NCT04070456

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
Last Updated

January 10, 2022

Status Verified

June 1, 2021

Enrollment Period

1.7 years

First QC Date

August 22, 2019

Last Update Submit

December 17, 2021

Conditions

Keywords

Physician Burnoutsocial determinants of healthMini-Z

Outcome Measures

Primary Outcomes (3)

  • Mini-Z Scale

    This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.

    Baseline

  • Mini-Z Scale

    This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.

    6 month post baseline

  • Mini-Z Scale

    This scales measures clinician satisfaction. Total score 10 to 45. Higher scores denotes better outcome.

    12 month post baseline

Secondary Outcomes (9)

  • The number of clinicians who report a joyful workplace

    Baseline

  • The number of clinicians who report a joyful workplace

    6 months post baseline

  • The number of clinicians who report a joyful workplace

    12 months post baseline

  • The number of clinicians who report a supportive practice

    Baseline

  • The number of clinicians who report a supportive practice

    6 months post baseline

  • +4 more secondary outcomes

Study Arms (2)

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.

Other: Tablet-based SDH tool

Control sites

NO INTERVENTION

Care as usual, no tablet-based SDH tool.

Interventions

A tablet-based SDH tool, which integrates responses into the EpicCare electronic health record (EHR).

Intervention sites-Tablet-based SDH tool

Eligibility Criteria

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

You may qualify if:

  • All clinicians and primary care teams at participating sites will be eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wake Forest Downtown Health Plaza (DHP)

Winston-Salem, North Carolina, 27101, United States

Location

Family Medicine-Piedmont Plaza

Winston-Salem, North Carolina, 27104, United States

Location

Internal Medicine-Janeway Tower

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (38)

  • 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.

    PMID: 22911330BACKGROUND
  • 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.

    PMID: 26653297BACKGROUND
  • 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.

    PMID: 27871627BACKGROUND
  • C M, S J, M L. Maslach Burnout Inventory Manual. Consulting Psychologist Press. 1996;3rd edition.

    BACKGROUND
  • 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.

    PMID: 21242446BACKGROUND
  • 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.

    PMID: 19934755BACKGROUND
  • 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.

    PMID: 24470006BACKGROUND
  • 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
  • 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.

    PMID: 27814840BACKGROUND
  • 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.

    PMID: 27046522BACKGROUND
  • 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.

    PMID: 28418518BACKGROUND
  • 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.

    PMID: 29924700BACKGROUND
  • 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.

    PMID: 29188543BACKGROUND
  • 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.

    PMID: 27488970BACKGROUND
  • 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.

    PMID: 30227912BACKGROUND
  • 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.

    PMID: 27063997BACKGROUND
  • 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.

    PMID: 28688725BACKGROUND
  • 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.

    PMID: 11297647BACKGROUND
  • 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.

    PMID: 9242799BACKGROUND
  • 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.

    PMID: 26731305BACKGROUND
  • 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.

    PMID: 27367226BACKGROUND
  • 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.

    PMID: 23619825BACKGROUND
  • 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.

    PMID: 25913331BACKGROUND
  • Services USDoHaH. HealthyPeople 2020. 2017; https://http://www.healthypeople.gov/2020/topics-objectives/topic/nutrition-and-weight-status. Accessed Sept 30, 2017.

    BACKGROUND
  • 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.

    PMID: 26951584BACKGROUND
  • 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.

    PMID: 25367545BACKGROUND
  • 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.

    PMID: 26215831BACKGROUND
  • 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.

    PMID: 29685872BACKGROUND
  • 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.

    PMID: 27282195BACKGROUND
  • 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.

    PMID: 29357313BACKGROUND
  • 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.

    PMID: 27899799BACKGROUND
  • 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.

    PMID: 26951582BACKGROUND
  • 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.

    PMID: 27627965BACKGROUND
  • 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.

    PMID: 26481906BACKGROUND
  • 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.

    PMID: 27138425BACKGROUND
  • 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.

    PMID: 29532054BACKGROUND
  • 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.

    PMID: 28400354BACKGROUND
  • 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.

    PMID: 21854695BACKGROUND

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Deepak Palakshappa, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

November 18, 2019

Primary Completion

July 31, 2021

Study Completion

October 29, 2021

Last Updated

January 10, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deindentification

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Immediately following publication, no end date
Access Criteria
Researchers who provide a methodologically sound proposal

Locations