Burn OutNCT04805294
Pediatrician Wellbeing Program
An observational study of Burn Out and Burn Out (Psychology), run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators propose to implement a comprehensive Pediatrician Wellbeing Program initiated through and aligning with departmental faculty development and mentorship processes and goals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burn Out, Burn Out (Psychology), Work Related Stress
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 3 Feb 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Assistant, Associate or Full Professor, either in fixed-term and tenure-track positions in the Department of Pediatrics on the UNC main campus, at the time of consent.
Who may be able to join
- Provision of signed and dated informed consent form.
- An Assistant, Associate or Full Professor, either in fixed-term and tenure-track positions in the Department of Pediatrics on the UNC main campus, at the time of consent.
Who cannot join
- Not an Assistant, Associate or Full Professor in either fixed-term or tenure-track position within the Department of Pediatrics on the UNC main campus.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Coaching a Wellbeing Leadership Culture: Bringing a Pediatrician Wellbeing Program Into Practice
The investigators propose to implement a comprehensive Pediatrician Wellbeing Program initiated through and aligning with departmental faculty development and mentorship processes and goals. The Investigators hypothesize that a wellbeing intervention that incorporates an innovative health coaching model to cultivate individual behavior change supportive of one's own and others' wellbeing will lead to improvements in self-reported wellbeing.
Read the detailed description
The investigators hypothesize that a wellbeing intervention that incorporates an innovative health coaching model to cultivate individual behavior change supportive of one's own and others' wellbeing can be implemented using existing institutional infrastructure and will lead to improvements in self-reported wellbeing.
This is a nonrandomized pilot study of a convenience sample. Participants will be assigned to 1 of 2 coaches, based upon availability of schedules. Participants who perform research will be assigned to the remote coach whenever possible to avoid potential concerns with the internal coach's dual role as Administrative Director of the Children's Research Institute.
The sample size for this pilot study (up to 30) was selected for feasibility and not power. This study is funded for 1-year and study participation is for 6-months. The study will be conducted at a single site; the University of North Carolina Department of Pediatrics Chapel Hill. Assistant, Associate and Full Professors, tenure-track or fixed-term, on the UNC main campus are eligible.
The Pediatric Wellbeing Program consists of coaching sessions from a certified National Board for Health and Wellness Coach (NBHWC) through the National Board of Medical Examiners. The NBHWC pioneered science-based training, education, and research of health and wellness coaches over the past 15 years. NBHWC became an accredited institution through National Board of Medical Examiners in 2016, providing certification through examination. By using NBHWC-certified coaches, the investigators are adhering to a standard and measured foundational competencies: the knowledge, tasks and skills essential to the practice of health and wellness coaching. Coaches will assist participants in constructing their Wellbeing-Individual Development Plan (Wellbeing-IDP). The Wellbeing-IDP is designed to assist with identifying the participant's vision, goals, and plan for wellbeing; assess current wellbeing with the WHO-5 to identify areas where they have high wellbeing and areas they need to develop; secure support and accountability (e.g., UNC resources, familial, peer, social, professional); and create a timeline for what they want to accomplish when.
As needed, faculty will also receive up to 5 additional coaching sessions from a certified health coach via video conferencing. All coaching sessions will use principles for health coaching, including brief motivational interviewing, self-empowerment and determination, transtheoretical model of stages of change, mindset, sense making, and making SMART goals (Specific, Measurable, Achievable, Relevant, Timely).
- Conditions
- Burn Out, Burn Out (Psychology), Work Related Stress
- Keywords
- Wellbeing, Burn Out, Physician Burn Out, Mindfulness
- Medical subject headings
- Burnout, Psychological, Occupational Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Persons Who Were Contacted to Enroll in the Study
Percentage of persons who were contacted to enroll in the study
Measured: through study completion, an average of 180 days
Percentage of Persons Who Ultimately Enrolled in the Study
Potential persons who were contacted for study participation versus the number who ultimately enrolled in the study.
