Clinical trial NCT02955563: CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool
Official title: CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention Compliance
Usability
Acceptability
Keywords: decision making for incapacitated patients
intensive care
surrogate decision making
patient centered care
Palliative Care
End of Life
Quality of Communication
Anxiety
Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal is to develop a pragmatic, scalable intervention to overcome problems with surrogate decision making in ICUs.

The aim is to conduct a pilot study among surrogates and clinicians of 50 incapacitated patients at high risk of death to assess the feasibility of deploying the web-based tool as well as to examine the tools impact on the patient and family outcome measures summarized in the hypotheses below.

Detailed description: Roughly 600,000 Americans annually die in or shortly after an ICU admission, generally after decisions by surrogates to forego life support. Several decades of research indicate:

1. Family members in ICUs often struggle in the role of surrogate and experience high rates of lasting psychological sequelae (e.g. depression, anxiety, PTSD). For example, a systematic review found that one third of surrogates have long term feelings of guilt and doubt about the decisions they made.
2. Patients often receive treatment that is inconsistent with their values and preferences. For example, in the SUPPORT trial, physicians were frequently unaware of patients' wishes regarding end-of-life care, and patients often died receiving more invasive treatment than they preferred.
3. Intensive care near the end of life is a significant contributor to health care costs. For example, medical care in the last year of life accounts for 25% of Medicare costs, and ICU care contributes substantially.

Breakdowns in clinician-family communication in ICUs are common and an important target for interventions. Using quantitative analysis of audiorecorded goals of care discussions in ICUs, we found that in more than 50% of conversations clinicians did not inquire about the patient's values and treatment preferences, and in a similar proportion failed to explicitly offer alternatives to indefinite life-prolonging treatment, such as time-limited trials or comfort-focused treatment. We have also documented frequent omissions of important prognostic information during such conversations and other researchers have documented that surrogates often hold unduly optimistic estimates of patients' prognosis. These data highlight the importance of improving the quality of collaborative decision making in ICUs.

This proposal is responsive to national research priorities: The proposed research addresses priority areas for national action from the Institute of Medicine and NIH: improving clinician-family communication and end-of-life care for patients with advanced organ system failure. It is responsive to calls by the Institute on Aging to promote patient-centered decision making for elderly patients.

A critical barrier to addressing these problems is the absence of a scalable intervention. No empirically validated decision support tools exist for the range of critical illnesses confronted in ICUs. Prior interventions to address these problems (e.g., proactive palliative care consultation or adding a family support counselor to the ICU team) face major barriers to dissemination due to projected palliative care workforce shortages and the high cost of adding more personnel to ICU care teams.

A pragmatic, scalable intervention to overcome these problems has been developed. This pilot study among surrogates and clinicians of 50 incapacitated patients will assess the feasibility of deploying the web-based tool as well as to examine the tools impact on measures of communication and decision quality.

Eligibility criteria: Inclusion Criteria:

* Surrogate decision maker for ICU patient that lacks decisional capacity
* Permission from Patient's ICU Primary Attending Physician

Exclusion Criteria:

