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

February 22, 2016 updated by: Michael Paasche-Orlow, Boston Medical Center

Testing a Video Decision Support Tool to Supplement Goals-of-Care Discussions With Patients and Surrogates Receiving an Inpatient Palliative Care Consult

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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.
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.
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.
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.
Time Frame: Measured at 7-14 days, 2-3 months or 5-6 months post-discharge.
Measured at 7-14 days, 2-3 months or 5-6 months post-discharge.
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.
Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • H29666

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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