Burnout, ProfessionalROBSTANCT03355144
Resident Observed Burnout After Daily Supplementation With Coffee
A study testing Daily Supplementation with Coffee in people with Burnout, Professional, run by NYU Langone Health at 1 site in United States.
Trial summary
Coffee drinking is frequently reported as a negative outcome in studies on burnout, but the effect of an increased coffee intake on resident burnout has not been reported in the literature. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Daily Supplementation with Coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to 12 Apr 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A resident in the NYU Internal Medicine residency program
Who cannot join
- Allergy or intolerance to coffee or caffeine
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Coffee drinking is frequently reported as a negative outcome in studies on burnout, but the effect of an increased coffee intake on resident burnout has not been reported in the literature. This study is a prospective, interventional cohort study enrolling up to 50 residents from the Internal Medicine Residency Program to look at the relationship between coffee and resident burnout.
Read the detailed description
Resident burnout is increasingly being recognized as detrimental to both physician well being and patient care. It has been linked to an increased rate of medical errors and a reduced quality of patient care. In addition, there have been multiple high-profile physician suicides in the past years. This has resulted in a renewed focus on physician mental health and workload.
- Conditions
- Burnout, Professional
- Being tested
- Daily Supplementation with Coffee
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Supplementation with CoffeeDietary supplement
At the beginning of study week 2 (study day 8), two coffee machines (one Nespresso Inissia and one Hamilton Beach 46205 12 Cup Programmable Coffee Maker) will be installed in the resident work rooms at each site.
Subjects will be provided with free coffee beans, milk, cream, sugar and sweetener
| Study group | Role | What they receive |
|---|---|---|
| Internal Medicine residents at NYU | Experimental | effect of supplying Internal Medicine residents at NYU with free coffee on self reported features of psychological health, energy and burnout Receives: Dietary Supplement: Daily Supplementation with Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported feelings of burnout
14 question survey measuring number of cups of coffee and level of exhaustion
Measured: 1 Month
Secondary outcomes (3)
Coffee consumption measured by self reporting questionaire
Measured by self reporting questionnaire
Measured: 1 Month
Self reported emotional well being
14 question survey with questions measuring emotional wellbeing
Measured: 1 Month
Self reported feelings of value
14 question survey with questions measuring feelings of self value
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start22 Mar 2018
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Liu, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355144
- Sponsor's protocol ID
- 17-01011
- Acronym
- ROBSTA
- Status last verified
- May 2018
- First submitted
- 22 Nov 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resident Observed Burnout After Daily Supplementation With Coffee
- ClinicalTrials.gov ID
- NCT03355144
- Acronym / sponsor ID
- ROBSTA / 17-01011
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 28 Nov 2017 (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.
Coffee drinking is frequently reported as a negative outcome in studies on burnout, but the effect of an increased coffee intake on resident burnout has not been reported in the literature. This study is a prospective, interventional cohort study enrolling up to 50 residents from the Internal Medicine Residency Program to look at the relationship between coffee and resident burnout.
Detailed description
Resident burnout is increasingly being recognized as detrimental to both physician well being and patient care. It has been linked to an increased rate of medical errors and a reduced quality of patient care. In addition, there have been multiple high-profile physician suicides in the past years. This has resulted in a renewed focus on physician mental health and workload.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internal Medicine residents at NYU | Experimental | Dietary Supplement: Daily Supplementation with Coffeeeffect of supplying Internal Medicine residents at NYU with free coffee on self reported features of psychological health, energy and burnout |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A resident in the NYU Internal Medicine residency program
Key exclusion criteria (2 listed)
- Allergy or intolerance to coffee or caffeine
- Pregnancy
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 |
|---|---|---|
| Daily Supplementation with CoffeeAt the beginning of study week 2 (study day 8), two coffee machines (one Nespresso Inissia and one Hamilton Beach 46205 12 Cup Programmable Coffee Maker) will be installed in the resident work rooms at each site. Subjects will be provided with free coffee beans, milk, cream, sugar and sweetener | Dietary supplement | Internal Medicine residents at NYU |
Primary outcome
Self reported feelings of burnout
Time frame: 1 Month
14 question survey measuring number of cups of coffee and level of exhaustion
3 secondary outcomes
Coffee consumption measured by self reporting questionaire
Time frame: 1 Month
Self reported emotional well being
Time frame: 1 Month
Self reported feelings of value
Time frame: 1 Month
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 22 May 2018.
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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.
Steven Liu, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Supplementation with Coffee in people with Burnout, Professional, run by NYU Langone Health 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 22 May 2018. 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?
Self reported feelings of burnout (time frame: 1 Month). 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 22 May 2018.