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BurnoutNCT02146326

The Impact of Burnout on Patient-Centered Care: A Comparative Effectiveness Trial in Mental Health

A study testing Motivational Interviewing (MI) and Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE) in people with Burnout and Quality of Care, run by Indiana University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Healthcare providers play an important role in helping patients be actively involved in treatment and recover from mental illness. But mental health clinicians, like other healthcare providers, are at risk for experiencing burnout-feeling emotionally drained from their work, having cynical thoughts toward patients and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burnout, Quality of Care
What is being tested?
Motivational Interviewing (MI) and Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
679 participants
Where
2 sitesUnited States
Study dates
Dec 2013to Jun 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Clients younger than 18 years old.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Four County Counseling Center

    Logansport, Indiana, 46947

  • Places for People

    St Louis, Missouri, 63108

Other trials in United States

About this study

Healthcare providers play an important role in helping patients be actively involved in treatment and recover from mental illness. But mental health clinicians, like other healthcare providers, are at risk for experiencing burnout-feeling emotionally drained from their work, having cynical thoughts toward patients and others, and feeling little accomplishment in their work. Burnout can lead to problems for the clinician including poor overall health, depression, and lower job satisfaction. Burnout also can impact how clinicians perform on the job; for example, people with high levels of burnout take more time off, show lower commitment to their job, and are more likely to quit or be fired. There is some evidence that burnout can affect the quality of care for patients, but very little rigorous research has tested this assumption. The purpose of our study is threefold. First, we will investigate how patients perceive burnout in clinicians and whether (and/or how) burnout impacts the care they receive. Next, we will test an intervention to reduce clinician burnout called Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE). BREATHE brings together tools that mental health clinicians are already familiar with, including relaxation and mindfulness exercises, setting boundaries, using social supports, and changing negative thought patterns and replacing them with more helpful ways of thinking. We have found this intervention effective in reducing burnout in other organizations, but have yet to study whether it also can improve patient outcomes. Clinicians (approximately 200) who participate will receive either the BREATHE intervention or training in motivational interviewing, which could also improve patient involvement in treatment and patient outcomes, but is unlikely to significantly reduce clinician burnout. We will also recruit up to 600 adult patients served by participating clinicians. We will survey clinicians and interview patients over a 12-month period after the intervention to determine how the intervention impacts clinician burnout and patient perceptions of care (relationship with the clinician, degree of autonomy in decision making), patient involvement in care, and outcomes (confidence in managing mental health, symptoms, functioning, and hope). Finally, this study will use a statistical procedure called Structural Equation Modeling to test a theoretical model of the relationship between burnout and patient outcomes. Findings from this study will show whether reducing clinician burnout can improve patient outcomes and the quality of care that patients receive. Our intervention will have the potential to be easily implemented in a variety of settings where burnout is a problem. Knowing how clinician burnout impacts patient outcomes, and whether improving burnout can improve patient care, can help improve the healthcare system.

Being tested
Motivational Interviewing (MI), Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)
Medical subject headings
Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational Interviewing (MI)Behavioural

    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.

  • Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)Behavioural

    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.

Study groups in NCT02146326
Study groupRoleWhat they receive
Motivational Interviewing-Mental Health StaffActive comparatorNot described
Receives: Behavioral: Motivational Interviewing (MI)
BREATHE-Mental Health StaffActive comparatorNot described
Receives: Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)
Motivational Interviewing-ClientsActive comparatorNot described
Receives: Behavioral: Motivational Interviewing (MI)
BREATHE-ClientsActive comparatorNot described
Receives: Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maslach Burnout Inventory (MBI): Emotional Exhaustion

    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.

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  2. Maslach Burnout Inventory (MBI): Depersonalization

    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.

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  3. Maslach Burnout Inventory (MBI): Personal Accomplishment

    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.

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

Secondary outcomes (36)
  1. Job Satisfaction

    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.

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  2. Turnover Intentions-Considered Leaving

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  3. Turnover Intentions-Likely to Leave

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  4. Work Interference With Home Life

    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.

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  5. Home Life Interference With Work

    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.

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  6. Emotional Labor Scale: Surface Acting

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  7. Emotional Labor Scale: Deep Acting

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  8. Emotional Labor Scale: Genuine Emotions

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  9. Importance: Reduce Work-Related Stress

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  10. Confidence: Reduce Work-Related Stress

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  11. Importance: Client Interaction

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  12. Confidence: Client Interaction

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  13. Quality of Care: Person Centered Care

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  14. Quality of Care: Discordant Care

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  15. Quality of Care-Total

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  16. Perceptions of Supervisory Support

    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)

    Measured: Measured with staff at baseline, 3 months, 6 months, and 12 months

  17. Staff Turnover

    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.

    Measured: Measured with staff at 12 months

  18. Adult State Hope Scale

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  19. Medication Adherence Rating Scale (MARS) - Medication Adherence - 4-item

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  20. Medication Adherence Rating Scale (MARS) - Medication Attitudes - 10-item

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  21. Health-Care Climate Questionnaire

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  22. Working Alliance Inventory (WAI)

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  23. Working Alliance Inventory (WAI) - Tasks Subscale

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  24. Working Alliance Inventory (WAI) - Goals Subscale

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  25. Working Alliance Inventory (WAI) - Bonds Subscale

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  26. Patient Activation Measure-Mental Health (PAM-MH)-0 to 100 Scale

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  27. Short-Form Health Survey (SF-12)-Physical Health Functioning

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  28. Short-Form Health Survey (SF-12)-Mental Health Functioning

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  29. Patient Health Questionnaire 9-item (PHQ-9)

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  30. Generalized Anxiety Disorder (GAD-7)

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

  31. Client Satisfaction Questionnaire

    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).

    Measured: Measured with clients at baseline, 6 months, and 12 months

  32. Quality of Care-Person Centered Care

    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)

    Measured: Measured with clients at baseline, 6 months, and 12 months

  33. Quality of Care-Negative Interactions

    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)

    Measured: Measured with clients at baseline, 6 months, and 12 months

  34. Quality of Care-Inattentive Care

    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)

    Measured: Measured with clients at baseline, 6 months, and 12 months

  35. Quality of Care Total

    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)

    Measured: Measured with clients at baseline, 6 months, and 12 months

  36. Patient Engagement-Missed Appointments

    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.

    Measured: Measured with clients at baseline, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionApr 2016
  4. Study completionJun 2016

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
679 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146326
Sponsor's protocol ID
IH-1304-6597
Status last verified
Apr 2017
First submitted
21 May 2014
Last updated
14 Apr 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing (MI) and Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE) in people with Burnout and Quality of Care, run by Indiana University at 2 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 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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?

Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maslach Burnout Inventory (MBI): Emotional Exhaustion (time frame: Measured with staff at baseline, 3 months, 6 months, and 12 months). The study lists 3 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 14 Apr 2017.

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