Burnout, ProfessionalREAD-SGNCT03163251
The READ-SG Study: Effect of Peer-Facilitated Small Group Discussions
A study testing READ-SG Sessions in people with Burnout, Professional and Emotional Intelligence, run by Columbia University at 1 site in United States.
Trial summary
This study evaluates the effect of peer facilitated monthly small group topic-based small group discussions on various themes common to physician training that pertain to aspects of humanism on rates of burnout. Attendance to these sessions and completion of the surveys is voluntary. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Emotional Intelligence, Peer Influence
- What is being tested?
- READ-SG Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 1 Jul 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Internal Medicine trainees in the PGY-1 through PGY-3 years at New York Presbyterian - Columbia University Medical Center.
Who cannot join
- Not open to anyone outside of the Internal Medicine trainees at New York Presbyterian - Columbia University Medical Center.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: The Reflect, Empathize, Analyze, and Discuss in Small Groups Study: The Effect of Peer-facilitated Small Group Discussions on Burnout and Professional Development Among Physician Trainees
This study evaluates the effect of peer facilitated monthly small group topic-based small group discussions on various themes common to physician training that pertain to aspects of humanism on rates of burnout. Attendance to these sessions and completion of the surveys is voluntary.
Read the detailed description
It is widely known that physicians have rates of suicide that are far higher than in other professions: 70% higher for men and 250-400% higher for women. While the reasoning behind why this occurs has not been well elucidated, physicians do face some unique challenges including the responsibilities of the lives of others, a duty to always uphold the highest level of a moral and ethical standard, as well as being faced with both physical and emotional exhaustion. Trainees in particular seem at risk due to the rigors of the job in addition to the stress of the rapid expansion of the physical and emotional expectations put upon them.
To the investigator's knowledge, there has yet to be any study that has shown any beneficial outcomes regarding burnout using a small group curriculum among physician trainees that also encompasses analysis of the effect of an intervention on the emotional development of trainees. However, there has been a randomized trial on the effect of small groups for junior attendings that showed decreased rates of depersonalization, emotional exhaustion, and physician burnout in the intervention group. The implications of such programs on the trainee population could result in decreased levels of physician/ trainee burnout, depression, and potentially even suicide, aside from providing trainees with a sense of increased job satisfaction.
While many people in the scientific community judge the success of a physician by their medical achievements and diagnostic acumen, many patients judge the successes of their doctors based on empathy, communication, and bedside manner. While many resources exist to teach residents about the science of medicine, there does not exist to my knowledge a standardized curriculum to teach residents about the humanistic side of medicine and the importance of emotional development. Implementing such a curriculum could provide exactly what is missing from formal residency training as it stands now. Such a program that could be easily adapted to a large number of trainees would seem to be beneficial and also be in line with the Accreditation Council for Graduate Medical Education (ACGME)'s core competencies intended for residents to improve on patient care, professionalism, and interpersonal communication.
Peer support and teamwork seem like logical coping mechanisms for a vulnerable population that can feel isolated, such as physician trainees. The study aims to elucidate whether the peer-facilitated READ-SG method is effective at reducing burnout, as assessed by the Maslach Burnout Inventory, the gold standard in the field of assessing burnout, as well as to gauge the perceived effect of each session on participants' professional development and symptoms of burnout.
- Being tested
- READ-SG Sessions
- Keywords
- READ-SG, Burnout, Professional identity, Empathy, Emotional intelligence
- Medical subject headings
- Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
READ-SG SessionsBehavioural
Also called READ-SG
In the Internal Medicine residency program at Columbia University Medical Center, PGY-1 trainees receive an hour of protected time to attend a monthly peer-facilitated small group session, outlined above. PGY-2 and 3 trainees have a similar combined session separate from the PGY-1s. Facilitators are chosen by the READ-SG Committee, which is comprised of Mark P. Abrams (Director, Co-Investigator), Evelyn Granieri (Faculty Advisor, PI), a Chief Resident from the program (Program Liaison), and the facilitators.
| Study group | Role | What they receive |
|---|---|---|
| READ-SG Cohort | Experimental | Each post-graduate year (PGY) will receive the intervention of a monthly peer-facilitated small group sessions (READ-SG Sessions) based on topics that are common to residency training and based on themes regarding humanism in medicine. Receives: Behavioral: READ-SG Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS) Personal Accomplishment Score (section 1)
This is designed to prospectively measure whether the intervention affects and/or mitigates burnout rates over residency training. The survey has 3 sections.
