- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746574
Achieving the Quadruple Aim by Reducing Burnout
Achieving the Quadruple Aim by Reducing Burnout: A Randomized Trial of a Compassion Based Curriculum for Outpatient Teams
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All employees working in selected clinics
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Clinics
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.
|
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.
|
No Intervention: Control Clinics
Completed baseline, end of curriculum, and 6 month follow up survey.
Otherwise no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Burnout Score on Maslach Burnout Inventory
Time Frame: Baseline, 6 Months and 12 Months
|
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).
|
Baseline, 6 Months and 12 Months
|
Change in Compassion: Score on Santa Clara Brief Compassion Scale
Time Frame: Baseline, 6 Months and 12 Months
|
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."
|
Baseline, 6 Months and 12 Months
|
Change in Mindfulness: Mindful Attention Awareness Score
Time Frame: Baseline, 6 Months and 12 Months
|
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
|
Baseline, 6 Months and 12 Months
|
Change in Intent to stay on Caregiver survey
Time Frame: Baseline and 12 months
|
Intent to stay on Caregiver survey
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change inCaregiver Engagement measured on annual Willis Tower Watson Survey
Time Frame: Baseline and 12 months
|
Caregiver Engagement measured on annual Willis Tower Watson Survey
|
Baseline and 12 months
|
Change in Patient Experience on routine Press Ganey Survey
Time Frame: Baseline, 6 Months and 12 Months
|
Patient Experience on routine Press Ganey Survey
|
Baseline, 6 Months and 12 Months
|
Change in Visit per month
Time Frame: Baseline, 6 Months and 12 Months
|
Average number of visits
|
Baseline, 6 Months and 12 Months
|
Change in Panel Size
Time Frame: Baseline, 6 Months and 12 Months
|
Panel Size per FTE
|
Baseline, 6 Months and 12 Months
|
Change in Diabetes Control
Time Frame: Baseline, 6 Months and 12 Months
|
HbA1c
|
Baseline, 6 Months and 12 Months
|
Change in BP control
Time Frame: Baseline, 6 Months and 12 Months
|
% people with blood pressure <140/80
|
Baseline, 6 Months and 12 Months
|
Change in Cancer Screening Rate
Time Frame: Baseline, 6 Months and 12 Months
|
Average of rates of screening for breast, colon, and cervical cancer
|
Baseline, 6 Months and 12 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Rosenberg, MD, Providence St. Joseph
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Burnout, Professional
-
Region SkaneLund University; Swedish Council for Working Life and Social Research; County...CompletedProfessional BurnoutSweden
-
Mayo ClinicCompletedJob Stress | Professional Burnout | Professional StressUnited States
-
Colleen J KleinRecruitingJob Stress | Professional BurnoutUnited States
-
University of MichiganRecruiting
-
University of Colorado, DenverMayo Clinic; Physicians FoundationRecruiting
-
michal rollTel Aviv University; Association for Children at RiskUnknownBurnout, Professional | Professional-Patient Relations
-
West University of TimisoaraCompletedMental Health Wellness | Professional BurnoutRomania
-
Inonu UniversityCompletedAnxiety | Mindfulness | Job Satisfaction | Midwives | Professional BurnoutTurkey
-
University Grenoble AlpsCompletedMedical Education | Anesthesia | Anxiety State | Professional Burnout | High Fidelity Simulation | Professional StressFrance
-
Mayo ClinicCompletedStress | Anxiety | Leadership | Professional Role | Goals | Well-Being | Physician's Role | Professional Burnout | Development, HumanUnited States
Clinical Trials on Compassion Curriculum
-
University of ArizonaEmory UniversityCompletedImmune System Processes | Inflammatory Activation and Modulation | ANS FunctionUnited States
-
University of ArizonaCompletedImmune System Processes | Inflammatory Activation and Modulation | ANS FunctionUnited States
-
The University of Hong KongRecruitingADHD | Self-Compassion | Psychological Well-BeingHong Kong
-
Penn State UniversityNational Institute on Drug Abuse (NIDA); Ohio State UniversityCompleted
-
University of ChicagoActive, not recruitingLanguage Environments of Children of Low-socioeconomic StatusUnited States
-
Robert SimpsonNot yet recruitingMultiple Sclerosis | Self-CompassionCanada
-
University Hospitals Cleveland Medical CenterAmerican Academy of Pediatrics; Mt. Sinai Health Care FoundationCompleted
-
Weill Medical College of Cornell UniversityCompletedPediatric Residents Rotating in Pediatric OncologyUnited States
-
Canterbury Christ Church UniversityCompletedAn Online, Compassion Intervention for Adults With Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM).Type 1 Diabetes | Type 2 DiabetesUnited Kingdom