Measured: through study completion, an average of 180 days
Percentage of Mentors Who Attended First Session
Percentage of mentors who attended first session with mentee
Measured: through study completion, an average of 180 days
Percentage of Health Coach Visits Scheduled
Percentage of visits scheduled with health coaches
Measured: through study completion, an average of 180 days
Percentage of Health Coach Visits Missed
Percentage of visits missed with health coaches
Measured: through study completion, an average of 180 days
Percentage of Health Coach Visits Attended
Percentage of visits attended with health coaches
Measured: through study completion, an average of 180 days
Percentage of Total Surveys Completed
Participants are asked to complete 6 surveys at baseline, 4 surveys after 3-months in the program and 7 surveys after 6-months in the program; the measure reports the number of fully executed surveys as a percentage to determine engagement.
Measured: Day 180
Percentage of Participants Who Complete the Study
Percentage of participants who fully complete all visits and surveys in the study
Measured: Day 180
Secondary outcomes (4)
Change in World Health Organization Wellbeing Index (WHO-5) Scores
The WHO-5 is a 5-item measure assessing subjective psychological well-being based on respondent ratings of cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. Responses are provided on a 6-point scale: 0 ("at no time") to 5 ("all of the time") according to the proportion of time over the preceding 2 weeks that applied to each attribute. Scores range from 0-25; higher scores reflect better well-being.
Measured: Day 1, Day 180
Change in Breslau Post Traumatic Stress Disorder (PTSD) Scores
The Breslau Post Traumatic Stress Disorder screen is a 7-symptom measure assessing presence of PTSD in accordance with Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) and World Health Organization guidelines. Responses are provided on a 2-point scale: 1 ("Yes") or 0 ("No") in response to 7 questions. Scores of 4 or more indicate a likelihood of PTSD.
Measured: Day 1, Day 180
Change in Perceived Stress Scale (PSS-4) Scores
The Perceived Stress Scale is a 4-item measure, self-report scale that generates a global stress score based on general questions rather than specific experiences. Response are provided on a 5-point scale: 0 ("Never") to 4 ("very often") according to the proportion of time over the preceding month that applied to each attribute. Scores range from 0-16. Scores of 0-7 indicate low to moderate stress; scores of 8-16 indicate moderate to high stress level.
Measured: Day 1, Day 180
Change in Utrecht Work Engagement Scale (UWES) Scores
The UWES is a 3-item measure assessing engagement in an individual's work based on respondent ratings of vigor, dedication, and absorption. Responses are provided on a 7-point scale: 0 ("never") to 6 ("always, every day") and averaged. Scores range from 0-6; scores within 0-4 indicate low engagement and satisfaction in the workplace.
Measured: Day 1, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start22 Sep 2020
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn OutStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry Noah, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805294
- Sponsor's protocol ID
- 20-0987
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Kennedy S, Carmack S, Li L, Lin FC, Hatch JE, Chan K, Tolleson-Rinehart S, Noah TL. Coaching Pediatricians for Wellbeing: A Pilot Feasibility and Acceptability Study. Acad Pediatr. 2025 Mar;25(2):102586. doi: 10.1016/j.acap.2024.09.010. Epub 2024 Oct 1.
PubMed 39362630
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching a Wellbeing Leadership Culture: Bringing a Pediatrician Wellbeing Program Into Practice
- ClinicalTrials.gov ID
- NCT04805294
- Acronym / sponsor ID
- 20-0987
- Conditions
- Burn Out, Burn Out (Psychology), Work Related Stress
- Keywords
- Wellbeing, Burn Out, Physician Burn Out, Mindfulness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 18 Mar 2021 (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.
The investigators propose to implement a comprehensive Pediatrician Wellbeing Program initiated through and aligning with departmental faculty development and mentorship processes and goals. The Investigators hypothesize that a wellbeing intervention that incorporates an innovative health coaching model to cultivate individual behavior change supportive of one's own and others' wellbeing will lead to improvements in self-reported wellbeing.
Detailed description
The investigators hypothesize that a wellbeing intervention that incorporates an innovative health coaching model to cultivate individual behavior change supportive of one's own and others' wellbeing can be implemented using existing institutional infrastructure and will lead to improvements in self-reported wellbeing.
This is a nonrandomized pilot study of a convenience sample. Participants will be assigned to 1 of 2 coaches, based upon availability of schedules. Participants who perform research will be assigned to the remote coach whenever possible to avoid potential concerns with the internal coach's dual role as Administrative Director of the Children's Research Institute.
The sample size for this pilot study (up to 30) was selected for feasibility and not power. This study is funded for 1-year and study participation is for 6-months. The study will be conducted at a single site; the University of North Carolina Department of Pediatrics Chapel Hill. Assistant, Associate and Full Professors, tenure-track or fixed-term, on the UNC main campus are eligible.
