NCT03746574

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

November 14, 2018

Last Update Submit

November 16, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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).

    Baseline, 6 Months and 12 Months

  • 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."

    Baseline, 6 Months and 12 Months

  • 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

    Baseline, 6 Months and 12 Months

  • Change in Intent to stay on Caregiver survey

    Intent to stay on Caregiver survey

    Baseline and 12 months

Secondary Outcomes (7)

  • Change inCaregiver Engagement measured on annual Willis Tower Watson Survey

    Baseline and 12 months

  • Change in Patient Experience on routine Press Ganey Survey

    Baseline, 6 Months and 12 Months

  • Change in Visit per month

    Baseline, 6 Months and 12 Months

  • Change in Panel Size

    Baseline, 6 Months and 12 Months

  • Change in Diabetes Control

    Baseline, 6 Months and 12 Months

  • +2 more secondary outcomes

Study Arms (2)

Intervention Clinics

EXPERIMENTAL

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.

Behavioral: Compassion Curriculum

Control Clinics

NO INTERVENTION

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

Interventions

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.

Intervention Clinics

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All employees working in selected clinics

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 25384822BACKGROUND
  • 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.

    PMID: 27391946BACKGROUND
  • 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.

    PMID: 27785668BACKGROUND
  • 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.

    PMID: 30193239BACKGROUND
  • 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.

    PMID: 24515493BACKGROUND
  • 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.

    PMID: 27692469BACKGROUND
  • 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.

    PMID: 27918798BACKGROUND

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Mark Rosenberg, MD

    Providence St. Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomization to intervention or control occuring at the level of clinic. All participants within a clinic are assigned to same group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Compassionate Care

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 19, 2018

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

December 31, 2016

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share