in the medical ICU (MICU) over a 4 week duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Front-line healthcare providers in the Medical Intensive Care Unit (MICU): nurses, respiratory therapists, resident physicians, fellow physicians, and attending physicians
Key exclusion criteria (2 listed)
- Healthcare providers providing only consultatory care in the MICU
- Front-line healthcare providers not working in the MICU during the study period
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 |
|---|---|---|
| Positive feedbackParticipants will submit positive feedback comments to their colleagues (anonymously or signed, participant-dependent) through an anonymous survey link, a minimum of twice weekly to 6 uniquely different individuals over a 4 week period (total minimum 24 unique individuals over the study period). | Behavioural | Positive feedback |
Primary outcome
Teamwork climate, as measured by selected items from the validated Safety Attitude Questionnaire (SAQ)
Time frame: 4 weeks
The SAQ measures teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. The six items assessing teamwork climate will be used. 5 point likert scale is used. Mean of the items - 1 * 25 will convert each participant's results to a 100 point scale (0, 25, 50, 75, 100 points).
Resiliency, as measured by the validated Brief Resilience Scale (BRS)
Time frame: 4 weeks
The BRS is comprised of 6 items on a likert scale. Responses varying from 1-5 for all six items give a total range of 6-30. This sum will be divided by the total number of questions for a final score.
Burnout, as validated by the single-item burnout scale inventory
Time frame: 4 weeks
This single item inventory provides 5 definitions of burnout that the participant will choose that most closely fits their personal level of burnout at the moment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Jack Green, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive feedback in people with Burnout and Stress, Emotional, run by Cedars-Sinai Medical Center 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 2 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: finished, as of the sponsor's last update on 12 Aug 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Teamwork climate, as measured by selected items from the validated Safety Attitude Questionnaire (SAQ) (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 12 Aug 2020.