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Achieving the Quadruple Aim by Reducing Burnout

Primary Purpose

Burnout, Professional

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compassion Curriculum
Sponsored by
Providence Health & Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burnout, Professional

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All employees working in selected clinics

Exclusion Criteria:

  • none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Clinics

    Control Clinics

    Arm Description

    Participants in the intervention clinics experienced a 12 session compassion curriculum intevention offered every other week for six months. Each session lasted 80 minutes and all staff at the intervention clinics were expected to participate. A total of 16 hours of experiences were provided.

    Completed baseline, end of curriculum, and 6 month follow up survey. Otherwise no intervention

    Outcomes

    Primary Outcome Measures

    Change in Burnout Score on Maslach Burnout Inventory
    Score on Maslach Burnout Inventory: Maslach Burnout Inventory - Human Services Survey (MBI-HSS) is a 22-item survey that covers 3 areas: Emotional exhaustion (EE), Depersonalization (DP), and Low sense of personal accomplishment (PA). There are multiple questions for each of these subscales and responses are in the form of a frequency rating scale (never, a few times a year or less, once a month or less, a few times a month, once a week, a few times a week, every day).
    Change in Compassion: Score on Santa Clara Brief Compassion Scale
    Score on Santa Clara Brief Compassion Scale: The Santa Clare Brief Compassion Scale is a brief index that assesses compassion and its link to prosocial behaviors. An example from a 'compassion for humanity' item include ""When I hear about someone (a stranger) going through a difficult time, I feel a great deal of compassion for him or her." Responses are given on a 7-point scale from "Not at all true for me" to "Very true for me."
    Change in Mindfulness: Mindful Attention Awareness Score
    Mindful Attention Awareness Score: The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Scored on a scale 1=almost never--> 6=almost always
    Change in Intent to stay on Caregiver survey
    Intent to stay on Caregiver survey

    Secondary Outcome Measures

    Change inCaregiver Engagement measured on annual Willis Tower Watson Survey
    Caregiver Engagement measured on annual Willis Tower Watson Survey
    Change in Patient Experience on routine Press Ganey Survey
    Patient Experience on routine Press Ganey Survey
    Change in Visit per month
    Average number of visits
    Change in Panel Size
    Panel Size per FTE
    Change in Diabetes Control
    HbA1c
    Change in BP control
    % people with blood pressure <140/80
    Change in Cancer Screening Rate
    Average of rates of screening for breast, colon, and cervical cancer

    Full Information

    First Posted
    November 14, 2018
    Last Updated
    November 16, 2018
    Sponsor
    Providence Health & Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03746574
    Brief Title
    Achieving the Quadruple Aim by Reducing Burnout
    Official Title
    Achieving the Quadruple Aim by Reducing Burnout: A Randomized Trial of a Compassion Based Curriculum for Outpatient Teams
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    July 1, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Providence Health & Services

