- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06598540
Comparison of Two Nutrition-Based Interventions on Physician Well-being (COMPASSION)
Comparison of Two Nutrition-Based Interventions on Physician Well-being - A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
We will conduct a randomized controlled trial to compare the impact on physician well-being outcomes of a brief mindset intervention that frames daily food choices as an opportunity for demonstrating self-kindness to a brief nutrition education intervention among physicians. Surveys will be completed at baseline and in weeks 3 and 6 after the start of the intervention.
If this proof-of-concept intervention is effective, it will not only provide evidence regarding the value of the specific intervention tested for increasing self-valuation in physicians but also provide a novel framework for future interventions evaluating the ability of mindset interventions to foster self-valuation and clinician well-being.
Primary outcome measures: percentage change in mean scores from baseline at week 6 in scores of the measures below.
1) Self-valuation: We will use two standardized measures to assess self-valuation:
1a. The 4-item Clinician Self-valuation Scale assesses deferment of self-care to meet work demands and harsh responses to personal imperfections and errors during the past two weeks. (1) This assessment will be collected at baseline, week 3, and week 6.
1b. The 3-item self-kindness subscale of the Modified State Self-Compassion Measure, a validated construct developed by Kristin Neff, PhD in 2021 (2). This assessment will be collected at baseline, week 3, and week 6.
2) We will also evaluate participants' self-reported readiness to practice self-valuation, and the importance and confidence in practicing it on a sliding scale.
3) Burnout: We will use the burnout sub-scales of the validated Stanford Professional Fulfillment Index which includes 4 items evaluating the Work Exhaustion domain of burnout and 6 items assessing the Interpersonal Disengagement domain of burnout over the past 2 weeks. These assessments will be collected at baseline, week 3, and week 6.(3)
Secondary outcome measure: percentage change in mean score from baseline at week 6 in scores of diet quality assessed by the validated 9-item Mini-EAT dietary questionnaire designed to assess diet quality in clinician practice. (4) This assessment will be collected at baseline, week 3, and week 6.
In the final survey ( week 6) we will collect participant feedback about satisfaction with the program and recommendations for improvement.
References:
- Trockel MT, Hamidi MS, Menon NK, et al. Self-valuation: Attending to the Most Important Instrument in the Practice of Medicine. Mayo Clin Proc. 2019;94(10):2022-2031.
- Neff, K. D., Tóth-Király, I., Knox, M. C., Kuchar, A., & Davidson, O. (2021). The Development and Validation of the State Self-Compassion Scale (Long-and Short Form). Mindfulness, 12(1), 121-140.
- Trockel M, Bohman B, Lesure E, et al. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018;42(1):11-24.
- Lara-Breitinger KM, Medina Inojosa JR, Li Z, et al. Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT (Eating Assessment Tool). J Am Heart Assoc. 2023;12(1):e025064.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Physicians of all genders and racial/ethnic backgrounds licensed to practice medicine in the US, and
- Physicians who spend at least 8 hours per week doing clinical work (based on self-report)
Exclusion Criteria:
- Anyone who is not a licensed physician in the US
- Physicians who are not licensed to practice medicine in the US, and
- Physicians who spend less than 8 hours per week doing clinical work.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kindness-focused intervention arm
Mindset intervention framing food choices as an opportunity to practice self-kindness.
Individuals randomized to this arm will participate in a 15-20-minute live virtual educational session delivered via the Stanford Zoom platform.
The recording of the session will be available for 7 days on a private and secure educational platform for those who cannot attend the live session and for future review.
After participating in the initial educational session, participants can engage in brief (less than 10 minutes) web-based activities on their own time during weeks 2 and 5.
|
This mindset intervention frames food choices as an opportunity to practice self-kindness.
Individuals randomized to this arm will participate in a 15-20-minute live virtual educational session delivered via the Stanford Zoom platform.
The recording of the session will be available for 7 days on a private and secure educational web-based platform.
After participating in the initial educational session, participants will have the option to engage in brief (less than 10-minute) web-based activities on their own time during weeks 2 and 5. Examples of such activities include sharing their experiences about considering food choices as an act of self-kindness with other study participants or writing an encouraging letter to a study participant and physician colleague through the private and secure message board of a web-based educational platform.
|
|
Active Comparator: Health-focused intervention arm
Brief education intervention framing food choices as a component of a healthy lifestyle.
Individuals randomized to this arm will participate in a 15-20-minute live virtual educational session.
The recording of the session will be available for 7 days on a private and secure educational platform for those who cannot attend the live session and for future review.
After participating in the initial educational session, participants will have the option to engage in brief (less than 10-minute) web-based activities on their own time during weeks 2 and 5.
|
Brief education intervention framing food choices as a component of a healthy lifestyle.
