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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Boston Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01391429
First received: June 21, 2011
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Advance Care Planning
Palliative Care
Behavioral: Video Decision Support Tool

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Testing a Video Decision Support Tool to Supplement Goals-of-Care Discussions With Patients and Surrogates Receiving an Inpatient Palliative Care Consult

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The level of uncertainty regarding treatment preferences. [ Time Frame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team. ] [ Designated as safety issue: No ]
  • Satisfaction with pain control and symptom management. [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Healthcare proxy satisfaction with end-of-life care following subjects' death. [ Time Frame: Measured at 7-14 days, 2-3 months or 5-6 months post-discharge. ] [ Designated as safety issue: No ]
  • Concordance between patient subjects' and staffs' ranking of symptoms. [ Time Frame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Video decision support tool
Video decision support tool for goals-of-care options
Behavioral: 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.
No Intervention: Verbal description
Standard verbal description of goals-of-care options provided by an inpatient palliative care team

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria-patient subjects/proxies:

  • 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.

Inclusion Criteria-staff subjects:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391429

Contacts
Contact: Michael Paasche-Orlow, MD MA MPH 617-414-5877 Michael.PaascheOrlow@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Michael Paasche-Orlow, MD MA MPH    617-414-5877    Michael.PaascheOrlow@bmc.org   
Sub-Investigator: Nicole M LaRue, MD         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Michael Paasche-Orlow, MD MA MPH Boston University
Principal Investigator: Angelo Volandes, MD MPH Massachusetts General Hospital
Study Director: Nicole LaRue, MD Boston University
  More Information

Publications:

Responsible Party: Michael Paasche-Orlow/Principal Investigator, Boston University Medical Center
ClinicalTrials.gov Identifier: NCT01391429     History of Changes
Other Study ID Numbers: H29666
Study First Received: June 21, 2011
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014