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To demonstrate that a multimodal intervention can reduce burnout in a multidisciplinary primary care practice while improving other components of the Quadruple Aim including staff engagement, patient experience, productivity and quality.
    Detailed Description
    Recruitment This was a randomized trial of eleven internal medicine and family medicine clinics of Providence Medical Group (PMG) in Portland Oregon. All of the clinics were non-residency clinics. The study was conducted between January 2015 and January 2016. Introductory meetings were held with leadership dyads (medical director and manager) of all 23 clinics in the Portland area to overview the curriculum and outline conditions of study participation. Expectations included: holding the curriculum sessions during usual work hours, endorsement of participation by clinic staff, and that specific individuals would be identified to facilitate sessions for the clinic. Leadership of each clinic, subsequently, discussed the curriculum with the staffs of the clinics and eleven committed to participate and were then randomized. The staffs of the intervention clinics then received the twelve session Strengthening Compassion curriculum. Four of the intervention clinics held the sessions at the beginning of the day and opened clinic 80 minutes late. One clinic held the sessions during an extended lunch hour. Randomization and Follow-up Eleven clinics volunteered to participate. (47.8% of eligible clinics) Five clinics were randomly selected to participate in the Strengthening Compassion curriculum and six were selected as controls. 341 individuals participated in the study, including providers, clinical, and administrative staff. The baseline survey was completed by 153 participants in the intervention clinics and 188 participants in the control clinics. 244 of the initial participants completed a survey at the end of the intervention period and 191 at 6 month follow up Participants in the intervention clinics engaged in a 12 session curriculum offered every other week for six months. Each session lasted 80 minutes and all staff at the intervention clinics were expected to participate. A total of 16 hours of experiences were provided. Each session was facilitated by internal non-physician staff (e.g. social workers, medical assistants, nurses) recruited by clinic leadership. The facilitators received two hours of on-line training in group facilitation, mindfulness meditation, content/exercises for each session, and were provided with a detailed facilitators guide. The facilitators also received one half hour of additional training before each session via networked phone calls and were supported by on-line materials. Study Outcomes Outcomes were measured utilizing a fifty one question survey administered at baseline, at the end of the 6-month curriculum and at 6 months follow-up. This survey was a composite of validated surveys that measure compassion, mindfulness, burnout, clinic relations, job satisfaction, and clinical satisfaction. The Compassion component of the survey used the Santa Clara Brief Compassion Scale (SCBCS). Mindfulness was measured with the Mindful Attention Awareness Scale (MAAS). Burnout was measured with the Maslach Burnout Inventory-Human Services Survey for Medical Personnel (MBI-HSS (MP)) comprised of three sub-scales that measure emotional exhaustion, depersonalization, and personal accomplishment. Questions about caregiver roles in the clinic, clinic relations, job satisfaction, clinical satisfaction, time working in the clinic, and time working in healthcare, were derived from a previously utilized survey provided by the Center for Outcomes Research and Education of the Providence Health and Services. Data on caregiver engagement was collected in October 2015 and October 2016 via organization wide survey through Willis-Tower-Watson. Engagement and disengagement are pre-defined categories on the Willis-Tower Watson survey. Patient experience data was collected by Press Ganey as part of their standard survey process. Impact on productivity and quality were assessed from data, routinely collected, in the Providence St. Joseph Health administrative data base.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burnout, Professional

