NCT01776333

Brief Summary

Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

January 22, 2013

Last Update Submit

November 16, 2020

Conditions

Respiratory FailureCardiac Event

Keywords

ICU

Outcome Measures

Primary Outcomes (1)

  • preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.)

    at baseline admission to the ICU during family meeting up to one week

Secondary Outcomes (4)

  • level of medical care delivered to patient at time of death or discharge from the ICU

    at time of death or discharge from the ICU up to one week

  • anxiety and depression

    anxiety and depression at follow up phone call at 3 months after ICU death or discharge

  • satisfaction with ICU experience

    after 3 months from time of death or discharge from ICU

  • number of medical interventions during ICU stay

    during time period in the ICU up to one week

Study Arms (2)

usual care

NO INTERVENTION

video arm

EXPERIMENTAL

video decision aid intervention

Behavioral: video decision aid

Interventions

video decision aidBEHAVIORAL
video arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge

You may not qualify if:

  • \- Patients who are imminently dying and admitted to the ICU are excluded Wards if the state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedars Sinai Medical Center

Los Angeles, California, United States

Location

BMC

Boston, Massachusetts, United States

Location

MGH

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Respiratory InsufficiencyCardiovascular Diseases

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Angelo Volandes

    MGH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelo Volandes

CONTACT

617 726 2000avolandes@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 28, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

US(3)