Clinical trial NCT04239209: Effect of Intensivist Communication on Surrogate Prognosis Interpretation
Official title: The Effect of Intensivist Communication on Prognosis Interpretation by Family Members of Patients at High Risk for Intensive Care Unit Admission: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Gordon and Betty Moore Foundation
First posted: 2020-01-27
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized in a 1:1:1:1 ratio to view a video depicting one of four different ways intensivists answered a patient surrogate's prognostic question "What do you think is most likely to happen?" during a simulated ICU family meeting.
Primary purpose: OTHER

Brief summary: This study evaluates the effect of physician communication styles on the interpretation of prognosis by family members of chronically-ill patients. Participants were randomized to view one of four videos how depicting different physicians disclose prognosis when physicians expect an ICU patient to die.

Detailed description: Intensivist-surrogate discordance about prognosis is common in the intensive care unit. Minimizing discordance and empowering families to make informed decisions about participants' loved one's care is important, but it is unclear how best to communicate prognostic information to vulnerable surrogates when a patient is expected to die. Participants are randomized to view one of 4 intensivist communication styles in response to the question "What do you think is most likely to happen?": 1) a direct response (control), 2) an indirect response comparing the patient's condition to other patients, 3) an indirect response describing physiology, or 4) redirection to a discussion of patient values and goals.

The participant will then be asked a series of questions to measure participants' interpretation of what the intensivist says.

Eligibility criteria: Inclusion Criteria:

* spouse/partner, sibling, or adult child of a patient with Chronic Obstructive Pulmonary Disease (COPD) on home oxygen
* over age 18

Exclusion Criteria:

* ever working in healthcare as a nurse, advanced practice provider, or physician

