Burnout, ProfessionalNCT05938556
Coaching for Advanced Practice Providers
A study testing hybrid asynchronous-synchronous group coaching program and treatment as usual group (TAU) in people with Burnout, Professional, run by Emory University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- hybrid asynchronous-synchronous group coaching program and treatment as usual group (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Jul 2023to 30 Jun 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Pregnant women will be included in this population, though this inclusion is incidental.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory Healthcare System
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30329
University of Colorado
Denver, Colorado, 80220
About this study
Official title: The Impact of a Multicenter Randomized Control Trial of Hybrid Synchronous-Asynchronous Virtual Group Coaching on Burnout and Retention in Advanced Practice Providers
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.
Read the detailed description
The purpose of this study is to determine the feasibility of establishing a coaching program directed toward Advanced Practice Providers (APPs), to determine the generalizability of tools shown to relieve physician burnout in the population of APPs, and to advance research in the field of healthcare wellness.
The coaching group will have a curriculum of self-study modules, pre-recorded webinars, and worksheets. The coaching group will also have access to two live group calls per week as well as an online forum to receive anonymously written coaching. After four months, participants will be switched to the other group, so that each participant is exposed to treatment but at separate times. At the completion of each intervention time point, participants will fill out a post-study survey.
- Conditions
- Burnout, Professional
- Being tested
- hybrid asynchronous-synchronous group coaching program, treatment as usual group (TAU)
- Keywords
- Advanced Practice Providers, APPs, Coaching, Healthcare provider, Nurse burnout, Wellness
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid asynchronous-synchronous group coaching programBehavioural
Also called group coaching program
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.
treatment as usual group (TAU)Other
Also called TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: treatment as usual group (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 months, 9 months
Secondary outcomes (7)
Change in Trauma Symptoms of Discrimination Scale
This two-part scale measures the experiences of discrimination using trauma symptoms. Part 1 includes 21 questions where the participant can respond to agree or disagree with the statement using Likert scale response options. Part 2 of the scale allows the respondent to allocate what percentage of their identity they experience discrimination on (i.e. race/ethnicity: 70%, disability: 20 %, and gender: 10%).
Measured: Baseline, 4 months, 9 months
Change in Self-Compassion
Self-Compassion as defined by Neff's Self Compassion Score Short Form is a 12-item measurement of self-compassion. Possible scores range from 0-6 on a Likert scale for each item, where the higher scale scores indicate greater self-compassion. Scores of 1.0- 2.49 are considered to be low, between 2.5-3.5 to be moderate, and 3.51-5.0 to be high.
Measured: Baseline, 4 months, 9 months
Change in Moral Injury
Moral Injury as defined by the Moral Injury Symptom Scale for Health Professions. (MISS-HP) is a 10-item measurement of moral injury. Possible scores range from 0-5 on a Likert scale for each item, where the higher scale scores indicate greater moral injury. Scores >35 (on a possible score range of 10 to 100) are considered high for moral injury symptoms causing moderate to extreme problems with family, social, and occupational functioning.
Measured: Baseline, 4 months, 9 months
Change in the Young's Imposter Syndrome Symptoms Scale
Imposter Syndrome as defined by Young's Imposter Syndrome Symptoms Scale. (YISS) is an 8-item measurement of imposter syndrome. Scoring is yes/no where a score of >5/8 is felt to be positive for imposter syndrome.
Measured: Baseline, 4 months, 9 months
Change in the intention to leave
Intent-to-leave is defined by a single-item question, on a 3-point Likert scale, where the higher the score reflects more intention to leave the current position. Followed by a single multiple-choice question as to why the participant is leaving.
Measured: Baseline, 4 months, 9 months
Change in Loneliness
Loneliness as defined by the University of California, Los Angeles (UCLA) 3-item Loneliness Scale. It is a 3-item measure of relational connectedness, social connectedness, and self-perceived isolation. Items are measured on a 3-point scale where a score range of 3-5 is "not lonely" and a score range of 6-9 is "lonely".
Measured: Baseline, 4 months, 9 months
Change in Self Reflection and Insight Scale
Self-reflection and insight as defined by Self Reflection and Insight Short Scale (SIRSS). It is a 12-point item measurement of the capacity to reflect on oneself and to think about one's thoughts, experiences, and actions on a 7-point Likert scale, where higher scores reflect more inspection, evaluation and perception of thoughts, beliefs, feelings, and behaviors.