Measured: Baseline, 1 year
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS) Depersonalization Score (section 2)
This is designed to prospectively measure whether the intervention affects and/or mitigates burnout rates over residency training. The survey has 3 sections.
Measured: Baseline, 1 year
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS) Emotional Exhaustion Score (section 3)
This is designed to prospectively measure whether the intervention affects and/or mitigates burnout rates over residency training. The survey has 3 sections.
Measured: Baseline, 1 year
Secondary outcomes (2)
Dose response relationship ratio
This is designed to evaluate whether there is a dose response relationship between the number of sessions attended and the effect of the sessions on burnout scores, measured by p-value.
Measured: Up to 1 year
Change in Likert-scale Score
This is designed to validate whether the READ-SG Study Survey correlate with the already validated single-question/abbreviated burnout questions.
Measured: Baseline, monthly for up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jun 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single institution, single arm, prospective cohort study stratified by post-graduate training year
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark P Abrams, MD, Study director, Postdoctoral Clinical Fellow in the Department of Medicine, Dept of Medicine CardiologyEvelyn Granieri, MD, Principal investigator, Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Geriatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163251
- Sponsor's protocol ID
- AAAP0006
- Acronym
- READ-SG
- Status last verified
- Aug 2021
- First submitted
- 19 May 2017
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387.
PubMed 24515493Abrams MP, Granieri E. Peer facilitation and burnout: the READ-SG pilot. Clin Teach. 2018 Jun;15(3):226-230. doi: 10.1111/tct.12666. Epub 2017 May 10.
PubMed 28493398Abrams MP. Improving Resident Well-Being and Burnout: The Role of Peer Support. J Grad Med Educ. 2017 Apr;9(2):264. doi: 10.4300/JGME-D-16-00805.1. No abstract available.
PubMed 28439373
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reflect, Empathize, Analyze, and Discuss in Small Groups Study: The Effect of Peer-facilitated Small Group Discussions on Burnout and Professional Development Among Physician Trainees
- ClinicalTrials.gov ID
- NCT03163251
- Acronym / sponsor ID
- READ-SG / AAAP0006
- Keywords
- READ-SG, Burnout, Professional identity, Empathy, Emotional intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 23 May 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.
This study evaluates the effect of peer facilitated monthly small group topic-based small group discussions on various themes common to physician training that pertain to aspects of humanism on rates of burnout. Attendance to these sessions and completion of the surveys is voluntary.
Detailed description
It is widely known that physicians have rates of suicide that are far higher than in other professions: 70% higher for men and 250-400% higher for women. While the reasoning behind why this occurs has not been well elucidated, physicians do face some unique challenges including the responsibilities of the lives of others, a duty to always uphold the highest level of a moral and ethical standard, as well as being faced with both physical and emotional exhaustion. Trainees in particular seem at risk due to the rigors of the job in addition to the stress of the rapid expansion of the physical and emotional expectations put upon them.
To the investigator's knowledge, there has yet to be any study that has shown any beneficial outcomes regarding burnout using a small group curriculum among physician trainees that also encompasses analysis of the effect of an intervention on the emotional development of trainees. However, there has been a randomized trial on the effect of small groups for junior attendings that showed decreased rates of depersonalization, emotional exhaustion, and physician burnout in the intervention group. The implications of such programs on the trainee population could result in decreased levels of physician/ trainee burnout, depression, and potentially even suicide, aside from providing trainees with a sense of increased job satisfaction.
