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Burnout, ProfessionalNCT03746574

Achieving the Quadruple Aim by Reducing Burnout

A study testing Compassion Curriculum in people with Burnout, Professional, run by Providence Health & Services.

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

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Burnout, Professional
What is being tested?
Compassion Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
341 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 31 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • All employees working in selected clinics

Who cannot join

  • none

About this study

Official title: Achieving the Quadruple Aim by Reducing Burnout: A Randomized Trial of a Compassion Based Curriculum for Outpatient Teams

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.

Read the 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.

Being tested
Compassion Curriculum
Medical subject headings
Burnout, Professional

What participants receive

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

  • Compassion CurriculumBehavioural

    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.

Study groups in NCT03746574
Study groupRoleWhat they receive
Intervention ClinicsExperimentalParticipants 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.
Receives: Behavioral: Compassion Curriculum
Control ClinicsNo interventionCompleted baseline, end of curriculum, and 6 month follow up survey. Otherwise no intervention

What is being measured

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

  1. 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).

    Measured: Baseline, 6 Months and 12 Months

  2. 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."

    Measured: Baseline, 6 Months and 12 Months

  3. 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

    Measured: Baseline, 6 Months and 12 Months

  4. Change in Intent to stay on Caregiver survey

    Intent to stay on Caregiver survey

    Measured: Baseline and 12 months

Secondary outcomes (7)
  1. Change inCaregiver Engagement measured on annual Willis Tower Watson Survey

    Caregiver Engagement measured on annual Willis Tower Watson Survey

    Measured: Baseline and 12 months

  2. Change in Patient Experience on routine Press Ganey Survey

    Patient Experience on routine Press Ganey Survey

    Measured: Baseline, 6 Months and 12 Months

  3. Change in Visit per month

    Average number of visits

    Measured: Baseline, 6 Months and 12 Months

  4. Change in Panel Size

    Panel Size per FTE

    Measured: Baseline, 6 Months and 12 Months

  5. Change in Diabetes Control

    HbA1c

    Measured: Baseline, 6 Months and 12 Months

  6. Change in BP control

    % people with blood pressure <140/80

    Measured: Baseline, 6 Months and 12 Months

  7. Change in Cancer Screening Rate

    Average of rates of screening for breast, colon, and cervical cancer

    Measured: 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 posted19 Nov 2018
  2. Study start1 Jan 2016
  3. Primary completion1 Jul 2016
  4. Study completion31 Dec 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
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)
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03746574
Sponsor's protocol ID
15-132
Status last verified
Nov 2018
First submitted
14 Nov 2018
Last updated
19 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25384822
  • 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.

    PubMed 27391946
  • 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.

    PubMed 27785668
  • 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.

    PubMed 30193239
  • 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.

    PubMed 24515493
  • 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.

    PubMed 27692469
  • 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.

    PubMed 27918798

Questions about this trial

What is this clinical trial studying?

A study testing Compassion Curriculum in people with Burnout, Professional, run by Providence Health & Services.

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 1 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Burnout Score on Maslach Burnout Inventory (time frame: Baseline, 6 Months and 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03746574, which also lists 7 linked publications.

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 19 Nov 2018.

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