Measured: Baseline, 4 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start14 Jul 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Emory 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, University of Colorado, Denver
- Responsible party
- Principal investigator, Zahidee (Saidie) Rodriguez, Emory University
- Investigators
- Zahidee (Saidie) Rodriguez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938556
- Sponsor's protocol ID
- STUDY00005675
- Status last verified
- Jul 2024
- First submitted
- 8 Jun 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share all of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Multicenter Randomized Control Trial of Hybrid Synchronous-Asynchronous Virtual Group Coaching on Burnout and Retention in Advanced Practice Providers
- ClinicalTrials.gov ID
- NCT05938556
- Acronym / sponsor ID
- STUDY00005675
- Conditions
- Burnout, Professional
- Keywords
- Advanced Practice Providers, APPs, Coaching, Healthcare provider, Nurse burnout, Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, University of Colorado, Denver
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Jul 2023 (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 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.
Detailed description
The purpose of this study is to determine the feasibility of establishing a coaching program directed toward Advanced Practice Providers (APPs), to determine the generalizability of tools shown to relieve physician burnout in the population of APPs, and to advance research in the field of healthcare wellness.
The coaching group will have a curriculum of self-study modules, pre-recorded webinars, and worksheets. The coaching group will also have access to two live group calls per week as well as an online forum to receive anonymously written coaching. After four months, participants will be switched to the other group, so that each participant is exposed to treatment but at separate times. At the completion of each intervention time point, participants will fill out a post-study survey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group Coaching Program | Experimental | Behavioral: hybrid asynchronous-synchronous group coaching programThe 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. |
| Usual Treatment | Placebo comparator | Other: treatment as usual group (TAU)This group will participate in the study intervention following a 4-month waitlist/control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- Pregnant women will be included in this population, though this inclusion is incidental.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| hybrid asynchronous-synchronous group coaching programAlso: group coaching programA 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. | Behavioural | Group Coaching Program |
| treatment as usual group (TAU)Also: TAUThe 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. | Other | Usual Treatment |
Primary outcome
Change in Burnout
Time frame: Baseline, 4 months, 9 months
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.
Change in the percentage of participants that accept the program course
Time frame: Baseline, 4 months, 9 months
Data collection will be at baseline, month 4, and month 9 for both groups.
Percentage of participants who watch program calls
Time frame: 4 month or 9 months
Number of participants who watch program calls. Data collection will only be at the end of participation Group Coaching Program.
Change in the percentage of participants that complete >50% of self-study worksheets
Time frame: 4 month or 9 months
Number of participants who complete >50% of self-study worksheets. Data collection will only be at the end of participation Group Coaching Program.
Change in the percentage of participants that use the Ask A Coach Forum at least once
Time frame: 4 month or 9 months
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.
Change in the rate of participation in the program
Time frame: Baseline, 4 months, 9 months
Percentage of participants that complete the outcome measures (pre/post surveys). Data collection will be at month 4 and month 9 for both groups.
7 secondary outcomes
Change in Trauma Symptoms of Discrimination Scale
Time frame: Baseline, 4 months, 9 months
Change in Self-Compassion
Time frame: Baseline, 4 months, 9 months
Change in Moral Injury
Time frame: Baseline, 4 months, 9 months
Change in the Young's Imposter Syndrome Symptoms Scale
Time frame: Baseline, 4 months, 9 months
Change in the intention to leave
Time frame: Baseline, 4 months, 9 months
Change in Loneliness
Time frame: Baseline, 4 months, 9 months
Change in Self Reflection and Insight Scale
Time frame: Baseline, 4 months, 9 months
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 19 Jul 2024.
- Individual participant dataSharing planned: Yes. Investigators will share all of the individual participant data collected during the trial, after deidentification.
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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.
Zahidee (Saidie) Rodriguez, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hybrid asynchronous-synchronous group coaching program and treatment as usual group (TAU) in people with Burnout, Professional, run by Emory University at 4 sites 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 2 inclusion and 5 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 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 Burnout (time frame: Baseline, 4 months, 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2024.