While many people in the scientific community judge the success of a physician by their medical achievements and diagnostic acumen, many patients judge the successes of their doctors based on empathy, communication, and bedside manner. While many resources exist to teach residents about the science of medicine, there does not exist to my knowledge a standardized curriculum to teach residents about the humanistic side of medicine and the importance of emotional development. Implementing such a curriculum could provide exactly what is missing from formal residency training as it stands now. Such a program that could be easily adapted to a large number of trainees would seem to be beneficial and also be in line with the Accreditation Council for Graduate Medical Education (ACGME)'s core competencies intended for residents to improve on patient care, professionalism, and interpersonal communication.
Peer support and teamwork seem like logical coping mechanisms for a vulnerable population that can feel isolated, such as physician trainees. The study aims to elucidate whether the peer-facilitated READ-SG method is effective at reducing burnout, as assessed by the Maslach Burnout Inventory, the gold standard in the field of assessing burnout, as well as to gauge the perceived effect of each session on participants' professional development and symptoms of burnout.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single institution, single arm, prospective cohort study stratified by post-graduate training year
| Arm | Type | Receives |
|---|---|---|
| READ-SG Cohort | Experimental | Behavioral: READ-SG SessionsEach post-graduate year (PGY) will receive the intervention of a monthly peer-facilitated small group sessions (READ-SG Sessions) based on topics that are common to residency training and based on themes regarding humanism in medicine. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Internal Medicine trainees in the PGY-1 through PGY-3 years at New York Presbyterian - Columbia University Medical Center.
Key exclusion criteria (1 listed)
- Not open to anyone outside of the Internal Medicine trainees at New York Presbyterian - Columbia University Medical Center.
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 |
|---|---|---|
| READ-SG SessionsAlso: READ-SGIn the Internal Medicine residency program at Columbia University Medical Center, PGY-1 trainees receive an hour of protected time to attend a monthly peer-facilitated small group session, outlined above. PGY-2 and 3 trainees have a similar combined session separate from the PGY-1s. Facilitators are chosen by the READ-SG Committee, which is comprised of Mark P. Abrams (Director, Co-Investigator), Evelyn Granieri (Faculty Advisor, PI), a Chief Resident from the program (Program Liaison), and the facilitators. | Behavioural | READ-SG Cohort |
Primary outcome
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS) Personal Accomplishment Score (section 1)
Time frame: Baseline, 1 year
This is designed to prospectively measure whether the intervention affects and/or mitigates burnout rates over residency training. The survey has 3 sections.
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS) Depersonalization Score (section 2)
Time frame: Baseline, 1 year
This is designed to prospectively measure whether the intervention affects and/or mitigates burnout rates over residency training. The survey has 3 sections.
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS) Emotional Exhaustion Score (section 3)
Time frame: Baseline, 1 year
This is designed to prospectively measure whether the intervention affects and/or mitigates burnout rates over residency training. The survey has 3 sections.
2 secondary outcomes
Dose response relationship ratio
Time frame: Up to 1 year
Change in Likert-scale Score
Time frame: Baseline, monthly for up to 1 year
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 17 Aug 2021.
- Background: PubMed 24515493West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387.
- Background: PubMed 28493398Abrams MP, Granieri E. Peer facilitation and burnout: the READ-SG pilot. Clin Teach. 2018 Jun;15(3):226-230. doi: 10.1111/tct.12666. Epub 2017 May 10.
- Background: PubMed 28439373Abrams MP. Improving Resident Well-Being and Burnout: The Role of Peer Support. J Grad Med Educ. 2017 Apr;9(2):264. doi: 10.4300/JGME-D-16-00805.1. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Mark P Abrams, MD study director
Postdoctoral Clinical Fellow in the Department of Medicine, Dept of Medicine Cardiology
Evelyn Granieri, MD principal investigator
Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Geriatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing READ-SG Sessions in people with Burnout, Professional and Emotional Intelligence, run by Columbia University 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: finished, as of the sponsor's last update on 17 Aug 2021. 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?
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS) Personal Accomplishment Score (section 1) (time frame: Baseline, 1 year). 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?
On the ClinicalTrials.gov record for NCT03163251, which also lists 3 linked publications.
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 17 Aug 2021.