Testing a Video Decision Support Tool to Supplement Goals-of-Care Discussions

NCT ID: NCT01391429

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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The investigators research will be conducted as a non-randomized, temporal intervention study. The specific aim of the study is 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 first seven months of the study, or until 25 patient subjects are recruited, will be the observational phase. All participants recruited will receive the usual standard of care provided by an inpatient palliative care service. Using a battery of surveys, data will be collected regarding treatment preferences near the end of life, level of certainty with decision making, pain and symptom management, resource utilization and whether patient subjects die in accordance with their stated preferences. Once the observational phase is complete, the intervention phase of the study will begin. Over the following seven months, or until 25 patient subjects are recruited, all participants will view a six-minute digital video outlining different options for care near the end of life. The same endpoints will then be followed. In addition to the primary analysis involving patient-proxy dyads, an additional exploratory analysis will be performed. This analysis will involve surveying additional medical staff including attendings, residents, interns and nurses regarding their perceptions of patients' symptoms at the time of the palliative care consult. This data will be used to measure concordance between patient subjects' and staffs' ranking of symptoms.

Conditions

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Advance Care Planning Palliative Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Video decision support tool

Video decision support tool for goals-of-care options

Group Type EXPERIMENTAL

Video Decision Support Tool

Intervention Type BEHAVIORAL

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

Verbal description

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Video Decision Support Tool

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Paasche-Orlow

BMC Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Paasche-Orlow, MD MA MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University

Angelo Volandes, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Nicole LaRue, MD

Role: STUDY_DIRECTOR

Boston University

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7677304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2000111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7474243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9214246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10809474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8410396 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7860277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9735081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19477893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19675323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19949010 (View on PubMed)

Other Identifiers

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H29666

Identifier Type: -

Identifier Source: org_study_id

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