Individuals randomized to this arm will participate in a 15-20-minute live virtual educational session.
The recording of the session will be available for 7 days on a private and secure educational web-based platform.
After participating in the initial educational session, participants will have the option to engage in brief (less than 10-minute) web-based activities on their own time during weeks 2 and 5. Examples of such activities include writing a brief statement about their perspective on the usefulness of healthy eating and sharing it with physician colleagues in their group through the private and secure message board of a web-based educational platform.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage change in mean score of self-kindness from baseline at week 6
Time Frame: 6 weeks
|
The 3-item self-kindness subscale of the Modified State Self-Compassion Measures: A validated construct developed by Kristin Neff, PhD in 2021. This assessment will be collected at baseline, week 3, and week 6. Instructions ask respondents to answer questions about their relevant experience "during the past 2 weeks." An example of an item is "I'm being kind to myself."; Scale items are scored on a 5-point Likert scale (Not at all true for me=1;Very true for me=5). The scale range is standardized to 0 to 10. Higher scores are more favorable. |
6 weeks
|
|
Percentage change in mean score of self-valuation from baseline at week 6
Time Frame: 6 weeks
|
The 4-item Clinician Self-valuation Scale assesses deferment of self-care to meet work demands and harsh responses to personal imperfections and errors during the past two weeks.
This assessment will be collected at baseline, week 3, and week 6.
Instructions ask respondents to answer questions about their relevant experience "during the past 2 weeks."
Example items are "When I made a mistake, I felt more self-condemnation than self-encouragement to learn from the experience" and "I put off taking care of my own health due to time pressure."
Scale items are scored on a 5-point Likert scale (always = 0; never = 4) and reverse scored such that higher scores are more favorable.
The scale range is 0 to 10.
|
6 weeks
|
|
Changes in Stage of Change from baseline at week 6
Time Frame: 6 weeks
|
Perceptions of importance and confidence in practicing self-valuation will be measured on a sliding scale that ranges from 0 to 10 with higher scores being more favorable.
Together, indicate how ready the client is to change target behaviors.
Lower scores of both ( less than 30) indicate pre-contemplation stage and higher scores ( more than 90) indicate the maintenance stage in terms of four stages of the change: Precontemplation, Contemplation, Action, and Maintenance.
We will also evaluate participants' self-reported readiness (5 option Likert scale from not ready to practice: 0, to have been practicing it consistently for 6 months: 4).These assessments will be collected at baseline, week 3 and week 6.
|
6 weeks
|
|
Physician Burnout
Time Frame: 6 weeks
|
We will use the burnout sub-scales of the validated Stanford Professional Fulfillment Index which includes 4 items evaluating the Work Exhaustion domain of burnout and 6 items assessing the Interpersonal Disengagement domain of burnout over the past 2 weeks.
This includes 4 items that assess work exhaustion and 6 items that assess interpersonal disengagement.
Items are scored on a 5-point Likert scale from "not at all" to "extremely."
The average item score from the 10 work exhaustion items and interpersonal disengagement items is used to derive an overall burnout score ranging from 0 to 10 with lower scores being favorable.
This assessment will be collected at baseline, week 3 and week 6.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage change in mean scores from baseline at week 6 in diet quality
Time Frame: 6 weeks
|
Diet quality: assessed by the validated 9-item Mini-EAT dietary questionnaire designed to assess diet quality in clinician practice.
This assessment will be collected at baseline, week 3, and week 6.
The scores range from 53 to 72 with scores of less than 61: Unheathy, 61-69: Intermediate, mand ore than 69: Healthy indicating diet qualities respectively.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maryam Makowski, PhD, Stanford University
Publications and helpful links
General Publications
- Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.
- Lara-Breitinger KM, Medina Inojosa JR, Li Z, Kunzova S, Lerman A, Kopecky SL, Lopez-Jimenez F. Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT (Eating Assessment Tool). J Am Heart Assoc. 2023 Jan 3;12(1):e025064. doi: 10.1161/JAHA.121.025064. Epub 2022 Dec 30.
- Neff, K.D., Tóth-Király, I., Knox, M.C. et al. The Development and Validation of the State Self-Compassion Scale (Long- and Short Form). Mindfulness 12, 121-140 (2021). https://doi.org/10.1007/s12671-020-01505-4
- Trockel MT, Hamidi MS, Menon NK, Rowe SG, Dudley JC, Stewart MT, Geisler CZ, Bohman BD, Shanafelt TD. Self-valuation: Attending to the Most Important Instrument in the Practice of Medicine. Mayo Clin Proc. 2019 Oct;94(10):2022-2031. doi: 10.1016/j.mayocp.2019.04.040. Epub 2019 Sep 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 75576
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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