Clinician Burnout and Social Determinants
Primary Purpose
Burnout, Professional
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tablet-based SDH tool
Sponsored by
About this trial
This is an interventional health services research trial for Burnout, Professional focused on measuring Physician Burnout, social determinants of health, Mini-Z
Eligibility Criteria
Inclusion Criteria:
- All clinicians and primary care teams at participating sites will be eligible
Exclusion Criteria:
- There are no specific exclusion criteria
Sites / Locations
- Wake Forest Downtown Health Plaza (DHP)
- Family Medicine-Piedmont Plaza
- Internal Medicine-Janeway Tower
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention sites-Tablet-based SDH tool
Control sites
Arm Description
All clinicians and primary care teams at a practice that are randomized to the intervention will receive the tablet-based SDH tool.
Care as usual, no tablet-based SDH tool.
Outcomes
Primary Outcome Measures
Mini-Z Scale
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Mini-Z Scale
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Mini-Z Scale
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Secondary Outcome Measures
The number of clinicians who report a joyful workplace
The number of clinicians who report a joyful workplace
The number of clinicians who report a joyful workplace
The number of clinicians who report a supportive practice
The number of clinicians who report a supportive practice
The number of clinicians who report a supportive practice
The number of clinicians who report a good work pace
The number of clinicians who report a good work pace
The number of clinicians who report a good work pace
Full Information
NCT ID
NCT04070456
First Posted
August 22, 2019
Last Updated
December 17, 2021
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04070456
Brief Title
Clinician Burnout and Social Determinants
Official Title
Addressing Social Determinants of Health to Reduce Physician Burnout
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional
Keywords
Physician Burnout, social determinants of health, Mini-Z
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention sites-Tablet-based SDH tool
Arm Type
Experimental
Arm Description
All clinicians and primary care teams at a practice that are randomized to the intervention will receive the tablet-based SDH tool.
Arm Title
Control sites
Arm Type
No Intervention
Arm Description
Care as usual, no tablet-based SDH tool.
Intervention Type
Other
Intervention Name(s)
Tablet-based SDH tool
Intervention Description
A tablet-based SDH tool, which integrates responses into the EpicCare electronic health record (EHR).
Primary Outcome Measure Information:
Title
Mini-Z Scale
Description
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Time Frame
Baseline
Title
Mini-Z Scale
Description
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Time Frame
6 month post baseline
Title
Mini-Z Scale
Description
This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.
Time Frame
12 month post baseline
Secondary Outcome Measure Information:
Title
The number of clinicians who report a joyful workplace
Time Frame
Baseline
Title
The number of clinicians who report a joyful workplace
Time Frame
6 months post baseline
Title
The number of clinicians who report a joyful workplace
Time Frame
12 months post baseline
Title
The number of clinicians who report a supportive practice
Time Frame
Baseline
Title
The number of clinicians who report a supportive practice
Time Frame
6 months post baseline
Title
The number of clinicians who report a supportive practice
Time Frame
12 months post baseline
Title
The number of clinicians who report a good work pace
Time Frame
Baseline
Title
The number of clinicians who report a good work pace
Time Frame
6 months post baseline
Title
The number of clinicians who report a good work pace
Time Frame
12 months post baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All clinicians and primary care teams at participating sites will be eligible
Exclusion Criteria:
There are no specific exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Palakshappa, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Downtown Health Plaza (DHP)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Family Medicine-Piedmont Plaza
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Internal Medicine-Janeway Tower
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deindentification
IPD Sharing Time Frame
Immediately following publication, no end date
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal
Citations:
PubMed Identifier
22911330
Citation
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.
Results Reference
background
PubMed Identifier
26653297
Citation
Shanafelt 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. Erratum In: Mayo Clin Proc. 2016 Feb;91(2):276.
Results Reference
background
PubMed Identifier
27871627
Citation
Shanafelt 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.
Results Reference
background
Citation
C M, S J, M L. Maslach Burnout Inventory Manual. Consulting Psychologist Press. 1996;3rd edition.
Results Reference
background
PubMed Identifier
21242446
Citation
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.
Results Reference
background
PubMed Identifier
19934755
Citation
Shanafelt 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.
Results Reference
background
PubMed Identifier
24470006
Citation
Shanafelt 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.
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
27814840
Citation
Shanafelt 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.
Results Reference
background
PubMed Identifier
27046522
Citation
Shanafelt 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.
Results Reference
background
PubMed Identifier
28418518
Citation
Dyrbye 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.
Results Reference
background
PubMed Identifier
29924700
Citation
Eisenstein 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.
Results Reference
background
PubMed Identifier
29188543
Citation
Byhoff 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.
