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
About this trial
This is an interventional prevention trial for Burnout, Professional
Eligibility Criteria
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
NCT ID
NCT03746574
First Posted
November 14, 2018
Last Updated
November 16, 2018
Sponsor
Providence Health & Services
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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