Primary outcomes:
measure: Participant perception of the intensivist's prognostic estimate.
timeFrame: approximately 5 minutes
Secondary outcomes:
measure: Participant prognostic estimate.
timeFrame: approximately 5 minutes
measure: Participant difference in belief about prognosis.
timeFrame: approximately 5 minutes
Other outcomes:
measure: Participant confidence that they understood the intensivist's belief about prognosis.
timeFrame: approximately 5 minutes
measure: Participant confidence in their own prognostic estimate.
timeFrame: approximately 5 minutes
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Alison E Turnbull, DVM MPH PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fischer S, Min SJ, Cervantes L, Kutner J. Where do you want to spend your last days of life? Low concordance between preferred and actual site of death among hospitalized adults. J Hosp Med. 2013 Apr;8(4):178-83. doi: 10.1002/jhm.2018. Epub 2013 Feb 25.
citation: Barnato AE, Herndon MB, Anthony DL, Gallagher PM, Skinner JS, Bynum JP, Fisher ES. Are regional variations in end-of-life care intensity explained by patient preferences?: A Study of the US Medicare Population. Med Care. 2007 May;45(5):386-93. doi: 10.1097/01.mlr.0000255248.79308.41.
citation: Auriemma CL, Nguyen CA, Bronheim R, Kent S, Nadiger S, Pardo D, Halpern SD. Stability of end-of-life preferences: a systematic review of the evidence. JAMA Intern Med. 2014 Jul;174(7):1085-92. doi: 10.1001/jamainternmed.2014.1183.
citation: Needham DM, Bronskill SE, Calinawan JR, Sibbald WJ, Pronovost PJ, Laupacis A. Projected incidence of mechanical ventilation in Ontario to 2026: Preparing for the aging baby boomers. Crit Care Med. 2005 Mar;33(3):574-9. doi: 10.1097/01.ccm.0000155992.21174.31.
citation: Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.
citation: Teno JM, Gozalo P, Trivedi AN, Bunker J, Lima J, Ogarek J, Mor V. Site of Death, Place of Care, and Health Care Transitions Among US Medicare Beneficiaries, 2000-2015. JAMA. 2018 Jul 17;320(3):264-271. doi: 10.1001/jama.2018.8981.
citation: Teno JM, Gozalo P, Khandelwal N, Curtis JR, Meltzer D, Engelberg R, Mor V. Association of Increasing Use of Mechanical Ventilation Among Nursing Home Residents With Advanced Dementia and Intensive Care Unit Beds. JAMA Intern Med. 2016 Dec 1;176(12):1809-1816. doi: 10.1001/jamainternmed.2016.5964.
citation: Wunsch H, Linde-Zwirble WT, Harrison DA, Barnato AE, Rowan KM, Angus DC. Use of intensive care services during terminal hospitalizations in England and the United States. Am J Respir Crit Care Med. 2009 Nov 1;180(9):875-80. doi: 10.1164/rccm.200902-0201OC. Epub 2009 Aug 27.
citation: Bekelman JE, Halpern SD, Blankart CR, Bynum JP, Cohen J, Fowler R, Kaasa S, Kwietniewski L, Melberg HO, Onwuteaka-Philipsen B, Oosterveld-Vlug M, Pring A, Schreyogg J, Ulrich CM, Verne J, Wunsch H, Emanuel EJ; International Consortium for End-of-Life Research (ICELR). Comparison of Site of Death, Health Care Utilization, and Hospital Expenditures for Patients Dying With Cancer in 7 Developed Countries. JAMA. 2016 Jan 19;315(3):272-83. doi: 10.1001/jama.2015.18603.
citation: Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010 Oct 10;28(29):4457-64. doi: 10.1200/JCO.2009.26.3863. Epub 2010 Sep 13.
citation: Halpern SD, Becker D, Curtis JR, Fowler R, Hyzy R, Kaplan LJ, Rawat N, Sessler CN, Wunsch H, Kahn JM; Choosing Wisely Taskforce; American Thoracic Society; American Association of Critical-Care Nurses; Society of Critical Care Medicine. An official American Thoracic Society/American Association of Critical-Care Nurses/American College of Chest Physicians/Society of Critical Care Medicine policy statement: the Choosing Wisely(R) Top 5 list in Critical Care Medicine. Am J Respir Crit Care Med. 2014 Oct 1;190(7):818-26. doi: 10.1164/rccm.201407-1317ST.
citation: Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010 Apr 1;362(13):1211-8. doi: 10.1056/NEJMsa0907901.
citation: Turnbull AE, Hartog CS. Goal-concordant care in the ICU: a conceptual framework for future research. Intensive Care Med. 2017 Dec;43(12):1847-1849. doi: 10.1007/s00134-017-4873-2. Epub 2017 Jun 27. No abstract available.
citation: Committee on Approaching Death: Addressing Key End of Life Issues; Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. Washington (DC): National Academies Press (US); 2015 Mar 19. Available from http://www.ncbi.nlm.nih.gov/books/NBK285681/
