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

Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01391429
Collaborator
(none)
37
1
2
18
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Video Decision Support Tool
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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.]

  2. 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.]

  3. 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.]

  4. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Boston Medical Center Boston Massachusetts United States 02118

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Michael Paasche-Orlow, BMC Attending Physician, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01391429
Other Study ID Numbers:
  • H29666
First Posted:
Jul 12, 2011
Last Update Posted:
Feb 23, 2016
Last Verified:
Feb 1, 2016

Study Results

No Results Posted as of Feb 23, 2016