Results Reference
background
PubMed Identifier
27488970
Citation
Long 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.
Results Reference
background
PubMed Identifier
30227912
Citation
Gottlieb 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.
Results Reference
background
PubMed Identifier
27063997
Citation
Chetty R, Stepner M, Abraham S, Lin S, Scuderi B, Turner N, Bergeron A, Cutler D. The Association Between Income and Life Expectancy in the United States, 2001-2014. JAMA. 2016 Apr 26;315(16):1750-66. doi: 10.1001/jama.2016.4226. Erratum In: JAMA. 2017 Jan 3;317(1):90.
Results Reference
background
PubMed Identifier
28688725
Citation
Gottlieb LM, Wing H, Adler NE. A Systematic Review of Interventions on Patients' Social and Economic Needs. Am J Prev Med. 2017 Nov;53(5):719-729. doi: 10.1016/j.amepre.2017.05.011. Epub 2017 Jul 5.
Results Reference
background
PubMed Identifier
11297647
Citation
Marmot M, Shipley M, Brunner E, Hemingway H. Relative contribution of early life and adult socioeconomic factors to adult morbidity in the Whitehall II study. J Epidemiol Community Health. 2001 May;55(5):301-7. doi: 10.1136/jech.55.5.301.
Results Reference
background
PubMed Identifier
9242799
Citation
Marmot MG, Bosma H, Hemingway H, Brunner E, Stansfeld S. Contribution of job control and other risk factors to social variations in coronary heart disease incidence. Lancet. 1997 Jul 26;350(9073):235-9. doi: 10.1016/s0140-6736(97)04244-x.
Results Reference
background
PubMed Identifier
26731305
Citation
Alley DE, Asomugha CN, Conway PH, Sanghavi DM. Accountable Health Communities--Addressing Social Needs through Medicare and Medicaid. N Engl J Med. 2016 Jan 7;374(1):8-11. doi: 10.1056/NEJMp1512532. Epub 2016 Jan 5. No abstract available.
Results Reference
background
PubMed Identifier
27367226
Citation
Garg A, Boynton-Jarrett R, Dworkin PH. Avoiding the Unintended Consequences of Screening for Social Determinants of Health. JAMA. 2016 Aug 23-30;316(8):813-4. doi: 10.1001/jama.2016.9282. No abstract available.
Results Reference
background
PubMed Identifier
23619825
Citation
Garg A, Jack B, Zuckerman B. Addressing the social determinants of health within the patient-centered medical home: lessons from pediatrics. JAMA. 2013 May 15;309(19):2001-2. doi: 10.1001/jama.2013.1471. No abstract available.
Results Reference
background
PubMed Identifier
25913331
Citation
Nuruzzaman N, Broadwin M, Kourouma K, Olson DP. Making the social determinants of health a routine part of medical care. J Health Care Poor Underserved. 2015 May;26(2):321-7. doi: 10.1353/hpu.2015.0036. No abstract available.
Results Reference
background
Citation
Services USDoHaH. HealthyPeople 2020. 2017; https://http://www.healthypeople.gov/2020/topics-objectives/topic/nutrition-and-weight-status. Accessed Sept 30, 2017.
Results Reference
background
PubMed Identifier
26951584
Citation
DeVoe JE, Bazemore AW, Cottrell EK, Likumahuwa-Ackman S, Grandmont J, Spach N, Gold R. Perspectives in Primary Care: A Conceptual Framework and Path for Integrating Social Determinants of Health Into Primary Care Practice. Ann Fam Med. 2016 Mar;14(2):104-8. doi: 10.1370/afm.1903. No abstract available.
Results Reference
background
PubMed Identifier
25367545
Citation
Gottlieb L, Hessler D, Long D, Amaya A, Adler N. A randomized trial on screening for social determinants of health: the iScreen study. Pediatrics. 2014 Dec;134(6):e1611-8. doi: 10.1542/peds.2014-1439. Epub 2014 Nov 3.
Results Reference
background
PubMed Identifier
26215831
Citation
Hassan A, Scherer EA, Pikcilingis A, Krull E, McNickles L, Marmon G, Woods ER, Fleegler EW. Improving Social Determinants of Health: Effectiveness of a Web-Based Intervention. Am J Prev Med. 2015 Dec;49(6):822-31. doi: 10.1016/j.amepre.2015.04.023. Epub 2015 Jul 26.
