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Randomized Controlled Trial
. 2020 Mar 2;3(3):e201742.
doi: 10.1001/jamanetworkopen.2020.1742.

Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial

Scott D Halpern  1   2   3   4   5 , Dylan S Small  1   2   6 , Andrea B Troxel  2   7   8 , Elizabeth Cooney  1 , Brian Bayes  1 , Marzana Chowdhury  1   3 , Heather E Tomko  9 , Derek C Angus  10   11   12 , Robert M Arnold  13   14   15   16 , George Loewenstein  2   17 , Kevin G Volpp  1   2   3   4   18 , Douglas B White  10   15   19 , Cindy L Bryce  9   12
Affiliations
Randomized Controlled Trial

Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial

Scott D Halpern et al. JAMA Netw Open. .

Abstract

Importance: There is limited evidence regarding how patients make choices in advance directives (ADs) or whether these choices influence subsequent care.

Objective: To examine whether default options in ADs influence care choices and clinical outcomes.

Design, setting, and participants: This randomized clinical trial included 515 patients who met criteria for having serious illness and agreed to participate. Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months. Data analysis was conducted from November 2018 to April 2019.

Interventions: Patients were randomly assigned to complete 1 of the 3 following ADs: (1) a comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD).

Main outcomes and measures: This trial was powered to rule out a reduction in hospital-free days in the intervention groups. Secondary outcomes included choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care.

Results: Among 515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer). Of these, 264 (53.7%) returned legally valid ADs and were debriefed about their assigned intervention. Among these, patients completing comfort ADs were more likely to choose comfort care (54 of 85 [63.5%]) than those returning standard ADs (45 of 91 [49.5%]) or life-extending ADs (33 of 88 [37.5%]) (P = .001). Among 492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the life-extending AD chose comfort care (P = .02), with patients not returning ADs coded as not selecting comfort care. In mITT analyses, median (interquartile range) hospital-free days among 168 patients assigned to comfort ADs and 159 patients assigned to life-extending default ADs were each noninferior to those among 165 patients assigned to standard ADs (standard AD: 486 [306-717] days; comfort AD: 554 [296-833] days; rate ratio, 1.05; 95% CI, 0.90-1.23; P < .001; life-extending AD: 550 [325-783] days; rate ratio, 1.03; 95% CI, 0.88-1.20; P < .001). There were no differences among groups in other secondary outcomes.

Conclusions and relevance: In this randomized clinical trial, default options in ADs altered the choices seriously ill patients made regarding their future care without changing clinical outcomes.

Trial registration: ClinicalTrials.gov Identifier: NCT02017548.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Angus reported receiving personal fees from Bristol-Myers Squibb, Bayer, and Ferring Pharmaceuticals outside the submitted work; owning stock in Alung Technologies outside the submitted work; and having a patent to Selepressin compounds, compositions, and methods for treating sepsis pending and to Proteomic biomarkers of sepsis in elderly patients pending. Dr Arnold reported receiving personal fees from UpToDate outside the submitted work and being the founder of VitalTalk. Dr Volpp reported receiving grants from the National Institutes of Health and the Otto Haas Foundation during the conduct of the study; receiving grants from Oscar, Vitality/Discovery, Humana, Hawaii Medical Services Association, and Weight Watchers; receiving personal fees from the Center for Corporate Innovation; and receiving personal fees and being the part owner of VAL Health outside the submitted work. Dr White reported receiving grants from the National Institutes of Health during the conduct of the study and receiving personal fees from UpToDate and the American Journal of Respiratory and Critical Care Medicine outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient FlowDiagram
AD indicates advance directive. a P for AD completion and debriefing by treatment group = .62
Figure 2.
Figure 2.. Selected Goals of Care Chosen
A, The first panel plots the proportions of the 492 patients in the modified intention-to-treat analysis who chose comfort-oriented care, life-extending care, and choices not to specify a preference. The 228 patients who did not complete an advance directive (AD) and/or were not debriefed are coded as incomplete. B, The second panel plots the same proportions among the 264 patients with completed ADs who were also debriefed.
Figure 3.
Figure 3.. Hospital-Free Days
This figure plots hospital-free days among the 492 patients in the modified intention-to-treat sample across the 3 intervention arms. The horizontal line represents the median; the height of the box, the interquartile range; and the vertical lines, the range.
See this image and copyright information in PMC

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References

    1. Halpern SD. Shaping end-of-life care: behavioral economics and advance directives. Semin Respir Crit Care Med. 2012;33(4):393–400. doi:10.1055/s-0032-1322403 - DOI - PubMed
    1. White DB, Arnold RM. The evolution of advance directives. JAMA. 2011;306(13):1485–1486. doi:10.1001/jama.2011.1430 - DOI - PubMed
    1. Fields MJ, Cassel CK. Approaching Death, Improving Care at the End of Life. National Academies Press; 1997. - PubMed
    1. Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002;346(14):1061–1066. doi:10.1056/NEJMsa012528 - DOI - PubMed
    1. Emanuel LL, Emanuel EJ. The medical directive: a new comprehensive advance care document. JAMA. 1989; 261(22):3288–3293. doi:10.1001/jama.1989.03420220102036 - DOI - PubMed

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