The Impact of Burnout on Patient-Centered Care: A Comparative Effectiveness Trial in Mental Health
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02146326 |
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Recruitment Status :
Completed
First Posted : May 23, 2014
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Burnout Quality of Care | Behavioral: Motivational Interviewing (MI) Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 679 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Impact of Burnout on Patient-Centered Care: A Comparative Effectiveness Trial in Mental Health |
| Study Start Date : | December 2013 |
| Actual Primary Completion Date : | April 2016 |
| Actual Study Completion Date : | June 2016 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Motivational Interviewing-Mental Health Staff |
Behavioral: Motivational Interviewing (MI)
MI is a common counseling technique. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to MI. Each session occurred approximately one month apart. |
| Active Comparator: BREATHE-Mental Health Staff |
Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)
BREATHE is a program developed to attempt to improve or prevent the symptoms of burnout. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to BREATHE. Each session occurred approximately one month apart. |
| Active Comparator: Motivational Interviewing-Clients |
Behavioral: Motivational Interviewing (MI)
MI is a common counseling technique. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to MI. Each session occurred approximately one month apart. |
| Active Comparator: BREATHE-Clients |
Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)
BREATHE is a program developed to attempt to improve or prevent the symptoms of burnout. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to BREATHE. Each session occurred approximately one month apart. |
- Maslach Burnout Inventory (MBI): Emotional Exhaustion [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]
Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were asked to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).
Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.
- Maslach Burnout Inventory (MBI): Depersonalization [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]
Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).
Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.
- Maslach Burnout Inventory (MBI): Personal Accomplishment [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]
Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).
Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.
- Job Satisfaction [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]
Job satisfaction was assessed with one item from the Job Diagnostics Survey: Overall, I am satisfied with my job. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree)
Hackman JR, Oldham GR. The Job Diagnostic Survey: An Instrument for the Diagnosis of Jobs and the Evaluation of Job Redesign Projects. 1974.
- Turnover Intentions-Considered Leaving [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]This is the first of two questions in which staff were asked about turnover intentions. Staff were asked, "How often have you seriously considered leaving your job in the past six months?" Scale: 1 (Never), 2 (Once every few months), 3 (Once a month), 4 (several times a month), 5 (Once a week), 6 (Several times a week)
- Turnover Intentions-Likely to Leave [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]This is the second of two questions in which staff were asked about turnover intentions. Staff were asked, "How likely are you to leave your job in the next six months?" Scale: 1 (Not likely at all), 2 (Not very likely), 3 (Somewhat likely), 4 (Very likely)
- Work Interference With Home Life [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]
Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is work conflict with family. The measure consists of a series of statements regarding one's work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged.
Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work-family conflict. Journal of Vocational Behavior. 2000;56(2):249-276.
- Home Life Interference With Work [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]
Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is family conflict with work. The measure consists of a series of statements regarding one's work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged.
Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work-family conflict. Journal of Vocational Behavior. 2000;56(2):249-276.
