NCT01527331

Brief Summary

The purpose of this study is to compare the decision making of hospitalized subjects with advanced cancer having a verbal discussion about CPR compared to subjects using a video.

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

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

June 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

January 26, 2012

Last Update Submit

November 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • preferences for medical care regarding CPR (yes, no or unsure)

    within 5 minutes of surveyor asking the questions

Secondary Outcomes (2)

  • knowledge of CPR

    5 minutes after the surveyor asks questions

  • code status on subsequent admissions (Full code, DNR/DNI, etc.)

    subsequent hospital admissions within one year

Study Arms (2)

control group

NO INTERVENTION

usual care

Video decision aid arm

EXPERIMENTAL
Behavioral: video decision aid

Interventions

cpr video decision aid

Video decision aid arm

Eligibility Criteria

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

You may qualify if:

  • Potential subjects will be identified by the research assistant. The specific eligibility criteria include:
  • Over the age of 60
  • The ability to provide informed consent
  • The ability to communicate in English
  • An established diagnosis of metastatic cancer with a prognosis of one year or less confirmed with the attending physician on service.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Central Study Contacts

Angelo Volandes, MD

CONTACT

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

January 26, 2012

First Posted

February 7, 2012

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations