Burnout, ProfessionalNCT04070456
Clinician Burnout and Social Determinants
A study testing Tablet-based SDH tool in people with Burnout, Professional, run by Wake Forest University Health Sciences at 3 sites in United States.
Trial summary
Although clinicians recognize the impact of the social determinants of health (SDH) on patient care, clinicians feel they do not have the time or knowledge to effectively address patients' unmet social needs in the clinic. This can lead to feelings of distress and helplessness. 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?
- Tablet-based SDH tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Nov 2019to 29 Oct 2021
- 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 clinicians and primary care teams at participating sites will be eligible
Who cannot join
- There are no specific exclusion criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Wake Forest Downtown Health Plaza (DHP)
Winston-Salem, North Carolina, 27101
Family Medicine-Piedmont Plaza
Winston-Salem, North Carolina, 27104
Internal Medicine-Janeway Tower
Winston-Salem, North Carolina, 27157
About this study
Official title: Addressing Social Determinants of Health to Reduce Physician Burnout
Although clinicians recognize the impact of the social determinants of health (SDH) on patient care, clinicians feel they do not have the time or knowledge to effectively address patients' unmet social needs in the clinic. This can lead to feelings of distress and helplessness. The objective of this study is to test the impact of a tablet-based platform that enhances the role of support staff to address SDH on clinician burnout.
Read the detailed description
Clinician burnout has risen over the last decade, and studies have found that almost 50% of U.S. physicians show signs of burnout. Burnout is characterized by emotional exhaustion, feelings of cynicism, and patient detachment. Clinicians at the front lines of care, such as family medicine and internal medicine, are at highest risk, and burnout is associated with an increased risk of cardiovascular disease, alcoholism, and suicide. Burnout also negatively impacts patient care. The drivers of burnout are complex, and a growing body of research has focused on developing strategies to address both clinician and organizational factors. One potential contributor to clinician burnout that has received less attention is their patients' SDH.
The SDH, or the circumstances in which people are born, grow, live, and age, have a profound impact on morbidity and mortality. Increasingly, national organizations have called for healthcare systems to address SDH, such as food and housing insecurity, to improve population health. Although clinicians recognize the importance of SDH on patient care, clinicians feel they do not have the time, knowledge, or tools to effectively address SDH, which can leading to feelings of distress and helplessness in addressing patients' unmet social needs. The SDH can lead to increased patient complexity and clinician workload. Also, the seemingly insurmountable social needs faced by many patients are a major contributor to the decline in medicine residents choosing a career in primary care. Thus, the lack of a tool to assist the primary care team in addressing SDH is a critical problem that can negatively affect both patients and clinicians.
Our long-term goal is to enhance the primary care teams' ability to address the SDH by utilizing a mobile health tool that can assist the team in addressing patients' unmet social needs in clinical settings. Mobile health tools, such as tablets, have shown promise in reducing disparities in care and addressing unmet social needs in pediatric practices. However, there is little data about how addressing SDH affects physician burnout. Mobile health tools have the potential to collect patient-reported data and connect patients to appropriate support personnel without interfering with clinic workflow and enhance the primary care teams' ability to provide patients with resources. The objective of this study is to test the impact of a tablet-based platform that enhances the role of support staff to address SDH on clinician burnout.
- Conditions
- Burnout, Professional
- Being tested
- Tablet-based SDH tool
- Keywords
- Physician Burnout, social determinants of health, Mini-Z
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-based SDH toolOther
A tablet-based SDH tool, which integrates responses into the EpicCare electronic health record (EHR).
| Study group | Role | What they receive |
|---|---|---|
| Intervention sites-Tablet-based SDH tool | Experimental | All clinicians and primary care teams at a practice that are randomized to the intervention will receive the tablet-based SDH tool. Receives: Other: Tablet-based SDH tool |
| Control sites | No intervention | Care as usual, no tablet-based SDH tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Z Scale
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Measured: Baseline
Mini-Z Scale
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Measured: 6 month post baseline
Mini-Z Scale
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Measured: 12 month post baseline
Secondary outcomes (9)
The number of clinicians who report a joyful workplace
Measured: Baseline
The number of clinicians who report a joyful workplace
Measured: 6 months post baseline
The number of clinicians who report a joyful workplace
Measured: 12 months post baseline
The number of clinicians who report a supportive practice
Measured: Baseline
The number of clinicians who report a supportive practice
Measured: 6 months post baseline
The number of clinicians who report a supportive practice
Measured: 12 months post baseline
The number of clinicians who report a good work pace
Measured: Baseline
The number of clinicians who report a good work pace
Measured: 6 months post baseline
The number of clinicians who report a good work pace
Measured: 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start18 Nov 2019
- Primary completion31 Jul 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepak Palakshappa, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070456
- Sponsor's protocol ID
- IRB00059798
- Other IDs
- 1902014
- Status last verified
- Jun 2021
- First submitted
- 22 Aug 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deindentification
Publications
Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.
PubMed 22911330Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.
PubMed 26653297Shanafelt TD, Noseworthy JH. Executive Leadership and Physician Well-being: Nine Organizational Strategies to Promote Engagement and Reduce Burnout. Mayo Clin Proc. 2017 Jan;92(1):129-146. doi: 10.1016/j.mayocp.2016.10.004. Epub 2016 Nov 18.
PubMed 27871627C M, S J, M L. Maslach Burnout Inventory Manual. Consulting Psychologist Press. 1996;3rd edition.
Shanafelt TD, Balch CM, Dyrbye L, Bechamps G, Russell T, Satele D, Rummans T, Swartz K, Novotny PJ, Sloan J, Oreskovich MR. Special report: suicidal ideation among American surgeons. Arch Surg. 2011 Jan;146(1):54-62. doi: 10.1001/archsurg.2010.292.
PubMed 21242446Shanafelt TD, Balch CM, Bechamps G, Russell T, Dyrbye L, Satele D, Collicott P, Novotny PJ, Sloan J, Freischlag J. Burnout and medical errors among American surgeons. Ann Surg. 2010 Jun;251(6):995-1000. doi: 10.1097/SLA.0b013e3181bfdab3.
PubMed 19934755Shanafelt TD, Gradishar WJ, Kosty M, Satele D, Chew H, Horn L, Clark B, Hanley AE, Chu Q, Pippen J, Sloan J, Raymond M. Burnout and career satisfaction among US oncologists. J Clin Oncol. 2014 Mar 1;32(7):678-86. doi: 10.1200/JCO.2013.51.8480. Epub 2014 Jan 27.
PubMed 24470006Panagioti 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 30193239Shanafelt TD, Dyrbye LN, West CP, Sinsky CA. Potential Impact of Burnout on the US Physician Workforce. Mayo Clin Proc. 2016 Nov;91(11):1667-1668. doi: 10.1016/j.mayocp.2016.08.016. No abstract available.
PubMed 27814840Shanafelt TD, Mungo M, Schmitgen J, Storz KA, Reeves D, Hayes SN, Sloan JA, Swensen SJ, Buskirk SJ. Longitudinal Study Evaluating the Association Between Physician Burnout and Changes in Professional Work Effort. Mayo Clin Proc. 2016 Apr;91(4):422-31. doi: 10.1016/j.mayocp.2016.02.001.
PubMed 27046522Dyrbye LN, Trockel M, Frank E, Olson K, Linzer M, Lemaire J, Swensen S, Shanafelt T, Sinsky CA. Development of a Research Agenda to Identify Evidence-Based Strategies to Improve Physician Wellness and Reduce Burnout. Ann Intern Med. 2017 May 16;166(10):743-744. doi: 10.7326/M16-2956. Epub 2017 Apr 18. No abstract available.
PubMed 28418518Eisenstein L. To Fight Burnout, Organize. N Engl J Med. 2018 Aug 9;379(6):509-511. doi: 10.1056/NEJMp1803771. Epub 2018 Jun 20. No abstract available.
PubMed 29924700Byhoff E, Freund KM, Garg A. Accelerating the Implementation of Social Determinants of Health Interventions in Internal Medicine. J Gen Intern Med. 2018 Feb;33(2):223-225. doi: 10.1007/s11606-017-4230-8. Epub 2017 Nov 29. No abstract available.
PubMed 29188543Long T, Chaiyachati K, Bosu O, Sircar S, Richards B, Garg M, McGarry K, Solomon S, Berman R, Curry L, Moriarty J, Huot S. Why Aren't More Primary Care Residents Going into Primary Care? A Qualitative Study. J Gen Intern Med. 2016 Dec;31(12):1452-1459. doi: 10.1007/s11606-016-3825-9. Epub 2016 Aug 3.
PubMed 27488970Gottlieb LM, Francis DE, Beck AF. Uses and Misuses of Patient- and Neighborhood-level Social Determinants of Health Data. Perm J. 2018;22:18-078. doi: 10.7812/TPP/18-078.
PubMed 30227912
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Social Determinants of Health to Reduce Physician Burnout
- ClinicalTrials.gov ID
- NCT04070456
- Acronym / sponsor ID
- IRB00059798
- Conditions
- Burnout, Professional
- Keywords
- Physician Burnout, social determinants of health, Mini-Z
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although clinicians recognize the impact of the social determinants of health (SDH) on patient care, clinicians feel they do not have the time or knowledge to effectively address patients' unmet social needs in the clinic. This can lead to feelings of distress and helplessness. The objective of this study is to test the impact of a tablet-based platform that enhances the role of support staff to address SDH on clinician burnout.
Detailed description
Clinician burnout has risen over the last decade, and studies have found that almost 50% of U.S. physicians show signs of burnout. Burnout is characterized by emotional exhaustion, feelings of cynicism, and patient detachment. Clinicians at the front lines of care, such as family medicine and internal medicine, are at highest risk, and burnout is associated with an increased risk of cardiovascular disease, alcoholism, and suicide. Burnout also negatively impacts patient care. The drivers of burnout are complex, and a growing body of research has focused on developing strategies to address both clinician and organizational factors. One potential contributor to clinician burnout that has received less attention is their patients' SDH.
The SDH, or the circumstances in which people are born, grow, live, and age, have a profound impact on morbidity and mortality. Increasingly, national organizations have called for healthcare systems to address SDH, such as food and housing insecurity, to improve population health. Although clinicians recognize the importance of SDH on patient care, clinicians feel they do not have the time, knowledge, or tools to effectively address SDH, which can leading to feelings of distress and helplessness in addressing patients' unmet social needs. The SDH can lead to increased patient complexity and clinician workload. Also, the seemingly insurmountable social needs faced by many patients are a major contributor to the decline in medicine residents choosing a career in primary care. Thus, the lack of a tool to assist the primary care team in addressing SDH is a critical problem that can negatively affect both patients and clinicians.
Our long-term goal is to enhance the primary care teams' ability to address the SDH by utilizing a mobile health tool that can assist the team in addressing patients' unmet social needs in clinical settings. Mobile health tools, such as tablets, have shown promise in reducing disparities in care and addressing unmet social needs in pediatric practices. However, there is little data about how addressing SDH affects physician burnout. Mobile health tools have the potential to collect patient-reported data and connect patients to appropriate support personnel without interfering with clinic workflow and enhance the primary care teams' ability to provide patients with resources. The objective of this study is to test the impact of a tablet-based platform that enhances the role of support staff to address SDH on clinician burnout.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention sites-Tablet-based SDH tool | Experimental | Other: Tablet-based SDH toolAll clinicians and primary care teams at a practice that are randomized to the intervention will receive the tablet-based SDH tool. |
| Control sites | No intervention | –Care as usual, no tablet-based SDH tool. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All clinicians and primary care teams at participating sites will be eligible
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet-based SDH toolA tablet-based SDH tool, which integrates responses into the EpicCare electronic health record (EHR). | Other | Intervention sites-Tablet-based SDH tool |
Primary outcome
Mini-Z Scale
Time frame: Baseline
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Mini-Z Scale
Time frame: 6 month post baseline
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Mini-Z Scale
Time frame: 12 month post baseline
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
9 secondary outcomes
The number of clinicians who report a joyful workplace
Time frame: Baseline
The number of clinicians who report a joyful workplace
Time frame: 6 months post baseline
The number of clinicians who report a joyful workplace
Time frame: 12 months post baseline
The number of clinicians who report a supportive practice
Time frame: Baseline
The number of clinicians who report a supportive practice
Time frame: 6 months post baseline
The number of clinicians who report a supportive practice
Time frame: 12 months post baseline
The number of clinicians who report a good work pace
Time frame: Baseline
The number of clinicians who report a good work pace
Time frame: 6 months post baseline
The number of clinicians who report a good work pace
Time frame: 12 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Background: PubMed 22911330Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.