Results Reference
background
PubMed Identifier
29685872
Citation
Wu S, Ell K, Jin H, Vidyanti I, Chou CP, Lee PJ, Gross-Schulman S, Sklaroff LM, Belson D, Nezu AM, Hay J, Wang CJ, Scheib G, Di Capua P, Hawkins C, Liu P, Ramirez M, Wu BW, Richman M, Myers C, Agustines D, Dasher R, Kopelowicz A, Allevato J, Roybal M, Ipp E, Haider U, Graham S, Mahabadi V, Guterman J. Comparative Effectiveness of a Technology-Facilitated Depression Care Management Model in Safety-Net Primary Care Patients With Type 2 Diabetes: 6-Month Outcomes of a Large Clinical Trial. J Med Internet Res. 2018 Apr 23;20(4):e147. doi: 10.2196/jmir.7692.
Results Reference
background
PubMed Identifier
27282195
Citation
Matthew-Maich N, Harris L, Ploeg J, Markle-Reid M, Valaitis R, Ibrahim S, Gafni A, Isaacs S. Designing, Implementing, and Evaluating Mobile Health Technologies for Managing Chronic Conditions in Older Adults: A Scoping Review. JMIR Mhealth Uhealth. 2016 Jun 9;4(2):e29. doi: 10.2196/mhealth.5127.
Results Reference
background
PubMed Identifier
29357313
Citation
Clark DO, Srinivas P, Bodke K, Keith N, Hood S, Tu W. Addressing people and place microenvironments in weight loss disparities (APP-Me): Design of a randomized controlled trial testing timely messages for weight loss behavior in low income Black and White Women. Contemp Clin Trials. 2018 Apr;67:74-80. doi: 10.1016/j.cct.2018.01.006. Epub 2018 Jan 31.
Results Reference
background
PubMed Identifier
27899799
Citation
Graham GN, Ostrowski M, Sabina AB. Population health-based approaches to utilizing digital technology: a strategy for equity. J Public Health Policy. 2016 Nov;37(Suppl 2):154-166. doi: 10.1057/s41271-016-0012-5.
Results Reference
background
PubMed Identifier
26951582
Citation
Kaufman A. Theory vs Practice: Should Primary Care Practice Take on Social Determinants of Health Now? Yes. Ann Fam Med. 2016 Mar;14(2):100-1. doi: 10.1370/afm.1915. No abstract available.
Results Reference
background
PubMed Identifier
27627965
Citation
Lyles CR, Altschuler A, Chawla N, Kowalski C, McQuillan D, Bayliss E, Heisler M, Grant RW. User-Centered Design of a Tablet Waiting Room Tool for Complex Patients to Prioritize Discussion Topics for Primary Care Visits. JMIR Mhealth Uhealth. 2016 Sep 14;4(3):e108. doi: 10.2196/mhealth.6187.
Results Reference
background
PubMed Identifier
26481906
Citation
Patel V, Hale TM, Palakodeti S, Kvedar JC, Jethwani K. Prescription Tablets in the Digital Age: A Cross-Sectional Study Exploring Patient and Physician Attitudes Toward the Use of Tablets for Clinic-Based Personalized Health Care Information Exchange. JMIR Res Protoc. 2015 Oct 19;4(4):e116. doi: 10.2196/resprot.3806.
Results Reference
background
PubMed Identifier
27138425
Citation
Linzer M, Poplau S, Babbott S, Collins T, Guzman-Corrales L, Menk J, Murphy ML, Ovington K. Worklife and Wellness in Academic General Internal Medicine: Results from a National Survey. J Gen Intern Med. 2016 Sep;31(9):1004-10. doi: 10.1007/s11606-016-3720-4. Epub 2016 May 2.
Results Reference
background
PubMed Identifier
29532054
Citation
Miller DP Jr, Denizard-Thompson N, Weaver KE, Case LD, Troyer JL, Spangler JG, Lawler D, Pignone MP. Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 17;168(8):550-557. doi: 10.7326/M17-2315. Epub 2018 Mar 13.
Results Reference
background
PubMed Identifier
28400354
Citation
Miller DP Jr, Weaver KE, Case LD, Babcock D, Lawler D, Denizard-Thompson N, Pignone MP, Spangler JG. Usability of a Novel Mobile Health iPad App by Vulnerable Populations. JMIR Mhealth Uhealth. 2017 Apr 11;5(4):e43. doi: 10.2196/mhealth.7268.
Results Reference
background
PubMed Identifier
21854695
Citation
Denizard-Thompson NR, Singh S, Stevens SR, Miller DP, Wofford JL. iPod technology for teaching patients about anticoagulation: a pilot study of mobile computer-assisted patient education. Prim Health Care Res Dev. 2012 Jan;13(1):42-7. doi: 10.1017/S146342361100034X. Epub 2011 Aug 22.
Results Reference
background
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Clinician Burnout and Social Determinants
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