* Non-English Speaking
* Inability to read or write

Primary outcomes:
measure: Intervention compliance
timeFrame: Duration of ICU stay, an expected average of 4 weeks
Secondary outcomes:
measure: Participants' ratings of usability of the tool
timeFrame: Duration of hospital stay, an expected average of 4 weeks
measure: Participants' ratings of acceptability of the tool
timeFrame: Duration of hospital stay, an expected average of 4 weeks
measure: Participants' ratings of perceived usefulness of the tool
timeFrame: Duration of hospital stay, an expected average of 4 weeks
measure: Feasibility of enrolling family members in a critical care setting
timeFrame: Through study completion, estimate one year past primary start date
measure: Feasibility of retaining family members in a critical care setting in a trial
timeFrame: Three months post-discharge
Other outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Three months post-discharge
measure: Impact of Events Scale
timeFrame: Three months post-discharge
measure: Inventory of Complicated Grief
timeFrame: Three months post-discharge
measure: Quality of Communication Scale
timeFrame: Three months post-discharge
measure: Mortality
timeFrame: Three months post-discharge
measure: Functional status
timeFrame: Three months post-discharge
measure: Patient-Perceived Centeredness of Care Scale
timeFrame: Three months post-discharge
measure: Hospital costs
timeFrame: Three months post-discharge
measure: 3-month health care utilization
timeFrame: Three months post-discharge
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Douglas B White, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.
citation: Lynn J, Teno JM, Phillips RS, Wu AW, Desbiens N, Harrold J, Claessens MT, Wenger N, Kreling B, Connors AF Jr. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997 Jan 15;126(2):97-106. doi: 10.7326/0003-4819-126-2-199701150-00001.
citation: Schenker Y, Tiver GA, Hong SY, White DB. Association between physicians' beliefs and the option of comfort care for critically ill patients. Intensive Care Med. 2012 Oct;38(10):1607-15. doi: 10.1007/s00134-012-2671-4. Epub 2012 Aug 11.
citation: Schenker Y, Tiver GA, Hong SY, White DB. Discussion of treatment trials in intensive care. J Crit Care. 2013 Oct;28(5):862-9. doi: 10.1016/j.jcrc.2013.04.015. Epub 2013 Jun 13.
citation: A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.
citation: White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461.
citation: White DB, Engelberg RA, Wenrich MD, Lo B, Curtis JR. Prognostication during physician-family discussions about limiting life support in intensive care units. Crit Care Med. 2007 Feb;35(2):442-8. doi: 10.1097/01.CCM.0000254723.28270.14.
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: Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011 Mar 1;154(5):336-46. doi: 10.7326/0003-4819-154-5-201103010-00008.
citation: Riley GF, Lubitz JD. Long-term trends in Medicare payments in the last year of life. Health Serv Res. 2010 Apr;45(2):565-76. doi: 10.1111/j.1475-6773.2010.01082.x. Epub 2010 Feb 9.
citation: Hogan C, Lunney J, Gabel J, Lynn J. Medicare beneficiaries' costs of care in the last year of life. Health Aff (Millwood). 2001 Jul-Aug;20(4):188-95. doi: 10.1377/hlthaff.20.4.188.
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: Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.
citation: Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002 Apr 4;346(14):1061-6. doi: 10.1056/NEJMsa012528.
citation: Sudore RL, Fried TR. Redefining the "planning" in advance care planning: preparing for end-of-life decision making. Ann Intern Med. 2010 Aug 17;153(4):256-61. doi: 10.7326/0003-4819-153-4-201008170-00008.
citation: Hua MS, Li G, Blinderman CD, Wunsch H. Estimates of the need for palliative care consultation across united states intensive care units using a trigger-based model. Am J Respir Crit Care Med. 2014 Feb 15;189(4):428-36. doi: 10.1164/rccm.201307-1229OC.
citation: Lupu D; American Academy of Hospice and Palliative Medicine Workforce Task Force. Estimate of current hospice and palliative medicine physician workforce shortage. J Pain Symptom Manage. 2010 Dec;40(6):899-911. doi: 10.1016/j.jpainsymman.2010.07.004.
citation: O'Connor AM, Llewellyn-Thomas HA, Flood AB. Modifying unwarranted variations in health care: shared decision making using patient decision aids. Health Aff (Millwood). 2004;Suppl Variation:VAR63-72. doi: 10.1377/hlthaff.var.63.
citation: O'Connor AM, Rostom A, Fiset V, Tetroe J, Entwistle V, Llewellyn-Thomas H, Holmes-Rovner M, Barry M, Jones J. Decision aids for patients facing health treatment or screening decisions: systematic review. BMJ. 1999 Sep 18;319(7212):731-4. doi: 10.1136/bmj.319.7212.731.
citation: Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Legare F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD001431. doi: 10.1002/14651858.CD001431.pub3.