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

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: Completed
• Conditions: Burnout; Medical Education; Adverse Event
• Intervention / Treatment: Behavioral: Coaching

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Medical errors in trainees	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	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	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

Outcome Measure	Measure Description	Time Frame
medical errors in faculty	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	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	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	Self-perceived medical errors amongst trainees based on survey response	up to 15 months
Burnout	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	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

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Harvard Risk Management Foundation
• Investigators: Principal Investigator: Ritika Parris, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Coaching; wellness; burnout; medical errors
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID 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