NCT04441632

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

June 18, 2020

Last Update Submit

August 11, 2020

Conditions

Keywords

wellnesshealthcareburnoutCOVID

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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

    4 weeks

Study Arms (1)

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.

Behavioral: Positive feedback

Interventions

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).

Positive feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Front-line healthcare providers in the Medical Intensive Care Unit (MICU): nurses, respiratory therapists, resident physicians, fellow physicians, and attending physicians

You may not qualify if:

  • Healthcare providers providing only consultatory care in the MICU
  • Front-line healthcare providers not working in the MICU during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Burnout, PsychologicalStress, Psychological

Interventions

Feedback, Physiological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HomeostasisPhysiological Phenomena

Study Officials

  • Jack Green, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 22, 2020

Study Start

June 15, 2020

Primary Completion

July 26, 2020

Study Completion

July 30, 2020

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations