The Impact of a Novel Coaching Program on Medical Errors and Well-Being of Physicians (CARE)

February 2, 2024 updated by: Ritika S. Parris, Beth Israel Deaconess Medical Center

A Randomized Controlled Trial on The Impact of a Novel Coaching Program on Medical Errors, Clinical Reasoning, and Well-Being of Physicians, or the CARE (Coaching to Advance Resilience and Reduce Error) Study

This is a randomized controlled trial with a mixed method design to determine the impact of coaching on self-perceived medical errors, burnout, and resilience. The study team developed a novel coaching curriculum based in principles of positive psychology and self-reflection with the hypothesis that the coaching intervention will lead to decreased medical errors, decreased burnout, and increased resilience in trainee and faculty participants. Resident and fellow trainees as well as faculty members were recruited across departments and randomized to coaching or control. Faculty in the coaching arm were trained in coaching techniques and paired with a trainee coachee. Survey results as well as focus groups will be used to analyze the impact of the coaching program as compared to standard mentorship (control).

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.

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.
332

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Residents and fellows in a training program at Beth Israel Deaconess Medical Center (BIDMC)
  • faculty members at BIDMC

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Trainees - treatment
Residents and fellows paired with a faculty coach from the "faculty - treatment" arm to participate in up to 4 coaching meetings
Behavioral: Coaching
A novel coaching curriculum based in positive psychology with an emphasis on self-reflection, goal setting and adverse event processing.
No Intervention: Trainees - control
Residents and fellows randomized to the control arm. They are not paired with a faculty coach and instead continue to receive standard mentorship as part of their training program.
Experimental: Faculty - treatment
Faculty members randomized to receive coaching training and are paired with a resident/fellow from the "trainees - treatment" arm to conduct up to 4 coaching sessions over the course of the academic year.
Behavioral: Coaching
A novel coaching curriculum based in positive psychology with an emphasis on self-reflection, goal setting and adverse event processing.
No Intervention: Faculty - control
Faculty members randomized to control arm. They are not paired with a trainee from this study and instead continue to provide mentorship as they typically would, as part of their role at an academic medical center

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
Medical errors in trainees
Time Frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Self-perceived medical errors amongst trainees based on survey response.
baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Burnout
Time Frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Burnout score amongst trainees and faculty based on Stanford Professional Fulfillment Index
baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Resilience
Time Frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Burnout score amongst trainees and faculty based on Connor Davidson Resilience Scale 2
baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months

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
medical errors in faculty
Time Frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Self-perceived medical errors amongst faculty based on survey response. Specifically, faculty are asked "Do you think you may have made any medical error in the last 3 months? A medical error is the failure of a planned action to be completed as intended, or the failure of an unplanned action that should have been completed" with answer choices yes, no, and unsure.
baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
delayed medical errors in faculty
Time Frame: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Self-perceived medical errors amongst faculty based on survey response
baseline (beginning of study, before intervention) compared to 6 months post coaching program
Mechanism of change
Time Frame: assessed an average of 1 year after intervention initiation
Mechanism of change in burnout, resilience and medical errors in both trainees and faculty as compared to standard mentorship
assessed an average of 1 year after intervention initiation
Delayed Medical errors in trainees
Time Frame: up to 15 months
Self-perceived medical errors amongst trainees based on survey response
up to 15 months
Burnout
Time Frame: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Burnout score amongst trainees and faculty based on Stanford Professional Fulfillment Index
baseline (beginning of study, before intervention) compared to 6 months post coaching program
Delayed Resilience
Time Frame: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Burnout score amongst trainees and faculty based on Connor-Davidson-RISC2
baseline (beginning of study, before intervention) compared to 6 months post coaching program

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.
Beth Israel Deaconess Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard Risk Management Foundation

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.
  • Principal Investigator: Ritika Parris, MD, Beth Israel Deaconess Medical Center

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.
August 10, 2021

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.
January 23, 2023

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.
December 31, 2023

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).
September 22, 2022

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.
September 23, 2022

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.
September 28, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
February 6, 2024

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.
February 2, 2024

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.
February 1, 2024

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.
  • 2021P000482

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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