The READ-SG Study: Effect of Peer-Facilitated Small Group Discussions (READ-SG)

August 13, 2021 updated by: Columbia University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Internal Medicine trainees in the PGY-1 through PGY-3 years at New York Presbyterian - Columbia University Medical Center.

Exclusion Criteria:

- Not open to anyone outside of the Internal Medicine trainees at New York Presbyterian - Columbia University Medical Center.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: READ-SG Cohort
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.
Behavioral: READ-SG Sessions
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.
Other Names:
  • READ-SG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 year
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.
Baseline, 1 year
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.
Baseline, 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose response relationship ratio
Time Frame: Up to 1 year
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.
Up to 1 year
Change in Likert-scale Score
Time Frame: Baseline, monthly for up to 1 year
This is designed to validate whether the READ-SG Study Survey correlate with the already validated single-question/abbreviated burnout questions.
Baseline, monthly for up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mark P Abrams, MD, Postdoctoral Clinical Fellow in the Department of Medicine, Dept of Medicine Cardiology
  • Principal Investigator: Evelyn Granieri, MD, Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Geriatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAP0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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