NCT01589107

Brief Summary

To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

April 28, 2012

Last Update Submit

November 16, 2020

Conditions

SurgeryTrauma

Outcome Measures

Primary Outcomes (1)

  • knowledge of risks and benefits of procedures

    knowledge of risks and benefits of procedures

    5 minutes after survey

Study Arms (2)

control group

NO INTERVENTION

usual care

Video Arm

EXPERIMENTAL
Behavioral: video decision aid

Interventions

video decision aidBEHAVIORAL

video decision aid

Video Arm

Eligibility Criteria

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

You may qualify if:

  • Clinical surrogates of the following patients will be eligible to participate in this opinion survey:
  • All patients admitted to the SICU and not expected to die within 48 hours.
  • Patient has been admitted to the acute care surgical service,
  • The patient is over the age of 50 and does not have decision making capacity.
  • Subjects must be over the age of 21 and English speaking to participate in the opinion survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Angelo Volandes

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 28, 2012

First Posted

May 1, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

US(1)