CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool

NCT02955563 | Completed

• 1 other identifier: PRO16050247
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Intervention compliance

  Data tracking analytics will be employed to determine the extent to which the tool is used as per protocol.

  Duration of ICU stay, an expected average of 4 weeks

Secondary Outcomes (5)

• Participants' ratings of usability of the tool

  Duration of hospital stay, an expected average of 4 weeks

• Participants' ratings of acceptability of the tool

  Duration of hospital stay, an expected average of 4 weeks

• Participants' ratings of perceived usefulness of the tool

  Duration of hospital stay, an expected average of 4 weeks

• Feasibility of enrolling family members in a critical care setting

  Through study completion, estimate one year past primary start date

• Feasibility of retaining family members in a critical care setting in a trial

  Three months post-discharge

Other Outcomes (9)

• Hospital Anxiety and Depression Scale

  Three months post-discharge

• Impact of Events Scale

  Three months post-discharge

• Inventory of Complicated Grief

  Three months post-discharge

Study Arms (2)

CSDM Tool

EXPERIMENTAL

Surrogate will complete educational sessions on CSDM tool prior to each family meeting with clinical team.

Other: CSDM Web-Based Tool Intervention

Control

NO INTERVENTION

Surrogates will receive augmented usual care. The augmentation is that there will be 2 family meetings scheduled during the first 10 days of enrollment.

Interventions

CSDM Web-Based Tool Intervention OTHER

The web and tablet-based tool is designed to help family members become familiar with ICU environment, routines, and clinicians, prepare for family meetings, and learn how to make values-based decisions for their loved one. The tool contains short videos, interactive exercises, and links to other resources. Family members work through the tool shortly after admission to the ICU, before each family meeting, and any other time they wish to during the ICU admission.

CSDM Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English Speaking
• Inability to read or write

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15216, United States

Location

Related Publications (20)

• 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.

  PMID: 10966293 BACKGROUND

• 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.

  PMID: 9005760 BACKGROUND

• 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.

  PMID: 22885651 BACKGROUND

• 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.

  PMID: 23768446 BACKGROUND

• 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.

  PMID: 7474243 BACKGROUND

• 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.

  PMID: 17353493 BACKGROUND

• 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.

  PMID: 17205000 BACKGROUND

• 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.

  PMID: 15665319 BACKGROUND

• 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.

  PMID: 21357911 BACKGROUND

• 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.

  PMID: 20148984 BACKGROUND

• 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.

  PMID: 11463076 BACKGROUND

• 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.

  PMID: 15090940 BACKGROUND

• 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.

  PMID: 9769276 BACKGROUND

• 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.

  PMID: 11932474 BACKGROUND

• 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.

  PMID: 20713793 BACKGROUND

• 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.

  PMID: 24261961 BACKGROUND

• 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.

  PMID: 21145468 BACKGROUND

• 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.

  PMID: 15471770 BACKGROUND

• 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.

  PMID: 10487995 BACKGROUND

• 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.

  PMID: 21975733 BACKGROUND

MeSH Terms

Conditions

Death; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Douglas B White, MD, MAS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair and Professor of Critical Care Medicine

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: May 1, 2017
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)