- Emotional Labor Scale: Surface Acting [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Surface Acting is a subset of these questions (e.g., I put on an act in order to deal with clients in an appropriate way). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)
- Emotional Labor Scale: Deep Acting [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Deep Acting is a subset of these questions (e.g., I try to actually experience the emotions that I must show to clients). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)
- Emotional Labor Scale: Genuine Emotions [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Genuine Emotions is a subset of these questions (e.g., The emotions that I express to clients are genuine). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)
- Importance: Reduce Work-Related Stress [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]Staff were asked, "How important is it for you to reduce your work-related stress right now?" This single item score was averaged. Scale: 1 (not at all important) to 10 (extremely important)
- Confidence: Reduce Work-Related Stress [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]Staff were asked, "How confident are you that you can reduce your work-related stress in your life?" Scale: 1 (not at all confident) to 10 (extremely confident)
- Importance: Client Interaction [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]Staff were asked, "How important is it for you to consistently interact with consumers/clients in a relaxed, non-judgmental way?" Scale: 1 (not at all important) to 10 (extremely important)
- Confidence: Client Interaction [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]Staff were asked, "How confident are you that you can consistently interact with consumers/clients in a relaxed, non-judgmental way?" Scale: 1 (not at all confident) to 10 (extremely confident)
- Quality of Care: Person Centered Care [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Person Centered Care was measured with a subset of questions from this scale (e.g., I felt like I was able to really show compassion to a client.). The item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care: Discordant Care [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Discordant Care was measured with a subset of questions from this scale (e.g., I had conflicts with clients.). The item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care-Total [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies participating in this project and then refined to 22 items through data collected and analyzed in this study. Items were related to person or client centered care, work conscientiousness, errors, interactions with clients, and how stress affects client interactions or outcomes. The item scores were averaged. Scale: 0 (never) to 5 (always)
- Perceptions of Supervisory Support [ Time Frame: Measured with staff at baseline, 3 months, 6 months, and 12 months ]The 19 item Perceptions of Supervisory Support Scale was used to gather information on staff's experience of interactions with their supervisors (e.g., How often did you think supervision improved your relationship with your supervisor?). The item scores were averaged. Scale: 1 (never) to 6 (always)
- Staff Turnover [ Time Frame: Measured with staff at 12 months ]Number of staff participants who separated from their respective agency before their anticipated study completion date. The mental health agencies provided separation dates, if applicable, for staff study participants.
- Adult State Hope Scale [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Hope was assessed with clients using the 12-item Adult State Hope Scale (e.g., I can think of many ways to get the things in life that are most important to me.). The item scores were averaged. Scale: 1 (Definitely False) to 8 (Definitely True)
Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. Journal of Personality and Social Psychology. 1996;70(2):321 - 335.
- Medication Adherence Rating Scale (MARS) - Medication Adherence - 4-item [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Medication adherence (for clients who are prescribed medications for their mental health) was rated with a subset of 4 items from the MARS, a 10-item scale assessing attitudes toward medication (e.g., Do you ever forget to take your medication? Are you careless at times about taking your medicine?). The item scores were summed and averaged (range: 0-4). Scale: 0 (No) to 1 (Yes)
Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247.
- Medication Adherence Rating Scale (MARS) - Medication Attitudes - 10-item [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Medication attitudes (for clients who are prescribed medications for their mental health) was rated with the MARS, a 10-item scale assessing attitudes toward medication (e.g., It is unnatural for my mind and body to be controlled by medication.). The items scores were summed and averaged (range: 0-10). Scale: 0 (No) to 1 (Yes)
Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247.
- Health-Care Climate Questionnaire [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Perceived autonomy support was assessed with this 15-item scale (e.g., I am able to be open with [name] at our meetings.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree)
Williams GC, McGregor HA, King D, Nelson CC, Glasgow RE. Variation in perceived competence, glycemic control, and patient satisfaction: relationship to autonomy support from physicians. Patient Education & Counseling. Apr 2005;57(1):39-45.
- Working Alliance Inventory (WAI) [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Perceived relatedness was assessed with this short form of the patient version of the WAI and is 12 items (e.g., We agree on what is important for me to work on.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Never) to 7 (Always)
Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207.
- Working Alliance Inventory (WAI) - Tasks Subscale [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the tasks subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)
Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207.
- Working Alliance Inventory (WAI) - Goals Subscale [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the goals subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)
Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207.
- Working Alliance Inventory (WAI) - Bonds Subscale [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the bonds subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)
Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207.
- Patient Activation Measure-Mental Health (PAM-MH)-0 to 100 Scale [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Competence related to mental health management was assessed with the 13-item Patient Activation Measure-Mental Health (PAM-MH) (e.g., I know what each of my prescribed mental health medications does.). Each question was answered on a 4-point Likert-type scale: 1 (Strongly Disagree) to 4 (Strongly Agree). Higher scores=greater activation.
Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Services Research. Dec 2005;40(6 Pt 1):1918-1930.