The Pediatric Wellbeing Program consists of coaching sessions from a certified National Board for Health and Wellness Coach (NBHWC) through the National Board of Medical Examiners. The NBHWC pioneered science-based training, education, and research of health and wellness coaches over the past 15 years. NBHWC became an accredited institution through National Board of Medical Examiners in 2016, providing certification through examination. By using NBHWC-certified coaches, the investigators are adhering to a standard and measured foundational competencies: the knowledge, tasks and skills essential to the practice of health and wellness coaching. Coaches will assist participants in constructing their Wellbeing-Individual Development Plan (Wellbeing-IDP). The Wellbeing-IDP is designed to assist with identifying the participant's vision, goals, and plan for wellbeing; assess current wellbeing with the WHO-5 to identify areas where they have high wellbeing and areas they need to develop; secure support and accountability (e.g., UNC resources, familial, peer, social, professional); and create a timeline for what they want to accomplish when.
As needed, faculty will also receive up to 5 additional coaching sessions from a certified health coach via video conferencing. All coaching sessions will use principles for health coaching, including brief motivational interviewing, self-empowerment and determination, transtheoretical model of stages of change, mindset, sense making, and making SMART goals (Specific, Measurable, Achievable, Relevant, Timely).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Assistant, Associate or Full Professor, either in fixed-term and tenure-track positions in the Department of Pediatrics on the UNC main campus, at the time of consent.
Key inclusion criteria (2 listed)
- Provision of signed and dated informed consent form.
- An Assistant, Associate or Full Professor, either in fixed-term and tenure-track positions in the Department of Pediatrics on the UNC main campus, at the time of consent.
Key exclusion criteria (1 listed)
- Not an Assistant, Associate or Full Professor in either fixed-term or tenure-track position within the Department of Pediatrics on the UNC main campus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Persons Who Were Contacted to Enroll in the Study
Time frame: through study completion, an average of 180 days
Percentage of persons who were contacted to enroll in the study
Percentage of Persons Who Ultimately Enrolled in the Study
Time frame: through study completion, an average of 180 days
Potential persons who were contacted for study participation versus the number who ultimately enrolled in the study.
Percentage of Mentors Who Attended First Session
Time frame: through study completion, an average of 180 days
Percentage of mentors who attended first session with mentee
Percentage of Health Coach Visits Scheduled
Time frame: through study completion, an average of 180 days
Percentage of visits scheduled with health coaches
Percentage of Health Coach Visits Missed
Time frame: through study completion, an average of 180 days
Percentage of visits missed with health coaches
Percentage of Health Coach Visits Attended
Time frame: through study completion, an average of 180 days
Percentage of visits attended with health coaches
Percentage of Total Surveys Completed
Time frame: Day 180
Participants are asked to complete 6 surveys at baseline, 4 surveys after 3-months in the program and 7 surveys after 6-months in the program; the measure reports the number of fully executed surveys as a percentage to determine engagement.
Percentage of Participants Who Complete the Study
Time frame: Day 180
Percentage of participants who fully complete all visits and surveys in the study
4 secondary outcomes
Change in World Health Organization Wellbeing Index (WHO-5) Scores
Time frame: Day 1, Day 180
Change in Breslau Post Traumatic Stress Disorder (PTSD) Scores
Time frame: Day 1, Day 180
Change in Perceived Stress Scale (PSS-4) Scores
Time frame: Day 1, Day 180
Change in Utrecht Work Engagement Scale (UWES) Scores
Time frame: Day 1, Day 180
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 3 Aug 2022.
- Derived from this study: PubMed 39362630Kennedy S, Carmack S, Li L, Lin FC, Hatch JE, Chan K, Tolleson-Rinehart S, Noah TL. Coaching Pediatricians for Wellbeing: A Pilot Feasibility and Acceptability Study. Acad Pediatr. 2025 Mar;25(2):102586. doi: 10.1016/j.acap.2024.09.010. Epub 2024 Oct 1.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Terry Noah, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Out and Burn Out (Psychology), run by University of North Carolina, Chapel Hill at 1 site 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 1 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Percentage of Persons Who Were Contacted to Enroll in the Study (time frame: through study completion, an average of 180 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805294, which also lists 1 linked publication.
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 3 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.