NCT01391429

Brief Summary

Subject preferences for care at the end-of-life show wide variability. In the setting of advanced disease, some subjects prefer all life-sustaining care while others forgo such procedures. The wide variability in preferences may be due to subjects' misconception of the disease condition when using solely verbal descriptions. The failure to participate in effective goals-of-care discussions may lead to overuse of medical interventions and life-sustaining measures that are inconsistent with patients' and families' wishes. Using video images -- in addition to words -- to convey goals-of-care options at end-of-life, adds a sense of verisimilitude to the condition described and may better inform subjects when making their preferences. Specific Aim: To assess the effect of a video decision support tool on preferences for end-of-life care in patients and surrogate decision makers consulted on by an inpatient palliative care service. The investigators hypothesize that those subjects who view video images as a supplement to a standard palliative care consult will be more likely to opt for comfort oriented care. In this study, patient subjects and/or their healthcare proxies who are consulted on by an inpatient palliative care team will be surveyed regarding their preferences for end-of-life care following either a standard palliative care consult or one which utilizes a short video to complement verbal descriptions. The primary analysis will involve the proportion of patient subjects/proxies in each group that prefer comfort oriented care and that die in accordance with their stated preferences. The investigators will also study the effect of the video on patient subjects' and/or proxies' uncertainty with regard to treatment preferences and overall satisfaction with the palliative care consult.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

June 21, 2011

Last Update Submit

February 22, 2016

Conditions

Advance Care PlanningPalliative Care

Outcome Measures

Primary Outcomes (1)

  • The difference in proportions of patient subjects/proxies in each group (observation vs video phase) who prefer comfort oriented care and who die in accordance with their stated preferences.

    Measured on average within 48 hours of the palliative care service's referral of the subject to the research team, as well as 7-14 days, 2-3 months and 5-6 months post-discharge.

Secondary Outcomes (4)

  • The level of uncertainty regarding treatment preferences.

    Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.

  • Satisfaction with pain control and symptom management.

    Measured on average within 48 hours of the palliative care service's referral of the subject to the research team, as well as 7-14 days, 2-3 months and 5-6 months post-discharge.

  • Healthcare proxy satisfaction with end-of-life care following subjects' death.

    Measured at 7-14 days, 2-3 months or 5-6 months post-discharge.

  • Concordance between patient subjects' and staffs' ranking of symptoms.

    Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.

Study Arms (2)

Video decision support tool

EXPERIMENTAL

Video decision support tool for goals-of-care options

Behavioral: Video Decision Support Tool

Verbal description

NO INTERVENTION

Standard verbal description of goals-of-care options provided by an inpatient palliative care team

Interventions

Video Decision Support ToolBEHAVIORAL

Six minute digital video illustrating specific treatments for three different levels of medical care: life-prolonging care, basic care and comfort oriented care.

Video decision support tool

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients and their healthcare proxies consulted on by an inpatient palliative care team.
  • English-speaking
  • Potential patient subjects and/or their healthcare proxies must have the ability to provide informed consent.
  • Must be members of the palliative care or primary medical team

You may not qualify if:

  • Potential patient subjects who are identified by the palliative care team as not being appropriate for a goals-of-care discussion will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (11)

  • Gillick MR. A broader role for advance medical planning. Ann Intern Med. 1995 Oct 15;123(8):621-4. doi: 10.7326/0003-4819-123-8-199510150-00009.

    PMID: 7677304BACKGROUND

  • Emanuel LL, Barry MJ, Stoeckle JD, Ettelson LM, Emanuel EJ. Advance directives for medical care--a case for greater use. N Engl J Med. 1991 Mar 28;324(13):889-95. doi: 10.1056/NEJM199103283241305.

    PMID: 2000111BACKGROUND

  • 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: 7474243BACKGROUND

  • Hofmann JC, Wenger NS, Davis RB, Teno J, Connors AF Jr, Desbiens N, Lynn J, Phillips RS. Patient preferences for communication with physicians about end-of-life decisions. SUPPORT Investigators. Study to Understand Prognoses and Preference for Outcomes and Risks of Treatment. Ann Intern Med. 1997 Jul 1;127(1):1-12. doi: 10.7326/0003-4819-127-1-199707010-00001.

    PMID: 9214246BACKGROUND

  • Covinsky KE, Fuller JD, Yaffe K, Johnston CB, Hamel MB, Lynn J, Teno JM, Phillips RS. Communication and decision-making in seriously ill patients: findings of the SUPPORT project. The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. J Am Geriatr Soc. 2000 May;48(S1):S187-93. doi: 10.1111/j.1532-5415.2000.tb03131.x.

    PMID: 10809474BACKGROUND

  • Garrett JM, Harris RP, Norburn JK, Patrick DL, Danis M. Life-sustaining treatments during terminal illness: who wants what? J Gen Intern Med. 1993 Jul;8(7):361-8. doi: 10.1007/BF02600073.

    PMID: 8410396BACKGROUND

  • Forrow L. The green eggs and ham phenomena. Hastings Cent Rep. 1994 Nov-Dec;24(6):S29-32. No abstract available.

    PMID: 7860277BACKGROUND

  • Tulsky JA, Fischer GS, Rose MR, Arnold RM. Opening the black box: how do physicians communicate about advance directives? Ann Intern Med. 1998 Sep 15;129(6):441-9. doi: 10.7326/0003-4819-129-6-199809150-00003.

    PMID: 9735081BACKGROUND

  • Volandes AE, Paasche-Orlow MK, Barry MJ, Gillick MR, Minaker KL, Chang Y, Cook EF, Abbo ED, El-Jawahri A, Mitchell SL. Video decision support tool for advance care planning in dementia: randomised controlled trial. BMJ. 2009 May 28;338:b2159. doi: 10.1136/bmj.b2159.

    PMID: 19477893BACKGROUND

  • Volandes AE, Barry MJ, Chang Y, Paasche-Orlow MK. Improving decision making at the end of life with video images. Med Decis Making. 2010 Jan-Feb;30(1):29-34. doi: 10.1177/0272989X09341587. Epub 2009 Aug 12.

    PMID: 19675323BACKGROUND

  • El-Jawahri A, Podgurski LM, Eichler AF, Plotkin SR, Temel JS, Mitchell SL, Chang Y, Barry MJ, Volandes AE. Use of video to facilitate end-of-life discussions with patients with cancer: a randomized controlled trial. J Clin Oncol. 2010 Jan 10;28(2):305-10. doi: 10.1200/JCO.2009.24.7502. Epub 2009 Nov 30.

    PMID: 19949010BACKGROUND

Study Officials

  • Michael Paasche-Orlow, MD MA MPH

    Boston University

    PRINCIPAL INVESTIGATOR

  • Angelo Volandes, MD MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Nicole LaRue, MD

    Boston University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMC Attending Physician

Study Record Dates

First Submitted

June 21, 2011

First Posted

July 12, 2011

Study Start

October 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(1)