Clinical trial NCT01391429: Testing a Video Decision Support Tool to Supplement Goals-of-Care Discussions
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Palliative Care
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: The level of uncertainty regarding treatment preferences.
timeFrame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.
measure: Satisfaction with pain control and symptom management.
timeFrame: 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.
measure: Healthcare proxy satisfaction with end-of-life care following subjects' death.
timeFrame: Measured at 7-14 days, 2-3 months or 5-6 months post-discharge.
measure: Concordance between patient subjects' and staffs' ranking of symptoms.
timeFrame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michael Paasche-Orlow, MD MA MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Angelo Volandes, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Nicole LaRue, MD
role: STUDY_DIRECTOR
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