NCT01325519

Brief Summary

The purpose of this study is to compare the decision making of hospitalized subjects 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

March 28, 2011

Last Update Submit

November 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • preferences for medical care

    preference for CPR

    within 48 hours of admission to the hospital

Secondary Outcomes (2)

  • knowledge of CPR

    baseline and post-intervention

  • code status on subsequent admissions

    subsequent hospital admissions

Study Arms (2)

no intervention control group

NO INTERVENTION

control subjects

experimental intervention group

EXPERIMENTAL

video decision aid viewed by subjects

Other: video decision aid

Interventions

video

Also known as: decision aid, film
experimental intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 60
  • The ability to provide informed consent
  • The ability to communicate in English
  • And one of the following:
  • An established diagnosis of metastatic cancer or
  • An established diagnosis of advanced heart failure (NYHA class III/IV heart failure) or
  • An established diagnosis of chronic obstructive lung disease with an FEV1 \< 50% or
  • Two hospitalizations within the last 6 months or
  • \. Subject scores 6 or less on the Short Portable Mental Status Questionnaire, which is indicative of cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

  • El-Jawahri A, Mitchell SL, Paasche-Orlow MK, Temel JS, Jackson VA, Rutledge RR, Parikh M, Davis AD, Gillick MR, Barry MJ, Lopez L, Walker-Corkery ES, Chang Y, Finn K, Coley C, Volandes AE. A Randomized Controlled Trial of a CPR and Intubation Video Decision Support Tool for Hospitalized Patients. J Gen Intern Med. 2015 Aug;30(8):1071-80. doi: 10.1007/s11606-015-3200-2. Epub 2015 Feb 18.

MeSH Terms

Interventions

Decision Support TechniquesMotion Pictures

Intervention Hierarchy (Ancestors)

Investigative TechniquesAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

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
PI

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations