NCT05938556

Brief Summary

This study aims to determine if online coaching is feasible in advanced practice providers (APP) and can impact burnout. The study will recruit APPs from Children's Healthcare of Atlanta (CHOA), Emory, Colorado University (CU), and their affiliate hospitals through online consent sent via email. Interventions will include online video coaching, written coaching, and self-coaching through self-study material.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

July 14, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

June 8, 2023

Last Update Submit

July 17, 2024

Conditions

Keywords

Advanced Practice ProvidersAPPsCoachingHealthcare providerNurse burnoutWellness

Outcome Measures

Primary Outcomes (6)

  • Change in Burnout

    Burnout as defined by the Maslach Burnout Inventory (MBI). The Maslach burnout inventory (MBI) is a 22-item measurement of worker burnout that assesses emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF) domains. Possible scores range from 0-6 on a Likert scale for each item. Scores of EE ≥ 27 points, DP ≥ 10, and PF \<33 would indicate a high degree of burnout. Scores of EE≤18 points, DP≤5 points, and PF≥40 points would indicate a low degree of burnout.

    Baseline, 4 months, 9 months

  • Change in the percentage of participants that accept the program course

    Data collection will be at baseline, month 4, and month 9 for both groups.

    Baseline, 4 months, 9 months

  • Percentage of participants who watch program calls

    Number of participants who watch program calls. Data collection will only be at the end of participation Group Coaching Program.

    4 month or 9 months

  • Change in the percentage of participants that complete >50% of self-study worksheets

    Number of participants who complete \>50% of self-study worksheets. Data collection will only be at the end of participation Group Coaching Program.

    4 month or 9 months

  • Change in the percentage of participants that use the Ask A Coach Forum at least once

    Percentage of participants that use the Ask A Coach Forum at least once. Data collection will only be at the end of participation Group Coaching Program.

    4 month or 9 months

  • Change in the rate of participation in the program

    Percentage of participants that complete the outcome measures (pre/post surveys). Data collection will be at month 4 and month 9 for both groups.

    Baseline, 4 months, 9 months

Secondary Outcomes (7)

  • Change in Trauma Symptoms of Discrimination Scale

    Baseline, 4 months, 9 months

  • Change in Self-Compassion

    Baseline, 4 months, 9 months

  • Change in Moral Injury

    Baseline, 4 months, 9 months

  • Change in the Young's Imposter Syndrome Symptoms Scale

    Baseline, 4 months, 9 months

  • Change in the intention to leave

    Baseline, 4 months, 9 months

  • +2 more secondary outcomes

Study Arms (2)

Group Coaching Program

EXPERIMENTAL

The study intervention is a hybrid asynchronous-synchronous group coaching treatment that will occur over four months. Participants will be given access to a members-only, web-based platform to access the intervention.

Behavioral: hybrid asynchronous-synchronous group coaching program

Usual Treatment

PLACEBO COMPARATOR

This group will participate in the study intervention following a 4-month waitlist/control group.

Other: treatment as usual group (TAU)

Interventions

A hybrid asynchronous-synchronous program. The synchronous part has two weekly recorded live group coaching calls for four months. The asynchronous consist of 1) on-demand replies to recorded coaching calls, 2) Self-coaching through weekly self-study modules and worksheets, and 3) written Ask A Coach. Content modified per needs of APPs by a physician, a certified coach, and an APP who is also a Co-I. The curriculum has weekly themes that build. Month-1 consists of 1) Introduction to the Model, 2) How to Feel Better, 3) Defining Your Purpose, and 4) Living Your Purpose. Month-2 consists of 1) Growth Mindset, 2) Welcoming Feedback and Assessment Bias, 3) Feeling Valued and Belonging, and 4) How to Deal with Hidden Expectations. Month-3 consists of 1) Imposter Syndrome, 2) Perfectionism, 3) Approval Addiction, and 4) How to Change Your Thoughts. Month-4 consists of 1) How to deal with Ambiguity, 2) Confidence, 3) Self-Appreciation and Self-Compassion, and 4) Celebrate the New You.

Also known as: group coaching program
Group Coaching Program

The treatment as usual group will consist of any structural or programmatic interventions, resources, lectures, curriculum, etc. offered at the participants' hospital of employment. Thus, this active control is designed to represent a best-case alternative to group coaching, making it a more rigorous form of control. Participants randomly assigned to TAU will also continue any structural or programmatic interventions or resources they were previously participating in.

Also known as: TAU
Usual Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced Practice Providers (nurse practitioners, physician assistants, certified midwife nurses, certified registered nurse anesthetists, anesthesiology assistants, and clinical nurse specialists) at Children's Healthcare of Atlanta, Emory University, and CU and its affiliate hospitals.

You may not qualify if:

  • adults unable to consent,
  • individuals who are not adults,
  • prisoners,
  • cognitively impaired or individuals with impaired decision-making capacity and
  • individuals who do not clearly understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Colorado

Denver, Colorado, 80220, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory Healthcare System

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Burnout, Professional

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Zahidee (Saidie) Rodriguez, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Participants will be randomly assigned to receive either four months of group coaching or treatment as usual. After fourth months of the assigned treatment, the two arms will switch for another four months of either group coaching or treatment as usual.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 8, 2023

First Posted

July 10, 2023

Study Start

July 14, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Investigators will share all of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Proposals should be directed to rodriguezz@kidsheart.com with a signed data access agreement, for up to 5 yrs (example 2 language)

Locations