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomization to intervention or control occuring at the level of clinic. All participants within a clinic are assigned to same group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    341 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Clinics
    Arm Type
    Experimental
    Arm Description
    Participants in the intervention clinics experienced a 12 session compassion curriculum intevention offered every other week for six months. Each session lasted 80 minutes and all staff at the intervention clinics were expected to participate. A total of 16 hours of experiences were provided.
    Arm Title
    Control Clinics
    Arm Type
    No Intervention
    Arm Description
    Completed baseline, end of curriculum, and 6 month follow up survey. Otherwise no intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Compassion Curriculum
    Intervention Description
    12 session curriculum offered every other week for six months. Each session lasted 80 minutes and all staff at the intervention clinics were expected to participate. A total of 16 hours of experiences were provided.
    Primary Outcome Measure Information:
    Title
    Change in Burnout Score on Maslach Burnout Inventory
    Description
    Score on Maslach Burnout Inventory: Maslach Burnout Inventory - Human Services Survey (MBI-HSS) is a 22-item survey that covers 3 areas: Emotional exhaustion (EE), Depersonalization (DP), and Low sense of personal accomplishment (PA). There are multiple questions for each of these subscales and responses are in the form of a frequency rating scale (never, a few times a year or less, once a month or less, a few times a month, once a week, a few times a week, every day).
    Time Frame
    Baseline, 6 Months and 12 Months
    Title
    Change in Compassion: Score on Santa Clara Brief Compassion Scale
    Description
    Score on Santa Clara Brief Compassion Scale: The Santa Clare Brief Compassion Scale is a brief index that assesses compassion and its link to prosocial behaviors. An example from a 'compassion for humanity' item include ""When I hear about someone (a stranger) going through a difficult time, I feel a great deal of compassion for him or her." Responses are given on a 7-point scale from "Not at all true for me" to "Very true for me."
    Time Frame
    Baseline, 6 Months and 12 Months
    Title
    Change in Mindfulness: Mindful Attention Awareness Score
    Description
    Mindful Attention Awareness Score: The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Scored on a scale 1=almost never--> 6=almost always
    Time Frame
    Baseline, 6 Months and 12 Months
    Title
    Change in Intent to stay on Caregiver survey
    Description
    Intent to stay on Caregiver survey
    Time Frame
    Baseline and 12 months
    Secondary Outcome Measure Information:
    Title
    Change inCaregiver Engagement measured on annual Willis Tower Watson Survey
    Description
    Caregiver Engagement measured on annual Willis Tower Watson Survey
    Time Frame
    Baseline and 12 months
    Title
    Change in Patient Experience on routine Press Ganey Survey
    Description
    Patient Experience on routine Press Ganey Survey
    Time Frame
    Baseline, 6 Months and 12 Months
    Title
    Change in Visit per month
    Description
    Average number of visits
    Time Frame
    Baseline, 6 Months and 12 Months
    Title
    Change in Panel Size
    Description
    Panel Size per FTE
    Time Frame
    Baseline, 6 Months and 12 Months
    Title
    Change in Diabetes Control
    Description
    HbA1c
    Time Frame
    Baseline, 6 Months and 12 Months
    Title
    Change in BP control
    Description
    % people with blood pressure <140/80
    Time Frame
    Baseline, 6 Months and 12 Months
    Title
    Change in Cancer Screening Rate
    Description
    Average of rates of screening for breast, colon, and cervical cancer
    Time Frame
    Baseline, 6 Months and 12 Months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All employees working in selected clinics Exclusion Criteria: none
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Rosenberg, MD
    Organizational Affiliation
    Providence St. Joseph
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25384822
    Citation
    Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6. doi: 10.1370/afm.1713.
    Results Reference
    background
    PubMed Identifier
    27391946
    Citation
    Hall LH, Johnson J, Watt I, Tsipa A, O'Connor DB. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review. PLoS One. 2016 Jul 8;11(7):e0159015. doi: 10.1371/journal.pone.0159015. eCollection 2016.
    Results Reference
    background
    PubMed Identifier
    27785668
    Citation
    Salyers MP, Bonfils KA, Luther L, Firmin RL, White DA, Adams EL, Rollins AL. The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis. J Gen Intern Med. 2017 Apr;32(4):475-482. doi: 10.1007/s11606-016-3886-9. Epub 2016 Oct 26.
    Results Reference
    background
    PubMed Identifier
    30193239
    Citation
    Panagioti M, Geraghty K, Johnson J, Zhou A, Panagopoulou E, Chew-Graham C, Peters D, Hodkinson A, Riley R, Esmail A. Association Between Physician Burnout and Patient Safety, Professionalism, and Patient Satisfaction: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Oct 1;178(10):1317-1331. doi: 10.1001/jamainternmed.2018.3713. Erratum In: JAMA Intern Med. 2019 Apr 1;179(4):596.
    Results Reference
    background
    PubMed Identifier
    24515493
    Citation
    West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387.
    Results Reference
    background
    PubMed Identifier
    27692469
    Citation
    West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.
    Results Reference
    background
    PubMed Identifier
    27918798
    Citation
    Panagioti M, Panagopoulou E, Bower P, Lewith G, Kontopantelis E, Chew-Graham C, Dawson S, van Marwijk H, Geraghty K, Esmail A. Controlled Interventions to Reduce Burnout in Physicians: A Systematic Review and Meta-analysis. JAMA Intern Med. 2017 Feb 1;177(2):195-205. doi: 10.1001/jamainternmed.2016.7674.
    Results Reference
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    Achieving the Quadruple Aim by Reducing Burnout

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