Testing a Video Decision Support Tool to Supplement Goals-of-Care Discussions
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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 |
- 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 ]
- 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 |
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| Contact: Michael Paasche-Orlow, MD MA MPH | 617-414-5877 | Michael.PaascheOrlow@bmc.org |
| 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 | |
| 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 May 21, 2013