- Background: PubMed 26653297Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.
- Background: PubMed 27871627Shanafelt TD, Noseworthy JH. Executive Leadership and Physician Well-being: Nine Organizational Strategies to Promote Engagement and Reduce Burnout. Mayo Clin Proc. 2017 Jan;92(1):129-146. doi: 10.1016/j.mayocp.2016.10.004. Epub 2016 Nov 18.
- BackgroundC M, S J, M L. Maslach Burnout Inventory Manual. Consulting Psychologist Press. 1996;3rd edition.
- Background: PubMed 21242446Shanafelt TD, Balch CM, Dyrbye L, Bechamps G, Russell T, Satele D, Rummans T, Swartz K, Novotny PJ, Sloan J, Oreskovich MR. Special report: suicidal ideation among American surgeons. Arch Surg. 2011 Jan;146(1):54-62. doi: 10.1001/archsurg.2010.292.
- Background: PubMed 19934755Shanafelt TD, Balch CM, Bechamps G, Russell T, Dyrbye L, Satele D, Collicott P, Novotny PJ, Sloan J, Freischlag J. Burnout and medical errors among American surgeons. Ann Surg. 2010 Jun;251(6):995-1000. doi: 10.1097/SLA.0b013e3181bfdab3.
- Background: PubMed 24470006Shanafelt TD, Gradishar WJ, Kosty M, Satele D, Chew H, Horn L, Clark B, Hanley AE, Chu Q, Pippen J, Sloan J, Raymond M. Burnout and career satisfaction among US oncologists. J Clin Oncol. 2014 Mar 1;32(7):678-86. doi: 10.1200/JCO.2013.51.8480. Epub 2014 Jan 27.
- Background: PubMed 30193239Panagioti 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.
- Background: PubMed 27814840Shanafelt TD, Dyrbye LN, West CP, Sinsky CA. Potential Impact of Burnout on the US Physician Workforce. Mayo Clin Proc. 2016 Nov;91(11):1667-1668. doi: 10.1016/j.mayocp.2016.08.016. No abstract available.
- Background: PubMed 27046522Shanafelt TD, Mungo M, Schmitgen J, Storz KA, Reeves D, Hayes SN, Sloan JA, Swensen SJ, Buskirk SJ. Longitudinal Study Evaluating the Association Between Physician Burnout and Changes in Professional Work Effort. Mayo Clin Proc. 2016 Apr;91(4):422-31. doi: 10.1016/j.mayocp.2016.02.001.
- Background: PubMed 28418518Dyrbye LN, Trockel M, Frank E, Olson K, Linzer M, Lemaire J, Swensen S, Shanafelt T, Sinsky CA. Development of a Research Agenda to Identify Evidence-Based Strategies to Improve Physician Wellness and Reduce Burnout. Ann Intern Med. 2017 May 16;166(10):743-744. doi: 10.7326/M16-2956. Epub 2017 Apr 18. No abstract available.
- Background: PubMed 29924700Eisenstein L. To Fight Burnout, Organize. N Engl J Med. 2018 Aug 9;379(6):509-511. doi: 10.1056/NEJMp1803771. Epub 2018 Jun 20. No abstract available.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deindentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Palakshappa, MD principal investigator
Wake Forest University Health Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet-based SDH tool in people with Burnout, Professional, run by Wake Forest University Health Sciences at 3 sites in United States.
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 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mini-Z Scale (time frame: Baseline). The study lists 3 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 NCT04070456, which also lists 38 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 10 Jan 2022.