citation: Lee Char SJ, Evans LR, Malvar GL, White DB. A randomized trial of two methods to disclose prognosis to surrogate decision makers in intensive care units. Am J Respir Crit Care Med. 2010 Oct 1;182(7):905-9. doi: 10.1164/rccm.201002-0262OC. Epub 2010 Jun 10.
citation: Barnato AE, Arnold RM. The effect of emotion and physician communication behaviors on surrogates' life-sustaining treatment decisions: a randomized simulation experiment. Crit Care Med. 2013 Jul;41(7):1686-91. doi: 10.1097/CCM.0b013e31828a233d.
citation: White DB, Ernecoff N, Buddadhumaruk P, Hong S, Weissfeld L, Curtis JR, Luce JM, Lo B. Prevalence of and Factors Related to Discordance About Prognosis Between Physicians and Surrogate Decision Makers of Critically Ill Patients. JAMA. 2016 May 17;315(19):2086-94. doi: 10.1001/jama.2016.5351.
citation: Fried TR, Bradley EH, O'Leary J. Prognosis communication in serious illness: perceptions of older patients, caregivers, and clinicians. J Am Geriatr Soc. 2003 Oct;51(10):1398-403. doi: 10.1046/j.1532-5415.2003.51457.x.
citation: Chiarchiaro J, Buddadhumaruk P, Arnold RM, White DB. Quality of communication in the ICU and surrogate's understanding of prognosis. Crit Care Med. 2015 Mar;43(3):542-8. doi: 10.1097/CCM.0000000000000719.
citation: Boyd EA, Lo B, Evans LR, Malvar G, Apatira L, Luce JM, White DB. "It's not just what the doctor tells me:" factors that influence surrogate decision-makers' perceptions of prognosis. Crit Care Med. 2010 May;38(5):1270-5. doi: 10.1097/CCM.0b013e3181d8a217.
citation: Verceles AC, Corwin DS, Afshar M, Friedman EB, McCurdy MT, Shanholtz C, Oakjones K, Zubrow MT, Titus J, Netzer G. Half of the family members of critically ill patients experience excessive daytime sleepiness. Intensive Care Med. 2014 Aug;40(8):1124-31. doi: 10.1007/s00134-014-3347-z. Epub 2014 Jun 5.
citation: Glick DR, Motta M, Wiegand DL, Range P, Reed RM, Verceles AC, Shah NG, Netzer G. Anticipatory grief and impaired problem solving among surrogate decision makers of critically ill patients: A cross-sectional study. Intensive Crit Care Nurs. 2018 Dec;49:1-5. doi: 10.1016/j.iccn.2018.07.006. Epub 2018 Jul 26.
citation: Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med. 2001 Oct;29(10):1893-7. doi: 10.1097/00003246-200110000-00007.
citation: Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
citation: Paulus MP, Yu AJ. Emotion and decision-making: affect-driven belief systems in anxiety and depression. Trends Cogn Sci. 2012 Sep;16(9):476-83. doi: 10.1016/j.tics.2012.07.009. Epub 2012 Aug 13.
citation: Turnbull AE, Hashem MD, Rabiee A, To A, Chessare CM, Needham DM. Evaluation of a strategy for enrolling the families of critically ill patients in research using limited human resources. PLoS One. 2017 May 25;12(5):e0177741. doi: 10.1371/journal.pone.0177741. eCollection 2017.
citation: Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Gunther A, Witte OW, Reinhart K, Hartog CS. Family satisfaction in the intensive care unit: a quantitative and qualitative analysis. Intensive Care Med. 2013 Jun;39(6):1071-9. doi: 10.1007/s00134-013-2862-7. Epub 2013 Feb 16.
citation: Bein T, Hackner K, Zou T, Schultes S, Bosch T, Schlitt HJ, Graf BM, Olden M, Leitzmann M. Socioeconomic status, severity of disease and level of family members' care in adult surgical intensive care patients: the prospective ECSSTASI study. Intensive Care Med. 2012 Apr;38(4):612-9. doi: 10.1007/s00134-012-2463-x. Epub 2012 Jan 25.
citation: Bahadori K, FitzGerald JM. Risk factors of hospitalization and readmission of patients with COPD exacerbation--systematic review. Int J Chron Obstruct Pulmon Dis. 2007;2(3):241-51.
citation: Turnbull AE, Krall JR, Ruhl AP, Curtis JR, Halpern SD, Lau BM, Needham DM. A scenario-based, randomized trial of patient values and functional prognosis on intensivist intent to discuss withdrawing life support. Crit Care Med. 2014 Jun;42(6):1455-62. doi: 10.1097/CCM.0000000000000227.
citation: Turnbull AE, Hayes MM, Brower RG, Colantuoni E, Basyal PS, White DB, Curtis JR, Needham DM. Effect of Documenting Prognosis on the Information Provided to ICU Proxies: A Randomized Trial. Crit Care Med. 2019 Jun;47(6):757-764. doi: 10.1097/CCM.0000000000003731.
citation: Oppenheim IM, Lee EM, Vasher ST, Zaeh SE, Hart JL, Turnbull AE. Effect of Intensivist Communication in a Simulated Setting on Interpretation of Prognosis Among Family Members of Patients at High Risk of Intensive Care Unit Admission: A Randomized Trial. JAMA Netw Open. 2020 Apr 1;3(4):e201945. doi: 10.1001/jamanetworkopen.2020.1945.