- Short-Form Health Survey (SF-12)-Physical Health Functioning [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100).
Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 -233.
- Short-Form Health Survey (SF-12)-Mental Health Functioning [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100).
Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 -233.
- Patient Health Questionnaire 9-item (PHQ-9) [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
The PHQ-9 is a brief, self-report assessment. It provides a summed total score that indicates likelihood of major depressive disorder. Scores ≥10 are considered a positive screen (sensitivity 88%, specificity 88%) and also effectively measures response to treatment (<5 indicate remission, of 5-9 indicate partial response, and ≥10 indicates no response). Item scores are summed and averaged (range: 0-27). Scale: 0 (Not at all), 1 (Several days), 2 (More than half the days), 4 (Nearly every day). When problems are identified, the difficulty of those problems are rated on 4 point scale (Not difficult at all to Extremely difficult).
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine. Sep 2001;16(9):606-613.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders - Text Revision (4th ed.). Washington, DC: American Psychiatric Association; 2000.
- Generalized Anxiety Disorder (GAD-7) [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]
Anxiety was assessed with the 7-item Generalized Anxiety Disorder (GAD-7). It can be scored continuously on a 0-21 severity scale and cutpoints have been established for estimating the probability of the 4 most common and clinically relevant anxiety disorders - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Scale: 0 (not at all), 1 (several days), 2 (more than half the days), 3 (nearly every day)
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of Internal Medicine. May 22 2006;166(10):1092-1097.
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. Mar 6 2007;146(5):317-325.
- Client Satisfaction Questionnaire [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]Engagement was assessed with patient satisfaction using the Client Satisfaction Questionnaire, an 8-item satisfaction checklist (e.g., How would you rate the quality of service you have received? and, If a friend were in need of similar help, would you recommend [name of agency] to him or her?). The item scores were averaged. Scale: 1 to 4 with response text dependent upon the question (e.g., 1-Poor to 4-Excellent, 1-No, definitely not to 4-Yes, definitely, or 1-Quite dissatisfied to 4-Very satisfied).
- Quality of Care-Person Centered Care [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Person Centered Care was measured with a subset of questions from this scale. The item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care-Negative Interactions [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Negative Interactions were measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care-Inattentive Care [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Inattentive care was measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care Total [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.) and then refined to 22 items through data collected and analyzed in this study. This scale for clients was adapted from the one developed for staff. Item scores were averaged. Scale: 0 (never) to 5 (always)
- Patient Engagement-Missed Appointments [ Time Frame: Measured with clients at baseline, 6 months, and 12 months ]Patient engagement was assessed by the proportion of missed appointments (when the client cancelled or did not show for a scheduled appointment divided by the total scheduled). This data was retrieved from client medical records at the agencies. Data from 3 time periods were analyzed (6 months prior to baseline through baseline, baseline to 6 months, and 6 months to 12 months). The below table illustrates the missed appointments for each time period.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A staff member with client contact at either Four County Counseling or Places for People.
- Randomly chosen client from the participating staff lists. Must be 18 years old or older.
Exclusion Criteria:
- Clients younger than 18 years old.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146326
| United States, Indiana | |
| Four County Counseling Center | |
| Logansport, Indiana, United States, 46947 | |
| United States, Missouri | |
| Places for People | |
| St. Louis, Missouri, United States, 63108 | |
| Principal Investigator: | Michelle P Salyers, PhD | Indiana University School of Medicine |
| Responsible Party: | Michelle Salyers, Professor, Department of Psychology, Indiana University |
| ClinicalTrials.gov Identifier: | NCT02146326 |
| Other Study ID Numbers: |
IH-1304-6597 |
| First Posted: | May 23, 2014 Key Record Dates |
| Results First Posted: | April 14, 2017 |
| Last Update Posted: | April 14, 2017 |
| Last Verified: | April 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Burnout, Psychological Stress, Psychological Behavioral Symptoms |

